Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) Intervention
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Sponsor: University of Massachusetts, Worcester

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Cover Page 
 
Study Title: Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) 
Intervention.    
 
ClinicalTrials.GOV ID: STUDY00002240 
 
NCT Number: TBD 
 
Document Last Updated:  January 30, 2025 
 

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eIRB study ID number: STUDY00002240 
 
Current Version date for this document: January 30, 2025 
 
1. TITLE 
Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) intervention.    
 
2. EXTERNAL IRB REVIEW HISTORY* 
NA 
 
3. PRIOR APPROVALS: 
NA 
 
Conflict of Interest (COI):   
NA 
 
Clinical Engineering Department: 
NA 
 
Biohazardous Agents: 
NA 
  
Radiation: 
NA 
 
Students as Subjects:  
NA 
 
Research Informatics Core: 
The Research Informatics Core will be providing support for this project including assistance 
with participant recruitment.  Details of their involvement will be described in Section 11: 
Procedures Involved and Section 24: Local Recruitment Methods. 
 
UMCCTS Protocol Review Committee (PRC) 
NA 
 
4. OBJECTIVES* 
 
Evidence-based strategies to ensure that patients with COPD have reliable, timely, 
equitable access to treatment are lacking. This deficit is particularly evident in communities 
impacted by determinants of health that adversely impact preventive health behavior and care access.1    
On-demand Mobile Integrated Health (MIH) teams, comprised of community paramedics 
supported by centralized physicians, have been developed to care for patients outside of conventional 
hospital settings.2-5 These teams empower physicians to provide enhanced remote care by collecting 
essential clinical information about patients in their living environment, performing diagnostic 
testing, and administering therapy in the home.3, 6 MIH programs decrease emergency medical 

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services utilization and improve patient satisfaction in select populations, but the impact of MIH 
programs on the outcomes of patients with COPD exacerbation has not been evaluated.7 
In this project, the study team will implement and refine an MIH intervention for patients 
living with COPD. The Paramedic Evaluation for Acute COPD Exacerbation (PEACE) intervention 
will dispatch community paramedics to execute a home-based evaluation and treatment strategy in 
collaboration with a supervising physician and the patient’s ambulatory medical team during and after 
acute COPD exacerbation to promote wellness and recovery. This intervention is intended to improve 
clinical outcomes and reduce acute care costs by eliminating barriers to care, generating actionable 
clinical data that can facilitate appropriate diagnosis, accelerating treatment, and simplifying care 
coordination. Our central hypothesis, based on preliminary data and input from key informants, is 
that an intervention that facilitates community-based management of COPD exacerbation will be 
acceptable and highly adoptable by patients and clinicians. 
The Practical Robust Implementation and Sustainability Model (PRISM) implementation 
framework 8, 9 will be used to describe factors impacting project implementation, with the 
embedded Expanded RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) 
model guiding outcomes measurements.10 Leveraging our prototypical intervention design,  we 
will test and Refine the prototype PEACE intervention in real clinical practice with a cohort 
of patients who are at high risk of COPD exacerbation. We will use a mixed-methods approach 
to evaluate the usability and acceptability of each operational and clinical component of PEACE. 
Measures will include a systematic assessment of protocol adherence, survey instruments, and 
qualitative interviews to explore contextual factors impacting intervention performance.11, 12 We 
will confirm our findings and adapt the protocols informed by a working group comprised of 
clinicians and community partners. Up to 25 patient participants will be enrolled in the 
intervention, plus up to 11 clinician participants will be enrolled to participate in 
usability/acceptability ratings and qualitative evaluations/focus groups. 
 
5. BACKGROUND* 
 
Chronic obstructive pulmonary disease (COPD) claims 150,000 lives every year in the United States, 
diminishes patient quality of life, costs billions of dollars in healthcare expenditures, and widens 
health disparities.13-16 Acute COPD exacerbations cause 873,000 emergency department visits and 
700,000 hospitalizations annually,13, 17 with disproportionate morbidity and mortality in patients 
impacted by social and racial inequities.1, 18-20  Frequent assessment and early treatment are 
effective in mitigating COPD exacerbations and preventing severe complications including 
hospitalization, worsening disability, and mortality.21-24 However, evidence-based strategies to 
ensure that patients with COPD have reliable, timely, equitable access to treatment when 
experiencing acute symptoms are lacking. This project seeks to address this question and provide 
evidence describing the use of MIH models to care for patients living with COPD. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Inclusion Criteria/Exclusion Criteria for Patient Subjects: 
• Inclusion Criteria: 1) Diagnosis of COPD, 2) At least one COPD exacerbation resulting 
in ED utilization in the six months prior to enrollment, 3) Over 18 years of age, 4) Speaks 
English, 5) Resides in the geographical catchment area allowed by the UMass Memorial 
Medical Center MIH Program’s license 6) Referred by a clinician at UMMH to the 
Wellinks pulmonary rehabilitation program 

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• Exclusion Criteria: 1) No prior diagnosis of COPD, 2) Under 18 years of age, 3) Does not 
speak English, 4) Pregnancy, 5) Cannot provide informed consent 6) Not referred to 
Wellinks pulmonary rehabilitation program 
 
Inclusion Criteria/Exclusion Criteria for clinician subjects: 
• Inclusion Criteria: 1) Pulmonologist, primary care physician, emergency physician, or 
paramedic affiliated with the UMMH system, 2) Has provided care to an enrolled patient 
subject, 3) Speaks English, and 4) Over 18 years of age. 
• Exclusion Criteria: 1) Has not provided care to an enrolled patient subject  2) Does not 
speak English, 3) Under 18 years of age, and 4) Cannot provide informed consent. 
 
