Crossing the Divide: Piloting an Integrated Care Model to Bridge Rural-urban Healthcare Systems and Reduce Major Amputations Among Rural Patients With Diabetic Foot Ulcers
Phase: NA
Conditions: Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
Sponsor: University of Wisconsin, Madison

 
 
 
 
 
 
Crossing the Divide: Piloting an Integrated Care Model to Bridge 
Rural-Urban Healthcare Systems and Reduce Major Amputations 
among Rural Patients with Diabetic Foot Ulcers  
 
5/13/2025 
 
NCT05203471  
 

~ i ~ 
 
 
 
 
 
 
 
Crossing the Divide: Piloting an Integrated Care Model to 
Bridge Rural-Urban Healthcare Systems and Reduce Major 
Amputations among Rural Patients with Diabetic Foot Ulcers 
 
 
 
Protocol Number: 2022-1338-CP 
Principal Investigator: Meghan Brennan, MD, MS 
 
 
National Institute of Diabetes and Digestive and Kidney Diseases R01 
 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior 
authorization from the Sponsor or Principal Investigator. 
 
 
Protocol Version History 
 
Protocol 
Version 
Version 
Date 
Summary of Revisions Made 
Rationale 
1.0 
09/26/2022 
Initial version 
Version sent to IRB with initial application 
1.1 
10/17/2022 
Addressed initial IRB comments 
Addressed initial IRB comments 
1.2 
11/17/2022 
Addressed full IRB review comments 
Addressed full IRB review comments 
1.3 
12/07/2022 
Addressed final IRB review 
comments 
Addressed final IRB review comments 
1.4 
02/17/2023 
Updated amount paid to clinics for 
participation 
After the PI had several clinics decline 
enrollment, she increased the incentive for 
clinic participation from $1000/year to 
$4500 for enrollment. 
1.5 
07/07/2023 
Added information about using the 
UW Health’s Clinical Research Data 
Service for assistance with 
recruitment efforts for UW Health 
site(s) 
The research team has had difficulty using 
HealthLink to identify potential patients at 
the UW Health Belleville clinic, so are 
enlisting CRDS for assistance. 
2.0 
09/18/2023 
Additional CRFs and recruitment 
materials were added, as well as 
edits/additions to some forms based 
on specific clinic requests and 
feedback. 
We made some edits and additions based 
on feedback from our first ICTR DMC 
meeting, as well as feedback and requests 
from clinics interested in enrolling in the 
study. We also had to make some edits 
based on creation of our REDCap database 
for this project and usability of that 
program. 

~ ii ~ 
2.1 
04/26/2024 
Updated Interview guide with edits/ 
additions to retention interview 
questions 
In preparation for starting retention 
interviews soon and based on some of the 
feedback we received in recruitment 
interviews and PI clinic visits with HCWs, 
we have updated the questions and added 
some additional ones. 
3.0 
06/24/2024 
1) Updated “Zoe Boston” with 
“Devan McClain” (name and 
contact info) 
2) Updated qualitative retention 
interview inclusion criteria 
3) Updates and additions were 
made to the qualitative retention 
interview portion of the interview 
guide 
 
1) Devan McClain has replaced Zoe 
Boston as research coordinator of the 
study. 
2) We expanded our inclusion criteria and 
anticipated number of participants for 
the retention interviews so that we could 
include key informants from the clinic 
level, such as administrators. 
3) We made some edits/additions after 
review of the first few retention 
interviews conducted with patient 
participants. 
3.1 
08/28/2024 
Increased the number of healthcare 
worker (HCW) participants and 
patient participants for qualitative 
retention interviews by 1 each 
A HCW that we’d like to interview was out 
on medical leave when we were recruiting; 
she has since returned to work and got 
back to us expressing interest in 
participating (and we have the funds to 
cover additional interviews). We are also 
increasing our maximum patient 
participants by one. 
4.0 
10/14/2024 
Changed reimbursement method to 
Advarra, added patient information 
letter as a new retention strategy, 
added qualitative questions to see 
what patients thought about the new 
letter 
UW policy is mandating switching to 
Advarra for study reimbursements as of 
01/01/2025; initial qualitative interviews of 
patients suggested we should add a letter 
to serve as a reminder about the goals of 
the study and what to expect  
5.0 
02/06/2025 
Updated ratio of active patients to 
historical controls & removed the 
date constraint for historical controls; 
removed Jamie’s work phone 
number 
Per our statistician, with our final number of 
active patients, we need 135 historical 
controls for 80% power. We have 
exhausted our options within the date 
constraint initially included due to COVID. 
We think it’s more important to be 
adequately powered and will include 
COVID as a limitation.  
Jamie will no longer have a dedicated UW 
number as of 2/28/25 
6.0 
05/05/2025 
1) Location of where study files, 
both paper and electronic, are 
stored was changed and updated 
2) Verbiage was added regarding 
adding the study’s de-identified 
dataset to a new UW Box folder 
for the statistician to access 
3) Dr. Brennan’s and Dr. Smith’s 
information was updated as 
needed 
1) The Health Innovation Program (HIP) 
recently lost their office space at 800 
University Bay Dr, so the paper files and 
consent forms had to be moved to the 
PI’s new office at UW MFCB. With 
those and other recent changes at HIP, 
Dr. Brennan was informed the HIP 
servers would potentially be phased out, 
so she worked with DOM IT to move 
everything to her UW Restricted 
ResearchDrive 
2) A de-identified dataset will need to be 
stored somewhere the statistician can 
access it, so we’re using UW Box 

~ iii ~ 
3) Addresses recently changed due to the 
Health Innovation Program losing their 
office space, and Dr. Brennan’s title has 
also changed 

~ v ~ 
 
Table of Contents 
 
1.0 
STATEMENT OF COMPLIANCE ................................................................................................................ 1 
2.0 
LIST OF ABBREVIATIONS ........................................................................................................................ 2 
3.0 
STUDY SUMMARY ..................................................................................................................................... 3 
 
Synopsis .......................................................................................................................................... 3 
 
Schematic of Study Design .............................................................................................................. 5 
4.0 
KEY ROLES ................................................................................................................................................ 7 
5.0 
INTRODUCTION ......................................................................................................................................... 9 
 
Disease Background ........................................................................................................................ 9 
 
Current Standard of Care ................................................................................................................. 9 
 
Integrated Care Model to Reduce Amputations from Diabetic Foot Ulcers in Rural Clinics ............ 9 
 
Rationale .......................................................................................................................................... 9 
5.4.1 
Integrated Care Model ........................................................................................................................................ 9 
5.4.2 
Recruitment and Retention Strategies .............................................................................................................. 10 
6.0 
STUDY OBJECTIVES AND ENDPOINTS ................................................................................................ 10 
7.0 
STUDY DESIGN ........................................................................................................................................ 11 
 
General Design .............................................................................................................................. 11 
 
End of Study Definition .................................................................................................................. 11 
8.0 
SUBJECT SELECTION ............................................................................................................................ 12 
 
Inclusion & Exclusion Criteria ........................................................................................................ 12 
8.1.1 
Healthcare Workers .......................................................................................................................................... 12 
8.1.2 
Patients (including Historical Controls) ............................................................................................................. 12 
 
Vulnerable Populations .................................................................................................................. 12 
 
Participant Identification ................................................................................................................. 13 
8.3.1 
Clinic Identification ............................................................................................................................................ 13 
8.3.2 
Healthcare Worker Identification ....................................................................................................................... 13 
8.3.3 
Patient Participant Identification ........................................................................................................................ 13 
 
Subject Recruitment ....................................................................................................................... 13 
8.4.1 
Healthcare Worker Recruitment ........................................................................................................................ 13 
8.4.2 
Patient Participant Recruitment ......................................................................................................................... 13 
 
Remuneration and Retention Strategies ........................................................................................ 14 
8.5.1 
Retention Strategies ......................................................................................................................................... 14 
8.5.2 
Remuneration ................................................................................................................................................... 15 
 
Early Termination and Withdrawal ................................................................................................. 15 
9.0 
INTEGRATED CARE MODEL INTERVENTION ....................................................................................... 16 
 
Integrated Care Model ................................................................................................................... 16 
10.0 INTEGRATED CARE MODEL STUDY VISITS AND PROCEDURES ...................................................... 16 
 
Healthcare Workers ....................................................................................................................... 16 
10.1.1 
Screening and Enrollment ................................................................................................................................. 16 
10.1.2 
On-Study and Follow-up Procedures ................................................................................................................ 17 
 
Patient Participants ........................................................................................................................ 17 
10.2.1 
Study Calendar ................................................................................................................................................. 17 
10.2.2 
Screening and Enrollment ................................................................................................................................. 17 
10.2.3 
On-Study and Follow-up Procedures ................................................................................................................ 19 
 
Historical Control Patient Participants ............................................................................................ 19 
10.3.1 
Screening and Enrollment ................................................................................................................................. 19 
10.3.2 
Data Abstraction ............................................................................................................................................... 20 

~ v ~ 
11.0 ADAPTIVE RECRUITMENT AND RETENTION PROCEDURES ............................................................. 20 
 
Interview Procedures (Qualitative Data Collection)........................................................................ 20 
11.1.1 
Subject Identification and Recruitment .............................................................................................................. 20 
11.1.2 
Enrollment ......................................................................................................................................................... 21 
11.1.3 
Interviews .......................................................................................................................................................... 21 
11.1.4 
Remuneration ................................................................................................................................................... 21 
 
Recruitment and Retention Data Collection (Quantitative Data Collection) ................................... 21 
 
Recruitment and Retention Data Analysis ..................................................................................... 22 
11.3.1 
Qualitative Data Analysis .................................................................................................................................. 22 
11.3.2 
Quantitative Data Analysis ................................................................................................................................ 22 
 
Cooperative Co-design for Recruitment & Retention Adaptations ................................................. 23 
12.0 DATA HANDLING AND RECORD KEEPING .......................................................................................... 23 
 
Data Collection ............................................................................................................................... 23 
12.1.1 
Data Collection .................................................................................................................................................. 23 
12.1.2 
Data Management ............................................................................................................................................ 24 
 
Confidentiality and Privacy ............................................................................................................. 24 
 
Records Retention ......................................................................................................................... 25 
 
Retention for Future Research: Data and Audio- or Video-Recording Banking ............................. 25 
12.4.1 
Purpose of Storage ........................................................................................................................................... 25 
12.4.2 
Data and/or Biospecimens Being Stored .......................................................................................................... 25 
12.4.3 
Location of Storage ........................................................................................................................................... 25 
12.4.4 
Duration of Storage ........................................................................................................................................... 25 
12.4.5 
Access to Data, Images, Recordings and/or Biospecimens and Security Measures ........................................ 26 
12.4.6 
Procedures to Release Data or Biospecimens .................................................................................................. 26 
12.4.7 
Process for Returning Results .......................................................................................................................... 26 
12.4.8 
Process for Tracking Subject Consent and Authorization ................................................................................. 26 
 
Protocol Deviations ........................................................................................................................ 27 
 
Publication and Data Sharing Policies ........................................................................................... 27 
13.0 STUDY ANALYSIS ................................................................................................................................... 27 
 
Statistical Hypotheses .................................................................................................................... 27 
 
Sample Size and Statistical Analysis ............................................................................................. 28 
 
Planned Interim Analysis ............................................................................................................... 28 
 
Handling of Missing Data ............................................................................................................... 28 
14.0 RISK/BENEFIT ASSESSMENT ................................................................................................................ 28 
 
Known Potential Benefits to the Subjects ...................................................................................... 28 
 
Known Potential Risks ................................................................................................................... 28 
 
Risk/Benefit Analysis ..................................................................................................................... 29 
15.0 DATA AND SAFETY MONITORING ........................................................................................................ 29 
 
Unanticipated Problems ................................................................................................................. 29 
 
Safety Oversight ............................................................................................................................ 30 
16.0 STUDY FEASIBILITY ................................................................................................................................ 30 
 
Economic Burden to Subjects ........................................................................................................ 30 
 
Facilities and Locations .................................................................................................................. 30 
 
Feasibility of Recruiting the Required Number of Subjects ............................................................ 30 
 
Principal Investigator Considerations ............................................................................................. 31 
16.4.1 
Time Devoted to Conducting the Research ...................................................................................................... 31 
16.4.2 
Process for Informing Study Teams .................................................................................................................. 31 
 
Availability of Medical or Psychological Resources ....................................................................... 31 
17.0 REFERENCES .......................................................................................................................................... 32 

~ v ~ 
18.0 APPENDICES ........................................................................................................................................... 35 
 
Appendix 1: Recruitment Table Top Flyer for Belleville ................................................................. 35 
 
Appendix 2: Recruitment Bi-fold Pamphlet for Belleville ................................................................ 36 
 
Appendix 3: Recruitment Table Top Flyer for Sauk Prairie Healthcare ......................................... 37 
 
Appendix 4: Recruitment Bi-fold Pamphlet for Sauk Prairie Healthcare ........................................ 38 
 
Appendix 5: Recruitment Telephone Screening Script for Patient Participants for the 
Integrated Care Model ................................................................................................................... 39 
 
Appendix 6: Integrated Care Algorithm for Rural Providers at Belleville ........................................ 43 
 
Appendix 7: Integrated Care Algorithm for Rural Providers at Sauk Prairie Healthcare ................ 44 
 
Appendix 8: Referral Form for Patients with Diabetic Foot Ulcers at Belleville .............................. 45 
 
Appendix 9: Referral Form for Patients with Diabetic Foot Ulcers at Sauk Prairie Healthcare ...... 46 
 Appendix 10: Integrated Care Model Chart Review Variables ....................................................... 47 
 Appendix 11: Phone Script for Recruitment of Participants for Qualitative Recruitment 
Interviews ....................................................................................................................................... 48 
 Appendix 12: Email Template for Recruitment of Participants for Qualitative Recruitment 
Interviews ....................................................................................................................................... 50 
 Appendix 13: Phone Script for Recruitment of Participants for Qualitative Retention Interviews .. 51 
 Appendix 14: Email Template for Recruitment of Participants for Qualitative Retention 
Interviews ....................................................................................................................................... 53 
 Appendix 15: Script for Verbal Consent for Participants of Qualitative Interviews ......................... 54 
 Appendix 16: Qualitative Interview Guides .................................................................................... 55 
18.17 Appendix 17: Patient Information Letter ......................................................................................... 55 
 

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1.0 
STATEMENT OF COMPLIANCE 
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies.  
 
I agree to ensure that all study team members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment.  
 
