Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Proportion of the program components addressed
研究概览
简要总结
This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).
Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise.
Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed.
This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.
详细描述
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a pilot trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. DFU healing rates remain low in the US. DFUs that fail to heal within 30 days are at a higher risk. Unfortunately, there is a resurgence in diabetes-related amputations. Healing requires complex, multidisciplinary care, focused on glycemic control, wound management, vascular disease treatment, and infection therapy. A strategy to facilitate multidisciplinary DFU care and support patients in their healing journey that can be widely implemented is essential to improve DFU healing rates and curb the diabetes-related limb loss pandemic, particularly for underserved and high-risk populations.
Patient navigators are healthcare personnel who mitigate barriers to care by facilitating care logistics, connecting patients to available resources, and promoting patient engagement. While navigators have been shown to improve diabetes outcomes, their effectiveness in improving DFU care and promoting healing remains untested. Informed by extensive preliminary data and community input, the investigators developed the CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program.
This study aims to determine whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations)
- •English-speaking patients (available patient navigators are English-speaking).
排除标准
- •Patients who are unable to understand the nature and scope of the study,
- •Enrolled in another clinical trial,
- •Planned discharge to an acute or long-term care facility,
- •Planning to receive outpatient DFU care outside of Grady.
研究组 & 干预措施
Intervention Group
Participants will be assigned a dedicated DFU patient navigator.
干预措施: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (Other)
结局指标
主要结局
Proportion of the program components addressed
时间窗: Up to 20 weeks during program participation
Researchers will measure the program fidelity by the proportion of the program components addressed by the navigators. Navigators will address 16 components during the weekly encounters and 22 components at every fourth encounter. Researchers will record all encounters and will listen to the recordings of encounters and count which components were or were not discussed (binary outcome, yes/no), and measure consistency across navigators.
Acceptability of the CARE-D-Foot-Nav intervention
时间窗: Up to 20 weeks during program participation
Researchers will conduct focus group discussions and/or one-on-one interviews with the participants to understand the program's likes and dislikes. There is no measuring scale.
次要结局
- Wound area reduction(Baseline and week 20)
- Number of participants with wound healing with complete re-epithelialization of the wound.(Baseline and week 20 (day 140 +/- 7 days))
- Number of participants with confirmed wound healing(Baseline and week 22)
- DFU care clinic attendance(At 14 days and 30 days after hospital discharge)
- Major amputations(After hospital discharge (up to 20 weeks))
- Number of amputations(After hospital discharge (up to 20 weeks))
- Mortality(After hospital discharge (up to 20 weeks))
- Change in hemoglobin A1c(Baseline and week 20)
- EuroQol five-dimensional (EQ-5D) score(Baseline and week 20)
- Diabetic foot ulcer - short form (DFS-SF) score(Baseline and week 20)
- Change in the Interpersonal Support Evaluation List-12(Baseline and week 20)
- Change in the Trust in Physicians' Scale(Baseline and week 20)
- Tobacco cessation(Baseline and 20 weeks)
- Acute care utilization(up to 20 weeks after hospital discharge)
- Services accessed(Baseline and 20 weeks)
- Food insecurity(Baseline and 20 weeks)
- Housing stability(Baseline and 20 weeks)
- Financial resource strain questionnaire(Baseline and 20 weeks)
- Transportation needs(Baseline and 20 weeks)
- Peer support group attendance(After hospital discharge (up to 20 weeks))
研究者
Marcos C. Schechter
Associate Professor
Emory University