PCORI: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01947283
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 481
• Locations: 8
• Arms: 7
• Duration (Months): 37
• Patients Per Site: 60.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to learn more about how patients and healthcare providers interact in order to improve shared decision making. The investigators plan to test an intervention with two separate educational components-one for patients and one for providers-designed to encourage patients to ask questions and increase their level of involvement in their own care, while simultaneously training providers to be more receptive to patients' questions and concerns. Patients in the intervention group will receive three short (30-45 minute) trainings focused on developing and asking questions and will be interviewed three times over the course of the intervention to see how it has affected the quality of their care. Providers receiving the intervention will participate in three separate trainings, including a 12-hour group workshop, an additional two hour training, and six hours of individual instruction, including personalized feedback based on three audio-recorded patient visits. Previous studies looking at patient engagement and involvement in decision-making have shown that increased engagement is linked with improved outcomes, but that providers are sometimes not prepared to develop a collaborative relationship with patients. The investigators think that training both patients and providers to work together and communicate more effectively will improve quality of care and increase patient satisfaction more than interventions that focus on only one side of the clinical encounter. One of the major goals in studying patient-provider communication is to improve shared decision-making and see how it contributes to racial and ethnic disparities in mental health care, since minority patients have been shown to be less involved in care and have been shown to be perceived and treated differently by providers.

Condition or Disease	Intervention/Treatment	Phase
Mental Disorders	Behavioral: DECIDE-PA; Behavioral: DECIDE-PC	N/A

Detailed Description

The Center for Multicultural Mental Health Research (CMMHR) at Cambridge Health Alliance has recently been selected for funding by the Patient Centered Outcomes Research Institute (PCORI) to address the importance of patient-provider communication, shared decision making, and therapeutic alliance. Our research team demonstrated that a psycho-educational intervention (DECIDE-PA) improves patient activation and self-management in behavioral health care. However, the investigators found that providers were unresponsive or reacted negatively to patients' activation. In response, the investigators propose to combine DECIDE-PA with provider coaching (DECIDE-PC) to increase providers' receptivity to patient activation, and improve Shared Decision Making (SDM). The investigators also focus on quality of care, responding to clinic administrators who require interventions that improve quality of behavioral health care (mental health and substance treatments).

Aims: 1) Test the effectiveness of DECIDE PA+PC compared to usual care in improving SDM and patient-perceived quality of behavioral health care; 2) Test whether patient-centered communication and therapeutic alliance mediate the effect of the DECIDE PA+PC intervention on SDM; 3) Explore whether ethnic/racial or language matching between patient and provider moderates the effect of DECIDE PA+PC on SDM and quality of behavioral health care.

Intervention: The DECIDE PA+PC intervention is designed to improve the quality of mental health care for adult behavioral health patients by engaging minority participants in asking questions about their treatment. The intervention is administered to patients and providers and is designed to improve patient activation, self-management, and therapeutic alliance.

For 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 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 concordant and discordant ethnic/racial dyads. The DECIDE PC training for providers consists of 1.5 days of training which focuses on augmenting patient-centered communication and therapeutic alliance as a possible underlying pathway by which SDM can take place. The training also addresses 1) lack of perspective taking; 2) frequent attributional errors that providers make; and 3) decreased receptivity to patient participation and collaboration in decision making. The training includes provider coaching totaling 15-20 hours.

Methods: For Aim 1, implement a randomized controlled trial comparing DECIDE-PA+PC with usual care on Shard Decision Making (SDM) and perceived quality of care. Identify treatment effects using multi-level models that account for nesting of observations, patients, providers, and clinics. For Aim 2, identify underlying mechanisms of the effect of the DECIDE-PA+PC intervention on SDM. Mediation analysis techniques are used that allow for rigorous testing of causal pathways and statistical adjustment for spurious correlation is used in instances where mediators and SDM measurement are contemporaneous. For Aim 3, expand Aim 1 models to test whether DECIDE-PA+PC impacts SDM and perceived quality differentially by ethnic/racial concordant/discordant dyads.

Usual Care: Usual care across clinics is described by clinicians as answering their patients' questions during the clinical encounter. Clinicians report that on average they perceive their patients as having limited involvement in decision-making. No DECIDE training for patients or providers will be applied to the control condition while the control provider and control patient are participating in the study. Once the control provider and control patient complete their participation in the study, they will be offered the DECIDE trainings.

Participating Sites: The investigators plan to administer the intervention to patients and providers at four participating Cambridge Health Alliance clinics, along with Beth Israel Deaconess Medical Center, Boston Children's Hospital, South Cove Community Health Center, Edward M Kennedy Health Center (Great Brook Valley Health Center), and two community health centers through Harbor Health Services (Neponset Health Center and Geiger Gibson Community Health Center).

