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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Proportion of patients receiving guideline-concordant vascular and infectious disease care processes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: integrated care model (Other)
Healthcare Worker
Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers.
结局指标
主要结局
Proportion of patients receiving guideline-concordant vascular and infectious disease care processes
时间窗: up to 2 years and 3 months
(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)
Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes
时间窗: up to 3 months
(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)
次要结局
- Proportion of patients undergoing amputation(up to 2 years and 3 months)
- Proportion of Patients Undergoing Amputation(up to 3 months)