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

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05203471
• Other study ID #: 2022-1338
• Secondary ID: R01DK132569-01Pr
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 237
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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