Clinical trial NCT05203471: Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Diabetic Ulcer of Left Foot
Diabetic Ulcer of Right Foot
Amputation
Keywords: Multidisciplinary care
Integrated care
Rural disparities
Recruitment
Retention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-01-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is an adaptive study design where recruitment and retention protocols are modified to improve involvement of rural study participants over three waves. Actively enrolled participants receive/ provide care for diabetic foot ulcers using a care algorithm and referral checklist. Results are compared to historical controls.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthcare worker inclusion criteria:

  * Willing to provide informed consent
  * Willing to comply with study procedures
  * Rural providers (primary care physicians at the UW Health Belleville Family Medicine Clinic, diabetes and wound care specialists at Sauk Prairie Healthcare Diabetes and Wound Care Clinic) and schedulers placing referrals.
  * Employed at a participating clinic
  * 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.
  * Available for the duration of the study
* Patient inclusion criteria:

  * Able and willing to provide informed consent.
  * Willing to comply with study procedures and be available for the duration of the study.
  * 18 years of age and older.
  * Patient with either type 1 or type 2 diabetes at a participating rural clinic.
  * Develops diabetic foot ulcer during enrollment period.

Exclusion Criteria:

* Healthcare worker exclusion criteria:

  * Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination.
* Patient exclusion criteria:

  * receiving palliative care such that referral to urban centers for aggressive limb salvage would be inappropriate, as assessed by patient rural provider
  * insurance does not cover referral to the University of Wisconsin's specialty clinics
  * Not suitable for study participation due to other reasons at the discretion of the investigators.

Primary outcomes:
measure: Proportion of patients receiving guideline-concordant vascular and infectious disease care processes
timeFrame: up to 2 years and 3 months
Secondary outcomes:
measure: Proportion of patients undergoing amputation
timeFrame: up to 2 years and 3 months
Other outcomes:
measure: Patient recruitment rate
timeFrame: up to 2 years and 3 months
measure: Patient retention rate
timeFrame: up to 2 years and 3 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Meghan B Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References: