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
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Principal Investigator
- Telefonnummer: (303) 724-2268
- E-post: amy.huebschmann@cuanschutz.edu
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University Of Colorado Hospital
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
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Hovedetterforsker:
- Amy Huebschmann
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Denver, Colorado, Forente stater, 80206
- Rekruttering
- UCHealth Cherry Creek Medical Center
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
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Hovedetterforsker:
- Amy Huebschmann
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Denver, Colorado, Forente stater, 80045
- Rekruttering
- UCHealth Women's Integrated Services in Health (WISH)
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
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Denver, Colorado, Forente stater, 80230
- Rekruttering
- UCHealth Internal Medical Clinic - Lowry
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
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Hovedetterforsker:
- Amy Huebschmann
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Lone Tree, Colorado, Forente stater, 80124
- Rekruttering
- UCHealth Lone Tree Medical Center
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
-
Hovedetterforsker:
- Amy Huebschmann
-
Westminster, Colorado, Forente stater, 80021
- Rekruttering
- UCHealth Family Medicine - Westminster
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Ta kontakt med:
- Rebekah Gomes
- Telefonnummer: 303-724-3115
- E-post: rebekah.gomes@cuanschutz.edu
-
Hovedetterforsker:
- Amy Huebschmann
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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)).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Control Arm
Standardized version of usual care
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Regular (standard) care provided by healthcare provider team
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of MOHR risk factors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 25-0224.cc
- 1R01CA282292-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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