Study Design

• Study Type: Interventional
• Actual Enrollment: 481 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: DECIDE-PA; The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.
Experimental: 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.	Behavioral: DECIDE-PA; The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.
No Intervention: 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.
No Intervention: 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."
No Intervention: 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.
No 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.
Experimental: 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.	Behavioral: DECIDE-PC; The DECIDE-PC intervention trains providers in patient-centered communication techniques and encourages providers to be receptive to patients who take a more active role during the clinical encounter in order to improve shared decision making.

Outcome Measures

Primary Outcome Measures

1. Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores [Follow-up assessment (2 months)]

   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).

2. Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) [End-of-intervention Assessment (5 months)]

   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).

3. Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version [Follow-up Assessment (2 months)]

   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.

4. Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) [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).

5. Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) [End-of-intervention Assessment (5 months)]

   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).

6. Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version [End-of-intervention Assessment (5 months)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patient Inclusion Criteria:

-Patients ages 18-80 who are receiving mental health treatment at one of the collaborating clinics.

Patient Exclusion Criteria:

-Patients will be excluded if they screen with mania, psychosis, or suicidality to ensure their safety and minimize the stress of receiving the intervention. Patients over the age of 65 will be assessed with a cognitive functioning screening instrument and excluded if possible cognitive impairment is indicated.

Provider Inclusion Criteria:

-Providers will be permitted to participate in this study if they are regular, paid staff that provide behavioral health services at any of the participating clinics. No other criteria will be required.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Cove Community Health Center	Boston	Massachusetts	United States	02111
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	South End Community Health Center	Boston	Massachusetts	United States	02118
4	Family Services of Greater Boston	Boston	Massachusetts	United States	02130
5	Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)	Boston	Massachusetts	United States	02215
6	Beth Israel Deaconess Medical Center (Latino Mental Health)	Boston	Massachusetts	United States	02215
7	Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)	Cambridge	Massachusetts	United States	02139
8	Edward M Kennedy Health Center (Great Brook Valley Health Center)	Worcester	Massachusetts	United States	01605

Sponsors and Collaborators

• Massachusetts General Hospital
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Margarita Alegria, Ph.D., Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Disparities Research Unit (DRU) website

Publications

None provided.

• Responsible Party: Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01947283
• Other Study ID Numbers: CD-12-11-4187
• First Posted: Sep 20, 2013
• Last Update Posted: Mar 8, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital: Patient-Provider Relationship; Shared Decision Making; Therapeutic Alliance; Mental Health; Minority Health; Patient Activation; Communication
• Additional relevant MeSH terms: Mental Disorders

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Period Title: Overall Study
STARTED	89	68	83	72	95	34	40
Baseline Assessment	89	68	83	72	0	34	40
Follow-up Assessment	64	51	65	59	0	27	36
Clinical Recording	65	54	68	57	0	0	0
End-of-Intervention Assessment	74	53	73	66	0	32	33
In Analysis	89	68	83	72	95	30	38
Completed NRCT Baseline Assessment	0	0	0	0	95	0	0
COMPLETED	60	45	62	55	95	27	32
NOT COMPLETED	29	23	21	17	0	7	8

Baseline Characteristics

Arm/Group Title	Intervention Providers & Patients	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers	Total
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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 of all reporting groups
Overall Participants	89	68	83	72	95	34	40	481
Age, Customized (Count of Participants)
<=18 years	1 1.1%	1 1.5%	2 2.4%	0 0%	2 2.1%	0 0%	0 0%	6 1.2%
Between 18 and 65 years	83 93.3%	60 88.2%	75 90.4%	65 90.3%	88 92.6%	31 91.2%	38 95%	440 91.5%
>=65 years	5 5.6%	7 10.3%	6 7.2%	7 9.7%	5 5.3%	2 5.9%	2 5%	34 7.1%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.9%	0 0%	1 0.2%
Sex: Female, Male (Count of Participants)
Female	58 65.2%	47 69.1%	56 67.5%	51 70.8%	57 60%	24 70.6%	32 80%	325 67.6%
Male	31 34.8%	21 30.9%	27 32.5%	21 29.2%	38 40%	10 29.4%	8 20%	156 32.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	41 46.1%	26 38.2%	34 41%	29 40.3%	38 40%	8 23.5%	7 17.5%	183 38%
Not Hispanic or Latino	48 53.9%	42 61.8%	49 59%	43 59.7%	57 60%	26 76.5%	33 82.5%	298 62%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 1.2%	0 0%	0 0%	0 0%	0 0%	1 0.2%
Asian	7 7.9%	5 7.4%	9 10.8%	5 6.9%	7 7.4%	5 14.7%	6 15%	44 9.1%
Native Hawaiian or Other Pacific Islander	2 2.2%	0 0%	2 2.4%	1 1.4%	1 1.1%	0 0%	0 0%	6 1.2%
Black or African American	14 15.7%	6 8.8%	12 14.5%	6 8.3%	9 9.5%	2 5.9%	1 2.5%	50 10.4%
White	36 40.4%	32 47.1%	31 37.3%	33 45.8%	43 45.3%	22 64.7%	30 75%	227 47.2%
More than one race	2 2.2%	15 22.1%	0 0%	6 8.3%	3 3.2%	2 5.9%	2 5%	30 6.2%
Unknown or Not Reported	28 31.5%	10 14.7%	28 33.7%	21 29.2%	32 33.7%	3 8.8%	1 2.5%	123 25.6%
Region of Enrollment (participants) [Number]
United States	89 100%	68 100%	83 100%	72 100%	95 100%	34 100%	40 100%	481 100%
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	77.15 (20.31)	76.31 (18.27)	77.82 (17.54)	74.24 (21.04)	75.4 (23.57)	76.23 (20.32)
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	90.78 (10.44)	88.29 (12.33)	90.74 (9.90)	88.32 (12.45)	92.75 (8.74)	90.39 (10.77)
Patient Shared Decision Making in Behavioral Health (SDM-BH) Patient Version (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	49.35 (8.91)	46.23 (8.26)	48.58 (7.00)	47.76 (9.30)	48.18 (8.39)
Provider Shared Decision Making in Behavioral Health (SDM-BH) Provider Version (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	46.29 (4.91)	46.85 (3.97)	46.60 (4.37)

