Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
type 2 hybrid comparative effectiveness implementation trial
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: Providing reminder and resources via messages
    Patients will be provided reminders and resources using messages sent to patients.
  • Behavioral: Regular care
    Regular (standard) care provided by healthcare provider team
Experimental
R2 Navigation only
Reminder and Resources provided to patient via health navigator
  • 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
Experimental
R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
  • 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

Recruiting Locations

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

UCHealth Women's Integrated Services in Health (WISH)
Denver, Colorado 80045
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

UCHealth Cherry Creek Medical Center
Denver, Colorado 80206
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

UCHealth Internal Medical Clinic - Lowry
Denver, Colorado 80230
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

UCHealth Lone Tree Medical Center
Lone Tree, Colorado 80124
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

UCHealth Family Medicine - Westminster
Westminster, Colorado 80021
Contact:
Rebekah Gomes
303-724-3115
rebekah.gomes@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Principal Investigator
(303) 724-2268
amy.huebschmann@cuanschutz.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.