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

NCT01947283 | Completed Results

• 1 other identifier: CD-12-11-4187
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 8

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.

Conditions

Mental Disorders

Keywords

Patient-Provider Relationship; Shared Decision Making; Therapeutic Alliance; Mental Health; Minority Health; Patient Activation; Communication

Outcome Measures

Primary Outcomes (6)

• 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).

  Follow-up assessment (2 months)

• 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).

  End-of-intervention Assessment (5 months)

• 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.

  Follow-up Assessment (2 months)

• 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).

  Follow-up Assessment (2 months)

• 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).

  End-of-intervention Assessment (5 months)

• 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.

  End-of-intervention Assessment (5 months)

Study Arms (7)

Intervention Patients & Providers

EXPERIMENTAL

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

Intervention Patients, Control Providers

EXPERIMENTAL

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

Control Patients, Intervention Providers

NO INTERVENTION

Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.

Control Patients & Providers

NO INTERVENTION

Participants in this arm are control patients who will not receive the DECIDE-PA intervention. These patients receive care from Control providers, who will not receive the DECIDE-PC intervention. Control patients will receive a pamphlet called "Managing Your Mental Health Care."

Non-Randomized Controlled Trial Patients

NO INTERVENTION

Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.

Control Providers

NO INTERVENTION

Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.

Intervention Providers

EXPERIMENTAL

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

Interventions

DECIDE-PA BEHAVIORAL

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 Patients & Providers; Intervention Patients, Control Providers

DECIDE-PC BEHAVIORAL

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.

Intervention Providers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (8)

South Cove Community Health Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

South End Community Health Center

Boston, Massachusetts, 02118, United States

Location

Family Services of Greater Boston

Boston, Massachusetts, 02130, United States

Location

Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Medical Center (Latino Mental Health)

Boston, Massachusetts, 02215, United States

Location

Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)

Cambridge, Massachusetts, 02139, United States

Location

Edward M Kennedy Health Center (Great Brook Valley Health Center)

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• 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.

  PMID: 29466533 DERIVED

Related Links

• Disparities Research Unit (DRU) website

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Patient Participation; Communication

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Limitations and 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.

Results Point of Contact

• Title: Margarita Alegria
• Organization: Disparities Research Unit, Department of Medicine, Massachusetts General Hospital

malegria@mgh.harvard.edu

617-724-4987

Study Officials

• Margarita Alegria, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Disparities Research Unit

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-11

Locations

US (8)