Justifications for Criteria:  
 
-Our intervention targets community-dwelling patients who have a diagnosis of COPD, so 
patients who do not meet this criteria are necessarily excluded.   
a. Children are excluded as they rarely have a diagnosis of COPD and will not meet any 
inclusion criteria as clinician subjects 
b. prisoners represent a special population that is routinely excluded from similar research 
studies. They represent an inaccessible population. Additionally, they will be excluded as 
they are not residing in a community setting. They will not meet any inclusion criteria as 
clinician subjects 
c. COPD is rare in young women of childbearing age, thus pregnant women are 
extremely unlikely to be eligible as patient subjects for this study. Pregnant women will 
be ineligible for inclusion as patient subjects. They will be eligible as clinician subjects as 
the components of the study in which they participate are minimal risk and will have no 
bearing on their pregnancy. 
d. The commercial products that are used as part of this study, specifically the Wellinks 
telepulmonary rehabilitation program, are only available in English, thus necessitating 
that only English-speaking participants are included in this small pilot study  
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
NA 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
NA 
 
9. STUDY TIMELINES* 
 
Overall timeline:  Recruitment will begin upon the disbursement of study funding and will be 
completed within 18 months of that date.  Primary analyses will be completed no later than two 
years from the disbursement of funds. 
 
Involvement of Subjects in PEACE Beta Testing:  
 
1.0 Recruitment (Day 0) 
1.1 Informed consent  

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1.2 Patient-facing education 
1.3 Data Intake Patients 
1.3.1 Demographic and Background Survey 
1.3.2 Baseline COPD Assessment Test 
1.3.3 Baseline Data collection 
 
2.0 Intervention Period I (~Day 1-182) 
2.1 The subject will have on-demand access to PEACE Intervention via their primary 
care or subspecialty clinicians as well as the Wellinks team  
2.2 Subjects will be asked to fill out a survey within 7 days of each PEACE encounter 
2.3 PEACE visits and Healthcare utilization will be tracked by the research team 
 
3.0 Working Group 1 (~Day 182) 
3.1 Qualitative working group.  All subjects will be asked to attend a single (~1-2 hour) 
structured interview on Zoom 
 
4.0 Intervention Period II (~Day 182-365) 
4.1 The patient will have on-demand access to PEACE Intervention via their primary care 
or subspecialty clinicians as well as the Wellinks team  
4.2 Subjects will be asked to fill out a survey within 7 days of each PEACE encounter 
4.3 PEACE visits and Healthcare utilization will be tracked 
 
5.0  Working Group 2 (~365) 
5.1 Qualitative working group.  All subjects will be asked to attend a single (~1-2 hour) 
structured interview. 
5.2 Follow-up COPD Assessment Test (patient subjects only) 
 
6.0 Follow-up Data Collection (~Day 365-Day 730) 
6.1 Records review only, no subject interaction 
 
10. STUDY ENDPOINTS* 
 
Our primary outcome The primary feasibility measure will be the recruitment rate. The 
primary process outcome will be the number of PEACE referrals during the study period. 
Additional qualitative outcomes are described below in Table 1, organized by PRISM domain. 
Primary and secondary outcome measures, their timing, and how they will be measured are 
summarized in Tables 1 and 2 below. 
There are no primary or secondary safety measures being recorded for this study. 
 
 
 
 
 
 

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Table 1:  Beta Testing Outcome by PRISM Domain 
PRISM 
Domain 
Outcome 
Data Source 
Analysis 
Patient 
Characteristics 
• Sample Demographic characteristics 
• Excluded/Declined Demographics 
Study Records 
Interviews 
Descriptive 
Qualitative  
Organizational 
Characteristics 
• Participating clinic size/structure 
Interviews 
Descriptive 
Qualitative 
Intervention 
Clinician and 
Patient 
Perspective  
 
 
 
• Affective Attitude 
• Intervention Coherence 
• Self-Efficacy 
• Ethicality 
• Burden and anticipated cost 
• Opportunity cost 
• Fidelity to PEACE protocol 
Video review 
Interviews 
 
Intervention 
Usability Scale 
 
Acceptability E-
S
l
Qualitative 
Descriptive 
External 
Environment 
• Institutional, local, and state resources 
that could be leveraged for 
intervention delivery  
Interviews 
Literature Review 
Descriptive  
Implementation 
and 
Sustainability 
Infrastructure 
• Staff Fidelity to Intervention (see 
Figure 3) 
• Cost of  intervention  
Clinical Records 
Interviews 
Study Records 
Descriptive 
Qualitative   
Table 2: Feasibility and Clinical Measures   
Outcome 
Measure 
Frequenc
y 
 
0 
6 
12 
Sample 
Descriptio
n  
Demographic Characteristics of Study Sample: Participant age, gender 
identity, race and ethnicity, education level, smoking status, insurance type, 
employment status, living arrangements, driving status, and comorbidities  
X 
 
 
Sample COPD Severity: Gold Score, ED visits and hospitalizations in year 
before enrollment  
X 
 
 
Feasibility 
Outcomes 
Recruitment and enrollment: Number of participants approached, met 
eligibility, and randomized; reason for refusal of nonparticipants 
(primary feasibility outcome) 
X 
 
 
Baseline Measures: Completeness of data collection 
X 
 
 
Retention: Loss to follow-up, perceived reason for discontinuation, 
completeness of post-intervention data collection 
 
X 
X 
PEACE Referrals during study period: Number of encounters requested 
(Primary process outcome) 
 
X 
X 
Clinical 
Outcomes 
  
  
PEACE Visits and Disposition: Number of PEACE visits completed and 
rate of home treatment versus ED referral 
 
X 
X 
Ambulatory Visits: Number of ambulatory visits for COPD (routine/acute)  
 
