Trial Outcomes & Findings for Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation (NCT NCT01947283)

NCT ID: NCT01947283

Last Updated: 2019-03-08

Results Overview

12 items designed to assess SDM quality in medical visit. Rated on 5 point Likert scales ranging from 0 (behavior not observed) -- 4 (clinician exhibited behavior to high standard). Final scores are the sum of the rating and range from 0-44. Final scores were transformed to a scale that ranges from 0 (lowest SDM) - 100 (highest SDM).

Recruitment status

COMPLETED

Study phase

Target enrollment

481 participants

Primary outcome timeframe

Follow-up assessment (2 months)

Results posted on

2019-03-08

Participant Flow

Recruitment began in August 2014 and ended in September 2016. Participants were recruited at behavioral health community clinics and psychiatric outpatient clinics in Massachusetts. Participants were assessed for eligibility and then randomized into a study arm.

Patients were excluded due to ineligibility (positive screening for mania, psychosis, and/or active suicidal ideation) or treatment discontinuation. Providers were excluded due to a lack of patients enrolled in the study. Both patient and provider study participants were excluded if they withdrew before randomization into a study arm.

Participant milestones

Participant milestones
Measure	Intervention Patients & Providers Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Overall Study STARTED	89	68	83	72	95	34	40
Overall Study Baseline Assessment	89	68	83	72	0	34	40
Overall Study Follow-up Assessment	64	51	65	59	0	27	36
Overall Study Clinical Recording	65	54	68	57	0	0	0
Overall Study End-of-Intervention Assessment	74	53	73	66	0	32	33
Overall Study In Analysis	89	68	83	72	95	30	38
Overall Study Completed NRCT Baseline Assessment	0	0	0	0	95	0	0
Overall Study COMPLETED	60	45	62	55	95	27	32
Overall Study NOT COMPLETED	29	23	21	17	0	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patients & Providers Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Overall Study Death	1	1	1	0	0	0
Overall Study Lost to Follow-up	4	6	5	5	2	5
Overall Study Withdrawal by Subject	10	8	4	1	0	2
Overall Study No Clinical Recording	12	6	8	10	0	0
Overall Study Non-coding Clinical Recording language	0	0	0	1	0	0
Overall Study Missing Follow-up Assessment	2	2	3	0	2	0
Overall Study No patients were enrolled in study	0	0	0	0	3	1