Name 
Signature 
Date 
 
Meghan B. Brennan, MD, MS 
 
02/17/2023 
 
__________________________________ 
_____________________________ 
___________________ 
Principal Investigator 
 
 
 
 
 
 
 
 

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2.0 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
BAA 
Business Associate Agreement 
CCC 
Clinical Coordinating Center 
CFR 
Code of Federal Regulations 
CHDR 
The Center for Health Disparities Research  
CMP 
Clinical Monitoring Plan 
Cooperative 
Rural Wisconsin Health Cooperative 
CRF 
Case Report Form 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTMS 
Clinical Trial Management Software 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DMC 
Data Monitoring Committee 
DSMB 
Data & Safety Monitoring Board  
DSMC 
Data & Safety Monitoring Committee 
DSMP 
Data & Safety Monitoring Plan 
eCRF 
Electronic Case Report Forms 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
HIP 
Health Innovation Program 
HIPAA 
Health Insurance Portability and Accountability Act 
ICTR 
Institute for Clinical and Translational Research 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
IT 
Information Technology 
MOP 
Manual of Procedures 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OnCore 
Online Collaborative Research Environment 
PCP 
Primary Care Provider 
PHI 
Protected Health Information 
PI 
Principal Investigator 
POC 
Point of Contact 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
sIRB 
single IRB 
SMART IRB 
Streamlined, Multisite, Accelerated Resources for Trials IRB 
SMC 
Safety Monitoring Committee 
SMPH 
School of Medicine and Public Health 
SPH 
Sauk Prairie Healthcare 
UP 
Unanticipated Problem 
 
 
 

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3.0 
STUDY SUMMARY 
 Synopsis 
Full Title 
Crossing the Divide: Piloting an Integrated Care Model to Bridge Rural-Urban Healthcare 
Systems and Reduce Major Amputations Among Rural Patients with Diabetic Foot Ulcers 
Short Title 
Crossing the Divide 
Protocol Number 
2022-1338-CP 
ClinicalTrials.gov 
Identifier & 
Summary 
NCT05203471 
 
This study is being done to pilot an integrated care model that focuses on improving 
collaboration between rural primary care providers and urban specialists, particularly 
infectious disease physicians and vascular surgeons 
Number of Sites 
This is a single site study conducted in the United States. A total of 3 clinics serving rural 
Wisconsin with preference for those participating in the Rural Wisconsin Health Cooperative 
will be identified. Attempts will be made to select one clinic each from a rural advantaged, 
rural, and rural disadvantaged community. 
Main Inclusion 
Criteria 
Healthcare Workers:  
• 
Rural providers (primary care providers at UW Health Belleville and wound care and 
diabetes care specialists at Sauk Prairie Healthcare) and schedulers placing referrals 
• 
Employment at a rural advantaged, rural, or rural disadvantaged community clinic 
selected for participation 
 
Patient Participants: 
• 
Participating rural provider 
• 
Diabetic foot ulcer diagnosis  
Main Exclusion 
Criteria 
Healthcare Workers:  
• 
Insufficient overlap in work schedules between rural providers and schedulers 
 
Patient Participants: 
• 
Receiving palliative care 
• 
No insurance to cover referral to University of Wisconsin Specialty Clinics  
Objective(s) 
Primary Objectives 
• 
Evaluate the potential of our integrated care model to reduce major amputations by 
examining its impact on guideline-concordant care processes, including urban specialty 
referral 
• 
Build recruitment and retention strategies for the trial that work across diverse, rural 
clinics 
Endpoints 
Primary Endpoints 
• 
Completion of 5 vascular and 4 infectious disease care processes, modeled as percent 
indicated and dichotomously (all relevant completed vs. missing ≥1) 
• 
Development and refinement of recruitment and retention strategies that meet our goal 
targets of 60% and 80%, respectively 
Secondary Endpoints 
• 
Amputation, either major or minor, within 3 months of follow-up 

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Study Design 
This is a phase II pre-post serial cohort design trial with adaptive recruitment and retention 
strategies. Enrollment will be implemented in two phases; healthcare systems will be enrolled 
in consecutive 6-month periods.  
Study 
Intervention 
A rural integrated care model consisting of a care algorithm for use by rural primary care 
providers to guide integrated care for patients with diabetic foot ulcers, and a referral 
checklist for use by rural schedulers to place referrals with urban specialists. 
Total Number of 
Subjects 
Up to 45 patient participants will be enrolled in the study with additional historical control 
patients obtained via chart review (1 active patient participant; 5 historical control patients, up 
to 180 patients total). Up to 30 healthcare workers will be enrolled (180+30=210 individuals 
participating in the care algorithm pilot). From the pool of patients and healthcare workers 
approached for recruitment, we will ask up to 36 individuals, consisting of 18 patient 
participants and 18 healthcare worker participants, to participate in feedback interviews; this 
group will be a mix of both those that enrolled in the integrated care intervention study and 
those that declined participation in the study. These individuals will provide qualitative data 
needed to build recruitment and retention strategies, meeting our second objective. We are 
uncertain of the exact mix of qualitative participants who will have consented or not to 
participate in the care algorithm pilot. Therefore, the total number of subjects is anticipated to 
be between 190 and 246, including historical controls.  
Study Population 
Patient participants are adults aged 18+ diagnosed with diabetic foot ulcers and receiving 
care at a participating clinic. Health workers include primary care providers, other healthcare 
providers such as specialists, and schedulers employed at a participating clinic.  
Statistical 
Methodology 
Although this sample size is not powered to detect differences in major amputation, it does 
provide adequate power to find a difference in care processes proximal to major 
amputations. With a fixed sample size of 27 active patients, matched 1:5 pre/post with 
historical controls, alpha of 0.05, we are powered at >0.90 to detect an absolute increase of 
30% (from 20% to 50% completion, measured dichotomously) in the group receiving 
integrated care.  
Estimated 
Subject Duration 
The duration of the study for each patient participant is approximately 3 months. 
Estimated 
Enrollment 
Period & Study 
Duration 
Study enrollment and follow-up will occur over 24 months with the total expected duration of 
the trial to be 36 months. 
 
 
 

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 Schematic of Study Design 
Phase II pre-post serial cohort design schematic to test the rural integrated care model 
 
 
 
 
 

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Adaptive recruitment & retention study design to build recruitment & retention strategies that work 
across diverse, rural clinics 
 
 

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4.0 
KEY ROLES 
The following is a list of all key personnel and roles: 
 
Principal Investigator 
Meghan Brennan, MD, MS 
Associate Professor of Medicine  
University of Wisconsin–Madison 
4263 UW Medical Foundation Centennial Building 
1685 Highland Ave 
Madison, WI 53705  
(608) 220-8488 
mbbrennan@medicine.wisc.edu 
Participating Sites 
Clinic 1: UW Health Belleville Family Medicine 
1121 Bellwest Blvd 
Belleville, WI 53508 
Clinic 2: Sauk Prairie Healthcare Diabetes 
Management Clinic 
260 26th Street 
Prairie du Sac, WI 53578 
Clinic 3: Sauk Prairie Healthcare Wound Care Clinic 
260 26th Street 
Prairie du Sac, WI 53578 
Data and Safety Monitoring Board 
ICTR Data Monitoring Committee 
University of Wisconsin–Madison 
asiedschlag@wisc.edu (contact: Amy Siedschlag) 
Funding Sponsor 
National Diabetes and Digestive and Kidney Diseases 
Institute (NIDDK) 
Bethesda, Maryland 20892 
NIH Point of Contact 
Eunica Haynes 
Grants Management Specialist 
NIDDK 
(301) 827-4018 
haynese@mail.nih.gov 
 
Yan Li 
Program Director 
NIDDK 
(301) 435-3721 
Yan.li5@nih.gov  
Biostatistician 
Emmanuel Sampene, PhD  
Associate Scientist, Biostatistician  
University of Wisconsin–Madison 
610 Walnut St, WARF 230 
Madison, WI 53726 
(608) 265-8725 
sampene@biostat.wisc.edu 
Community-based Participatory Research Expert 
Maureen Smith, MD, MPH, PhD 
Professor of Population Health Sciences and Family 
Medicine & Community Health 
Director, Health Innovation Program 
Director, Community Academic Partnerships 
University of Wisconsin–Madison 
WARF Office Building 
310 Walnut St 
Madison, WI 53726 
(608) 262-4802 

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maureensmith@wisc.edu 
Implementation Scientist 
Christie Bartels, MD, MS 
Associate Professor of Medicine 
Division Chief, Rheumatology 
University of Wisconsin–Madison 
4132 UW Medical Foundation Centennial Building 
1685 Highland Ave 
Madison, WI 53705 
(608) 265-6319 
cb4@medicine.wisc.edu 
Qualitative Research Methodologist 
Kristen Pecanac, PhD, RN 
Assistant Professor, School of Nursing 
University of Wisconsin–Madison 
4167 Signe Skott Cooper Hall 
701 Highland Avenue 
Madison, WI 53705 
(608) 262-1938 
lund2@wisc.edu 
Data Coordinating Center 
University of Wisconsin–Madison  
Health Innovation Program 
(608) 262-1301 
 
Devan McClain, BS 
Research Coordinator 
dmcclain@medicine.wisc.edu; (608) 262-2390 
jnlamantia@medicine.wisc.edu (additional contact: 
Jamie LaMantia) 
 
 
 

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5.0 
INTRODUCTION 
 Disease Background 
Over two million Americans develop a diabetic foot ulcer each year, costing >$1.3 billion.1,2 While other 
diabetes complications are decreasing, the CDC estimates that, since 2009, all diabetes-related 
amputations have increased 63%.3,4 Above-ankle, major amputations increased 29% ― the worst rates in 
more than 20 years.3,5 The impact is unquestioned: patients with diabetic foot ulcers fear major amputation 
more than death.6 Six million patients living with diabetes in rural areas have even poorer outcomes.7 
 
Our team and others found that rural patients have 37% higher odds of major amputation and 40% higher 
odds of premature death than their urban counterparts, even after controlling for other sociodemographics, 
ulcer severity, and comorbidities.8,9 Furthermore, baseline rates of diabetes and other amputation risk 
factors, like smoking, are higher in rural populations compared to urban; these rates are rising in the wake 
of the COVID-19 pandemic.7,10-14 We urgently need interventions to assist rural healthcare teams in caring 
for these high-risk, rural patients with diabetic foot ulcers. 
 Current Standard of Care 
Many urban, tertiary care centers have decreased the risk of major amputation and death by approximately 
40% after implementing integrated care models that focus on centralizing multiple specialists into a single 
clinic to facilitate side-by-side collaboration.15 Urban integrated care models work by co-locating multiple 
specialists in the same clinic and using algorithms to address four physiologic factors: 1) poor glycemic 
control, 2) vascular disease, 3) mechanical complications, and 4) secondary infection. However, the urban 
integrated care model has never been adapted to rural, primary care settings until our team partnered with 
the Rural Wisconsin Health Cooperative to design such a model. The current work aims to pilot our 
integrated care model for the first time in preparation for a statewide clinical trial of its effectiveness. 
 Integrated Care Model to Reduce Amputations from Diabetic Foot Ulcers in Rural Clinics 
Our integrated care model promotes cross-setting collaboration without co-location through the utilization of 
two tools: 1) a care algorithm and 2) a referral checklist. The care algorithm supports rural primary care in 
providing high quality, local care to most patients. It also addresses obstacles to collaborating with urban 
specialists by providing a priori agreed upon referral criteria including timeframes, clinical indications, and 
pre-consultation diagnostics for severe disease. The referral checklist will support rural clinic schedulers, 
who place referrals to urban specialty clinics, by providing schedulers with a list of documents that should 
be included, reducing barriers of time-consuming triage and disjointed electronic health records. 
 Rationale 
5.4.1 Integrated Care Model 
Adapting the urban model of integrated care to rural settings is a highly promising solution to overcome 
rural disparities in major amputations. Our systematic review of 33 studies found that integrated care 
reduces major amputation and death for patients with diabetic foot ulcers by approximately 40%.15 It 
uses a coordinated, systematic approach to address four physiologic factors: 1) poor glycemic control, 
2) vascular disease, 3) mechanical complications, and 4) secondary infection. Multi-specialist teams 
average five disciplines and rely on co-location, urban referral pathways, and care algorithms to guide 
care for shared patients.15 Multiple professional societies recommend integrated care for patients with 
diabetic foot ulcers.16,17 These models have been successfully implemented in major cities spanning 
four continents.15 However, integrated care models have never been adapted to rural settings, where 
co-location with multiple specialists is not feasible. 
 

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Among rural patients, poor collaboration with specialists accounts for 55% of excess hospitalizations 
and 40% of excess mortality, compared to urban residents.18 This is most salient for high-risk patients 
requiring vascular surgery or infectious disease input, who face a 90-fold increased risk of major 
amputation.19 Using a national Medicare sample of 56,440 patients with diabetic foot ulcers, our team 
reported that infectious disease physicians are associated with a reduced risk of major amputations 
(HR 0.83, p<0.001).20 Others found that vascular surgeons are associated with a 38% reduction in 
major amputations.21 However, both specialties almost exclusively practice in urban settings.22 For rural 
patients to receive integrated care including input from these limb salvage specialists, teams must 
collaborate across the rural-urban health system divide.23 
 
Our qualitative research highlights that, without a systematic way to provide integrated care, rural 
healthcare teams struggle to collaborate with urban specialists.23,24 Our analysis of 44 interviews with 
rural patients, their caregivers, and healthcare workers emphasized the impact of delayed, poorly 
coordinated care with urban specialists. Rural-urban healthcare worker collaborations are stymied by: 
1) time-consuming referrals, 2) negative interactions, and 3) multiple, disjointed electronic health 
records.23 
 
In preliminary work, our team, in partnership with the Rural Wisconsin Health Cooperative 
(Cooperative), developed an intervention to address this critical gap. The Cooperative is a nationally 
recognized consortium of 43 rural health systems throughout the state dedicated to improving rural 
diabetes care. Together, we co-designed the first integrated care model adapted to the rural setting that 
promotes collaboration across the rural-urban divide.23,24 The model streamlines the referral process 
and overcomes disjointed electronic health records by providing a checklist to be used by rural support 
staff (clinic schedulers) when faxing critical triage information between clinics. It establishes a priori, 
mutually agreed-upon criteria for timely, urban specialty referrals. We hypothesize that our rural 
integrated care model will reduce major amputations for rural patients with diabetic foot ulcers. Our 
hypothesis is based upon 1) implementing a model that directly addresses the most pressing health 
system barriers identified in our prior work, 2) the documented success of urban integrated care, and 3) 
the strength of our partnership with rural stakeholders in the co-design and pilot phases of our 
research.25,26 
 
5.4.2 Recruitment and Retention Strategies 
Inadequate recruitment and retention into clinical trials are the two top reasons clinical trials fail.27 
Furthermore, rural participants are under-represented in clinical trials, and there is a paucity of data 
regarding how to improve rural participation.28,29 Therefore, it is critical that we develop strong 
recruitment and retention strategies during this pilot to assure subsequent trial success. We will collect 
quantitative data on the number of recruited patients and 3-month retention over the pilot. To improve 
these metrics, we will analyze qualitative data from healthcare workers and patients using an existing 
conceptual model of participant-centered recruitment and retention.30 Our 2-wave, adaptive design 
allows us to pilot two iterations of recruitment and retention strategies. Adaptations will be co-designed 
with the Cooperative prior to activating the second and third clinics and upon completion of the pilot. 
Using qualitative data to drive improvements in recruitment and retention is a proven approach.31,32 In 
one instance, recruitment rates nearly doubled from 35% at the beginning of the pilot to 69% during the 
definitive trial.31-33 Our goal is to develop strategies that achieve a recruitment rate of 60% and retention 
rate of 80%, which would place us in the top tertile of clinical trial performance and ensure an 
adequately powered statewide trial.34,35 
6.0 
STUDY OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 

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Evaluate the potential of our integrated 
care model to reduce major amputations 
by examining its impact on guideline-
concordant care processes, including 
urban specialty referral 
A) Completion of 5 vascular and 4 infectious 
disease care processes, modeled as percent 
indicated and dichotomously (all relevant 
completed vs. missing ≥1) 
B) Amputation, either major or minor, within 3-
month follow-up 
Build recruitment and retention strategies 
for the trial that work across diverse, rural 
clinics 
Development and refinement of recruitment and 
retention strategies that meet our goal targets of 
60% and 80%, respectively 
 
7.0 
STUDY DESIGN 
 General Design  
This is a phase II pilot of an integrated care model for treatment of diabetic foot ulcers in rural patient 
populations and includes adaptive recruitment and retention strategies. The protocol uses a pre-post serial 
cohort design, where the second and third clinics are activated six months after the first clinic and all clinics 
complete the trial simultaneously. This design allows: 1) use of refined recruitment and retention strategies 
when the final two clinics are activated, and 2) dispersion of activation efforts to facilitate completion by 
small research teams. Subject accrual will occur over 24 months. The design was modified so that clinics 2 
and 3 could be activated simultaneously based on 1) our 100% recruitment of healthcare workers from 
clinic 1, which was greater than expected, and 2) our lower than expected patient recruitment from clinic 1. 
Having the third clinic activated for longer than initially planned should increase our likelihood of recruiting 
enough patients into the trial.   
 