X 
X 
EMS Utilization: Number of prehospital encounters related to COPD  
 
X 
X 
Hospitalizations: Number and length of hospitalizations for COPD  
 
X 
X 

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11.PROCEDURES INVOLVED* 
 
Subject Screening (day -1) 
→ The UMass Chan research informatics core will identify eligible patients by 
creating an automated report that flags patients who meet the inclusion criteria 
(filtering by diagnosis, city of residence, and use of Wellinks) 
→ The RIC will securely (via encrypted secure  excel document) provide the study 
team with reports containing the contact information for potentially eligible 
patients  
» STUDY00002240_PEACE_HIPAA Waiver of Authorization 
 
 
Enrollment & Intake Visit of Patient Subjects: 
- 
Recruitment: See Section 24.  
→ Documents: 
§ STUDY00002240_PEACE_HIPAA Waiver of Authorization  
§ STUDY00002240_PEACE_SCREENER 
§ STUDY00002240_PEACE_DeclinedIneligibleLog  
STUDY00002240_SOLICITATIONMESSAGEPATIENTSUBJECT 
 
- 
Consent: See Sections 30 & 31. Study Staff will obtain at least three ways (email address, 
primary phone number and mailing address) to contact participants to schedule 
interviews and fill out ad-hoc surveys. 
→ Documents: 
§ STUDY00002240_PEACE_Consent 
§ STUDY00002069_PEACE_PATIENTMASTERCODE 
 
- 
Intake: After obtaining consent, the study staff will access EMRs to obtain baseline data.  
Patients will also be asked to complete a baseline COPD Assessment Test.  
Other institutional stays: Number and length of stay in skilled nursing 
facilities or acute rehabilitation settings  
 
X 
X 
COPD Assessment Test (CAT): health-related quality of life and COPD 
symptom severity assessment 
X 
X 
X 
Unanticipated ED visits:  ED visits within 72 hours after PEACE visit  
 
X 
X 
Mortality: Death will be ascertained through chart review 
 
X 
X 
Exacerbation Relapse:  An event where COPD symptoms worsen and 
require a second pharmacological intervention25    
 
X 
X 
COPD related medication changes: Number of adjustments made to study 
participants’  treatment regimen (initiation, discontinuation, dosage 
adjustment, or substitution of medications aimed at managing COPD) 
 
X 
X 

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→ Documents:  
§ STUDY00002240_PEACE_DemographicsData 
§ STUDY00002240_PEACE_COPD_Assessment Test 
 
Enrollment of clinician subjects: 
- 
Recruitment: See Section 24.  
→ Documents: 
§ STUDY00002240_PEACE_CONSENTEMAILCLINICIANSUBJECTS 
§ STUDY0002240_PEACE_QualitativeIntake 
§ STUDY00002240_PEACE_DeclinedIneligibleLogClinician 
 
- 
Consent: See Sections 30 & 31 
→ Documents 
§ STUDY00002240_PEACE_CONSENTEMAILCLINICIANSUBJECTS 
 
- 
Master Code Contact Information: Study Staff will obtain at least two ways (primary 
phone number and mailing address) to contact participants to schedule interviews and 
prompt participants to complete surveys.  
→ Documents: 
§ STUDY00002069_PEACE_CLINICIANMASTERCODE 
 
- 
Intervention Period I (~Day 1-182) 
→ The patient will have on-demand access to PEACE Intervention via their primary care 
or subspecialty clinicians as well as the Wellinks team. 
1..1 
The Paramedic Evaluation for Acute COPD Exacerbation (PEACE) 
intervention is a mobile integrated health home visit specifically designed 
to manage acute COPD exacerbation in the community. PEACE was 
developed using high-quality literature, stakeholder feedback, and 
observations from the UMMHC pilot MIH studies.  
1..2 
Ambulatory teams are empowered to refer patients for PEACE visits when 
patients need more focused, in-person care but a brick-and-mortar setting 
is inaccessible or inappropriate.  PEACE visits are available 7 days a 
week/24 hours a day. All clinical teams participating in this study are 
familiar with the MIH program as they have engaged with it for other 
purposes 
1..3 
 Once a visit is requested via an electronic health record (EHR) order, a 
community paramedic presents to the patient’s home within 2 hours, 
evaluates the patient using mobile diagnostic testing, and initiates 
pharmacological therapy if necessary. A standardized clinical approach 
and documentation strategy is used including a focused history and 
physical exam, venous blood gas, trending pulse-oximetry, medication 
reconciliation, smoking cessation resources, mobile x-ray etc.  
1..4 
The community paramedic is supervised in real-time by a physician to 
establish a care plan and disposition- either treatment at home with 
ambulatory follow-up or, if the patient is too acutely ill to be treated in 
place, transfer to the ED. While often used during periods of acute 

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exacerbation, PEACE can also be used to support post-acute care and 
augment telepulmonary rehabilitation services. 
 
