Trial Outcomes & Findings for Standardized Versus Tailored Implementation of Measurement Based Care for Depression (NCT NCT02266134)
NCT ID: NCT02266134
Last Updated: 2023-06-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
382 participants
Primary outcome timeframe
Week 0 (baseline) and Week 12 of treatment
Results posted on
2023-06-02
Participant Flow
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.
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).
Unit of analysis: Health Clinics
Participant milestones
| Measure |
Standardized Implementation, Patients
Sites in the standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).
|
Tailored Implementation, Patients
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.
|
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.
|
Tailored Condition, Therapists
Sites in 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 tailored clinic.
|
|---|---|---|---|---|
|
Clinics #1-2: Beginning Aug 2015
STARTED
|
9 1
|
11 1
|
14 1
|
14 1
|
|
Clinics #1-2: Beginning Aug 2015
COMPLETED
|
3 1
|
8 1
|
14 1
|
14 1
|
|
Clinics #1-2: Beginning Aug 2015
NOT COMPLETED
|
6 0
|
3 0
|
0 0
|
0 0
|
|
Clinics #3-6: Beginning Dec 2015
STARTED
|
47 2
|
24 2
|
14 2
|
17 2
|
|
Clinics #3-6: Beginning Dec 2015
COMPLETED
|
39 2
|
22 2
|
14 2
|
17 2
|
|
Clinics #3-6: Beginning Dec 2015
NOT COMPLETED
|
8 0
|
2 0
|
0 0
|
0 0
|
|
Clinics #7-10: Beginning May 2016
STARTED
|
39 2
|
33 2
|
28 2
|
29 2
|
|
Clinics #7-10: Beginning May 2016
COMPLETED
|
26 2
|
28 2
|
28 2
|
29 2
|
|
Clinics #7-10: Beginning May 2016
NOT COMPLETED
|
13 0
|
5 0
|
0 0
|
0 0
|
|
Clinics #11-12: Beginning Dec 2016
STARTED
|
46 1
|
19 1
|
15 1
|
23 1
|
|
Clinics #11-12: Beginning Dec 2016
COMPLETED
|
37 1
|
17 1
|
15 1
|
23 1
|
|
Clinics #11-12: Beginning Dec 2016
NOT COMPLETED
|
9 0
|
2 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Standardized Implementation, Patients
Sites in the standardized condition arm will receive the standard implementation of measurement-based care intervention (PHQ-9).
|
Tailored Implementation, Patients
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.
|
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.
|
Tailored Condition, Therapists
Sites in 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 tailored clinic.
|
|---|---|---|---|---|
|
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
|
|
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
|
Baseline Characteristics
Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Baseline characteristics by cohort
| Measure |
Standardized Implementation, Patients
n=141 Participants
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.
|
Tailored Implementation, Patients
n=87 Participants
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.
|
Standardized Implementation, Therapists
n=71 Participants
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.
|
Tailored Implementation, Therapists
n=83 Participants
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.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.06 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
40.14 years
STANDARD_DEVIATION 11.74 • n=7 Participants
|
45.23 years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
41.99 years
STANDARD_DEVIATION 13.22 • n=4 Participants
|
41.32 years
STANDARD_DEVIATION 12.36 • n=21 Participants
|
|
Sex/Gender, Customized
Gender Identity · Female
|
96 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
278 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender Identity · Male
|
44 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender Identity · Transgender
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender Identity · Non-binary
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Gender Identity · Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
347 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
299 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=5 Participants
|
87 participants
n=7 Participants
|
71 participants
n=5 Participants
|
83 participants
n=4 Participants
|
382 participants
n=21 Participants
|
|
Highest Education Status
Some high school
|
26 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Highest Education Status
High school diploma or equivalent
|
54 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Highest Education Status
Some college, but no degree
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Highest Education Status
Associate's degree
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Highest Education Status
Bachelor's degree
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Highest Education Status
Master's degree
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Highest Education Status
Doctoral degree or equivalent
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Highest Education Status
Other
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Highest Education Status
Missing or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0 (baseline) and Week 12 of treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Standardized Implementation
n=141 Participants
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. 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.
|
Tailored Implementation
n=87 Participants
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. 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.
|
|---|---|---|
|
Patient Health Questionnaire
12-Week
|
12.15 score on a scale
Standard Deviation 6.07
|
13.09 score on a scale
Standard Deviation 5.76
|
|
Patient Health Questionnaire
Baseline
|
18.04 score on a scale
Standard Deviation 4.10
|
16.77 score on a scale
Standard Deviation 4.73
|
PRIMARY outcome
Timeframe: 5-month implementation windowPopulation: 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.
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.
Outcome measures
| Measure |
Standardized Implementation
n=7570 Individual psychotherapy sessions
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. 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.
|
Tailored Implementation
n=8116 Individual psychotherapy sessions
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. 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.
|
|---|---|---|
|
PHQ-9 Completed Fidelity
1. PHQ-9 Not Completed
|
4894 Individual psychotherapy sessions
|
5270 Individual psychotherapy sessions
|
|
PHQ-9 Completed Fidelity
2. PHQ-9 Completed (Reported in EHR) Only
|
1564 Individual psychotherapy sessions
|
860 Individual psychotherapy sessions
|
|
PHQ-9 Completed Fidelity
3. PHQ-9 Completed and Discussed with Patient
|
1112 Individual psychotherapy sessions
|
1986 Individual psychotherapy sessions
|
Adverse Events
Standardized Implementation, Patients
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Tailored Implementation, Patients
Serious events: 8 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standardized Implementation, Patients
n=141 participants at risk
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. 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
|
Tailored Implementation, Patients
n=87 participants at risk
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. 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
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
3.5%
5/141 • Number of events 5 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
8.0%
7/87 • Number of events 7 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
|
Psychiatric disorders
Medical Hospitalization
|
0.00%
0/141 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
0.00%
0/87 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
|
Psychiatric disorders
Death
|
0.00%
0/141 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
1.1%
1/87 • Number of events 1 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
Other adverse events
| Measure |
Standardized Implementation, Patients
n=141 participants at risk
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. 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
|
Tailored Implementation, Patients
n=87 participants at risk
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. 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
|
|---|---|---|
|
Psychiatric disorders
Inappropriate Behavior Toward Staff
|
0.00%
0/141 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
1.1%
1/87 • Number of events 1 • Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
|
Additional Information
Dr. Cara C. Lewis
Kaiser Permanente Washington Health Research Institute
Phone: 206-422-4076
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place