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Standardized Versus Tailored Implementation of Measurement Based Care for Depression (iMBC)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Implementation of Measurement Based Care
Standard Implementation of Measurement Based Care
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring implementation, measurement based care, standardized, tailored

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (a) age 18 and above; (b) depression is one of the 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; (c) significant depressive symptom severity (PHQ-9 total score > 9); (d) receipt of individual psychotherapy; (e) fluency in English; and, (f) new client beginning treatment (g) with an enrolled study clinician during the proposed funding period

Exclusion Criteria:

  • an inability to sign the consent due to lack of competence or inability to read

Sites / Locations

  • Centerstone Connersville
  • Centerstone Martinsville
  • Centerstone Columbia
  • Centerstone Dede Wallace Campus
  • Centerstone Frank Luton Center
  • Centerstone Tullahoma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Standardized Implementation, Patients

Tailored Implementation, Patients

Standardized Implementation, Therapists

Tailored Implementation, Therapists

Arm Description

Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).

Sites in the tailored condition arm will receive the tailored implementation of measurement-based care intervention (PHQ-9).

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.

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.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2014
Last Updated
May 4, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT02266134
Brief Title
Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Acronym
iMBC
Official Title
Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
implementation, measurement based care, standardized, tailored

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized Implementation, Patients
Arm Type
Experimental
Arm Description
Sites in standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).
Arm Title
Tailored Implementation, Patients
Arm Type
Experimental
Arm Description
Sites in the tailored condition arm will receive the tailored implementation of measurement-based care intervention (PHQ-9).
Arm Title
Standardized Implementation, Therapists
Arm Type
Experimental
Arm Description
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.
Arm Title
Tailored Implementation, Therapists
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Implementation of Measurement Based Care
Intervention Description
Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire; the implementation of measurement-based care will be tailored based on clinic specific barriers and facilitators.
Intervention Type
Behavioral
Intervention Name(s)
Standard Implementation of Measurement Based Care
Intervention Description
Measurement-based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire (PHQ-9); the implementation of measurement-based care will be standardized such that clinicians will be encouraged to administer the PHQ-9 to depressed clients before each session.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire
Description
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).
Time Frame
Week 0 (baseline) and Week 12 of treatment
Title
PHQ-9 Completed Fidelity
Description
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.
Time Frame
5-month implementation window

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
To be included, Patients must: be age 18 or above at time of enrollment; 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; have significant depressive symptom severity (PHQ-9 total score > 9); receive individual psychotherapy; be fluent in English; and 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: be a practicing clinician at Centerstone; and see at least one adult (18+) patient Therapist Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cara C Lewis, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centerstone Connersville
City
Connersville
State/Province
Indiana
ZIP/Postal Code
47331
Country
United States
Facility Name
Centerstone Martinsville
City
Martinsville
State/Province
Indiana
ZIP/Postal Code
46151
Country
United States
Facility Name
Centerstone Columbia
City
Columbia
State/Province
Tennessee
ZIP/Postal Code
38401
Country
United States
Facility Name
Centerstone Dede Wallace Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Centerstone Frank Luton Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37217
Country
United States
Facility Name
Centerstone Tullahoma
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36271404
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.
Results Reference
derived
PubMed Identifier
34791490
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.
Results Reference
derived
PubMed Identifier
26345270
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.
Results Reference
derived

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Standardized Versus Tailored Implementation of Measurement Based Care for Depression

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