→ PEACE visits and Healthcare utilization will be tracked throughout the beta testing 
period. 
→ Every time a patient undergoes a PEACE visit, the study team will ask the patient, 
their primary care physician, pulmonologist, and the treating paramedic (if enrolled in 
the study) to complete a post-visit evaluation survey.  
1..1 
Documents: 
1..1.1 Study00002240 PEACE Visit Data 
1..1.2 STUDY002240 PEACE Post Visit Form 
1..1.3 STUDY00002240_PostVisitFormClinician 
 
 
7.0 Working Group 1 (~Day 182) 
7.1 Qualitative working group.  All subjects will be asked to attend a single (~1-2 hour) 
structured interview in a focus group-type setting  
7.2 The focus of these focus groups will be on 1) Selecting and engaging patients most 
likely to benefit from the PEACE intervention 2) Determining the best timing of the 
PEACE intervention in each patient’s healthcare trajectory, 3) optimizing the clinical 
and diagnostic capabilities of the mobile intervention 4) establishing relationships 
between the mobile clinical team and other members of patients’ personal and 
medical care team, and 5) measurements of the effectiveness of the program. 
7.2.1 Patient subjects will be informed that if they choose to participate in the 
focus groups, they may be asked to discuss their health and health 
information regarding their diagnosis of COPD with other patients and 
clinicians in the mixed-subject focus groups. 
7.3 Structured interviews will be scheduled at a mutually convenient time for subjects 
and study staff.   
7.4 Each subject will participate on one day for approximately 1-2 hours.   
7.5 Interviews may be held in person or via secure zoom video chat 
7.6 Interviews will be held in groups of 3-4 with a mix of subject types in each group  
7.7 After a brief reiteration of the study purpose, the interviewer will confirm consent to 
record the interview for transcription and analysis purposes before proceeding. 
Interview responses will be recorded by hand on the interview guide or typed into a 
document on the interviewer’s encrypted computer, and also digitally recorded to 
capture verbatim content and professionally transcribed by a member of the study 
team for later qualitative analysis.  
7.8 At the end of the interview, all participants will be asked to fill out a brief (10 minute) 
structured Redcap Survey. 
7.9 All interviews will be digitally recorded using the Zoom recording application with 
Microsoft Teams as a backup. This program will be run on a computer present in the 
room for in-person interviews or on the computer of the study team member 
conducting any Zoom interviews. Only audio recording will take place.  No video 
recording will take place at any time. 

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7.9.1 Immediately following each interview, the recording will be transcribed, 
and the original recording subsequently deleted once transcription is 
complete. 
7.9.2 Documents 
7.9.2.1 STUDY00002240_PEACE_SampleInterviewGuide 
7.9.2.2 Transcribed Interviews 
7.9.2.3 STUDY00002240_PEACE_QUALITATIVEINTERVIEWPOSTS
URVEY  
 
8.0 Intervention Period II (~Day 182-365) 
8.1 The patient will have on-demand access to PEACE Intervention via their primary care 
or subspecialty clinicians as well as the Wellinks team as described above 
8.2 PEACE visits and Healthcare utilization will be tracked 
8.3 Every time a patient undergoes a PEACE visit, the study team will ask the patient, 
their primary care physician, pulmonologist, and the treating paramedic (if enrolled in 
the study) to complete a post-visit evaluation survey.  
8.3.1 Documents: 
8.3.1.1 Study00002240 PEACE visit form 
8.3.1.2 Study00002240_PEACE_POSTVISITINSTRUMENT 
8.3.1.3 STUDY00002240_PostVisitFormClinician 
 
 
9.0  Working Group 2 (~365) 
9.1 Qualitative working group.  All subjects will be asked to attend a single (~1-2 hour) 
structured interview in a focus group setting as described above 
At the end of the interview, all participants will be asked to fill out a brief (10 minute) 
structured Redcap Survey. 
9.2 Patient subjects will be asked to also complete a follow up COPD Assessment Test  
9.2.1 Documents: 
9.2.1.1 STUDY00002240_PEACE_SampleInterviewGuide 
9.2.1.2 Transcribed Interviews  
9.2.1.3 STUDY00002240_PEACE_QUALITATIVEINTERVIEWPOSTS
URVEY  
9.2.1.4 STUDY00002240_PEACE_COPD_Assessment Test 2 
 
10.0 
Follow-up Data Collection (~Day 365-Day 548) 
10.1 
Records review only, no subject interaction. The study team will query the EHR 
to collect follow-up data points about enrolled subjects 
→ Documents:  
- 
Study00002240_PEACE_Utilizationsummary 
 
12. DATA AND SPECIMEN BANKING* 
NA 
 
13. Data Analysis and Management* 
 

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Sample Size:  
Analysis Strategy:  
 
Quantitative Analysis: As is appropriate for a pilot study, quantitative data including 
demographic data, exploratory clinical outcomes data, and subject usability and acceptability 
ratings as well as the evaluation of fidelity to each intervention component will be analyzed and 
reported descriptively. 
 
Qualitative Analysis: Analysis of qualitative data will be conducted using ATLAS.ti qualitative 
software. Three independent coders will inductively develop a preliminary set of codes 
organized by PRISM domain.8 The codebook will be elaborated upon based on emergent themes 
and adjusted as the interviews proceed.  The entire qualitative team will subsequently review 
each transcript and develop a revised codebook after reviewing ~ 20% of the interviews together. 
We will apply the codebook to all interviews, using constant comparison methods to generate 
higher-level themes and synthesize our results into a formative evaluation report of the key 
findings.  
 
Data Management Plan: 
All study data will be recorded on a REDCap database established on a secure encrypted server 
on Amazon Web Services. All access to the database will be through permissions established by 
the IT REDCap administrator. Investigators will have to log into the REDCap database to enter 
or view data. Logic data checks will be built into the data entry process to help clean the data at 
entry. Quality control edits will be run to identify inconsistencies and questionable values in the 
data. The audit trail will be activated for the duration of the study. 
Data for analysis will be downloaded directly from REDCap and converted to SAS, STATA, 
datasets or R data frames for analysis. The downloaded datasets will be deidentified and are 
HIPPA as well as 21 CFR Part 11 compliant. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
All unanticipated adverse events will be reported, and the study PI will closely monitor all 
aspects of the study.  
 
