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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01947283
Recruitment Status : Completed
First Posted : September 20, 2013
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Mental Disorders
Interventions Behavioral: DECIDE-PA
Behavioral: DECIDE-PC
Enrollment 481
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 Details 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
Hide 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
Reason Not Completed
Death             1             1             1             0             0             0             0
Lost to Follow-up             4             6             5             5             0             2             5
Withdrawal by Subject             10             8             4             1             0             0             2
No Clinical Recording             12             6             8             10             0             0             0
Non-coding Clinical Recording language             0             0             0             1             0             0             0
Missing Follow-up Assessment             2             2             3             0             0             2             0
No patients were enrolled in study             0             0             0             0             0             3             1
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
Hide 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 Number of Baseline Participants 89 68 83 72 95 34 40 481
Hide Baseline Analysis Population Description
All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
<=18 years Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
1
   1.1%
1
   1.5%
2
   2.4%
0
   0.0%
2
   2.1%
0
   0.0%
0
   0.0%
6
   1.2%
Between 18 and 65 years Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
83
  93.3%
60
  88.2%
75
  90.4%
65
  90.3%
88
  92.6%
31
  91.2%
38
  95.0%
440
  91.5%
>=65 years Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
5
   5.6%
7
  10.3%
6
   7.2%
7
   9.7%
5
   5.3%
2
   5.9%
2
   5.0%
34
   7.1%
Missing Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
1
   0.2%
[1]
Measure Description: All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
Female
58
  65.2%
47
  69.1%
56
  67.5%
51
  70.8%
57
  60.0%
24
  70.6%
32
  80.0%
325
  67.6%
Male
31
  34.8%
21
  30.9%
27
  32.5%
21
  29.2%
38
  40.0%
10
  29.4%
8
  20.0%
156
  32.4%
[1]
Measure Description: All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
Hispanic or Latino
41
  46.1%
26
  38.2%
34
  41.0%
29
  40.3%
38
  40.0%
8
  23.5%
7
  17.5%
183
  38.0%
Not Hispanic or Latino
48
  53.9%
42
  61.8%
49
  59.0%
43
  59.7%
57
  60.0%
26
  76.5%
33
  82.5%
298
  62.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.2%
0
   0.0%
0
   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
  15.0%
44
   9.1%
Native Hawaiian or Other Pacific Islander
2
   2.2%
0
   0.0%
2
   2.4%
1
   1.4%
1
   1.1%
0
   0.0%
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
  75.0%
227
  47.2%
More than one race
2
   2.2%
15
  22.1%
0
   0.0%
6
   8.3%
3
   3.2%
2
   5.9%
2
   5.0%
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%
[1]
Measure Description: All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 68 participants 83 participants 72 participants 95 participants 34 participants 40 participants 481 participants
89 68 83 72 95 34 40 481
[1]
Measure Description: All participants who were enrolled in the study after the baseline interview and whose data was analyzed.
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 86 participants 67 participants 83 participants 71 participants 91 participants 0 participants 0 participants 398 participants
77.15  (20.31) 76.31  (18.27) 77.82  (17.54) 74.24  (21.04) 75.4  (23.57) 76.23  (20.32)
[1]
Measure Description: Evaluates patient SDM from a patient-provider visit. The 9 items are 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).
[2]
Measure Analysis Population Description: 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)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 89 participants 67 participants 83 participants 71 participants 95 participants 0 participants 0 participants 405 participants
90.78  (10.44) 88.29  (12.33) 90.74  (9.90) 88.32  (12.45) 92.75  (8.74) 90.39  (10.77)
[1]
Measure 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).
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 62 participants 39 participants 57 participants 45 participants 0 participants 0 participants 0 participants 203 participants
49.35  (8.91) 46.23  (8.26) 48.58  (7.00) 47.76  (9.30) 48.18  (8.39)
[1]
Measure Description: Evaluates patient SDM from a patient-provider visit in behavioral health. The 10 items were developed by a research team and 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.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 21 participants 26 participants 47 participants
46.29  (4.91) 46.85  (3.97) 46.60  (4.37)
[1]
Measure Description: Evaluates provider SDM from a patient-provider visit in behavioral health. The 10 items were developed by a research team and 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.
[2]
Measure Analysis Population Description: Provider measure not assessed from patients. For providers, differences reflect missing observations.
1.Primary Outcome
Title Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 65 54 68 57 93 28 36
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 72 52 72 66 0 0 0
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 46 30 49 39 0 0 0
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 63 50 67 57 0 0 0
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 74 52 72 66 0 0 0
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 65 44 68 58 0 0 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
51.46  (6.63) 47.14  (10.54) 50.28  (7.85) 48.67  (7.89)
Time Frame Recruitment (0 months) to Completion of Study Participation (6 months)
Adverse Event Reporting Description [Not Specified]
 
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/89 (1.12%)   1/68 (1.47%)   1/83 (1.20%)   0/72 (0.00%)   0/95 (0.00%)   0/34 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/68 (0.00%)   0/83 (0.00%)   0/72 (0.00%)   0/95 (0.00%)   0/34 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/68 (0.00%)   0/83 (0.00%)   0/72 (0.00%)   0/95 (0.00%)   0/34 (0.00%)   0/40 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Margarita Alegria
Organization: Disparities Research Unit, Department of Medicine, Massachusetts General Hospital
Phone: 617-724-4987
Responsible Party: Margarita Alegria, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01947283     History of Changes
Other Study ID Numbers: CD-12-11-4187
First Submitted: September 18, 2013
First Posted: September 20, 2013
Results First Submitted: May 1, 2017
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019