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Évaluation de la mise en œuvre d'un programme collaboratif de santé comportementale en soins primaires (WBCBHP)

13 octobre 2026 mis à jour par: Allison Carroll, Northwestern University

This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.

With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.

Type d'étude

Observationnel

Inscription (Réel)

778

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Northwestern Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients attending primary care appointments within the Northwestern Medicine health system's central region.

La description

Inclusion Criteria:

• PHQ-9 score > 10

Exclusion Criteria:

  • Current suicidality
  • Bipolar disorder
  • Substance abuse disorder
  • Psychosis
  • Other severe mental health condition

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
NMG IM 211 E Chicago Avenue

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM ARKES

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1460 N Halsted St

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 201 Est, rue Huron

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG Médecine Intégrative 150 E Huron St

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1776 N Milwaukee Ave

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 20 S Clark St

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM FM 1704, avenue Maple

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 259 rue Erie E

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1135 S Delano Ct

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1333 W Belmont Ave

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Impact of implementation strategies on the speed of CBHP implementation (time, in days)
Délai: 2 years

Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)

2 years
Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)
Délai: 2 years

Trends in the number of CBHP participants over successive practices, as assessed by CBHP referrals, engagement, and treatment completion derived from the electronic health record

2 years
Acceptability of CBHP
Délai: 2 years

Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)

2 years
Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)
Délai: 2 years

Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals

2 years
Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)
Délai: 2 years

Proportion of patients who are eligible for CBHP who receive behavioral health services, including anti-depressant medication prescriptions, CBHP treatment sessions, and/or external referrals for behavioral health (e.g., psychiatry)

2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2018

Achèvement primaire (Réel)

31 janvier 2024

Achèvement de l'étude (Réel)

30 décembre 2025

Dates d'inscription aux études

Première soumission

23 mars 2020

Première soumission répondant aux critères de contrôle qualité

23 mars 2020

Première publication (Réel)

25 mars 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STU00208338

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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