The PI will be responsible for monitoring adverse events during the study. If an adverse event 
occurs, their role will be to identify the concern, to develop an appropriate response to alleviate 
or minimize any adverse event, and to ensure that the adverse event is reported in a timely 
manner to the appropriate authority. We anticipate that these adverse will be rare in this minimal 
risk study. We will assess whether an undesirable experience (adverse event) occurred and will 
record details of all adverse events on an adverse event case report form. We do not anticipate 
that any serious adverse events (death, life threatening illness, new serious or permanent 
disability) will occur. However, should such an event occur, we will report the event within five 
business days to the University of Massachusetts Chan Medical School (UMCMS) Institutional 
Review Board per HRP-103-Investigator Manual guidelines. 
 

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The adverse event case report form will include a description of all undesirable experiences, 
required interventions, and an assessment of the participant after the event if possible. An 
estimate of the extent of injury and prevention strategies will be reported. The principal 
investigators will classify the relationship of the study protocol to the event as follows: 
 
• Not related: The event is clearly related to factors not related to the study protocol. 
• Remote: The event was most likely related to factors not related to the study protocol. 
• Possible: The event follows a reasonable temporal sequence associated with participating in the 
study and/or is consistent with events related to the study protocol but is possibly related to 
factors such as the participant’s clinical state. 
• Probable: The event follows a reasonable temporal sequence associated with participating in 
the study and/or is consistent with events related to the study protocol and cannot be reasonably 
explained by factors such as the participant’s clinical state. 
 
The severity of an adverse event in both groups is defined as a qualitative assessment of the 
degree or intensity of an adverse event as determined by the principal investigator as follows: 
 
• Mild: No impact (in any way) on the participant. 
• Moderate: Impacts on the participant but is not life-threatening or incapacitating. 
• Severe: Fatal, life threatening, permanently disabling; severely incapacitating; 
requires/prolongs inpatient hospitalization. 
 
All adverse events will simultaneously be reported to institutional officials. The report will 
summarize the facts of the case, including the date and a description of the participant; whether 
the event is related to the study’s protocols; the steps that have been taken to address the issue; 
whether the event provides emerging knowledge about the risks of the study that should be 
conveyed to participants; and whether the consent form should be revised. 
 
As this is a minimal-risk study, we do not plan on having a data safety monitoring board review. 
The UMMH MIH program is a fully licensed program that meets clinical standards of care; it is 
supervised by the Massachusetts Department of Public Health and its medical director submits 
clinical data to them quarterly for quality and safety review.  The program also has an internal 
quality improvement/assurance protocol for all completed visits.  The program is accustomed to 
providing peri-acute care, particularly to patients with COPD. 
 
The frequency of data review for this study is summarized in the following table: 
 
Data Type: 
Frequency of Review: 
Participant recruitment (adherence to protocol 
on inclusion & exclusion criteria) 
The PI will directly observe recruitment for 
the first five cases, then will observe random 
cases bi-monthly once the study is 
established.  
Data collection methods 
The PI will directly observe data collection on 
the first five cases, then will observe random 
cases bi-monthly once the study is 
established.  

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Integrity of data storage procedures 
The PI will directly monitor data storage the 
first five cases, and then will review all data 
monthly once the study is established.  
 
The PI will report all new information required by the IRB within 5 business days including: 
Information that indicates a new or increased risk, or a new safety issue, a protocol violation that 
harmed subjects or others or that indicates subjects or others might be at increased risk of harm 
or any of the other required reporting parameters.  
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
NA 
 
16. RISKS TO SUBJECTS* 
The main risks to participants are: 
 
• Delays in definitive emergency care 
• Loss of confidentiality or privacy given that their contact information and PHI will be 
collected 
• Psychological distress from participating in the survey or qualitative interview 
 
 
1) Delays in definitive emergency care 
a. The mobile integrated health service provided as part of this study is licensed 
under the purview of the state Department of Public Health and is considered a 
standard of care. It is an already active program and is utilized by patients daily 
under the supervision of Dr. O’Connor, who is the medical director of the 
program, to provide peri-acute care.  To mitigate any risk of patients’ delaying 
emergency care by inappropriately requesting an MIH visit, patients and 
clinicians will be extensively educated about the purpose of the MIH program and 
its capabilities and limitations.  They will be counseled in symptoms and 
conditions necessitating immediate use of the 911 system instead of the MIH 
hotline. A copy of the licensure letter provided by the Massachusetts Department 
of Public Health is included with this application. 
b. The MIH team is also extremely well positioned to transition care into the 
traditional 911 care pathway should a participating patient be determined to be 
experiencing a medical emergency. The dispatch and ambulance services that 
support the MIH program are the same services that perform emergency 
transportation in the geographical catchment area where the study will be 
performed; therefore, their communications are integrated, and the nature of the 
care being performed can be transferred at any time. 
c. The MIH care pathway has several safeguards to transition care into an 
emergency response if needed. If a community paramedic is dispatched to the 
patient’s home and the paramedic or the consulting physician feels that the patient 
is experiencing an emergency, he/she may contact the program’s dispatch and 
activate the 911 pathway. If this happens, a transporting vehicle will be 
immediately dispatched to the patient’s home. The community paramedics are all 

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experienced professionals with years of work functioning in an urban 911 system 
and will render care until the transporting vehicle arrives.  
d. All community paramedics will be equipped with a full cadre of advanced life 
support level medications and supplies. The MIH program will only function in 
the geographical zone where the community paramedics belong to the same 
organization as the 911 responding service and no other organization’s 
involvement is anticipated. 
e. If the patient has any questions or clinical concerns during any research or clinical 
visit, there will always be both a physician on call for the research study as well 
as a clinical physician on call for the mobile integrated health program who can 
be contacted for additional real-time support. 
 