The study population will consist of 45 patient participants that develop diabetic foot ulcers during the 
enrollment period and receive care from participating rural providers (primary care providers (PCPs) at UW 
Health Belleville and diabetes or wound care providers at Sauk Prairie Healthcare) at rural clinics taking 
part in the study. Clinic schedulers, in addition to rural providers, will also be enrolled. Patient participants 
will be eligible only if their rural provider already consented and enrolled in the study. Patient participants 
will complete screening activities and their rural provider(s) and clinic scheduler will use the integrated care 
model to assist with care decisions (although rural providers will retain clinic discretion to deviate from the 
integrated care model to best serve the patient). Study activities include screening, chart reviews, and 
telephone assessments. Historical control data from up to 180 patients (1:5 active patient enrollment: 
historical control matching) will be obtained from medical records for comparison. Historical controls will be 
matched based on clinic and providers but no other factors due to the low overall volume of patients on any 
one provider’s panel with diabetic foot ulcers. 
 
Recruitment and retention strategies will be adapted iteratively during the study. Prior to enrollment of 
clinics 2 and 3, we will meet with administration and key healthcare workers from SPH to share our 
qualitative recruitment results from clinic 1 (Belleville) and brainstorm modifications that hold promise for 
successful recruitment of healthcare workers and patients at SPH’s clinics 2 and 3. Data on recruitment 
and retention will be obtained through interviews with a subset of healthcare workers (e.g., rural providers,  
schedulers, and administrators) and patient participants, and through tracking of recruitment and retention 
efforts. 
 End of Study Definition 
The end of the study is defined as the date of completion of any final follow-up activity or data collection 
described in the protocol. 

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8.0 
SUBJECT SELECTION 
 Inclusion & Exclusion Criteria  
8.1.1 Healthcare Workers 
Inclusion Criteria  
1. Willing to provide informed consent. 
2. Willing to comply with study procedures 
3. Rural providers (PCPs in Belleville; diabetes and wound care specialists in SPH) and 
schedulers placing referrals. 
4. Employed at a participating rural clinic.  
5. For rural providers, confirm understanding that they will retain clinical discretion to deviate from 
the integrated care model if they think it would best serve the patient.  
6. Available for the duration of the study. 
 
Exclusion Criteria 
1. Insufficient overlap in work schedules between rural provider and scheduler based on clinic 
manager determination. 
8.1.2 Patients (including Historical Controls) 
Eligibility will be determined by inclusion and exclusion criteria below and confirmed by medical record 
review as necessary. 
 
Inclusion Criteria  
1. Able and willing to provide informed consent. 
2. Willing to comply with study procedures and be available for the duration of the study. 
3. 18 years of age and older. 
4. Patient with either type 1 or type 2 diabetes at a participating rural clinic. 
5. Develops diabetic foot ulcer during enrollment period. 
 
Exclusion Criteria 
1. Receiving palliative care such that referral to urban centers for aggressive limb salvage would 
be inappropriate (as assessed by their rural provider). 
2. Insurance would not cover referral to the University of Wisconsin specialty clinic. 
3. Not suitable for study participation due to other reasons at the discretion of the investigators. 
 Vulnerable Populations 
Pregnant women, those who lack consent capacity, the mentally ill, prisoners, cognitively impaired 
persons, non-English speaking individuals and children will not be included in this research study.  
 
Employees of the clinics that agree to participate in this study will be enrolled, but these individuals do not 
have a status relationship with members of the research team that would constitute a vulnerable 
population.  

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 Participant Identification 
8.3.1 Clinic Identification 
The pilot will take place in three rural clinics: UW Health Family Practice Clinic in Belleville, Sauk Prairie 
Healthcare Diabetes Clinic, and Sauk Prairie Healthcare Wound Care Clinic.   
8.3.2 Healthcare Worker Identification 
Healthcare workers will be identified through their employment at each of the three rural clinics 
participating in the study. Lists of eligible employees will be obtained from clinic administrators. 
8.3.3 Patient Participant Identification 
Following identification of healthcare workers, the medical records of the participating clinics will be 
reviewed to identify patients with diabetes who are cared for by a participating healthcare worker. 
Those who develop a diabetic foot ulcer will further be identified by participating rural providers in the 
course of their normal work flow and referred to the research coordinators. Additionally, the research 
coordinators will monitor clinic schedules of participating rural providers to identify incoming patients 
with new foot ulcers.  
 Subject Recruitment 
A total of 45 patient participants and up to 30 healthcare workers will be recruited from the 3 rural clinic 
sites in Wisconsin. Recruitment will be staggered so that Clinic 1 will be active for 24 months with a target 
patient enrollment of 20; Clinics 2 and 3 will be active for 18 months with a target patient enrollment of 25 
total. This translates into a targeted rate of enrollment of 4.5 patients per activated clinic every 6 months. 
The initial recruitment strategy outlined below will be used to recruit patient participants from the first clinic. 
Recruitment strategies will be iteratively adapted one month prior to enrollment of the second and third 
clinics, and again at the end of the pilot. Changes to recruitment will be submitted to the IRB prior to 
implementation, as needed. Specific recruitment strategies are as follows: 
8.4.1 Healthcare Worker Recruitment 
Approximately one month prior to activating each clinic for patient enrollment, healthcare workers at 
each respective clinic will receive an email invitation to an informational meeting regarding the study. 
Up to three emails may be sent in the four weeks prior to the meeting with an opt-out option included in 
each email. The meeting will take place when patients are not scheduled and include light fare (e.g., 
pizza). The principal investigator and study coordinator will present details of the study. The email 
invitation will offer individual recruitment meetings for those interested in participating but unable to 
attend the dinner meeting. Attendees will be invited to register for a 1:1 interview to improve the 
recruitment session, regardless of their decision to participate in the pilot as part of purposeful sampling 
to obtain qualitative data on improving the recruitment process for healthcare workers. 
8.4.2 Patient Participant Recruitment 
8.4.2.1 
UW Health Family Practice Clinic in Belleville 
Potentially eligible patients at UW Health Family Practice Belleville clinic will be identified by the 
Clinical Research Data Service and provided on a weekly basis to the study team so that eligibility 
can be confirmed before patients are approached at the clinic. Providers can also refer patients 
directly to the study team. The clinic will be offered the option of introducing the study with 
information sheets in the waiting areas, such as a table top flyer and bi-fold brochure (see 
Appendix). 
 

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8.4.2.1 
SPH Clinics 
The study team will review upcoming clinic schedules one week in advance to identify potentially 
eligible patients using the SPH EHR. A Business Associates Agreement will be in place to formalize 
UW study team’s remote access to SPH EHR. Providers can also refer patients directly to the study 
team. The clinic will be offered the option of introducing the study with information sheets in the 
waiting areas, such as a table top flyer and bi-fold brochure (see Appendix).    
 
Telephone Contact: Research coordinators from the University of Wisconsin without clinical ties to the 
clinic or healthcare worker participants will review primary care provider schedules weekly to identify 
patients being seen for a diabetic foot ulcer. We anticipate that most patients will be identified very soon 
after the initial diagnosis, although some delay may occur between diagnosis and identifying these 
patients by the research coordinators during subsequent follow up. Additionally, rural providers will be 
able to directly contact the research coordinators when they identify a potentially eligible patient. After 
checking with the rural providers to ensure identified patients are eligible (i.e. not on hospice, truly have 
a diabetic foot ulcer), coordinators will telephone potential patient participants, using the preferred 
contact number listed in the clinic system. Patients will receive up to three calls on separate days and 
different times (morning, mid-day, and afternoon). If a call is not answered, coordinators will leave a 
message inviting the participant to return the call. When contact is made, coordinators will offer an in-
person face-to-face meeting to review eligibility, provide detailed information on the study, and obtain 
written consent. The standardized telephone script is available in the Appendix. Patients contacted by 
telephone, regardless of their decision to further engage in the pilot, will be asked if they are willing to 
participate in a future interview to improve the recruitment process. 
     See section 11.0 for additional information on adaptive recruitment strategies.  
 Remuneration and Retention Strategies 
8.5.1 Retention Strategies 
We will request feedback on communication throughout the study to ensure both formal and 
informal communications are clear and as part of the adaptive design process for retention (i.e. 
we will use feedback to improve recruitment and retention protocols before activating additional 
clinic sites and at the end of the study). The following initial retention strategies will be 
implemented, with revised strategies (in italics below) added as developed: 
• 
Our research coordinator will meet weekly with participating healthcare workers to 
review patient enrollment and assess, but not facilitate, use of the care algorithm/referral 
checklist.  
• 
Researchers will solicit formal feedback from both healthcare worker and patient 
participants during planned interviews and preliminary data (e.g. up-to-date recruitment 
and retention rates) will be shared during the interviews.  
• 
We will invite two research participants, optimally one healthcare worker and one 
patient, from each activated clinic to participate in the final co-design session with the 
Cooperative, incorporating on-the-ground patient and healthcare worker perspectives.  
• 
All enrolled patients and healthcare workers will receive emailed or mailed (per 
participant preference) study updates linking recruitment and retention changes to 
participant feedback after each adaptation and at the close of the study. Healthcare 
workers may also receive in-person study updates at standing meetings if that is their 
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• 
All enrolled patients will be mailed an informational letter describing the study no earlier 
than 1 month after consent. The purpose of this letter is to remind patient participants 
about the study, including its purpose, and serve as a way to keep them feeling 
engaged about the project. This retention strategy emerged from our qualitative 
interviews to improve study retention. The form letter has been added to the appendix. 
See section 11.0 for additional information on adaptive retention strategies. 
8.5.2 Remuneration 
Individual healthcare workers will not receive financial compensation for participating in the pilot. 
Rather, the clinics will be compensated $4500 for their involvement. We doubt this nominal fee 
(compared to their overall operating budgets) will be enough to risk coercion from clinic managers to 
healthcare workers to participate. Patient participants who consent will be given $100 upon enrollment 
and an additional $100 upon completion of the 3-month follow-up. This has been in the form of cash for 
most of the duration of the study. However, starting in 2025, per UW–Madison policy, stipends for 
research participation must be paid using the Advarra payments system. Within this system, 
participants have the choice of a Visa card, direct deposit, or check. Enrollment will be completed in 
2024 and payment for completion of the study is paid via mail. Since will be unable to work with the 
patient participants in person for this payment, and due to the nature of our patient participant 
demographics (majority elderly, several without email and/or limited access to internet/computers 
and/or transportation), we will be opting to send payment to all patient participants who complete the 
study in the form of a Visa card. Patient participants enrolled after 9/23/24 will be notified that although 
their enrollment payment is in the form of cash, they should expect payment for completion of the study 
in the form of a Visa card due to university policy changes. Patient remuneration may be revised as part 
of co-design adaptations.  
 Early Termination and Withdrawal 
All subjects are free to withdraw from participation in the study at any time upon request via letter as 
described on the consent form. 
 
The Principal Investigator (PI) may discontinue or withdraw a healthcare worker from the study at her 
discretion for failure to consider use of the integrated care model with their patient participants, although 
deviation from the model will be allowed based upon the rural provider’s clinical judgement. 
 
Patient participants who sign the informed consent form, receive the study intervention, then subsequently 
withdraw, or are withdrawn or discontinued from the study will not be replaced. 
 
The following actions will be taken if a patient participant withdraws or fails to return the three month follow-
up phone call: 
• 
Before a patient participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant where possible, by completing up to 3 telephone calls. 
These contact attempts shall be documented in the participant’s study file. Participants that do not 
agree to participate in the follow-up phone call will be asked to provide a reason for discontinuing 
participation. 
• 
If the patient participant continues to be unreachable, they will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. The withdrawn date is the last day of 
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9.0 
INTEGRATED CARE MODEL INTERVENTION  
 Integrated Care Model 
The integrated care model uses two tools to promote provider collaboration across rural and urban 
healthcare systems: 1) a care algorithm and 2) a referral checklist.  
The care algorithm will be used by rural providers—primary care providers (PCPs) at UW Health Belleville 
clinic and rural diabetes and wound care specialists at SPH clinics—to guide integrated care for patients 
with diabetic foot ulcers (see Appendix). It supports rural providers, allowing most patients to be cared for 
locally and reserving urban specialty referral for those with limb-threatening disease. The algorithm triggers 
intensive medical management, especially for key gaps in vascular care. The rural providers will retain final 
clinical decision making autonomy; the algorithm is there as a general guide and clinical support tool with 
the ability to deviate from the algorithm when it is in the best interests of the patient. The model also 
supports rural patients by allowing both in-clinic and telemedicine urban specialty consultation. Rural 
patients and urban specialists jointly decide between in-person and telemedicine consultation for each visit.  
The integrated care model’s referral checklist will be used by rural schedulers who place referrals to urban 
specialists (see Appendix). It prompts schedulers to fax appropriate supporting documents (e.g., notes, 
labs, vascular testing results) with the referral request. 
10.0 
INTEGRATED CARE MODEL STUDY VISITS AND PROCEDURES 
 
Healthcare Workers 
10.1.1 Screening and Enrollment 
10.1.1.1 
Informed Consent 
For healthcare workers participating in the informational meeting session, the PI and study 
coordinator will present details of the study to the group. Consent forms will be distributed to the 
group for review during the session. Participants will have time to ask questions during the group 
session or after the session is complete. Those willing to participate can sign and date the consent 
during the meeting. Having the rural providers and schedulers attend the same informational 
meeting is beneficial because it is efficient. The consents will be turned in without eliciting any 
formal knowledge of who signed or not, minimizing risk of coercion. 
For healthcare workers unable to attend the informational meeting session, the PI or study 
coordinator will meet with the participant to discuss the study. The consent form will be provided to 
the subject for review and the PI or study coordinator will give the subject time to review and ask 
questions. If the subject is willing to participate, they can sign and date the consent form at that 
time. Immediately following signed informed consent, self-reported demographics will be collected 
using a standardized form to comply with NIH sponsor requirements. 
All healthcare workers will be provided with the option to take the consent form home with them for 
additional consideration and to contact the study PI or research coordinators with additional 
questions. The study PI or a research coordinator will review all informed consent documents to 
ensure that all fields that require a response are completed. Each participant will be provided with a 
copy of the consent form to keep for their records. Original copies of the consent form will be 
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10.1.1.2 
Eligibility Confirmation Screening 
After informed consent is obtained from healthcare workers, screening will be performed to ensure 
an appropriate match between enrolled rural providers and schedulers. Healthcare workers will be 
excluded if the clinic manager determines there is insufficient overlap in work schedules between 
rural providers and schedulers. In the event a healthcare worker is excluded, they will be thanked 
for their interest and offered the opportunity to receive updates on the status of the study. 
Healthcare workers may also be approached for participation in recruitment and retention 
interviews. 
10.1.2 On-Study and Follow-up Procedures 
Healthcare workers will meet with the PI or a research coordinator to discuss the integrated care model 
in detail. Rural providers will be provided with a copy of the care algorithm and schedulers will be 
provided with a copy of the referral checklist to review. Healthcare workers will be encouraged to ask 
questions about the integrated care processes. Once eligible patient participants are identified, rural 
providers and schedulers will be informed of the patient participant’s enrollment in the trial. If a patient 
is enrolled through a Sauk Prairie Healthcare Clinic (diabetes or wound care clinics), an email will be 
sent to the patient’s PCP informing them of the patient’s enrollment in the study. A research coordinator 
will meet with rural providers and schedulers weekly to discuss the status of the study and answer any 
questions they may have. The PI will be available as back-up to answer any questions. 
 
