Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetic Foot; Amputation; Diabetic Ulcer of Left Foot; Diabetic Ulcer of Right Foot
• Intervention / Treatment: Other: integrated care model

• Study Type: Interventional
• Enrollment (Estimated): 237
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie LaMantia; Phone Number: 608-262-8316; Email: jnlamantia@medicine.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison
      • Contact: Meghan B Brennan, MD; Phone Number: 608-263-1545; Email: mbbrennan@medicine.wisc.edu
      • Principal Investigator: Meghan B Brennan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Historical controls; Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention.
Active Comparator: Integrated care; Patients with diabetic foot ulcers cared for by a primary care provider participating in the study after launching the integrated care intervention. Only patients who provide informed consent and enroll in the study will be treated with our integrated care model. All other patients with a participating primary care provider will be treated using a standard care model and will not be considered study participants.	Other: integrated care model; The investigators are piloting an integrated care model for rural patients with diabetic foot ulcers. The model uses two tools to promote collaboration between providers: a care algorithm and a referral checklist. The care algorithm will be used by rural primary care providers to guide integrated care addressing glycemic control, vascular disease, wound care, and infection. The referral checklist will be used by rural schedulers who place referrals to urban specialists. It prompts schedulers to fax appropriate supporting documents (e.g. notes, labs, vascular testing results) with the referral request.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients receiving guideline-concordant vascular and infectious disease care processes	(proportion of integrated care patients receiving guideline-concordant vascular and infectious disease care within 3 months of their enrollment) minus (the proportion of historical patients receiving guideline-concordant vascular and infectious disease care within 3 months of participant enrollment)	up to 2 years and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients undergoing amputation	(proportion of integrated care patients undergoing amputation within 3 months of their enrollment) minus (proportion of historical patients undergoing amputation within 3 months of their enrollment), where amputation is defined as major or minor amputation of the ipsilateral lower extremity to the index ulcer	up to 2 years and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient recruitment rate	Number of patients who enrolled in the study divided by the number of patients the study team attempted to contact for study recruitment	up to 2 years and 3 months
Patient retention rate	Number of patients who completed the 3-month follow-up telephone call divided by the number of patients who enrolled in the study	up to 2 years and 3 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Meghan B Brennan, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Multidisciplinary care; Integrated care; Rural disparities; Recruitment; Retention
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 2022-1338; R01DK132569-01 (U.S. NIH Grant/Contract); SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison); Protocol Version 9/18/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the study, after de-identification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Time Frame: Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
• IPD Sharing Access Criteria: Proposals should be directed to the PI, Dr. Meghan Brennan (mbbrennan@medicine.wisc.edu). If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No