Protections against the specific risks identified above include the following: 
 
• Loss of Privacy/Confidentiality 
o All data will be managed securely as noted above. We view this risk to be 
minimal. All data and personal information about subjects from both the 
observational cohort and the qualitative arm will be managed securely and 
accessible only by authorized members of the study team.  All identifiers will be 
disposed of as soon as appropriate (see section 26). 
 
• Psychological Distress  
o The informed consent process will discuss the potential risk that participating in 
discussions related to health and emergency care might cause distressing 
rumination about overall health and aging. We will inform all subjects verbally 
and in writing that they may decline to answer any question asked and may stop 
participating in the interviews at any time. We view this risk as minimal.  
o  
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
Patients who participate in the program may experience improved outcomes related to their 
COPD from the enhanced healthcare access provided by the PEACE program. 
 
18. VULNERABLE POPULATIONS* 
 
Employees of site 
No employees at the site will be purposely recruited but may be included incidentally.  
 
Children 
Children will not be included in this study. 
  
Prisoners 
Prisoners will not be included in the study. 
  
Adults Unable to Consent 
Adults unable to consent will not be included in this study 
 

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Page 15 of 24 
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Pregnant Women  
 
Pregnant women will be excluded from enrolling as patient participants. 
 
Pregnant women may be included as clinician participants. This part of the study is minimal risk 
and presents no intervention that will impact or pose additional risk to their pregnancy. No 
inducements, monetary or otherwise, will be offered to terminate a pregnancy. Individuals 
engaged in the research will have no part in any decisions as to the timing, method, or 
procedures used to terminate a pregnancy. Individuals engaged in the research will have no part 
in determining the viability of a neonate. 
 
19. MULTI-SITE RESEARCH* 
NA 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
NA 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
Individual results from surveys and interviews will be shared with subjects upon their request..  
Completed deliverables such as manuscripts, whitepapers, and posters may be shared with 
subjects at their request. 
 
22. SETTING 
 
- 
Enrollment & Informed Consent: Patients will be located in the community; study team 
will be located in private offices at the University Campus in the departments of 
medicine and emergency medicine  
 
- 
Data Abstraction: Private offices at the University Campus in the departments of family 
medicine and emergency medicine  
 
- 
Interviews: Subjects will be located in the community or in private offices at the 
university campus; the study team will be located in private offices at the University 
Campus in the departments of medicine and emergency medicine  
 
- 
Follow-up data collection: Private offices at the University Campus in the departments 
of medicine and emergency medicine  
 
- 
Data analyses and manuscript writing will occur in private offices at the University 
Campus in the departments of medicine and emergency medicine 
 
 
23. RESOURCES AVAILABLE 
 

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Page 16 of 24 
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Study Staff: All Study Staff members are up to date on CITI certification and are aware that this 
training must be renewed every three years. They will conduct this research in accordance with 
the current, IRB-approved protocol.  
- 
Study Investigators: 
→ Principle Investigator (PI): The PI is a board-certified Emergency Medicine 
physician with experience in human subjects research.  
§ Responsibilities: The PI will be responsible for overseeing the entire study 
including, but not limited to (1) dissemination of the research protocol to 
all Study Staff; (2) recruitment; (3) enrollment; (4) data collection; (5) 
data analysis; and (6) dissemination of results. The PI will ensure all Study 
Staff are adequately trained and monitor their progress to ensure they are 
following the protocol. 
→ Co-Investigators (Co-Is): The Co-Is are physicians from the departments of 
Emergency Medicine and Medicine 
§ Responsibilities: The Co-Is will assist the PI with all aspects of the study 
including, but not limited to: (1) recruitment; (2) enrollment; (3) 
administering questionnaires; (4) interpretation of results; and (5) 
preparation of the resulting manuscripts.  
- 
Additional Study Staff Roles:  
→ Research Assistants (RA): The RA will have basic training in research methods 
and human subjects’ research, as well as a bachelor’s degree in a human science 
field or equivalent.  
§ Responsibilities: They will be trained by the PI and co-investigators to 
complete most aspects of the study including, but not limited to: (1) 
explaining the study to eligible individuals; (2) obtaining informed 
consent; (3) how to conduct a chart review; (4) data handling; and (5) 
administering questionnaires.  
 
24. LOCAL RECRUITMENT METHODS 
 
Feasibility: We have completed similar studies in the target population and were able to recruit 
100 participants in one year.26 Therefore we feel that the small number of patients anticipated for 
inclusion in this pilot study will be minimal.   
 
Procedures: We have created a one-page basic solicitation to provide to prospective subjects 
that outlines the study details in an easy-to-read format. 
- 
Study staff will identify potentially eligible individuals through EHRs with assistance 
from the Research Informatics Care.  As described above, the RIC will securely provide 
the team with a list of patients who are potentially eligible for the study based on their 
age, city of residence, diagnosis of COPD, and participation in the Wellinks program. 
→ If the individual seems eligible based on the above information, the study staff 
will query other portions of the EMR (medical history, healthcare utilization 
patterns etc.) to verify EMR-based eligibility.  
→ If the individual still appears eligible, the study team will send the patient a 
MyChart message soliciting participation in the study. The message will include 

