Depression
Conditions
Keywords
implementation, measurement based care, standardized, tailored
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
12 community-based behavioral health clinics were randomized into four groups: (1) Sites 1-2; (2) Sites 3-6; (3) Sites 7-10; and (4) Sites 11-12. Therapist recruitment was in-person or via email from June 3, 2015-October 18, 2016. Patient recruitment was staggered such that each site began recruitment approximately five months apart. Recruitment start dates: (1) Sites 1-2: August 13, 2015; Sites 3-6: December 7, 2015; Sites 7-10: May 20, 2016; and Sites 11-12: December 2, 2016.
Pre-assignment details
Of the 2459 patients assessed for eligibility, 228 met inclusion criteria and were enrolled during the study's active implementation window (0-5 months). Of the 525 therapists assessed for eligibility, 154 met inclusion criteria and consented during the study's active implementation window (0-5 months).
Participants by arm
| Arm | Count |
|---|---|
| Standardized Implementation, Patients Sites in this arm will receive the standard implementation of measurement based care intervention.
Standard Implementation of Measurement Based Care: 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. | 141 |
| Tailored Implementation, Patients Sites in this arm will receive the tailored implementation of measurement based care intervention.
Tailored Implementation of Measurement Based Care: 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. | 87 |
| Standardized Implementation, Therapists Sites randomized to the standardized condition will be expected to use the Patient Health Questionnaire prior to each session with a depressed client and they will work as a team to maximize fidelity. | 71 |
| Tailored Implementation, Therapists Sites randomized to the tailored condition will develop a site-specific protocol for use of the Patient Health Questionnaire and they will work as a team to maximize the fit of measurement based care to this clinic. | 83 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Clinics #11-12: Beginning Dec 2016 | Lost to Follow-up | 6 | 2 | 0 | 0 |
| Clinics #11-12: Beginning Dec 2016 | Withdrawal by Subject | 3 | 0 | 0 | 0 |
| Clinics #1-2: Beginning Aug 2015 | Lost to Follow-up | 6 | 3 | 0 | 0 |
| Clinics #3-6: Beginning Dec 2015 | Lost to Follow-up | 8 | 2 | 0 | 0 |
| Clinics #7-10: Beginning May 2016 | Lost to Follow-up | 10 | 5 | 0 | 0 |
| Clinics #7-10: Beginning May 2016 | Withdrawal by Subject | 3 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Standardized Implementation, Patients | Tailored Implementation, Patients | Standardized Implementation, Therapists | Tailored Implementation, Therapists |
|---|---|---|---|---|---|
| Age, Continuous | 41.32 years STANDARD_DEVIATION 12.36 | 42.06 years STANDARD_DEVIATION 11.48 | 40.14 years STANDARD_DEVIATION 11.74 | 45.23 years STANDARD_DEVIATION 14.07 | 41.99 years STANDARD_DEVIATION 13.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 13 Participants | 15 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 347 Participants | 127 Participants | 70 Participants | 67 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Highest Education Status Associate's degree | 14 Participants | 9 Participants | 5 Participants | 0 Participants | 0 Participants |
| Highest Education Status Bachelor's degree | 16 Participants | 8 Participants | 4 Participants | 2 Participants | 2 Participants |
| Highest Education Status Doctoral degree or equivalent | 5 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants |
| Highest Education Status High school diploma or equivalent | 84 Participants | 54 Participants | 30 Participants | 0 Participants | 0 Participants |
| Highest Education Status Master's degree | 148 Participants | 2 Participants | 1 Participants | 66 Participants | 79 Participants |
| Highest Education Status Missing or not reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Highest Education Status Other | 11 Participants | 6 Participants | 4 Participants | 1 Participants | 0 Participants |
| Highest Education Status Some college, but no degree | 69 Participants | 34 Participants | 35 Participants | 0 Participants | 0 Participants |
| Highest Education Status Some high school | 34 Participants | 26 Participants | 8 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 22 Participants | 6 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 11 Participants | 12 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 299 Participants | 105 Participants | 65 Participants | 55 Participants | 74 Participants |
| Region of Enrollment United States | 382 participants | 141 participants | 87 participants | 71 participants | 83 participants |
| Sex/Gender, Customized Gender Identity Female | 278 Participants | 96 Participants | 61 Participants | 54 Participants | 67 Participants |
| Sex/Gender, Customized Gender Identity Male | 102 Participants | 44 Participants | 26 Participants | 17 Participants | 15 Participants |
| Sex/Gender, Customized Gender Identity Missing | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Gender Identity Non-binary | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Gender Identity Transgender | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 1 / 87 |
| other Total, other adverse events | 0 / 141 | 1 / 87 |
| serious Total, serious adverse events | 5 / 141 | 8 / 87 |
Outcome results
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).
Time frame: Week 0 (baseline) and Week 12 of treatment
Population: In the standardized implementation condition, 141 patients provided baseline data and 102/141 participants provided 12-week data. In the tailored implementation condition, 87 patients provided baseline data and 74/87 provided 12-week data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standardized Implementation | Patient Health Questionnaire | Baseline | 18.04 score on a scale | Standard Deviation 4.1 |
| Standardized Implementation | Patient Health Questionnaire | 12-Week | 12.15 score on a scale | Standard Deviation 6.07 |
| Tailored Implementation | Patient Health Questionnaire | Baseline | 16.77 score on a scale | Standard Deviation 4.73 |
| Tailored Implementation | Patient Health Questionnaire | 12-Week | 13.09 score on a scale | Standard Deviation 5.76 |
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.
Time frame: 5-month implementation window
Population: For each participating therapist, the raw counts of fidelity (scored as 1, 2, or 3) are included at the session-level for the 15,686 individual psychotherapy sessions.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standardized Implementation | PHQ-9 Completed Fidelity | 1. PHQ-9 Not Completed | 4894 Individual psychotherapy sessions |
| Standardized Implementation | PHQ-9 Completed Fidelity | 2. PHQ-9 Completed (Reported in EHR) Only | 1564 Individual psychotherapy sessions |
| Standardized Implementation | PHQ-9 Completed Fidelity | 3. PHQ-9 Completed and Discussed with Patient | 1112 Individual psychotherapy sessions |
| Tailored Implementation | PHQ-9 Completed Fidelity | 1. PHQ-9 Not Completed | 5270 Individual psychotherapy sessions |
| Tailored Implementation | PHQ-9 Completed Fidelity | 2. PHQ-9 Completed (Reported in EHR) Only | 860 Individual psychotherapy sessions |
| Tailored Implementation | PHQ-9 Completed Fidelity | 3. PHQ-9 Completed and Discussed with Patient | 1986 Individual psychotherapy sessions |