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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Principal Investigator
- Telefoonnummer: (303) 724-2268
- E-mail: amy.huebschmann@cuanschutz.edu
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Werving
- University Of Colorado Hospital
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Hoofdonderzoeker:
- Amy Huebschmann
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Denver, Colorado, Verenigde Staten, 80206
- Werving
- UCHealth Cherry Creek Medical Center
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Hoofdonderzoeker:
- Amy Huebschmann
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Denver, Colorado, Verenigde Staten, 80045
- Werving
- UCHealth Women's Integrated Services in Health (WISH)
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Denver, Colorado, Verenigde Staten, 80230
- Werving
- UCHealth Internal Medical Clinic - Lowry
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Hoofdonderzoeker:
- Amy Huebschmann
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Lone Tree, Colorado, Verenigde Staten, 80124
- Werving
- UCHealth Lone Tree Medical Center
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Hoofdonderzoeker:
- Amy Huebschmann
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Westminster, Colorado, Verenigde Staten, 80021
- Werving
- UCHealth Family Medicine - Westminster
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Contact:
- Rebekah Gomes
- Telefoonnummer: 303-724-3115
- E-mail: rebekah.gomes@cuanschutz.edu
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Hoofdonderzoeker:
- Amy Huebschmann
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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)).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Control Arm
Standardized version of usual care
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Regular (standard) care provided by healthcare provider team
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Experimenteel: R2 Message Only
Reminder and Resources Messages sent to patient
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
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Experimenteel: R2 Navigation only
Reminder and Resources provided to patient via health navigator
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using health navigators calling the patients.
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Experimenteel: R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
Patients will be provided reminders and resources using health navigators calling the patients.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of MOHR risk factors
Tijdsspanne: From enrollment to the follow-up survey timepoint at 2 months.
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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).
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From enrollment to the follow-up survey timepoint at 2 months.
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REACH - specifically representative engagement
Tijdsspanne: From enrollment to the follow-up survey timepoint at 6 months.
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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.
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From enrollment to the follow-up survey timepoint at 6 months.
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Patient experience
Tijdsspanne: From enrollment to the follow up survey time point at 6 months.
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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).
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From enrollment to the follow up survey time point at 6 months.
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 25-0224.cc
- 1R01CA282292-01A1 (Subsidie/contract van de Amerikaanse NIH)
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