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Page 17 of 24 
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PI contact information for questions and prompt interested patients to fill out an 
online screener indicating interest. 
→ Once subjects have completed the online screener, the study team will contact 
them via phone to discuss the study, answer any further questions, and proceed 
with study activities.   
→ We will inform patients during this initial phone conversation that consent forms 
and surveys will be sent via email which is not a secure form of communication 
and receive permission to email them links or QR codes to access the REDCap 
consent form/survey.  If patients do not want to receive links/QR codes to study 
instruments via email, we will offer patients the option of receiving them via snail 
mail. 
→ Patients will be given the option of reviewing and signing the consent form 
independently or doing it while on a teleconference with a member of the study 
team so that the consent can be reviewed in real-time. 
→ A $(50) gift card will be given to each participant after they complete baseline 
intake forms, and then again after each interview during the study. To be eligible 
to receive the research stipend - the subject’s name, address, phone number, and 
type of phone (mobile, landline) will be collected by the study team and provided 
to the UMass Chan business office to procure the payment.  Once this information 
is provided to the business office – this identifying information will be destroyed 
by the PI. 
→  
§ Documents 
• STUDY00002240_PEACE_HIPAA Waiver of Authorization  
• STUDY00002240_SCREENER_12.4.2024_V1 
• STUDY00002240_PEACE_DeclinedIneligibleLog 
• STUDY00002240_SOLICITATIONMESSAGEPATIENTSUBJE
CT 
 
Destruction of Identifiers:  
- 
Declined or Ineligible: Any participants who decline will be noted on the 
Declined/Ineligible Log. No identifiers are maintained on this log. 
- 
Agree to Participate: Following the enrollment and intake visit, identifiers from the 
Screening Log will be transferred to the Master Code and de-identified demographic 
information will be transferred to the appropriate Redcap Database. 
 
Professional Subjects: 
 
§ The study team will identify and subsequently email each subject (e.g. 
clinician, administrator) using a standardized email script to describe the 
study. 
§ Potential subjects will be identified and contacted individually. The 
invitation will include a description of the project and a summary of the 
topics to be covered in the interview.  
§ Only publicly available contact information (i.e., email address) will be 
used to contact clinicians 

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§ After initiating the recruitment email or phone call, the team will make a 
single follow-up attempt for non-responders.  
§ Interested participants will be invited to self-schedule interview in an 
online scheduling portal 
§ Once the interview has been scheduled, the study team will proceed with 
informed consent as per section 30. 
§ A $(50) gift card will be given to each participant after they complete each 
of their interviews and surveys. To be eligible to receive the research 
stipend - the subject’s name, address, phone number, and type of phone 
(mobile, landline) will be collected by the study team and provided to the 
UMass Chan business office to procure the payment.  Once this 
information is provided to the business office – this identifying 
information will be destroyed by the PI. 
§ Documents: 
» STUDY00002240_PEACE_CONSENTEMAILCLINICIANSUBJ
ECTS_12.4.2024_V1 
» STUDY00002240_PEACE_DeclinedIneligibleLogClinician_12.6.
2024_v1 
 
 
25. LOCAL NUMBER OF SUBJECTS 
 
We expect up to 25 patient participants will be enrolled in the intervention, plus up to 11 
clinician participants will be enrolled to participate in usability/acceptability ratings and the 
qualitative evaluation. 
 
26. CONFIDENTIALITY  
 
Because the National Institute of Health (NIH) is funding this research, this study will 
automatically have a Certificate of Confidentiality. The Certificate protects the study team from 
being forced to release information that may identify participants as part of a court, legislative, 
administrative, or other proceeding. 
 
 
Procedures to Secure the Data:  
- 
Participants will be assigned a unique Study ID# and most data related to a given 
participant will use this ID (see table below).  
- 
We may quote participant comments in presentations and publications; however, any 
direct quotations will be carefully reviewed to ensure that they do not include any 
potentially identifiable content.  
- 
UMMS/UMMMC computers are password-protected and encrypted.  
- 
Data will be stored in REDCap 
 
 
 

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Document 
Coding 
Access 
Storage 
Destruction 
Declined Ineligible 
Logs  
- De-identified 
demographic 
information will be 
recorded on this 
document  
- Will not 
contain any of 
the 18 HIPAA 
identifiers  
- Authorized 
Study Staff & 
Support 
Personnel  
- Securely stored 
on a password-
protected 
UMMMC/UMMS 
computer 
- Will be archived once 
results have been 
published  
Email 
Script/Solicitations- 
Patients 
 
 - *Identifiable 
information; 
Will contain 
potential 
participants’ 
name and 
email address 
- Authorized 
Study Staff 
 
- Securely stored 
on a password-
protected 
UMMMC/UMMS  
- Contact information 
will be deleted for each 
participant once data 
collection is complete.  
Email 
Script/Solicitations- 
Clinicians 
 
 - *Identifiable 
information; 
Will contain 
potential 
participants’ 
name and 
email address 
- Authorized 
Study Staff 
 
- Securely stored 
on a password-
protected 
UMMMC/UMMS  
- Contact information 
will be deleted for each 
participant once data 
collection is complete.  
Master Codes for 
Patient Subjects 
- Identifiers will be 
transferred to the 
Master Code; All other 
information will be 
entered into RedCap 
under a random ID 
 - *Identifiable 
information; 
The only place 
that 
identifying 
information 
will be linked 
with Study 
ID# 
- Authorized 
Study Staff 
 
- Securely stored 
on a password-
protected 
UMMMC/UMMS  
- Name, date of birth, 
and contact information 
will be deleted for each 
participant once data 
collection is complete.  
Master Code for- 
Clinician Participants 
- Contact information 
will be collected from 
participants using 
Redcap (Contact Info) 
and then transferred to 
the Master Code 
- *Identifiable 
information 
- Authorized 
Study Staff 
- N/A 
- Contact information 
will be transferred to 
the Master Code 
following completion of 
the enrollment and 
intake visit and the 
Redcap form will be 
destroyed  
Consent 
- Written 
documentation 
- *Identifiable 
information 
- Authorized 
Study Staff 
- Securely stored 
in the PI’s locked 
office 
- Forms will be retained 
for 6 years following 
completion of this 
research 
Transcribed 
Interviews  
No Identifiers 
 
