Clinical trial NCT02266134: Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Official title: Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: implementation
measurement based care
standardized
tailored
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: To be included, Patients must:

1. be age 18 or above at time of enrollment;
2. have depression as one of their primary treatment foci based on diagnosis made by clinicians using usual care interview methods to reflect major depressive disorder, dysthymic disorder, depressive disorder NOS, adjustment disorder with depressed mood;
3. have significant depressive symptom severity (PHQ-9 total score \> 9);
4. receive individual psychotherapy;
5. be fluent in English; and
6. receive therapy from an enrolled study clinician during the proposed funding period

Patients will be excluded if they have an inability to sign the consent form (due to lack of competence or inability to read).

Therapist Inclusion Criteria -- Therapists must:

1. be a practicing clinician at Centerstone; and
2. see at least one adult (18+) patient

Therapist Exclusion Criteria: N/A

Primary outcomes:
measure: Patient Health Questionnaire
timeFrame: Week 0 (baseline) and Week 12 of treatment
measure: PHQ-9 Completed Fidelity
timeFrame: 5-month implementation window
Secondary outcomes:
Other outcomes:
Locations:
city: Connersville
country: United States
facility: Centerstone Connersville
state: Indiana
city: Martinsville
country: United States
facility: Centerstone Martinsville
state: Indiana
city: Columbia
country: United States
facility: Centerstone Columbia
state: Tennessee
city: Nashville
country: United States
facility: Centerstone Dede Wallace Campus
state: Tennessee
city: Nashville
country: United States
facility: Centerstone Frank Luton Center
state: Tennessee
city: Tullahoma
country: United States
facility: Centerstone Tullahoma
state: Tennessee
Study officials:
affiliation: Indiana University
name: Cara C Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis CC, Boyd MR, Marti CN, Albright K. Mediators of measurement-based care implementation in community mental health settings: results from a mixed-methods evaluation. Implement Sci. 2022 Oct 21;17(1):71. doi: 10.1186/s13012-022-01244-1.
citation: Albright K, Navarro EI, Jarad I, Boyd MR, Powell BJ, Lewis CC. Communication strategies to facilitate the implementation of new clinical practices: a qualitative study of community mental health therapists. Transl Behav Med. 2022 Feb 16;12(2):324-334. doi: 10.1093/tbm/ibab139.
citation: Lewis CC, Scott K, Marti CN, Marriott BR, Kroenke K, Putz JW, Mendel P, Rutkowski D. Implementing measurement-based care (iMBC) for depression in community mental health: a dynamic cluster randomized trial study protocol. Implement Sci. 2015 Sep 7;10:127. doi: 10.1186/s13012-015-0313-2.