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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Massachusetts General Hospital
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01947283
First received: September 18, 2013
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
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 Intervention
Mental Disorders
Behavioral: DECIDE-PA
Behavioral: DECIDE-PC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Shared Decision Making (SDM-Q-9, SDM-Q-Doc and OPTION, and an internally developed measure) [ Time Frame: 2-6 Months in each data collection cycle (4 cycles) ] [ Designated as safety issue: No ]
    Both patients and providers will assess the quality of the patient-provider relationship using the SDM-Q-9 questionnaire (for patients) and the SDM-Q-Doc (for providers) during the baseline interview, during an interview immediately following the clinical visit, and at post-assessment (approximately 6 months after baseline). The clinical visit will also be recorded and coded using the OPTION scale by a third-party observer to assess shared decision making objectively. An additional 10-item measure, developed internally, will also be used to assess shared decision making for both patients and providers. This measure is more specific to the mental health context and addresses aspects of shared decision making that are targeted by both the patient and provider DECIDE interventions.


Secondary Outcome Measures:
  • Perceptions of Care Survey [ Time Frame: 2-6 Months in each data collection cycle (4 cycles) ] [ Designated as safety issue: No ]
    Patients will be asked to rate the quality of their care at baseline, after the clinical visit and at post-assessment.


Estimated Enrollment: 546
Study Start Date: September 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Providers & Patients

Providers in this arm will receive the DECIDE-PC intervention. Patients in this arm will receive the DECIDE-PA intervention.

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.

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.
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.
Experimental: Control Providers, Intervention Patients

Control Providers will not receive the DECIDE-PC intervention. Intervention Patients will receive the DECIDE-PA 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.
Experimental: Intervention Providers, Control Patients

Intervention providers will receive the DECIDE-PC intervention. Control patients will not receive the DECIDE-PA intervention.

For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.

Control patients will receive a pamphlet called "Managing Your Mental Health Care."

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.
No Intervention: Control Providers & Patients
Control providers and patients will not receive the DECIDE-PA or DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947283

Contacts
Contact: Margarita Alegria, Ph.D. 617-724-4987 malegria@mgh.harvard.edu
Contact: Natasha Ramanayake, MA 617-643-9251 nramanayake@partners.org

Locations
United States, Massachusetts
South Cove Community Health Center Completed
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Margarita Alegria, PhD    617-724-4987    malegria@mgh.harvard.edu   
Contact: Natasha Ramanayake, MA    617-643-9251    nramanayake@partners.org   
South End Community Health Center Active, not recruiting
Boston, Massachusetts, United States, 02118
Family Services of Greater Boston Active, not recruiting
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit) Active, not recruiting
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center (Latino Mental Health) Active, not recruiting
Boston, Massachusetts, United States, 02215
Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health) Active, not recruiting
Cambridge, Massachusetts, United States, 02139
Edward M Kennedy Health Center (Great Brook Valley Health Center) Completed
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
  More Information

Additional Information:
Responsible Party: Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01947283     History of Changes
Other Study ID Numbers: CD-12-11-4187 
Study First Received: September 18, 2013
Last Updated: June 30, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Patient-Provider Relationship
Shared Decision Making
Therapeutic Alliance
Mental Health
Minority Health
Patient Activation
Communication

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on July 21, 2016