search
Back to results

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

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DECIDE-PA
DECIDE-PC
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders focused on measuring Patient-Provider Relationship, Shared Decision Making, Therapeutic Alliance, Mental Health, Minority Health, Patient Activation, Communication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South Cove Community Health Center
  • Massachusetts General Hospital
  • South End Community Health Center
  • Family Services of Greater Boston
  • Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)
  • Beth Israel Deaconess Medical Center (Latino Mental Health)
  • Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)
  • Edward M Kennedy Health Center (Great Brook Valley Health Center)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

No Intervention

No Intervention

No Intervention

No Intervention

Experimental

Arm Label

Intervention Patients & Providers

Intervention Patients, Control Providers

Control Patients, Intervention Providers

Control Patients & Providers

Non-Randomized Controlled Trial Patients

Control Providers

Intervention Providers

Arm 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.

Outcomes

Primary Outcome Measures

Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores
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).
Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)
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).
Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version
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.
Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)
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).
Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)
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).
Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version
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.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2013
Last Updated
November 13, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01947283
Brief Title
Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Acronym
PCORI
Official Title
Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Patient-Provider Relationship, Shared Decision Making, Therapeutic Alliance, Mental Health, Minority Health, Patient Activation, Communication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Patients & Providers
Arm Type
Experimental
Arm 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.
Arm Title
Intervention Patients, Control Providers
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Patients, Intervention Providers
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control Patients & Providers
Arm Type
No Intervention
Arm Description
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."
Arm Title
Non-Randomized Controlled Trial Patients
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control Providers
Arm Type
No Intervention
Arm Description
Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
Arm Title
Intervention Providers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DECIDE-PA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DECIDE-PC
Intervention Description
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.
Primary Outcome Measure Information:
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)
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)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Alegria, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Cove Community Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
South End Community Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Family Services of Greater Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Latino Mental Health)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Facility Name
Edward M Kennedy Health Center (Great Brook Valley Health Center)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29466533
Citation
Alegria M, Nakash O, Johnson K, Ault-Brutus A, Carson N, Fillbrunn M, Wang Y, Cheng A, Harris T, Polo A, Lincoln A, Freeman E, Bostdorf B, Rosenbaum M, Epelbaum C, LaRoche M, Okpokwasili-Johnson E, Carrasco M, Shrout PE. Effectiveness of the DECIDE Interventions on Shared Decision Making and Perceived Quality of Care in Behavioral Health With Multicultural Patients: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Apr 1;75(4):325-335. doi: 10.1001/jamapsychiatry.2017.4585.
Results Reference
derived
Links:
URL
http://www.massgeneral.org/disparitiesresearch/
Description
Disparities Research Unit (DRU) website

Learn more about this trial

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

We'll reach out to this number within 24 hrs