Patient Participants 
10.2.1 Study Calendar 
The procedures performed at each study visit are listed in the table below. 
 
Procedure 
Screening 
Baseline visit  
Intervention 
Telephone 
contact  
End of 
Study/Early 
Withdrawal 
Visit Window 
Identification of 
Foot Ulcer 
Next Clinic Visit 
 
Month 3 
 
Telephone Screen 
X 
 
 
 
 
Informed Consent  
 
X 
 
 
 
Eligibility 
 
X 
 
 
 
Integrated Care Model 
 
 
X 
 
 
Chart Review 
 
X 
X 
X 
X 
Follow-up 
 
 
 
X 
 
10.2.2 Screening and Enrollment 
10.2.2.1 
Pre-screening 
Research coordinators will review the schedules of participating rural providers weekly to identify 
patients being seen for a diabetic foot ulcer. Additionally, rural providers will be encouraged to 
contact the research coordinators when they identify a potentially eligible patient. To assist with this 
process, providers will have access to a bi-fold brochure generally introducing the study and table 
top flyers to display in patient waiting rooms (see Appendix) For the UW Health Family Medicine 
Clinic in Belleville, CRDS will also generate a data report to help screen for potentially eligible 
patient participants. The report will be delivered via REDCap to the study team weekly and cover 
the upcoming week’s schedule. Once identified, telephone screening will be performed for initial 
eligibility and to schedule the consent discussion. The telephone script to screen for eligibility is 
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10.2.2.2 
Informed Consent 
Preliminarily eligible patient participants will be invited to participate in an informed consent 
discussion and formal screening at their next scheduled clinic visit. Potential patient participants are 
asked to come to the visit immediately after their scheduled clinic visit. The informed consent 
process will be conducted following all federal and institutional regulations relating to informed 
consent. The discussion will take place in a private room at the rural provider’s clinic. Informed 
consent will be obtained prior to conducting any study-related activities. Immediately following 
signed informed consent, self-reported demographics will be collected using a standardized form to 
comply with NIH sponsor requirements. 
 
The informed consent process will be performed as follows: 
• 
A trained research coordinator will review the informed consent form and discuss the study 
in detail with the potential research participant. 
• 
A trained research coordinator will explain the study, its risks and benefits, what would be 
required of the research participant, and alternatives to participation. 
• 
The research participant will be given the opportunity to take the informed consent form 
home so that they may discuss it with family members, friends, clergy, or others when 
possible.  
• 
The research participant will have the opportunity to ask questions and have all questions 
answered by the research coordinator. 
• 
The informed consent document must be signed and dated by the research participant. 
• 
A trained research coordinator will review the informed consent document to ensure that all 
fields that require a response are complete (i.e., checkbox marked yes or no, etc.) as 
applicable. 
• 
The research participant will be given a copy of the informed consent form. The original 
signed and dated informed consent form is kept with the study records. 
10.2.2.3 
Baseline Visit and Enrollment 
Following informed consent, subject eligibility will be confirmed as follows:  
 
A patient participant will be defined as “enrolled” in the study when they meet the following criteria: 
• 
The patient participant has been consented by a research coordinator.  
• 
The patient participant and a research coordinator have completed all screening 
documentation. 
• 
The PI has verified that the patient participant meets all of the inclusion criteria. 
• 
The PI has verified that patient participant meets none of the exclusion criteria. 
• 
The patient participant completed a clinic visit with the participating rural provider, who 
considered recommendations outlined in the integrated care algorithm. 
 
Following enrollment, the participant’s medical record will be reviewed, and patient characteristic 
data will be abstracted. This will include sociodemographic data, comorbidities, medications, lab 
values, and ulcer characteristics. See Appendix for full list of variables. 
10.2.2.4 
Screen Failure and Re-enrollment 
Individuals who do not meet the criteria for participation in this trial (screen failure) because they are 
determined not to have a diabetic foot ulcer may be rescreened if they develop a diabetic foot ulcer 
later. Rescreened patient participants should be assigned a new subject ID number when they are 
re-screened. 
 

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10.2.3 On-Study and Follow-up Procedures 
10.2.3.1 
Integrated Care Model Visit 
Integrated Care Model activities will be performed by the rural provider and scheduler following the 
patient participants’ enrollment in the study, as outlined above.  
 
Following the rural provider visit, data on care processes will be abstracted from the participant’s 
medical records. This includes information related to vascular disease care processes, infectious 
disease care processes, and other care processes. See Appendix for the full list of variables. 
 
10.2.3.2 
3 Month Follow-up 
Patient participants will receive a follow-up call 3 months after their integrated care model visit (i.e., 
enrollment) to assess ulcer status and screen for any adverse events. This will be done by a 
research coordinator. Additionally, data will be abstracted from the patient’s medical records. This 
includes medications, lab values, ulcer characteristics, and details of major or minor amputation, if 
applicable. If the patient participant is deceased at the time of the 3-month follow-up, information 
about the participant’s death will also be obtained from medical records. See Appendix for the full 
list of variables. The following is a list of adverse events that will be tracked by the study team: 
• 
Hypoglycemia requiring hospitalization or an emergency room visit 
• 
Adverse reaction to a smoking cessation product 
• 
Muscle aches after starting or changing a statin 
• 
Complication of a revascularization procedure 
• 
Adverse reaction to a wound care product or dressing 
• 
Adverse reaction to an antibiotic prescribed for an infection complicating the diabetic foot 
ulcer 
• 
Hospitalization for a diabetic foot ulcer (occurs in 30% of patients with diabetic foot ulcers) 
• 
Major (above-ankle) amputation (risk increases with ulcer severity but is 5% in the overall 
national cohort of patients with diabetic foot ulcers) 
• 
Death 
• 
Patient reported adverse events that the patient attributes to study participation 
All serious, unanticipated adverse events, deaths (whether anticipated or not), and major amputations 
(whether anticipated or not) will be reported to the ICTR DMC within 14 days of the study team 
becoming aware of these events. 
 
Historical Control Patient Participants 
10.3.1 Screening and Enrollment 
Controls will be matched 1:5 with enrolled patient participants based on clinic and primary care provider 
and identified through a review of medical records. Additionally, CRDS will be used to screen for 
historical controls at the UW Health Family Medicine Clinic in Belleville, and data will be delivered to the 
study team through REDCap. Controls will be identified and selected starting from the date 3 months 
prior to clinic activation and going back in time until the required number is reached. . The 3-month 
wash-out will avoid contaminating primary care teams with intervention activation events. Patients 
receiving palliative care, those unable to provide consent, and those who lacked insurance covering 
referral to University of Wisconsin specialty clinics will be excluded from the control population 
consistent with prospectively enrolled patient participants.  
A waiver of informed consent and HIPAA authorization waiver has been obtained for data abstraction 
activities for historical controls. This aspect of the study meets the four criteria for a waiver of HIPAA 
authorization. First, the research involves no more than minimal risk to the historical controls as it 
consists of a chart review only. Second, the research could not practicably be carried out without the 

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waiver since a substantial proportion of the historical controls are likely to have died (~20% in our 
national cohort study were dead within one year). Third, the research could not practically be carried 
out without using Identifiable Private Information because we need to access their medical records, 
which contain the most accurate record of what care they received for their foot ulcer. Fourth, the 
waiver is unlikely to adversely affect the rights and welfare of the subjects due to the procedures we 
have in place to maintain the confidentiality of all participants, both historical and prospective. 
10.3.2 Data Abstraction 
Medical records will be reviewed, and similar data collected from prospectively enrolled patient 
participants will be extracted from historical control patient participants. This includes sociodemographic 
data, comorbidities, medications, lab values, and ulcer characteristics at baseline and at 3 months post-
baseline. Amputation and death data will also be collected, if applicable. See Appendix for the full list of 
variables. 
11.0 
ADAPTIVE RECRUITMENT AND RETENTION PROCEDURES 
 
Interview Procedures (Qualitative Data Collection) 
11.1.1 Subject Identification and Recruitment 
11.1.1.1 
Recruitment Interviews 
Up to 9 healthcare workers and 9 patient participants from each clinic will be identified to participate 
in recruitment interviews (n=18 total participants). We will purposively sample across roles (i.e., 
rural providers/schedulers), those who consented or declined participation in the integrated care 
model intervention, and oversample both healthcare workers and patient participants from under-
represented minority populations. 
A research coordinator not participating directly in recruitment efforts will reach out to 
patients by telephone and healthcare workers by telephone or email to assess their interest 
in scheduling an interview. Up to three attempts will be made to reach potential interviewees. 
If a call is not answered, the coordinator will leave a message inviting the participant to 
return the call. A scripted telephone invitation and template email to participate in the 
qualitative portion of this study is included in the Appendix. The method of contact will be 
determined based on the participant’s preferred method of contact as noted when they filled 
out the Demographics CRF. 
Identification and recruitment activities will take place within 3 months of each clinic being 
activated for the integrated care model intervention. 
11.1.1.2 
Retention Interviews 
Up to ten healthcare workers and ten patient participants will be identified to participate in retention 
interviews (n=20 total participants). These individuals will be sampled to reflect their experiences 
across retention adaptations and clinics. In addition to healthcare workers enrolled in the 
quantitative portion, we will also recruit clinic administrators and staff who helped patient 
recruitment efforts and support clinic engagement with this study (e.g., help set-up meetings with 
clinicians, facilitate electronic health record access with the study coordinators, serve as 
ombudsmen to the larger healthcare system with respect to study activities). We anticipate 
significant overlap between people who agree to participate in the recruitment and retention 
interviews. In total, we will not enroll more than 36 people between these two efforts.  
A research coordinator not participating directly in recruitment and retention efforts at that clinic will 
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interest in scheduling an interview. Up to three attempts will be made to reach potential 
interviewees by phone. If a call is not answered, the coordinator will leave a message inviting the 
participant to return the call. A scripted telephone invitation and template email to participate in the 
qualitative portion of this study is included in the Appendix. The method of contact will be 
determined based on the participant’s preferred method of contact as noted when they filled out the 
Demographics CRF. 
11.1.2 Enrollment 
A separate informed consent for the qualitative sub-study will be verbally obtained from participants at 
the time of the interview. An oral consent script will be used to provide details of the interview 
procedures to research participants including study risks and benefits, what would be required of the 
research participant, and alternatives to participation. The script is available in the Appendix. Potential 
research participants will be given time to ask questions and can reschedule the interview if they would 
like additional time to consider participation. Interested participants will be able to provide oral consent 
to participate. Oral consent will be documented by the study coordinator in the original interview 
recording. Oral, rather than written, consent is being used because some interviews will take place by 
telephone. 
11.1.3 Interviews 
Interviews will take place at a time chosen by the interviewee and can be conducted in person, via 
telephone call, or via virtual meeting, based on the participant’s preference. Interviews will be audio 
recorded and transcribed verbatim with the exception that personal identifying information will be 
removed. Interviews will be semi-structured following our conceptual model of participant-centered 
recruitment and retention adapted from Chhatre et al. (see Appendix for interview guides).30 Probing 
questions will provide depth and detail about how recruitment and retention strategies could be 
improved. Following analysis of the interview materials (see section 11.3.1 below), a synthesis of the 
findings will be emailed to interviewees to ensure that the descriptions are salient and credible. Emails 
will also offer an opportunity for feeding back preliminary data as a means of improving study retention. 
For participants completing a recruitment interview that declined enrollment in the care algorithm part of 
the study, the Demographics form will be completed at the end of the interview.  
11.1.4 Remuneration 
Interviewees will receive $50, with an average interview lasting 30 minutes. 
 
Recruitment and Retention Data Collection (Quantitative Data Collection) 
We will use recruitment and retention data to assess the impact of the initial strategies and subsequent 
adaptations. We will keep logs of participant recruitment and retention. For healthcare worker (rural 
providers and schedulers) recruitment, we will record how many healthcare workers at each site: 1) were 
emailed an invitation to the recruitment meeting, 2) met with the study PI or research coordinator, and 3) 
consented to participate. Retention for healthcare workers will be defined as not having withdrawn consent 
to participate in the study and will not be based on their use of the integrated care model, since deviation 
from the model will be allowed if it is in the best interest of the patients as determined by the participating 
rural provider. Retention for administrators and other staff not formally consented in the quantitative portion 
will be defined as willingness of the clinic to continue to support the research endeavors.  
For patient participant recruitment, we will record the number of patients who: 1) were contacted by phone, 
2) completed the face-to-face appointment, and 3) consented to participate. For patient participant 
retention, we will log how many patient participants withdrew from the study or were lost to follow up before 
the 3-month telephone call. Logs will separate data into three distinct groups corresponding to adaptive 
iterations of the recruitment and retention strategies. 

