Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes

Официальное название

Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings

Обзор

This study is a hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinical linkage intervention in primary clinics to address unmet social needs for patients with diabetes living in rural communities. The study will take place in two rural communities in Kentucky, one in eastern Kentucky and one in western Kentucky.

Подробное описание

This study will convene clinical and community partners to complete a rapid process improvement workshop (RPIW) to co-create scalable strategies to address unmet social needs and to implement the developed strategy in primary care clinics in two rural communities in Kentucky. Results from the RPIW will be used to design an implementation template with specific implementation strategies tailored to each unique community-clinical linkage (CCL). While implementation strategies will be tailored to each CCL, the overarching intervention components for all CCL include: 1) patient navigators; 2) health information technology; and 3) quality improvement support to clinical and community partners. The finalized intervention will then be rolled out across partner clinics using a parallel-group cluster design that facilitates pragmatic randomization. The effect of the intervention on referrals will be assessed by comparing referrals between intervention and control clinics. Secondary effectiveness outcomes include status of social needs (improved or not), patient-reported quality of life, and diabetes control (A1c \< 9.0% controlled vs A1c =9% uncontrolled). To evaluate implementation outcomes, we will use a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention. This approach allows us to examine which strategies can be replicated and scaled up for implementation in other communities.

Вмешательства

• Поведенческое Community-Clinical Intervention
  The intervention involves enhancing usual care for screening patients with diabetes for unmet social needs and referring those who screen positive to a Community Health Worker. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations.

Первичные конечные точки

• Number of participants screened for social needs [Срок оценки: Baseline, month 6 and month 12]
• Number of referrals to community based organization by primary care clinic [Срок оценки: Baseline, month 6 and month 12]

Вторичные конечные точки (3)

• Change in Status of social needs [Срок оценки: Baseline, month 6 and month 12]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29 [Срок оценки: Baseline, month 6 and month 12]
• Percent of participants with A1c greater than or equal to 9.0% [Срок оценки: Baseline, month 6 and month 12]

Критерии участия

Clinic/Staff Inclusion Criteria:

• staff at the intervention or comparison clinic

Participant Inclusion Criteria:

• age 18 or older,
• is a patient at the intervention or comparison clinic
• diagnosed with diabetes

Clinic/Staff Exclusion Criteria:

• staff not at the intervention or comparison clinic

Participant Exclusion Criteria:

• being under the age of 18,
• not a patient at the intervention or comparison clinic
• not diagnosed with diabetes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT07196007 · 100380 · 75D30124C20318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