Baseline Characteristics

For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Providers & Patients n=89 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=68 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=83 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=72 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients n=95 Participants Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers n=34 Participants Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers n=40 Participants Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Total n=481 Participants Total of all reporting groups
Age, Customized <=18 years	1 Participants n=89 Participants	1 Participants n=68 Participants	2 Participants n=83 Participants	0 Participants n=72 Participants	2 Participants n=95 Participants	0 Participants n=34 Participants	0 Participants n=40 Participants	6 Participants n=481 Participants
Age, Customized Between 18 and 65 years	83 Participants n=89 Participants	60 Participants n=68 Participants	75 Participants n=83 Participants	65 Participants n=72 Participants	88 Participants n=95 Participants	31 Participants n=34 Participants	38 Participants n=40 Participants	440 Participants n=481 Participants
Age, Customized >=65 years	5 Participants n=89 Participants	7 Participants n=68 Participants	6 Participants n=83 Participants	7 Participants n=72 Participants	5 Participants n=95 Participants	2 Participants n=34 Participants	2 Participants n=40 Participants	34 Participants n=481 Participants
Age, Customized Missing	0 Participants n=89 Participants	0 Participants n=68 Participants	0 Participants n=83 Participants	0 Participants n=72 Participants	0 Participants n=95 Participants	1 Participants n=34 Participants	0 Participants n=40 Participants	1 Participants n=481 Participants
Sex: Female, Male Female	58 Participants n=89 Participants	47 Participants n=68 Participants	56 Participants n=83 Participants	51 Participants n=72 Participants	57 Participants n=95 Participants	24 Participants n=34 Participants	32 Participants n=40 Participants	325 Participants n=481 Participants
Sex: Female, Male Male	31 Participants n=89 Participants	21 Participants n=68 Participants	27 Participants n=83 Participants	21 Participants n=72 Participants	38 Participants n=95 Participants	10 Participants n=34 Participants	8 Participants n=40 Participants	156 Participants n=481 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=89 Participants	26 Participants n=68 Participants	34 Participants n=83 Participants	29 Participants n=72 Participants	38 Participants n=95 Participants	8 Participants n=34 Participants	7 Participants n=40 Participants	183 Participants n=481 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=89 Participants	42 Participants n=68 Participants	49 Participants n=83 Participants	43 Participants n=72 Participants	57 Participants n=95 Participants	26 Participants n=34 Participants	33 Participants n=40 Participants	298 Participants n=481 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=89 Participants	0 Participants n=68 Participants	0 Participants n=83 Participants	0 Participants n=72 Participants	0 Participants n=95 Participants	0 Participants n=34 Participants	0 Participants n=40 Participants	0 Participants n=481 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=89 Participants	0 Participants n=68 Participants	1 Participants n=83 Participants	0 Participants n=72 Participants	0 Participants n=95 Participants	0 Participants n=34 Participants	0 Participants n=40 Participants	1 Participants n=481 Participants
Race (NIH/OMB) Asian	7 Participants n=89 Participants	5 Participants n=68 Participants	9 Participants n=83 Participants	5 Participants n=72 Participants	7 Participants n=95 Participants	5 Participants n=34 Participants	6 Participants n=40 Participants	44 Participants n=481 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=89 Participants	0 Participants n=68 Participants	2 Participants n=83 Participants	1 Participants n=72 Participants	1 Participants n=95 Participants	0 Participants n=34 Participants	0 Participants n=40 Participants	6 Participants n=481 Participants
Race (NIH/OMB) Black or African American	14 Participants n=89 Participants	6 Participants n=68 Participants	12 Participants n=83 Participants	6 Participants n=72 Participants	9 Participants n=95 Participants	2 Participants n=34 Participants	1 Participants n=40 Participants	50 Participants n=481 Participants
Race (NIH/OMB) White	36 Participants n=89 Participants	32 Participants n=68 Participants	31 Participants n=83 Participants	33 Participants n=72 Participants	43 Participants n=95 Participants	22 Participants n=34 Participants	30 Participants n=40 Participants	227 Participants n=481 Participants
Race (NIH/OMB) More than one race	2 Participants n=89 Participants	15 Participants n=68 Participants	0 Participants n=83 Participants	6 Participants n=72 Participants	3 Participants n=95 Participants	2 Participants n=34 Participants	2 Participants n=40 Participants	30 Participants n=481 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=89 Participants	10 Participants n=68 Participants	28 Participants n=83 Participants	21 Participants n=72 Participants	32 Participants n=95 Participants	3 Participants n=34 Participants	1 Participants n=40 Participants	123 Participants n=481 Participants
Region of Enrollment United States	89 participants n=89 Participants	68 participants n=68 Participants	83 participants n=83 Participants	72 participants n=72 Participants	95 participants n=95 Participants	34 participants n=34 Participants	40 participants n=40 Participants	481 participants n=481 Participants
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)	77.15 units on a scale STANDARD_DEVIATION 20.31 • n=86 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	76.31 units on a scale STANDARD_DEVIATION 18.27 • n=67 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	77.82 units on a scale STANDARD_DEVIATION 17.54 • n=83 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	74.24 units on a scale STANDARD_DEVIATION 21.04 • n=71 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	75.4 units on a scale STANDARD_DEVIATION 23.57 • n=91 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	—	—	76.23 units on a scale STANDARD_DEVIATION 20.32 • n=398 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)	90.78 units on a scale STANDARD_DEVIATION 10.44 • n=89 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	88.29 units on a scale STANDARD_DEVIATION 12.33 • n=67 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	90.74 units on a scale STANDARD_DEVIATION 9.90 • n=83 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	88.32 units on a scale STANDARD_DEVIATION 12.45 • n=71 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	92.75 units on a scale STANDARD_DEVIATION 8.74 • n=95 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.	—	—	90.39 units on a scale STANDARD_DEVIATION 10.77 • n=405 Participants • For patients, row populations differ because of missing assessments. Patient assessments were not asked from providers.
Patient Shared Decision Making in Behavioral Health (SDM-BH) Patient Version	49.35 units on a scale STANDARD_DEVIATION 8.91 • n=62 Participants • Differences in number of patients analyzed reflect missing observations. Measure was not assessed for Non-RCT patients and providers.	46.23 units on a scale STANDARD_DEVIATION 8.26 • n=39 Participants • Differences in number of patients analyzed reflect missing observations. Measure was not assessed for Non-RCT patients and providers.	48.58 units on a scale STANDARD_DEVIATION 7.00 • n=57 Participants • Differences in number of patients analyzed reflect missing observations. Measure was not assessed for Non-RCT patients and providers.	47.76 units on a scale STANDARD_DEVIATION 9.30 • n=45 Participants • Differences in number of patients analyzed reflect missing observations. Measure was not assessed for Non-RCT patients and providers.	—	—	—	48.18 units on a scale STANDARD_DEVIATION 8.39 • n=203 Participants • Differences in number of patients analyzed reflect missing observations. Measure was not assessed for Non-RCT patients and providers.
Provider Shared Decision Making in Behavioral Health (SDM-BH) Provider Version	—	—	—	—	—	46.29 units on a scale STANDARD_DEVIATION 4.91 • n=21 Participants • Provider measure not assessed from patients. For providers, differences reflect missing observations.	46.85 units on a scale STANDARD_DEVIATION 3.97 • n=26 Participants • Provider measure not assessed from patients. For providers, differences reflect missing observations.	46.60 units on a scale STANDARD_DEVIATION 4.37 • n=47 Participants • Provider measure not assessed from patients. For providers, differences reflect missing observations.