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Recruitment and Retention Data Analysis 
11.3.1 Qualitative Data Analysis 
We will analyze interview transcripts using directed content analysis, where an existing conceptual 
model drives an a priori coding matrix.36 The columns of the matrix will be composed of categories 
derived from the conceptual model.30 Interview questions are placed in the matrix rows, with supporting 
quotes  populating each cell. We will allow our matrix to be unconstrained.37 This means that, while the 
majority of the coding matrix is predetermined, we will add new categories (columns) to reflect 
emerging facets of the data that may refute, extend, or enrich the conceptual model. We are using an 
unconstrained model because our intent is to capture all possible strategies to promote recruitment and 
retention.36 
Before coding begins, the PI and research coordinators will create a code book to define each 
category, tailoring definitions to rural recruitment and the current study. Core definitions will be based 
on those originally published.30 The group will refine the code book iteratively using emerging data to 
hone a priori codes and define new ones relevant to emerging themes. Two study team members will 
code all transcripts independently (PI and a research coordinator). First, transcripts will be read for 
immersion. Second, portions of the transcripts pertaining to barriers and facilitators of recruitment and 
retention will be highlighted, regardless of whether they represent core concepts in the matrix. Starting 
analysis in this way prevents researchers from focusing too narrowly on a priori codes. Third, 
highlighted passages will be coded using the predetermined categories. Fourth, any highlighted text 
that fell outside the predetermined categories will be given a new code and entered into the 
unconstrained matrix.36 Independent coders will meet to discuss discrepancies identified using NVivo 
comparisons of coded text and interpretations of code book definitions. If questions remain, Dr. 
Pecanac (qualitative co-investigator) will assist with resolution. Once the matrix is complete, 
researchers (Drs. Pecanac and Brennan) will examine the data in each category and describe how the 
current process of recruitment is working, how recruitment strategies are impacted by different 
conditions, and interactions between different strategies.36,37 Analysis will be shared with the 
participating clinics and Rural Wisconsin Health Cooperative during a final co-design session to adapt 
recruitment and retention strategies to meet our target goals of 60% recruitment and 80% retention in a 
subsequent, wider state trial. 
11.3.2 Quantitative Data Analysis 
Dr. Sampene will serve as the study’s biostatistician and be available to assist with the quantitative data 
analysis. We will calculate recruitment and retention rates prior to activating the next clinic. We will 
compare results to our goals of 60% and 80%, respectively.34,35 We will create recruitment and 
retention cascade graphics for both healthcare workers and patients to assist with determining which 
steps in the process have the highest attrition. Subsequent adaptations will focus on these steps. We 
will use descriptive statistics, such as counts, rates, and percentages, to summarize recruitment and 
retention during each cycle of adaptation. The denominator for healthcare worker recruitment steps will 
be the number of healthcare workers emailed to attend an informational meeting. The denominator for 
healthcare worker retention will be the number enrolled in the study. Retention will be assessed every 3 
months until the end of the study, varying across each clinic due to staggered activation. The 
denominator for patient recruitment will be the number of patients we attempted to contact by 
telephone. The denominator for patient retention, assessed at the 3-month follow-up telephone call, will 
be the number of patient participants enrolled in the study. Comparisons of recruitment and retention 
between adaptations will be performed using ANOVA or chi-square tests, depending on the outcome 
types for these endpoints. Also, correlative measures will be calculated when such methods are 
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Cooperative Co-design for Recruitment & Retention Adaptations 
Recruitment and retention strategies have been iteratively adapted prior to enrollment of clinics 2 and 3, 
leading to protocol changes from version 1.4 to 2.0. At the end of the pilot, a co-design meeting will occur 
with the Cooperative to further refine recruitment and retention strategies with the goal of preparing for a 
larger, statewide trial using their network of rural healthcare clinics. Our research study team, led by the PI, 
will present quantitative and qualitative analysis of the most current recruitment and retention strategies 
(outlined above). Cooperative participants include clinicians, nurses, administrators, and quality 
improvement experts. We will invite two patient representatives from each activated clinic to participate. 
Cooperative members include patients in their meetings specifically to ensure patient-centeredness.  
During the co-design session, we will use participatory ergonomics, which is a systems engineering 
approach where the researchers spearheading the study work side-by-side with stakeholders to design 
it.38,39 We used this same approach with the Cooperative to successfully identify health system barriers 
exacerbating rural disparities in major amputations and design our integrated care model.23,24 Research 
coordinators will distribute adaptations to participating healthcare workers at each activated clinic with 
explanations for the changes linked to their feedback.  
All enrolled patient participants will receive a mailed update after each modification and at the close of the 
study, detailing our findings and adaptations. These steps are critical not only in keeping participants 
informed of protocol changes but also in providing evidence of responsiveness to their feedback, which has 
been linked to study retention.40-43 
12.0 
DATA HANDLING AND RECORD KEEPING 
 
Data Collection  
12.1.1 Data Collection 
Standardized data collection forms (e.g., source documents, case report forms, standardized 
assessment forms, etc.) are used to ensure data collected are consistent and compliant with the 
protocol and IRB application.  
 
Data collection is the responsibility of the research coordinators under the supervision of the Principal 
Investigator (PI). The PI is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the recorded and reported data. 
 
All data collection forms must be completed in a legible manner; any missing data will be explained. 
Data entry errors will be corrected with a single line through the incorrect entry and the correct data is 
entered above/near the correction. All changes will be initialed and dated. Forms will be filled out 
electronically or using black or blue ink. 
 
Data collection forms are maintained in the subject files and retained as described in Section 12.3: 
Records Retention. 
 
Data collection will be done through manual chart abstraction by Devan McClain, Jamie LaMantia, 
and/or Meghan Brennan. These individuals will be granted remote access to all three clinics’ electronic 
medical record. A business associate agreement (BAA) with SPH will be put in place for this purpose. A 
unique study ID will be assigned to each patient participant. A key linking the patient participant’s ID 
and the study ID will be kept on the HIPAA compliant HIP server and UW Restricted ResearchDrive. A 
coded dataset will be created on the HIP servers/UW Restricted ResearchDrive and REDCap for 
analytic purposes and ICTR DMC oversight purposes.  
 

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Study data will be documented and monitored in SMPH REDCap. Data will be collected on paper as 
described above, recorded by either the study participant or research staff, then electronically entered, 
with confirmation of correct entry, by the research staff via REDCap on research computers. To gain 
access to the REDCap system, study team members will need to fill out a REDCap account request 
through ICTR and complete required training using the following link: 
https://redcap.ictr.wisc.edu/surveys/?s=DWJFCLFHYL8PKJRT  
Once approved, each user will have their own account. To ensure that REDCap users have access 
only to data and information that they are supposed to have access to within the application, each 
user’s privileges will be assigned by the study’s principal investigator or the study team member that 
created and manages the REDCap project database. After REDCap entry, source documents will be 
stored in a locked filing cabinet in Dr. Brennan’s office location within the secure UW Medical 
Foundation Centennial Building, and maintained for the length of time approved by the IRB.  
12.1.2 Data Management 
All electronic data will be stored on the Health Innovation Program’s servers and the PI’s/Meghan 
Brennan’s UW Restricted ResearchDrive and/or entered into the SMPH REDCap database. The study 
team will have access to these application servers for statistical processing; data storage for datasets 
with personal health information (PHI); backup and recovery; technical, physical, and management 
security and privacy controls; ongoing review of regulatory agreements and access compliance; remote 
access to IT resources; and IT helpdesk support. The data will be stored in a location on the servers 
that will be restricted to approved members of the study team. Additionally, the REDCap database will 
be used by the ICTR DMC, which is providing oversight for this clinical trial. Printed and signed consent 
forms and other printed study materials will be kept in a locked cabinet in Dr. Brennan’s office location 
within the secure UW Medical Foundation Centennial Building.   
 
Additionally, a spreadsheet of coded data collected from all study participants will be loaded to a UW 
Box folder for the statistician to access for data analysis. 
 
Confidentiality and Privacy 
Research participant confidentiality and privacy are strictly held in trust by the participating investigators, 
their study team, and the sponsor and their agents. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the study or 
the data will be released to any unauthorized third party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. Audio recordings of interviews 
will be obtained using a recording device that is kept in the possession of the research coordinator when in 
use and in locked rooms limited to essential personnel when not in use. Transcription will be conducted by 
members of the study team (HIP student hourlies with appropriate IRB and HIPAA training add to the 
research team roster for this specific purpose, Devan McClain and/or Jamie LaMantia) and individual 
identifiers will be redacted prior to sharing this information as part of interviews and co-design meetings. 
 
All study team members engaged in the conduct of this project have completed training on the protection of 
human subjects and the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. In addition, 
all key personnel (i.e., Principal Investigator, individuals involved in identifying/recruiting subjects, obtaining 
informed consent, or interacting and intervening with research study participants) have undergone both 
Human Subjects and Good Clinical Practice (GCP) training. 
 
Information about study participants will be kept confidential and managed according to HIPAA 
requirements. All study participants will provide informed consent, with prospective patient participants 
receiving the integrated care intervention also providing consent on a combined consent and HIPAA 

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authorization form that includes specific privacy and confidentiality rights. Study data will be maintained per 
federal, state, and institutional data policies. 
 
The investigator(s) will ensure that the identities of study participants are protected by using coded 
information specific to each participant. The log of participant-identifying information that links participants 
to their study-specific identification number will be maintained by the investigator and research study team. 
Hard copy logs and all study records will be maintained in locked rooms and access will be limited to 
essential study personnel. Electronic study records/files will be stored on HIPAA-compliant Health 
Innovation Program servers and Meghan Brennan’s Restricted ResearchDrive and accessed via 
networked computers that are password-protected with access provided only to authorized study 
personnel.  
 
Authorized representatives of the following groups may need to review this research as part of their 
responsibilities to protect research subjects: authorized representatives of the sponsor, representatives of 
the IRB, DSMB/DMC, regulatory agencies, and federal oversight agencies. The clinical study site will 
permit access to such records. 
 
Research coordinators may use e-mail to communicate with research participants, if the participant has 
agreed to using email in the Informed Consent form. The information contained in emails will be limited to 
study visit time and date information, general questions, etc. All emails to participants will be sent from 
UW/wisc.edu accounts; personal, home, or Gmail email accounts will not be used. 
 
Records Retention 
Essential documents will be maintained for a minimum period of 7 years following completion of the study 
per UW-Madison institutional policy. 
 
Retention for Future Research: Data and Audio- or Video-Recording Banking  
12.4.1 Purpose of Storage 
Essential documents will be maintained for a minimum period of 7 years following completion of the 
study per UW-Madison institutional policy. De-identified data will also be stored so that it can be made 
available to independent researchers wishing to verify our findings.  
12.4.2 Data and/or Biospecimens Being Stored 
Only de-identified data will be stored beyond completion of the study. De-identified data will include: a 
dataset comparing historical patients to those prospectively enrolled in the integrated care model and 
de-identified qualitative interview transcripts. 
12.4.3 Location of Storage 
De-identified data will be stored on the Health Innovation Program HIPAA compliant Server (P://), which 
is housed in a state-of-the-art data center at the Centennial Office Building managed by UW SMPH IT 
and is connected via fiber optic cable to the Health Innovation Program (HIP) suite at 800 University 
Bay Drive.  
 
Data will also be stored on Meghan Brennan’s UW Restricted ResearchDrive, the University of 
Wisconsin campus-wide file storage service managed by the Division of Information Technology. This 
is a secure space with data protection and security features based on the NIST Cybersecurity 
framework. It includes off-site backups, encryption, and monitoring by the University of Wisconsin 
Cybersecurity Operations Center.  
12.4.4 Duration of Storage 
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12.4.5 Access to Data, Images, Recordings and/or Biospecimens and Security Measures 
Access to identifiable data will be limited to those collecting it, so that they may check and confirm its 
accuracy, and those transcribing audio recordings of the qualitative interviews. The PI and research 
coordinators, and Drs. Pecanac and Sampene (co-investigators) will work with de-identified data. 
 
The following measures were put in place to protect confidentiality: 
1. Access to identifiable data will be limited to those collecting data, conducting interviews, and 
transcribing interviews. 
2. Data analysis, both quantitative and qualitative, will be performed on de-identified datasets and 
transcripts only. 
3. The key linking de-identified study data to identifiable study participants will be kept by the research 
assistants generating this data on the HIPAA-compliant HIP server and Dr. Meghan Brennan’s UW 
Restricted ResearchDrive. 
4. Audio recordings of interviews will be destroyed after they have been transcribed and the 
transcripts were verified to be accurate by the person who conducted the interview. This limits 
accidental disclosure of identifiable information. 
5. Original paper data abstraction forms will be kept in a locked filing cabinet in a locked office at the 
UW Medical Foundation Centennial Building. Using paper data abstraction forms limits cyber 
security issues. 
6. Laptops will not be used for data collection, storage, or access. 
7. Identifiable data will not be shared outside of UW. 
8. Electronic data will be stored on the HIPAA-complaint HIP server, which has the following levels of 
security, and UW Restricted ResearchDrive: 
a. Physical Security: the server is located in a secure data center under control of UW 
School of Medicine and Public Health (SMPH) IT, which is a dedicated computer 
machine room fitted with passkey access, video surveillance, emergency back-up 
power, an un-interruptible power supply, and an automatic fire detection and 
suppression system. SMPH IT does not have access to the server. 
b. Firewall: the server is located behind the SMPH firewall. 
c. Access Control: Data directory access is limited to HIP Faculty Director-approved 
individuals. 
d. Domain Access Restrictions: access to HIP computing resources is restricted to 
individuals with a logon ID for the HIP Domain. Logon IDs are issued only upon approval 
of the HIP Director. 
e. Authentication: Password protection is used at the network level for all transactions that 
allow entry and editing of data, provide access to electronic PHI data, or administrative 
activities.  
 
12.4.6 Procedures to Release Data or Biospecimens 
Authorized representatives of the following groups may need to review this research as part of their 
responsibilities to protect research subjects: authorized representatives of the sponsor, representatives 
of the IRB, DSMB/DMC, regulatory agencies, and federal oversight agencies. The clinical study site will 
permit access to such records following written request. The PI will also grant access to de-identified 
datasets upon reasonable request to independent researchers wishing to confirm our findings. 
 
12.4.7 Process for Returning Results 
N/A.  
12.4.8 Process for Tracking Subject Consent and Authorization 
Participants may withdraw consent by informing the PI in writing and specifying at that time whether 
they would like the study team to omit previously collected data pertaining to them from datasets and 
analysis. If this is not explicitly stated, the study team will use data collected about that study participant 

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from the time consent was originally signed up until the date the participant withdrew from the study. 
The research coordinator working with the clinic associated with the study participant who withdrew 
consent will be informed of their decision by the PI and asked to modify data sets and transcripts 
accordingly. It is the expectation that datasets will be amended due to participant withdrawal within one 
week of receiving written notice. 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol or investigational plan 
requirements. The noncompliance may be either on the part of the participant, the investigator, or another 
member of the study team. As a result of deviations, corrective actions are to be developed by the study 
team and implemented promptly.  
 
It is the responsibility of the Principal Investigator and all study team members to use continuous vigilance 
to identify and report deviations. The Principal Investigator is responsible for assessing whether the 
deviation constitutes noncompliance as defined by the reviewing IRB and if so, reporting it within the 
required time frames. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements. 
 
Publication and Data Sharing Policies 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central 
(https://www.ncbi.nlm.nih.gov/pmc/) upon acceptance for publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and resulting information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals. Data from this study may be requested from other researchers up to seven years after the 
completion of the primary endpoint by contacting the PI in writing.  
13.0 
STUDY ANALYSIS 
 
Statistical Hypotheses 
• 
Primary Efficacy Endpoint(s):  
• 
Completion of 5 vascular and 4 infectious disease care processes, modeled as percent 
indicated and dichotomously (all relevant completed vs. missing ≥1). Hypothesis: A larger 
proportion of patients in the integrated care model arm, compared to historical controls, will 
complete the 5 vascular and 4 infectious disease care processes. 
 