Authorized 
Study Staff  
 
- Securely stored 
on a password-
1) Transcriptions will 
be archived once results 
have been published  

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Page 20 of 24 
Template Revised 05/21/2024 
protected 
UMMMC/UMMS 
ALL Data Collection 
Sheets 
Collected using the 
Redcap form 
Study ID# 
only 
 
Authorized 
Study Staff  
 
Directly entered 
by the RA or 
subject into Recap 
REDCap database will 
be archived once results 
have been published  
Interview Guide 
No Identifiers 
 
Authorized 
Study Staff  
 
Written in 
advance by study 
staff 
1) Interview guide will 
be archived once results 
have been published  
HIPAA Waiver of 
Authorization 
No Identifiers 
 
Authorized 
Study Staff  
 
Written in 
advance by study 
staff 
1) HIPAA Waiver of 
authorization will be 
archived once results 
have been published  
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
 
Procedures to Protect Subjects: 
- 
To make subjects feel at ease, Study Staff will clearly explain the function of the PEACE 
program and the additional steps entailed by the research study.  Patients will be notified 
explicitly that they may participate in the home visits as part of the clinical protocol 
without participating in the research study. 
- 
 Participants will be informed that they can skip any question in the questionnaires or 
interviews that they feel uncomfortable answering.  
- 
Study Staff will remind participants that their participation is voluntary and withdrawal of 
participation at any time will not involve any penalty or loss of benefits to which they are 
otherwise entitled.  
- 
Participants will be given contact information for Study Staff should they have any 
questions or concerns at any time or if they wish to withdraw from the study.  
- 
Participants will be offered copies of all signed forms (Consent and HIPAA 
Authorization) and given contact information for Study Staff should they have any 
questions or concerns at any time, or if they wish to withdraw from the study.  
- 
Study Staff members directly involved with recruiting and consenting participants will 
not be involved in their clinical care.  
- 
The collection of sensitive information will be limited to the information that is necessary 
to conduct this research.  
 
Protected Health Information:  
- 
A HIPAA Waiver of Authorization has been obtained to allow Study Staff to identify 
eligible participants for recruitment (see Section 24).  
- 
Following consent, a signed HIPAA Authorization will be obtained to access and record 
additional information from the participant’s EMR. This information will be limited to 
information directly related to the study. 
 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 

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No funds have been set aside for research-related injury. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There are no anticipated costs for which participants will be responsible because of participation 
in this research.  
 
The Mobile Integrated Health (MIH) program is currently grant-funded because most insurance 
providers do not reimburse for it. Thus, while it is a clinical standard of care and licensed under 
state OEMS protocols, patients will not be billed for UMMH MIH services during research home 
visits. 
 
30. CONSENT PROCESS 
 
Study Staff Education: Only Study Staff with prior approval who have reviewed HRP-090 
Informed Consent will be obtaining consent. 
 
Patient Subjects: 
 
Consent Process:  
- 
We will be obtaining informed consent.  
- 
All consent will be collected electronically via the Redcap application. Patients will be 
able to review, sign, and date consent electronically 
- 
Subjects will be invited to independently read and sign the consent form or sign in with 
teleconferencing support from a member of the study team to review the consent 
document. 
- 
All of the potential risks, reasoning, and goals of this research will be explained to each 
individual prior to obtaining consent. They will be informed that enrollment is voluntary 
and declining to participate will not affect their treatment. Ample time will be given to 
answer any questions, and they will be informed that they may opt out of this voluntary 
study at any point.  
- 
-An electronic or printed copy of the consent will be provided to patients after the 
electronic signature, depending on the subject’s preference. 
o The electronic consent document/process allows subjects to proceed forward or 
backward or pause for review later if they choose. 
o Several measures are present to ensure that subjects have access to all of the 
consent-related materials, including hyperlinks or other external documents.  
o These measures include active guidance from the study team while reviewing the 
consent form to point out salient sections and key language, and access to paper 
copies of all relevant documents that patients may need to make their decision 
about participation. Patients will be allowed to read a paper copy of the consent 
before signing electronically if they prefer. 
 
 
Clinician Cohort: 
 

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Page 22 of 24 
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This study entails minimal risk for clinician subjects. Specifically, it will not cause harm or 
discomfort that is greater than those ordinarily encountered in daily life or routine medical 
practice.  This intervention does not impact participants’ care, decisions about their care, or 
future access to care and therefore a waiver will not adversely affect the rights and welfare of the 
subjects. A Fact Sheet will be provided to subjects explaining the study and its potential 
(minimal) risks  
 
All of the potential risks, reasoning, and goals of this research will be explained to each 
individual prior to obtaining consent. They will be informed that enrollment is voluntary and that 
declining to participate will not affect their treatment. Ample time will be given to answer any 
questions, and they will be informed that they may opt out of this voluntary study at any point.  
 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
 
Study Staff Education: Only appropriately trained Study Staff with prior approval who have 
been trained on best practices in Documentation of Informed Consent and are familiar with HRP-
091 SOP: Written Documentation of Consent will be obtaining consent during this study. The PI 
will train all co-investigators and research assistants on obtaining informed consent prior to 
initiating study activities.  Additionally, there will be a detailed study manual for the project 
which will obtain HRP-091 for quick reference when needed for this study. 
 
Documentation of Consent: Informed consent will be documented in writing for patient 
subjects. Written consent will not be obtained for provider subjects as the study activities for this 
cohort entail less than minimal risk and do not entail any activities that would normally require 
written consent outside of the research setting.  We request a waiver of written consent for 
clinician subjects. 
 
32. DRUGS OR DEVICES 
NA 
 
 
 
 
 
 
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