Outcome Measures

1. Primary Outcome

Title	Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores
Description	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).
Time Frame	Follow-up assessment (2 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	65	54	68	57	93	28	36
Mean (Standard Deviation) [units on a scale]	36.31 (11.77)	29.78 (10.53)	34.50 (14.96)	30.37 (13.54)	32.37 (12.96)	30.09 (12.12)	35.39 (13.48)

2. Primary Outcome

Title	Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)
Description	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).
Time Frame	End-of-intervention Assessment (5 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	72	52	72	66	0	0	0
Mean (Standard Deviation) [units on a scale]	81.10 (17.77)	77.5 (17.86)	75.85 (19.91)	76.75 (20.52)

3. Primary Outcome

Title	Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version
Description	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.
Time Frame	Follow-up Assessment (2 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Intervention Providers, Control Patients	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	46	30	49	39	0	0	0
Mean (Standard Deviation) [units on a scale]	41.26 (6.57)	40.10 (7.45)	41.96 (5.53)	38.41 (7.11)

4. Primary Outcome

Title	Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)
Description	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).
Time Frame	Follow-up Assessment (2 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	63	50	67	57	0	0	0
Mean (Standard Deviation) [units on a scale]	69.03 (12.51)	69.60 (14.30)	69.85 (10.14)	68.46 (16.97)

5. Primary Outcome

Title	Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)
Description	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).
Time Frame	End-of-intervention Assessment (5 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	74	52	72	66	0	0	0
Mean (Standard Deviation) [units on a scale]	94.60 (7.64)	91.15 (9.48)	90.50 (12.45)	89.00 (13.06)

6. Primary Outcome

Title	Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version
Description	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.
Time Frame	End-of-intervention Assessment (5 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention Patients & Providers	Intervention Patients, Control Providers	Control Patients, Intervention Providers	Control Patients & Providers	Non Randomized Controlled Trial Patients	Control Providers	Intervention Providers
Arm/Group Description	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.	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.	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.	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."	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.	Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.	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.
Measure Participants	65	44	68	58	0	0	0
Mean (Standard Deviation) [units on a scale]	51.46 (6.63)	47.14 (10.54)	50.28 (7.85)	48.67 (7.89)

Adverse Events

Time Frame	Recruitment (0 months) to Completion of Study Participation (6 months)
Arm/Group Title	Intervention Patients & Providers		Intervention Patients, Control Providers		Control Patients, Intervention Providers		Control Patients & Providers		Non-Randomized Controlled Trial Patients		Control Providers		Intervention Providers
Arm/Group Description	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.		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.		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.		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."		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.		Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.		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.
All Cause Mortality
	Intervention Patients & Providers		Intervention Patients, Control Providers		Control Patients, Intervention Providers		Control Patients & Providers		Non-Randomized Controlled Trial Patients		Control Providers		Intervention Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/89 (1.1%)		1/68 (1.5%)		1/83 (1.2%)		0/72 (0%)		0/95 (0%)		0/34 (0%)		0/40 (0%)
Serious Adverse Events
	Intervention Patients & Providers		Intervention Patients, Control Providers		Control Patients, Intervention Providers		Control Patients & Providers		Non-Randomized Controlled Trial Patients		Control Providers		Intervention Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/68 (0%)		0/83 (0%)		0/72 (0%)		0/95 (0%)		0/34 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Patients & Providers		Intervention Patients, Control Providers		Control Patients, Intervention Providers		Control Patients & Providers		Non-Randomized Controlled Trial Patients		Control Providers		Intervention Providers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/68 (0%)		0/83 (0%)		0/72 (0%)		0/95 (0%)		0/34 (0%)		0/40 (0%)

Limitations/Caveats

Due to research assistants being blinded to study assignment, 18.5% of intervention arm patients completed their Time 2 assessments before the patient intervention. This impacted patients by chance and does not invalidate effectiveness assessment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.