• 
Secondary Efficacy Endpoint(s): 
• 
Amputation, defined as either major or minor. Hypothesis: A smaller proportion of patients in the 
integrated care arm, compared to historical controls, will undergo either major or minor 
amputation within 3 months of diabetic foot ulcer diagnosis.  

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Sample Size and Statistical Analysis 
 
We have now finished enrolling active patients into the intervention.  Our final number of active patients is 
27. This is lower than our target enrollment of 45. Therefore, we re-calcuated the number of historical 
controls needed to achieve adequate power for care processes. First we assume the probability of 
exposure among sampled control subjects is 0.6 and the correlation coefficient for exposure between 
matched cases and control subjects in 0.3. To detect an odds ratio of 0.26 versus the alternative of equal 
odds with 27 active patients and a matching sample of 5 historical controls per active patient (totaling 162 
active and historical patients combined), and with a Type I error rate of 0.05, the power is 0.80706 
(computed using PASS 2024, version 24.0.1.  
 
When analyzing pilot data, descriptive statistics will be run on variables other than our primary and 
secondary outcomes. When analyzing our primary and secondary outcomes, we will stratify by clinic 
because they serve communities of differing socioeconomic status. Care processes will be modeled both 
dichotomously (all relevant completed vs. missing at least one) and continuously (as a percent of indicated 
care processes that occurred). In analyzing our primary outcome dichotomously, we will use a factorial 
experimental approach where the guideline-concordant and -discordant measures will be calculated. 
Additionally, due to the categorical nature of both our primary (dichotomously modeled care processes) 
and secondary (major and minor amputation) outcomes, we will build a multivariable Poisson regression 
model. When modeling guideline concordance care processes continuously, we use linear regression. In 
the primary analysis, we will require patients referred to a vascular or infectious disease specialist to be 
seen by that specialty, either in-person or via telemedicine, within 2 weeks per our algorithm. We will also 
conduct an intention-to-treat analysis where we include consults placed but not completed or delayed. 
Pre/post differences in completed referral rates, coupled with data on why a referral did not take place, will 
allow us to determine whether referral gaps would be best addressed by focusing on primary or specialty 
clinic processes. 
 
Planned Interim Analysis 
Not applicable. 
 
Handling of Missing Data 
Guidelines promulgated in the National Research Council report on handling of missing data will be 
followed.1,2   
14.0 
RISK/BENEFIT ASSESSMENT 
 
Known Potential Benefits to the Subjects 
The potential benefits to patient participants associated with this study includes possible improvement of 
care for their diabetic foot ulcers. These improvements may extend to a reduction in the risk of major or 
minor amputation due to ulcers. Healthcare workers are not expected to benefit directly, though 
participation in the integrated care model may provide improved understanding of guideline concordant 
care of diabetic foot ulcers. 
 
Known Potential Risks 
There are no direct physical risks associated with the integrated care model. Patient participants’ 
care will continue to be overseen by their primary care provider, who will retain final clinical decision 
making and will be allowed to deviate from the integrated care model should it be in the patient’s 
best interest. To ensure there are no unforeseen negative consequences, the study team will track 
adverse events. The following is a list of adverse events that will be tracked by the study team: 

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• 
Hypoglycemia requiring hospitalization or an emergency room visit 
• 
Adverse reaction to a smoking cessation product 
• 
Muscle aches after starting or changing a statin 
• 
Complication of a revascularization procedure 
• 
Adverse reaction to a wound care product or dressing 
• 
Adverse reaction to an antibiotic prescribed for an infection complicating the diabetic foot 
ulcer 
• 
Hospitalization for a diabetic foot ulcer (occurs in 30% of patients with diabetic foot ulcers) 
• 
Major (above-ankle) amputation (risk increases with ulcer severity but is 5% in the overall 
national cohort of patients with diabetic foot ulcers) 
• 
Death 
• 
Patient reported adverse events that the patient attributes to study participation 
All serious, unanticipated adverse events, deaths (whether anticipated or not), and major amputations 
(whether anticipated or not) will be reported to the ICTR DMC within 14 days of the study team 
becoming aware of these events as well as the IRB. The baseline rate of major amputations among 
patients with diabetic foot ulcers is ~5% using national cohort data, although risk varies by ulcer 
severity.8 If the baseline rate in our pilot exceeds 15%, the study will be stopped and reviewed by the 
DMC and IRB for any necessary changes to the protocol. Particular attention will be paid to whether or 
not the major amputation caused by the integrated care model. 
 
The primary risk to patient and healthcare worker participants is presented by a potential breach of 
confidentiality. These risks will be minimized by performing research activities in private spaces to the 
degree possible and complying with confidentiality procedures outlined above. Rural providers who 
participate may also face a risk to reputation. Again, this risk is minimized by protecting confidentiality. 
 
Risk/Benefit Analysis 
This project directly addresses the escalating national rate of major (above-ankle) amputations due to 
diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared 
to their urban counterparts. The project pilots the first integrated care model adapted to rural settings, an 
approach that has reduced major amputations in urban settings by approximately 40%. Pilot data will be 
used to improve recruitment and retention strategies and provide preliminary evidence of efficacy needed 
to conduct a robust, statewide efficacy trial. 
15.0 
DATA AND SAFETY MONITORING  
 
Unanticipated Problems 
An unanticipated problem (UP), as defined by the DHHS Office for Human Research Protection (OHRP), is 
any incident, experience, or outcome that meets all of the following criteria:  
• 
The incidence, experience, or outcome is unexpected given the research procedures described in 
protocol-related documents (e.g., the study protocol and informed consent documents) and the 
characteristics of the population being studied. An event may be considered unexpected if it exceeds 
the nature, severity, or frequency described in the study-related documents. 
• 
The incidence, experience, or outcome is related or probably related to participation in the research 
study. “Probably related” means the incidence, experience, or outcome is more likely than not to be 
caused by the research study procedures. 
• 
The occurrence of the incidence, experience, or outcome suggests that the research places subjects or 
others at a greater risk of harm (physical, psychological, economic, or social) than was previously 
known or recognized.  
 

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The investigator will report UPs to the reviewing IRB and ICTR DMC. The UP report will include the 
following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP;  
• 
A description of any changes to the protocol, informed consent documents, or other corrective actions 
that have been taken or are proposed in response to the UP. 
 
For this study, UPs will include all major amputations and deaths, even though these are anticipated to 
some degree in this study population. Please see section 14.2 (Known Potential Risks) for further details. 
Study Stopping Rule will be a major amputation rate of 10% or more. Report UPs within the timeframe 
specified by the IRB of record and DMC. 
 
Safety Oversight 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertise, including rural providers and specialists. Members of the DSMB 
should be independent from the study conduct and free of conflict of interest, or measures should be in 
place to minimize perceived conflict of interest. The DSMB will meet at least semiannually to assess safety 
and efficacy data on each arm of the study. The DMSB will operate under the rules of an approved charter 
that will be written and reviewed at the organizational meeting of the DSMB. At this time, each data 
element that the DSMB needs to assess will be clearly defined. The DSMB will provide its input to the PI 
and funder (NIDDK). 
 
The ICTR DMC will provide an independent biostatistician to create reports of overall data analysis 
preparation for review by the DMC for bi-annual meetings. 
16.0 
STUDY FEASIBILITY  
 
Economic Burden to Subjects 
Patient participants will be responsible for any costs related to the care they receive as part of the 
integrated care model, such as clinic visits, including costs associated with referrals to specialty clinics, and 
treatment costs, including all out-of-pocket costs.  
 
Facilities and Locations 
The first clinic will be UW Health Belleville Family Medicine. The second and third clinics will be SPH 
Diabetes and Wound Care clinics. Data will be collated, stored, and analyzed at the Health Innovation 
Program (HIP) and/or the UW Medical Foundation Centennial Building. A co-design session with the 
Cooperative will be conducted at their headquarters in Sauk City. 
 
The PI has ample experience working with UW Health Belleville Family Medicine, having enlisted the help 
of their providers in qualitative studies leading up to this intervention. She has over 5 years of experience 
working with the Cooperative on this issue as well. She is a HIP investigator. 
 
Feasibility of Recruiting the Required Number of Subjects 
The Cooperative clinics that will be approached for participation in this study each serve between 1513-
1791 patients with diabetes. Using a 2% annual incidence, we estimate 30-35 patients will be diagnosed 
with a diabetic foot ulcer at each clinic annually. Taking into consideration rolling activation of clinics over a 
two year period, and using a conservative estimate of 30 patients with diabetic foot ulcer, we would expect 

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a pool of 135 eligible patient participants during the course of the study. Given planned recruitment and 
retention efforts, we reasonably expect to be able to enroll 45 patient participants throughout the course of 
the study. However, patient recruitment has been slower than initially expected. To offset this, we are 1) 
activating clinic 3 simultaneously with clinic 2 to provider a longer timeframe over which to recruit patients, 
and 2) increasing our active: historical control ratio from 1:1 to 1:5o ensure we are adequately powered. 
 
Regarding the feasibility of recruiting healthcare workers, our prior engagement of these individuals in the 
research leading up to this interventions leads us to believe recruiting individual healthcare workers will be 
feasible at each clinic. Full healthcare worker participation at clinic 1 offers further data to suggest we will 
be able to make our healthcare worker recruitment goals. 
 
Principal Investigator Considerations 
16.4.1 Time Devoted to Conducting the Research 
The Principle Investigator, Meghan Brennan, has ensured that a sufficient amount of time will be 
devoted to conducting and completing this research, budgeting 30% of her effort on the NIDDK grant 
funding this project.  
16.4.2 Process for Informing Study Teams 
In the month leading up to a clinic’s activation and through the end of data collection at that site, the PI 
will meet weekly with research coordinators engaging active clinics. Meetings will include reviewing the 
study protocol, any changes, and research coordinator duties. The greater study team will meet to 
review preliminary findings just prior to presenting them to on-boarding clinics and after the co-design 
session, to debrief and finalize changes to the recruitment and retention strategies. Additional meetings 
will also be held as needed and at the conclusion of the study.  
 
Availability of Medical or Psychological Resources 
Not applicable. 

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17.0 
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among Medicare beneficiaries, 2006 to 2008: Data Points #2. In: Data Points Publication Series [Internet]. 
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2. Hicks CW, Selvarajah S, Mathioudakis N, et al. Burden of Infected Diabetic Foot Ulcers on Hospital 
Admissions and Costs. Ann Vasc Surg. 2016;33:149-158. 
3. Centers for Disease Control and Prevention. Diagnosed Diabetes. 2018; 
https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html. Accessed 28 December, 2021. 
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Cancer: A Case-Control Study. Dig Dis. 2019;37(4):291-296. 
5. Gregg EW, Hora I, Benoit SR. Resurgence in Diabetes-Related Complications. JAMA. 2019;321(19):1867-
1868. 
6. Wukich DK, Raspovic KM, Suder NC. Patients With Diabetic Foot Disease Fear Major Lower-Extremity 
Amputation More Than Death. Foot Ankle Spec. 2018;11(1):17-21. 
7. O'Connor A, Wellenius G. Rural-urban disparities in the prevalence of diabetes and coronary heart 
disease. Public Health. 2012;126(10):813-820. 
8. Brennan MB, Hess TM, Bartle B, et al. Diabetic foot ulcer severity predicts mortality among veterans with 
type 2 diabetes. J Diabetes Complications. 2017;31(3):556-561. 
9. Skrepnek GH, Mills JL, Sr., Armstrong DG. A Diabetic Emergency One Million Feet Long: Disparities and 
Burdens of Illness among Diabetic Foot Ulcer Cases within Emergency Departments in the United States, 
2006-2010. PLoS One. 2015;10(8):e0134914. 
10. Belanger MJ, Hill MA, Angelidi AM, Dalamaga M, Sowers JR, Mantzoros CS. Covid-19 and Disparities in 
Nutrition and Obesity. N Engl J Med. 2020;383(11):e69. 
11. Coughlin LN, Bonar EE, Bohnert KM, et al. Changes in urban and rural cigarette smoking and cannabis 
use from 2007 to 2017 in adults in the United States. Drug Alcohol Depend. 2019;205:107699. 
12. Doogan NJ, Roberts ME, Wewers ME, et al. A growing geographic disparity: Rural and urban cigarette 
smoking trends in the United States. Prev Med. 2017;104:79-85. 
13. Gonzalez M, Epperson AE, Halpern-Felsher B, Halliday DM, Song AV. Smokers Are More Likely to Smoke 
More after the COVID-19 California Lockdown Order. Int J Environ Res Public Health. 2021;18(5):2582. 
14. Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, et al. COVID-19 Lockdown and Changes of the 
Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. 
Nutrients. 2020;12(8):2327. 
15. Musuuza J, Sutherland BL, Kurter S, Balasubramanian P, Bartels CM, Brennan MB. A systematic review of 
multidisciplinary teams to reduce major amputations for patients with diabetic foot ulcers. J Vasc Surg. 
2020;71(4):1433-1446.e1433. 

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16. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline 
by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and 
the Society for Vascular Medicine. J Vasc Surg. 2016;63(2 Suppl):3S-21S. 
17. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice 
guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54(12):e132-173. 
18. Johnston KJ, Wen H, Joynt Maddox KE. Lack Of Access To Specialists Associated With Mortality And 
Preventable Hospitalizations Of Rural Medicare Beneficiaries. Health Aff (Millwood). 2019;38(12):1993-
2002. 
19. Prompers L, Huijberts M, Apelqvist J, et al. High prevalence of ischaemia, infection and serious comorbidity 
in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 
2007;50(1):18-25. 
20. Brennan MB, Allen GO, Ferguson PD, McBride JA, Crnich CJ, Smith MA. The Association Between 
Geographic Density of Infectious Disease Physicians and Limb Preservation in Patients With Diabetic Foot 
Ulcers. Open Forum Infect Dis. 2017;4(1):ofx015. 
21. Ho V, Wirthlin D, Yun H, Allison J. Physician supply, treatment, and amputation rates for peripheral arterial 
disease. J Vasc Surg. 2005;42(1):81-87. 
22. Dansky KH, Dirani R. The use of health care services by people with diabetes in rural areas. The Journal of 
Rural Health. 1998;14(2):129-137. 
23. Sutherland BL, Pecanac K, Bartels CM, Brennan MB. Expect delays: Poor connections between rural and 
urban health systems challenge multidisciplinary care for rural Americans with diabetic foot ulcers. J Foot 
Ankle Res. 2020;13(1):32. 
24. Sutherland BL, Pecanac K, LaBorde TM, Bartels CM, Brennan MB. Good working relationships: how 
healthcare system proximity influences trust between healthcare workers. J Interprof Care. 2021:1-9. 
25. Peterson JC, Czajkowski S, Charlson ME, et al. Translating basic behavioral and social science research 
to clinical application: the EVOLVE mixed methods approach. J Consult Clin Psychol. 2013;81(2):217-230. 
26. Strolla LO, Gans KM, Risica PM. Using qualitative and quantitative formative research to develop tailored 
nutrition intervention materials for a diverse low-income audience. Health Educ Res. 2006;21(4):465-476. 
27. Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of 
success: A review. Contemp Clin Trials Commun. 2018;11:156-164. 
28. McElfish PA, Long CR, Selig JP, et al. Health Research Participation, Opportunity, and Willingness Among 
Minority and Rural Communities of Arkansas. Clin Transl Sci. 2018;11(5):487-497. 
29. Morgan LL, Fahs PS, Klesh J. Barriers to research participation identified by rural people. J Agric Saf 
Health. 2005;11(4):407-414. 
30. Chhatre S, Jefferson A, Cook R, et al. Patient-centered recruitment and retention for a randomized 
controlled study. Trials. 2018;19(1):205. 
31. Donovan JL, Peters TJ, Noble S, et al. Who can best recruit to randomized trials? Randomized trial 
comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the 
ProtecT study). J Clin Epidemiol. 2003;56(7):605-609. 

