Testing the Impact of the MOHR Follow-up Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Providing reminder and resources via messages, Reminder and resources sent via navigation, Regular care.
- Who it may be relevant to
- Registry conditions: Implementation Strategy Bundles for Structured Follow-up. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition
Overview
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.
Detailed description
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.
Interventions
- Behavioral Providing reminder and resources via messages
Patients will be provided reminders and resources using messages sent to patients. - Behavioral Reminder and resources sent via navigation
Patients will be provided reminders and resources using health navigators calling the patients. - Behavioral Regular care
Regular (standard) care provided by healthcare provider team
Primary outcome measures
- Number of MOHR risk factors [Time frame: From enrollment to the follow-up survey timepoint at 2 months.]
- REACH - specifically representative engagement [Time frame: From enrollment to the follow-up survey timepoint at 6 months.]
- Patient experience [Time frame: From enrollment to the follow up survey time point at 6 months.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 6 centers
- 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
Identifiers
NCT: NCT07569224 · 25-0224.cc · 1R01CA282292-01A1