Standardized Versus Tailored Implementation of Measurement Based Care for Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Standard Implementation of Measurement Based Care; Behavioral: Tailored Implementation of Measurement Based Care

• Registration Number: NCT02266134
• Lead Sponsor: Indiana University

Brief Summary

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually; however, Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework that has been shown to improve outcomes for depressed clients by identifying those who are not making progress and reducing the likelihood that clients will deteriorate in treatment. Despite the demonstrated effectiveness of MBC, the majority of community mental health counselors do not regularly assess target problem symptoms to guide their work. This study will test a standardized versus a tailored approach to implementing MBC that will include the integration of symptom monitoring capacities into the electronic health record system of one of the nation's largest not-for-profit providers of behavioral health services.

Detailed Description

Depression remains among the nation's top 10 chronic illnesses, costing over $80 billion annually. Depression has been called the "Common Cold" of mental illness, but one with serious risk of morbidity and mortality. There are now many evidence-based practices for the treatment of depression, but unfortunately these practices remain largely unavailable to clients receiving services in community mental health centers. Measurement Based Care (MBC) is a relatively simple evidence-based intervention framework. MBC, by definition, is the practice of using symptom measurement to inform mental health care. Physicians who routinely measure the patient's blood pressure when the treatment target is high blood pressure demonstrate the medical corollary of MBC. When MBC is used in the treatment of depressed adults, it has been shown to improve outcomes by identifying clients who are not making progress and reducing the likelihood that clients will deteriorate in treatment. However, despite the demonstrated effectiveness of MBC, the majority of community mental health counselors (i.e., clinicians) do not regularly assess target problem symptoms to guide their work over the course of treatment. To our knowledge, no studies to date have focused on the process of implementing MBC in community mental health settings. The long-term goal of this research project is to provide generalizable and practical recommendations about implementation approaches that promote MBC use and fidelity in community mental health centers. Specifically, this study will test a standardized versus a tailored approach to implementing MBC in one of the nation's largest not-for-profit providers of behavioral health services. Although touted as superior, tailored implementations have rarely been compared to standardized approaches. Moreover, recent research has demonstrated an apparent need to adapt evidence-based practices to fit the specific context in which they are being implemented, particularly if they are to be sustained. This proposal reflects a movement in the field of implementation science in which planned adaptations are being tested and compared to standardized versions. The proposed research is a three-phase, mixed methods (quantitative/qualitative) study to investigate the effect of these two different approaches to MBC implementation on both clinician-level (e.g., MBC fidelity) and client-level (depression symptom change) outcomes. We will focus on contextual factors (e.g., attitudes, resources, process, etc.) that may influence the implementation process with the goal of identifying a generalizable and practical way of bringing MBC to community mental health centers treating depressed adults.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-12
• Study First Submitted QC: 2014-10-12
• Study First Posted: 2014-10-16
• Study Start: 2015-06
• Primary Completion: 2019-10-18
• Study Completion: 2019-11-15
• Results First Submitted: 2022-02-07
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Results First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

Not provided

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Exclusion Criteria

N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized Implementation, Patients	Standard Implementation of Measurement Based Care	Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).
Tailored Implementation, Therapists	Tailored Implementation of Measurement Based Care	Sites randomized to the tailored condition will develop a site-specific protocol for use of the measurement-based care intervention (PHQ-9), and they will work as a team to maximize the fit of measurement-based care to this clinic.
Tailored Implementation, Patients	Tailored Implementation of Measurement Based Care	Sites in the tailored condition arm will receive the tailored implementation of measurement-based care intervention (PHQ-9).
Standardized Implementation, Therapists	Standard Implementation of Measurement Based Care	Sites randomized to the standardized condition will be expected to use the measurement-based care intervention (PHQ-9) prior to each session with a depressed client and they will work as a team to maximize fidelity.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire	Week 0 (baseline) and Week 12 of treatment	Patient Health Questionnaire-9 (PHQ-9): screening tool for depression that can be used to monitor symptom change over time and inform care.; Minimum value: 0 Maximum value: 27 Higher scores indicate a greater severity of depression (i.e., worse outcome).
PHQ-9 Completed Fidelity	5-month implementation window	PHQ-9 fidelity was monitored for each individual psychotherapy session. Fidelity was scored as: (1) Therapist did not complete or record any PHQ-9 scores; (2) Therapist completed PHQ-9 and recorded scores in the EHR only; or (3) Therapist completed PHQ-9, recorded scores in the EHR, and discussed scores with the patient.; The unit of measure is the number individual psychotherapy sessions conducted during the 5-month implementation window. Patient data were included for any patient at least 18 years old at the time of their first session with a participating therapist, regardless of if the patient was enrolled in the study.

Trial Locations

Locations (6)

Centerstone Martinsville; 🇺🇸 Martinsville, Indiana, United States

Centerstone Columbia; 🇺🇸 Columbia, Tennessee, United States

Centerstone Connersville; 🇺🇸 Connersville, Indiana, United States

Centerstone Dede Wallace Campus; 🇺🇸 Nashville, Tennessee, United States

Centerstone Frank Luton Center; 🇺🇸 Nashville, Tennessee, United States

Centerstone Tullahoma; 🇺🇸 Tullahoma, Tennessee, United States