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32. Mills N, Donovan JL, Smith M, Jacoby A, Neal DE, Hamdy FC. Perceptions of equipoise are crucial to trial 
participation: a qualitative study of men in the ProtecT study. Control Clin Trials. 2003;24(3):272-282. 
33. Donovan J, Mills N, Smith M, et al. Quality improvement report: Improving design and conduct of 
randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and 
treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ. 
2002;325(7367):766-770. 
34. Abshire M, Dinglas VD, Cajita MI, Eakin MN, Needham DM, Himmelfarb CD. Participant retention practices 
in longitudinal clinical research studies with high retention rates. BMC Med Res Methodol. 2017;17(1):30. 
35. Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of the participants in clinical trials: 
Challenges and solutions. Perspect Clin Res. 2020;11(2):64-69. 
36. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 
2005;15(9):1277-1288. 
37. Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107-115. 
38. Wilson JR, Haines H, Morris W. Participatory Ergonomics. In: Wilson JR, Corlett N, eds. Evaluation of 
Human Work, Third Edition. Third ed. Boca Raton, FL: Taylor & Francis; 2005:933-962. 
39. Xie A, Carayon P, Cox ED, et al. Application of participatory ergonomics to the redesign of the family-
centred rounds process. Ergonomics. 2015;58(10):1726-1744. 
40. Allman RM, Sawyer P, Crowther M, Strothers HS, 3rd, Turner T, Fouad MN. Predictors of 4-year retention 
among African American and white community-dwelling participants in the UAB study of aging. 
Gerontologist. 2011;51 Suppl 1:S46-58. 
41. Ofstedal MB, Weir DR. Recruitment and retention of minority participants in the health and retirement 
study. Gerontologist. 2011;51 Suppl 1:S8-20. 
42. Sahin D, Yaffe MJ, Sussman T, McCusker J. A mixed studies literature review of family physicians' 
participation in research. Fam Med. 2014;46(7):503-514. 
43. Stineman MG, Strumpf N, Kurichi JE, Charles J, Grisso JA, Jayadevappa R. Attempts to reach the oldest 
and frailest: recruitment, adherence, and retention of urban elderly persons to a falls reduction exercise 
program. Gerontologist. 2011;51 Suppl 1:S59-72. 
44. Brennan MB, Huang ES, Lobo JM, et al. Longitudinal trends and predictors of statin use among patients 
with diabetes. J Diabetes Complications. 2018;32(1):27-33. 
45. Prompers L, Huijberts M, Apelqvist J, et al. Delivery of care to diabetic patients with foot ulcers in daily 
practice: results of the Eurodiale Study, a prospective cohort study. Diabet Med. 2008;25(6):700-707. 
46. Rosner B. Fundamentals of Biostatistics. Seventh ed. Boston, MA: Brooks/Cole; 2010. 
 
 

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18.0 
APPENDICES 
 
Appendix 1: Recruitment Table Top Flyer for Belleville 
 

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Appendix 2: Recruitment Bi-fold Pamphlet for Belleville 
 

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Appendix 3: Recruitment Table Top Flyer for Sauk Prairie Healthcare 
 

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Appendix 4: Recruitment Bi-fold Pamphlet for Sauk Prairie Healthcare 
 

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Appendix 5: Recruitment Telephone Screening Script for Patient Participants for the 
Integrated Care Model 
Recruitment Telephone Screening Script for Patient Participants for the Integrated Care Model 
If no answer… Hello, this message is for ____________. My name is ___________ from Dr. Meghan 
Brennan’s research team at the University of Wisconsin. Please give me a call back at your 
convenience at [phone number]. 
 
If someone else answers… Hello, may I speak with ___________? My name is ___________ from 
Dr. Meghan Brennan’s research team at the University of Wisconsin. (If not available): Will you 
please ask them to give me a call back at their earliest convenience at [phone number]? 
 
Hello ___________. My name is ____________ and I’m calling about the Crossing the Divide 
research study. Hopefully you received a letter from our study team about our pilot, and perhaps 
[name of participating provider] told you a bit about it. Is now a good time to chat? 
We received your contact information because [name of participating provider] is participating in our 
pilot study and you recently developed a diabetic foot ulcer. As an overview, the Crossing the Divide 
study was developed to improve treatment of diabetic foot ulcers for patients who live and receive 
healthcare in rural areas. This is a pilot study of an intervention to help clinicians provide care based 
on national standards. It was developed by clinicians and healthcare workers who practice in rural 
settings, with help from our research team. This current study will help us prepare for a larger study 
across rural Wisconsin, at which point we hope to find out how good the intervention is at getting 
people back on their feet.  
To participate in the study, I will need to do a screening now over the phone to see if you qualify. If 
you do qualify and are interested in participating, you would come in 30 minutes prior to your next 
clinic visit to review and sign informed consent. At that time, you would receive $100 for enrolling in 
the study. After that, participation includes just coming in for your regular visits with your doctor. We 
would also track your progress through your medical chart over the next 3 months. After that 3-month 
period, we would stop checking your medical record and give you a quick phone call to see whether 
your ulcer has healed. Once that phone call is done, you will have completed the study and receive 
another $100 for your participation. In total, you would receive $200 for enrolling in and completing 
the study. 
Do you have any questions about the study at this time? 
Would you be interested in completing the phone screening to see if you qualify for the study? 
If no… Thank you for your time. Goodbye. 
If yes, proceed. 

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As mentioned, if you choose to enroll and participate in the study, we would need to meet with you for 
30 minutes prior to your next clinic visit. Before I can schedule that, I need to ask you a few questions 
while on the phone. The purpose of the questions are to determine eligibility for the study. This phone 
screening is voluntary, and you can stop the phone screening at any time. If you are not eligible for 
this study, we will record the reason as to why you are not eligible. The purpose of keeping this 
information is to allow us to track the number of people who have decided to enroll or not enroll in the 
study. Only our study personnel will have access to this information. 
 
1. Call Attempt #1  
 
a. Telephone Screener: 
 
b. DATE (mm/dd/yyyy):        /        /                    
 
c. Check One: 
 
Answered  Proceed to #4 
 
Left message  END CALL (complete Call Attempt #2 at a later date) 
 
No message  END CALL (complete Call Attempt #2 at a later date) 
 
 
2. Call Attempt #2  
 
a. Telephone Screener:  
 
b. DATE (mm/dd/yyyy):            /        /        
            
 
c. Check One: 
 
Answered  Proceed to #4 
 
Left message  END CALL (complete Call Attempt #3 at a later date) 
 
No message  END CALL (complete Call Attempt #3 in at a later date) 
 
 
3. Call Attempt #3  
 
a. Telephone Screener:  
 
 
 
 
 
 
 
 
 

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b. DATE (mm/dd/yyyy):         /        /        
            
 
c. Check One: 
 
Answered  Proceed to next question 
 
No answer / No message  End Call  EXCLUDED 
 
 
4. Are you interested in proceeding to the next step in recruitment for the study by answering the 
following questions? 
 
If Yes  Proceed with questions 
 
If No  Thank you for your time. End call  EXCLUDED 
 
 
5. Do you feel comfortable reading and communicating in English? 
 
If NO  EXCLUDED; end call; no additional contact 
I am sorry we do not have translators at this time for this research study. We look 
forward to including translators for multiple languages in the future.  End call  
EXCLUDED 
 
If YES  proceed to next question 
 
 
6. Do you have an ulcer or sore on your foot? 
 
If NO  EXCLUDED; end call; no additional contact 
I am glad you don’t. The study is for patients with foot ulcers or sores, so you don’t 
qualify at this time. Thanks for your time today. End call  EXCLUDED 
 
If YES  proceed to next question 
 
 
7. Do you have health insurance? 
 
If NO insurance coverage  EXCLUDED; end call; no additional contact 
Okay. Unfortunately, you don’t qualify at this time because we don’t want you to get 
stuck with additional bills from specialty care that participating in this study might cause. 
Thanks so much for your time. End call  EXCLUDED  
 
 
 
 
 
 
 
 
 

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If YES  proceed to next question 
 
 
8. What health insurance do you currently have?   
Record name of health insurance:  
 
 
9. Does the insurance match the information provided by the clinic? 
If NO  NOTE! If insurance does NOT match information provided by clinic: 
 
Okay. I’m going to have to get back with you to see if you qualify to participate. We want 
to make sure your insurance would cover specialty care at UW Health should it be 
necessary, and we don’t want you to get stuck with the bill if it doesn’t. Is it okay if I give 
you a call back at this number? Are any dates and times better for you? End call   
Record potential dates/times to try back:  
 
 
 
If YES  Proceed. 
 
 
Based on your answers, you do qualify for the study. Are you willing to come in to the clinic 30 
minutes before your next scheduled visit? It is on ____________ at __________, so that would require 
you to come in at _____________ am/pm. This time would be for reviewing and signing consent to 
enroll and participate in the study. 
We will contact you with a reminder the business day prior to your visit. Would you prefer the reminder 
be a phone call or email? 
            
Phone call 
 
 
     Email 
 
Record email address or phone number here:  
 
Great! We look forward to seeing you on [DATE] at [TIME] before your next clinic visit. Thank you. 
 
 

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Appendix 6: Integrated Care Algorithm for Rural Providers at Belleville 
 

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Appendix 7: Integrated Care Algorithm for Rural Providers at Sauk Prairie Healthcare 
 

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Appendix 8: Referral Form for Patients with Diabetic Foot Ulcers at Belleville 
 

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Appendix 9: Referral Form for Patients with Diabetic Foot Ulcers at Sauk Prairie 
Healthcare 
 

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Appendix 10: Integrated Care Model Chart Review Variables 
 
 
Patient 
characteristics 
Sociodemographics 
Age, sex, race, marital status, area deprivation index, insurance, clinic 1-3, primary care provider, all 
assessed at baseline 
Comorbidities 
Charlson comorbidity index, hypertension, hyperlipidemia, coronary artery disease, stroke/TIA, 
peripheral vascular disease, end-stage renal disease, peripheral neuropathy, Charcot arthropathy, 
body mass index, smoking status, all assessed at baseline 
Medications 
Use of anticoagulant, angiotensin reductase inhibitor, angiotensin II receptor blocker, all assessed at 
baseline and 3-month follow-up 
Lab values 
Hemoglobin A1C, serum creatinine, both assessed at baseline and 3-month follow-up 
Ulcer characteristics 
Date of diagnosis, Wagner severity104 grade at baseline and 3-month follow-up 
Care processes 
5 Vascular disease 
care processes 
1) Baseline exam documents pedal pulse assessment 
2) Baseline visit documents smoking status and cessation counseling within 3-months if indicated 
3) Baseline visit documents statin use, and started within 3-months if indicated 
4) ABI completed in 1 week for patients with decreased/absent pulses 
5) Patients with ABIs ≤0.7 seen by vascular surgery within 2 weeks 
4 Infectious disease 
care processes 
1) Baseline plain films for serial assessment of osteomyelitis 
2) All exams document the presence/absence of findings suggestive of infection 
3) Initial soft tissue infections treated with 2 weeks of broad spectrum antibiotics 
4) Patients with concerns of, deep space abscess or osteomyelitis referred to a surgeon and/or 
infectious disease consultation in 2 weeks 
Other care processes 
ABI results, referral to additional consultants (e.g., podiatry), whether vascular surgery and 
infectious disease consults were in-person or via telehealth, whether vascular surgery or infectious 
disease consults were never scheduled, canceled, or no-shows, all assessed at 3-month follow-up 
Ulcer status 
Healed, ulcerated, major or minor amputation at 3 months, assessed by chart review for all patients 
& by patient report for those receiving integrated care 
Death 
Patient died within the 3-month follow-up 
  
 
 
 
 
 
 
 

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Appendix 11: Phone Script for Recruitment of Participants for Qualitative Recruitment 
Interviews 
Recruitment Telephone Script for Qualitative Recruitment Interviews 
*If enrolled/consented in the care algorithm pilot, check demographics form for preferred contact method to 
determine whether to call or email and check appropriate box for contact method 
 
Telephone call preferred 
 
Email preferred  
First call/email attempt (date & time): _____________________________________________ 
Second call/email attempt, if needed (date & time): __________________________________ 
Final call/email attempt, if needed (date & time): ____________________________________ 
 
If no answer… Hello, this message is for ____________. My name is ___________ from Dr. Meghan 
Brennan’s research team at the University of Wisconsin–Madison. Please give me a call back at your 
convenience at [phone number]. 
If someone else answers… Hello, may I speak with ___________? My name is ___________ from 
Dr. Meghan Brennan’s research team at the University of Wisconsin–Madison. (If not available): Will 
you please ask them to give me a call back at their earliest convenience at [phone number]? 
 
Hello, this is __________________ from the University of Wisconsin–Madison. I am calling to see if 
you might be interested in participating in an interview regarding the recruitment process for the 
Crossing the Divide research study that you [did or did not] choose to enroll in. We want to obtain 
feedback regarding the recruitment process in order to improve it. We’d like to get your opinion about 
what you think works well and what you would change. The interview will take about 30 minutes. You 
will be asked a number of open-ended questions, such as:  
[For healthcare workers]: ‘What do you think about your clinic participating in research?’ or 
‘How would you improve the recruitment process for healthcare workers at your clinic?’ 
[For patient participants]: ‘What do you think motivates people in your community to participate 
in clinical research?’ or ‘What makes you hesitate to participate in research like this?’  
The interview would take place in your preferred format, either in person at your primary care clinic, 
via video conference, or by phone. It will be audio recorded and transcribed with the exception that 
personal identifying information like your name will be removed. After the interview, you will receive 
$50 as a thank you for your participation. 
 
Are you willing to participate in an interview? 
 
Yes _____     No _____ 
 

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What date and time would work well for you? 
 