PRIMARY outcome

Timeframe: Follow-up assessment (2 months)

Population: All participants who enrolled in the study after the baseline interview and whose data was analyzed. Measure for "Control Providers" and "Intervention Providers" is the average across all of their RCT patients, irrespective of whether they were intervention or control patients. Differences from overall numbers are due to missing observations.

Outcome measures

Outcome measures
Measure	Intervention Patients & Providers n=65 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=54 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=68 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=57 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients n=93 Participants Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers n=28 Participants Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers n=36 Participants Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores	36.31 units on a scale Standard Deviation 11.77	29.78 units on a scale Standard Deviation 10.53	34.50 units on a scale Standard Deviation 14.96	30.37 units on a scale Standard Deviation 13.54	32.37 units on a scale Standard Deviation 12.96	30.09 units on a scale Standard Deviation 12.12	35.39 units on a scale Standard Deviation 13.48

PRIMARY outcome

Timeframe: End-of-intervention Assessment (5 months)

Population: All participants who enrolled in the study after the baseline interview and whose data was analyzed. SDM-Q-9 patient version was not administered to providers. Measure was not assessed for Non-RCT patients.

Evaluates patient SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

Outcome measures

Outcome measures
Measure	Intervention Patients & Providers n=72 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=52 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=72 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=66 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)	81.10 units on a scale Standard Deviation 17.77	77.5 units on a scale Standard Deviation 17.86	75.85 units on a scale Standard Deviation 19.91	76.75 units on a scale Standard Deviation 20.52	—	—	—

PRIMARY outcome

Timeframe: Follow-up Assessment (2 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. Each enrolled provider completed a follow-up assessment for each of their enrolled patients, following the audio recording of their clinical session.

The 10 items was developed by research team to evaluate provider SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the provider.

Outcome measures

Outcome measures
Measure	Intervention Patients & Providers n=46 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=30 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=49 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=39 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version	41.26 units on a scale Standard Deviation 6.57	40.10 units on a scale Standard Deviation 7.45	41.96 units on a scale Standard Deviation 5.53	38.41 units on a scale Standard Deviation 7.11	—	—	—

PRIMARY outcome

Timeframe: Follow-up Assessment (2 months)

Evaluates provider SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

Outcome measures

Outcome measures
Measure	Intervention Patients & Providers n=63 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=50 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=67 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=57 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)	69.03 units on a scale Standard Deviation 12.51	69.60 units on a scale Standard Deviation 14.30	69.85 units on a scale Standard Deviation 10.14	68.46 units on a scale Standard Deviation 16.97	—	—	—

PRIMARY outcome

Timeframe: End-of-intervention Assessment (5 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. PoC was not administered to providers. Measure was not assessed for Non-RCT patients.

Assesses patient perceptions of care in psychiatric settings. Includes 3 items, final scores are scored externally, and range from 0 (lowest quality) to 100 (highest quality).

Outcome measures

Outcome measures
Measure	Intervention Patients & Providers n=74 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers. For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Intervention Patients, Control Providers n=52 Participants Participants in this arm are intervention patients who will receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.	Control Patients, Intervention Providers n=72 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.	Control Patients & Providers n=66 Participants Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."	Non Randomized Controlled Trial Patients Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.	Control Providers Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	Intervention Providers Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)	94.60 units on a scale Standard Deviation 7.64	91.15 units on a scale Standard Deviation 9.48	90.50 units on a scale Standard Deviation 12.45	89.00 units on a scale Standard Deviation 13.06	—	—	—

PRIMARY outcome

Timeframe: End-of-intervention Assessment (5 months)

Population: All participants who were enrolled in the study after the baseline interview and whose data was analyzed. SDM-BH patient version was not administered to providers. Measure was not assessed for Non-RCT patients.

The 10 items was developed by research team to evaluate patient SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the patient.