Testing the Impact of the MOHR Follow-up Support

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

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.

Study Overview

• Status: Recruiting
• Conditions: Implementation Strategy Bundles for Structured Follow-up
• Intervention / Treatment: Behavioral: Regular care; Behavioral: Providing reminder and resources via messages; Behavioral: Reminder and resources sent via navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: (303) 724-2268; Email: amy.huebschmann@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
      • Principal Investigator: Amy Huebschmann
    • Denver, Colorado, United States, 80206
      • Recruiting
      • UCHealth Cherry Creek Medical Center
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
      • Principal Investigator: Amy Huebschmann
    • Denver, Colorado, United States, 80045
      • Recruiting
      • UCHealth Women's Integrated Services in Health (WISH)
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
    • Denver, Colorado, United States, 80230
      • Recruiting
      • UCHealth Internal Medical Clinic - Lowry
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
      • Principal Investigator: Amy Huebschmann
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • UCHealth Lone Tree Medical Center
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
      • Principal Investigator: Amy Huebschmann
    • Westminster, Colorado, United States, 80021
      • Recruiting
      • UCHealth Family Medicine - Westminster
      • Contact: Rebekah Gomes; Phone Number: 303-724-3115; Email: rebekah.gomes@cuanschutz.edu
      • Principal Investigator: Amy Huebschmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Standardized version of usual care	Behavioral: Regular care; Regular (standard) care provided by healthcare provider team
Experimental: R2 Message Only; Reminder and Resources Messages sent to patient	Behavioral: Regular care; Regular (standard) care provided by healthcare provider team; Behavioral: Providing reminder and resources via messages; Patients will be provided reminders and resources using messages sent to patients.
Experimental: R2 Navigation only; Reminder and Resources provided to patient via health navigator	Behavioral: Regular care; Regular (standard) care provided by healthcare provider team; Behavioral: Reminder and resources sent via navigation; Patients will be provided reminders and resources using health navigators calling the patients.
Experimental: R2 Message + R2 Navigation; Both reminder and resources messages and navigation provided to the patient	Behavioral: Regular care; Regular (standard) care provided by healthcare provider team; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MOHR risk factors	Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved. MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep. Each risk factor is evaluated as low risk, medium risk, or high risk. Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).	From enrollment to the follow-up survey timepoint at 2 months.
REACH - specifically representative engagement	Primary implementation outcome. Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages . Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months). To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.	From enrollment to the follow-up survey timepoint at 6 months.
Patient experience	Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC). Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).	From enrollment to the follow up survey time point at 6 months.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Implementation strategy; patient follow-up
• Other Study ID Numbers: 25-0224.cc; 1R01CA282292-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to HIPAA we cannot share IPD from EHR.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No