Date and time: ________________________ 
 
How would you like to do the interview: in person, by phone or via video call? 
a) in person at [clinic name and location]. [Provide information specific to the clinic, such as 
where to park, where to enter building, what to do once inside the building, etc. – will need to 
be determined with clinic staff] 
b) by phone. Is this the number that is best to reach you at? If not, record preferred number: 
______________________________ 
c) via video conference.  
[If enrolled – based on Demographics form]: I have your email address as [email address]. Is 
this the address that I should use to send you a reminder email with meeting link? If not, record 
preferred email address: _______________________ 
[If NOT enrolled]: Can I please get the email address that you’d prefer I use to send you a 
reminder email with meeting link? Record email address:  
________________________________ 
 
If “a” (in person) or “b” (by phone) above:  
[If enrolled]: I have your preferred contact method as phone. Is that still correct, and can I 
make a reminder call to this number the business day prior to your interview? 
If preferred contact method, email, or phone has changed, record that info here:  
_______________________________ 
[If enrollment was previously declined]: We will contact you with a reminder the business day 
prior to your visit. Would you prefer a phone call or email? 
Record phone or email here: _________________________________________ 
 
Thank you for your time, and I look forward to speaking with you on [interview date & time]. 
 
 
 

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Appendix 12: Email Template for Recruitment of Participants for Qualitative Recruitment 
Interviews 
 
Recruitment Email Template for Qualitative Recruitment Interviews 
*If enrolled/consented in the care algorithm pilot, check demographics form for preferred contact method to 
determine whether to call or email 
Subject: Interested in providing feedback on Crossing the Divide research study? 
 
Dear [name], 
 
My name is _________________ with the Crossing the Divide research study team. I am reaching 
out to see if you might be interested in participating in an interview regarding the recruitment process 
for the Crossing the Divide research study about diabetic foot ulcers that you [did or did not] choose 
to enroll in at your clinic. We want to obtain feedback regarding the recruitment process for our study. 
We’d like to get your opinion about what you think works well and what you would change. The 
interview will take about 30 minutes, and would take place in your preferred format, either in person at 
your primary care clinic, via video conference, or by phone. 
 
Might you be interested in participating in an interview? Please let me know if you are interested or 
not, by either replying to this email or calling me at _________________. 
 
Thank you for your time, 
____________________ from the Crossing the Divide research study team 
 
Email is generally not a secure way to communicate sensitive or health related information as there 
are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed 
personal information by email. Email should also not be used to convey information of an urgent 
nature. If you need to talk to someone immediately or would prefer not to receive study 
communication by email, please contact Jamie LaMantia, one of the study coordinators, at (608) 262-
8316.  
 
 
 

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Appendix 8: Phone Script for Recruitment of Participants for Qualitative Retention 
Interviews 
 
Recruitment Telephone Script for Qualitative Retention Interviews 
*Check demographics form for preferred contact method to determine whether to call or email and check 
appropriate box for contact method 
 
Telephone call preferred 
 
Email preferred 
First call/email attempt (date & time): _____________________________________________ 
Second call/email attempt, if needed (date & time): __________________________________ 
Final call/email attempt, if needed (date & time): ____________________________________ 
 
If no answer… Hello, this message is for ____________. My name is ___________ from Dr. Meghan 
Brennan’s research team at the University of Wisconsin–Madison. Please give me a call back at your 
convenience at [phone number]. 
If someone else answers… Hello, may I speak with ___________? My name is ___________ from 
Dr. Meghan Brennan’s research team at the University of Wisconsin–Madison. (If not available): Will 
you please ask them to give me a call back at their earliest convenience at [phone number]? 
 
Hello, this is __________________ from the University of Wisconsin–Madison. I am calling you to 
see if you might be interested in participating in an interview regarding the Crossing the Divide 
research study that you are enrolled in. We want to obtain feedback regarding how the study is doing 
in terms of keeping you enrolled and participating. We’d like to get your opinion about what you think 
works well and what you would change. The interview will take about 30 minutes. You will be asked a 
number of open-ended questions, such as:  
 ‘What types of changes have you experienced in terms of your attitude towards, or willingness to 
participate in, research?’ 
The interview would take place in your preferred format, either in person at your primary care clinic, 
via video conference, or by phone. It will be audio recorded and transcribed with the exception that 
personal identifying information like your name will be removed. After the interview, you will receive 
$50 as a thank you for your participation. 
 
Are you willing to participate in an interview? 
 
Yes _____     No _____ 
 

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Do you have a date and time that would work well for you?  
 
Date and time: ________________________ 
 
How would you liked to be interviewed: in person, by phone, or via a video call? 
a) in person at [clinic name and location]. [Provide information specific to the clinic, such as 
where to park, where to enter building, what to do once inside the building, etc. – will need to 
be determined with clinic staff] 
Can I verify the email address that you’d prefer I use to send you a reminder? Record email 
address: ________________________________ 
b) by phone. Is this the number that is best to reach you at? If not, record preferred number: 
______________________________ 
Can I verify the email address that you’d prefer I use to send you a reminder? Record email 
address: ________________________________ 
c) via video conference. Can I verify the email address that you’d prefer I use to send you a 
reminder email with meeting link? Record email address:  
________________________________ 
 
If “a” (in person) or “b” (by phone) above:  
I have your preferred contact method as phone. Is that still correct, and can I make a reminder 
call to this number the business day prior to your interview? 
If preferred contact method, email, or phone has changed, record that info here:  
_______________________________ 
 
Thank you for your time, and I look forward to speaking with you on [interview date & time]. 
 
 
 

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Appendix 14: Email Template for Recruitment of Participants for Qualitative Retention 
Interviews 
 
Recruitment Email Template for Qualitative Retention Interviews 
*Check demographics form for preferred contact method to determine whether to call or email 
 
Subject: Interested in providing feedback on Crossing the Divide research study? 
 
Dear [name], 
 
My name is _________________ with the Crossing the Divide research study team. I am reaching 
out to see if you might be interested in participating in an interview regarding participant retention for 
the Crossing the Divide research study about diabetic foot ulcers. We want to obtain feedback on how 
to improve retention for our study. We’d like to get your opinion about what you think works well and 
what you would change. The interview will take about 30 minutes, and would take place in your 
preferred format, either in person at your primary care clinic, via video conference, or by phone. 
 
Might you be interested in participating in an interview? Please let me know if you are interested or 
not, by either replying to this email or calling me at ________________. 
 
Thank you for your time, 
________________________ from the Crossing the Divide research study team 
 
Email is generally not a secure way to communicate sensitive or health related information as there 
are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed 
personal information by email. Email should also not be used to convey information of an urgent 
nature. If you need to talk to someone immediately or would prefer not to receive study 
communication by email, please contact Jamie LaMantia, one of the study coordinators, at (608) 262-
8316.  
 
 
 
 

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Appendix 15: Script for Verbal Consent for Participants of Qualitative Interviews 
 
Verbal Consent Script for Qualitative Recruitment and Retention Interviews 
My name is _________________. I am part of a research team from the University of Wisconsin–
Madison, and we are interested in getting your feedback regarding the [recruitment process -or- 
participant retention] for the Crossing the Divide study. The interview should take about 30 
minutes. We hope that the results of this study will improve recruitment and retention rates for not 
only this study, but future studies focused on rural health as well.  
A potential risk to participating in the interview is loss of confidentiality. We will do everything we 
can to minimize this risk. The interview will be audio-recorded, but the transcripts will be de-
identified before analysis and the audio recordings will be kept in a secure location. At the end of 
the study, all identifiable information will be destroyed. Any presentation of the results will NOT 
include your personal information, your healthcare system’s information, or patient information. The 
questions that we ask are not particularly sensitive, however, you can stop the interview or skip a 
question at any time. 
Do you have any questions? 
Do you agree to participate?   
 
 
 
 
 

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Appendix 16: Qualitative Interview Guides 
 
Interview Guides (~30 minutes each) 
Healthcare Worker Recruitment Interview 
You recently attended an informational session about a diabetic foot ulcer study called Crossing the Divide. 
What did you think of it? 
Probes: How was the study explained to you? Did it make sense to you why it was being done, and 
what we were asking of you? What do you think would be the best way to present information 
about research studies to healthcare workers at your clinic – group meeting, individual 
meetings, or an entirely different mode?  
What do you think about your clinic participating in research? 
Probes: What types of research, if any, have you participated in before? How about other people who 
work at your clinic? Do you think the clinic is set up for research like this – why or why not? 
What types of things did you factor or weigh in when making your decision to participate or not? 
Probes: Do you think you have enough patients with diabetic foot ulcers to make participating worth it? 
Are you interested in diabetic foot ulcers, or diabetes in general? 
How would you improve the recruitment process for healthcare workers at this clinic? 
Probes: What did you think about the email invitation (if applicable)? What did you think about the 
length of the meeting? Was there too much detail or not enough? What information were you 
missing to make the best decision for you? 
What else would you like to share? 
 
Additional Questions if healthcare worker attended the informational session/consent virtually: 
Was the presentation appropriate for virtual format? 
How did the process of signing the consent form go? 
How could we do either the virtual aspect of the presentation or the signing of the consent form for participants 
that attended virtually better? 
 
Additional Questions if healthcare worker was involved in the recruitment process of the clinic: 
We are also interested in the recruitment process of a clinic leading up to the informational session. 
1. Can you describe the process from your end? 
2. How did that work for you? 
3. What could have gone better? 

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4. Who do you think needs to be involved in those initial conversations? 
5. What is the key info we need to present to get us through the door? 
 
**Before ending call, complete demographics form for individuals who did not enroll in the care algorithm pilot 
part of the study. 
 
Patient Recruitment Interview 
You recently spoke with a research coordinator to discuss participating in a study for patients with diabetic foot 
ulcers called Crossing the Divide. How did that [insert “initial” for those that proceeded to meet with the 
research coordinator for consent] phone conversation go from your standpoint? 
Probes: What information was important to you when making your decision whether or not to meet and 
discuss the study further? What might have been clearer? What should we make sure we do 
the same? Did your provider let you know anything about the study? 
 
Was the timing of the phone call okay? (in terms of day of week, time) 
SPH Only: We put some brochures at the checkout desk. Did you notice them? Was this a good spot? What 
did you think of the brochures? 
 [Only for those patients who participated in an informed consent discussion]: Most recently, you 
met with a member of the research team at your clinic to discuss participation in Crossing the Divide and 
go through informed consent. How was that process from your standpoint? 
Probes: What parts of the form could have been clearer? What kinds of questions did you have? 
What did you think about meeting in clinic before your appointment to do this? Was there 
enough time? 
What types of things did you factor or weigh in when making your decision to participate or not? 
Probes: Did your provider talk to you about the study beforehand? If so, how did that conversation go? 
What seemed like the biggest risk for you? What seemed like the biggest benefit? 
Have you participated in research before? Why or why not? 
In general, what do you think about your clinic and community participating in research? 
 
Probes: Do you think it’s a good fit? Why or why not? 
What else would improve the recruitment process for patients? 
Probes: Would an information letter have been preferred? Would an onsite coordinator be more 
helpful? 
**Before ending call, complete demographics form for individuals who did not enroll in the care algorithm pilot 
part of the study. 
 
 

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Healthcare Worker Retention Interviews 
Thanks so much for participating in Crossing the Divide. We wanted to check in to see how we are doing in 
terms of retaining healthcare workers in our study. From your standpoint, how have things been going? 
Probes: How has communication with the research team been? What should we continue to do? What 
should we stop? What should we be doing differently? What should we start doing? 
FOR BELLEVILLE ONLY:  
Dr. Brennan came out in December (2023) and May (2024). Did her presentations contain information 
you were interested in? Was anything missing that you would like to know? 
What might be a better way to give updates? Email/letter?  
What about the frequency of contact with the study team? 
BOTH BELLEVILLE & SPH: 
What are your expectations about getting information/study updates moving forward?  
Do you want to see a final analysis? Do you want an opportunity to give input on preliminary analysis? 
Would you like us to distribute publications at the end of the study? 
What about the frequency and modality of updates and information shared? What would you prefer? 
FOR SPH ONLY: 
What, if anything, have you heard from other healthcare workers or patients about your clinic 
participating in research? 
BOTH BELLEVILLE & SPH:  
What do you think are the top 3 things we need to do to keep clinics like yours willing to participate in 
research? 
[Clinicians only]:  
How could we improve the workflow for identifying patients so that it is easy on you? 
How could we improve implementation of the care algorithm or referral checklist so that it is easier for 
you? 
When people like you are signing up to participate in the study, what sorts of things do you think they need to 
know in terms of roles and responsibilities?   
 
Probe: Did anything catch you off guard that you didn’t expect? 
Is there anything I’m missing that you think would improve retention in the study for the healthcare team? 

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Patient Retention Interviews 
Thanks so much for participating in the Crossing the Divide study. We wanted to check in to see how things 
went from your standpoint. 
We recently added a letter that we sent out to patients about a month after they enrolled.  Do you remember 
getting it?  What did you think about it? 
 
Probes: We wanted to send a letter to remind people why we were doing the study and what they could 
expect.  How clear was the information?  Did we leave anything out? Was it helpful, or did it seem redundant? 
Should we keep doing this?  Why or why not? 
What did you think about the 3-month follow-up phone call? 
 
Probes: How was the timing? Would you have liked any advanced notice that it was coming? 
How did the reimbursement process go for you? 
 
Probes: How could we improve it? Moving forward, the university is going to require studies to 
reimburse participants with a VISA card, check, or direct deposit. How do you think that might affect 
your decision to participate? Which of the new payment options appeals to you and why? 
What type of updates about the study would you like to receive? What information would you most like to 
know? 
 
Probes: Would you prefer graphics vs. words? The published manuscript? Just the abstract of the 
manuscript? A bulleted list of our key findings? 
How would you prefer to receive updates about the study?  
 
Probes: A flyer in the clinic? A letter sent via USPS? An email? 
When patients are signing up for the study, what types of information should they know about participating? Is 
there anything that we can make clearer up front, or anything that caught you off guard as you moved through 
the study? 
What did your family and friends think about you participating? How is the fit of this type of research for your 
community? 
What did you think about participating in research in general before agreeing to this study, and how has your 
opinion changed over the course of the study? 
 
Probes: Do you think you would be willing to sign up for something similar again? Why or why not? 
Is there anything else you’d like to share about your experience participating in this study, research in general, 
or anything else? 
 

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Appendix 17: Patient Information Letter 
 
 
Dear [NAME], 
Thank you for enrolling in our research study, Crossing the Divide. It’s been about a month since you agreed to 
participate, and we wanted to send a brief letter to remind you a bit about the study.  
The goal of our research is to improve treatment for rural patients with diabetic foot ulcers and prevent 
amputations. Right now, we are studying two things: 1) how to design a study based in rural clinics so that it 
runs effectively, and 2) whether a care algorithm that follows national recommendations and helps get people 
in to see specialists sooner might improve care. A few reminders about this study: 
• 
No extra research visits are required—keep attending your normally scheduled appointments. 
• 
Your clinician will use the care algorithm. You do not need to do anything special beyond following their 
medical advice. 
• 
We are following your progress through your medical record. 
• 
You will receive a brief (~10 minute) phone call from a member of our research team between [DATES] 
to complete the study. 
Thank you again for participating. If you have any questions, please do not hesitate to reach out to the 
research coordinator, Devan McClain (608-262-2390; dmcclain@medicine.wisc.edu), or myself with 
questions. 
Sincerely, 
[SIGNATURE] 
Principal Investigator, Crossing the Divide 
mbbrennan@medicine.wisc.edu 
+1 (608) 263-1545