Testing the Impact of the MOHR Follow-up Support

Официальное название

Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition

Обзор

This study will evaluate the impact of 3 different strategies to increase engagement of participants in My Own Health Report (MOHR) and health behavior change activities over time. This study will evaluate the level of engagement, outcomes, cost and cost-effectiveness of these strategies.

Подробное описание

In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p \< 0.001) and diet risk behaviors (p \< 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.

In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.

Вмешательства

• Поведенческое Providing reminder and resources via messages
  Patients will be provided reminders and resources using messages sent to patients.
• Поведенческое Reminder and resources sent via navigation
  Patients will be provided reminders and resources using health navigators calling the patients.
• Поведенческое Regular care
  Regular (standard) care provided by healthcare provider team

Первичные конечные точки

• Number of MOHR risk factors [Срок оценки: From enrollment to the follow-up survey timepoint at 2 months.]
• REACH - specifically representative engagement [Срок оценки: From enrollment to the follow-up survey timepoint at 6 months.]
• Patient experience [Срок оценки: From enrollment to the follow up survey time point at 6 months.]

Критерии участия

Критерии включения

• Adults, aged 18 years and older.
• Completion of the MOHR health risk assessment and goal-setting tool
• Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
• Patient at one of the participating clinics

Критерии исключения

• Incomplete or no MOHR assessment
• Language preference/proficiency other than English or Spanish
• Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).

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

Профилактика

Центры проведения

США · 6 центров

• University of Colorado Hospital — Aurora
• UCHealth Women's Integrated Services in Health (WISH) — Denver
• UCHealth Cherry Creek Medical Center — Denver
• UCHealth Internal Medical Clinic - Lowry — Denver
• UCHealth Lone Tree Medical Center — Lone Tree
• UCHealth Family Medicine - Westminster — Westminster

Идентификаторы

NCT: NCT07569224 · 25-0224.cc · 1R01CA282292-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