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Hybrid Collaborative Care Randomized Program Evaluation (BHIP-CCM)

maanantai 22. kesäkuuta 2020 päivittänyt: Mark Bauer, VA Boston Healthcare System

Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health

This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).

In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

Based on an internal system-wide review of mental health services and the Mental Health Action Plan submitted to Congress in November, 2011, the Office of Mental Health Operations (OMHO) has undertaken an effort to establish behavioral health interdisciplinary plans (BHIPs), which are intended to provide General Mental Health (GMH) care throughout the Department of Veterans Affairs (VA). The BHIP goal is to build effective interdisciplinary teams, which will provide the majority of care for Veterans in GMH. It is now expected that every Veterans Affairs Medical Center (VAMC) establish at least one BHIP in the current initial phase (begun in late fiscal year 2013), and that the effort scale-up subsequently. Not surprisingly, progress has been uneven.

In 2015 OMHO incorporated the Collaborative Chronic Care Model (CCM) as an evidence-based model by which to structure BHIPs. Consistent with BHIP goals, CCMs were developed to provide anticipatory, continuous, collaborative, evidence-based care. CCMs consist of 6 elements: delivery system redesign, use of clinical information systems, provider decision support, patient self-management support, linkage to community resources, and healthcare organization support. Replicating Effective Programs with External Facilitation (REP-F) has been shown to be effective in implementing complex care models, including CCMs for mental health, both within and beyond VA.

Thus in conjunction with OMHO, the investigators propose this project with the Specific Aim of evaluating the impact of REP-F in implementing CCM-based BHIPs and their effect on Veteran health status. The investigators propose a Hybrid Type III implementation-effectiveness stepped wedge controlled trial, specifically hypothesizing that:

H1: REP-F-based implementation to establish CCM-based BHIPs, compared to existing centralized technical assistance will result in: (H1a) increased Veteran perceptions of CCM-based care, (H1b) higher rates of achieving national BHIP clinical fidelity measures (implementation outcomes), and (H1c) higher provider ratings of the presence of CCM elements.

H2: CCM-based BHIPs, supported by REP-F implementation, will result in improved Veteran health outcomes compared to BHIPs supported by dissemination material alone (intervention outcomes).

The investigators will utilize the national BHIP rollout as a vehicle for this project. Using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

1112

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02131
        • VA Boston Healthcare System

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

At least three visits to the General Mental Health Clinic's BHIP team in prior year

Exclusion Criteria:

Chart evidence of dementia

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Peräkkäinen tehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Implementation Facilitation
Implementation Facilitation consists of the Center for Disease Control's Replicating Effective Programs, plus External Facilitation. The intervention lasts 6 months followed by a 6-month step-down period.
Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
Muut nimet:
  • REP-F
Placebo Comparator: Educational Materials
Dissemination of available materials explaining the Collaborative Chronic Care Model and implementation tools. Sites randomized to delay initiation of facilitation will have these materials plus technical assistance for 4 or 8 months prior to full implementation facilitation.
Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Veterans RAND-12 Mental Component Score (VR-12 MCS)
Aikaikkuna: one year
Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score.
one year

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Veterans RAND-12 Physical Component Scores (VR-12 PCS)
Aikaikkuna: One year
Veterans RAND-Physical Component Score: Overall self-rated physical health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Mental Component Score.
One year
Satisfaction Index
Aikaikkuna: One year
Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72.
One year
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Aikaikkuna: One year
Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100.
One year
Patient Assessment of Chronic Illness Care (PACIC)
Aikaikkuna: One year
Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33.
One year
Team Development Measure (TDM)- Cohesion
Aikaikkuna: baseline and during stepdown (6-12 months)

Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure.

Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.

baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Communication
Aikaikkuna: baseline and during stepdown (6-12 months)

Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure.

Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.

baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Role Clarity
Aikaikkuna: baseline and during stepdown (6-12 months)

Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure.

Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).

baseline and during stepdown (6-12 months)
Team Development Measure (TDM)- Team Primacy
Aikaikkuna: baseline and during stepdown (6-12 months)

Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure.

Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).

baseline and during stepdown (6-12 months)
Mental Health Hospitalization Rates
Aikaikkuna: Two years
Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months.
Two years

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Yhteistyökumppanit

Tutkijat

  • Päätutkija: Mark S Bauer, MD, VA Boston Healthcare System

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 7. maaliskuuta 2016

Ensisijainen valmistuminen (Todellinen)

Torstai 26. huhtikuuta 2018

Opintojen valmistuminen (Todellinen)

Torstai 26. huhtikuuta 2018

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 4. syyskuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 4. syyskuuta 2015

Ensimmäinen Lähetetty (Arvio)

Maanantai 7. syyskuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 23. kesäkuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 22. kesäkuuta 2020

Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2020

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 15-289
  • QUE-15-289 (Muu tunniste: U.S. Department of Veterans Affairs)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

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EI

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