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

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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

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

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: DECIDE-PA Behavioral: DECIDE-PC Not Applicable

  Show Detailed Description

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Patients & Providers

Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.

These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.

For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.

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

Behavioral: DECIDE-PA
The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.

Experimental: Intervention Patients, Control Providers

Participants in this arm are intervention patients who will receive the DECIDE-PA intervention.

These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.

For intervention patients, the DECIDE PA is designed to help patients identify concerns about their condition or treatment and generate questions for providers regarding these concerns. The DECIDE PA intervention consists of 3-4 brief training sessions for patients delivered by Care Managers.

Behavioral: DECIDE-PA
The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.

No Intervention: Control Patients, Intervention Providers

Participants in this arm are control patients who will not receive the DECIDE-PA intervention.

These patients receive care from Intervention providers, who will receive the DECIDE-PC intervention.

Control patients will receive a pamphlet called "Managing Your Mental Health Care." For intervention providers, the DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.

No Intervention: Control Patients & Providers

Participants in this arm are control patients who will not receive the DECIDE-PA intervention.

These patients receive care from Control providers, who will not receive the DECIDE-PC intervention.

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

No Intervention: Non-Randomized Controlled Trial Patients
Participants in this arm are patients who did not participate in the Randomized Controlled Trial. One to two patients will be recruited for each enrolled provider (Control and Intervention). One clinical session per patient will be audio recorded. These clinical recordings will be used to provide feedback only for Intervention providers during part 1 of the DECIDE-PC intervention.
No Intervention: Control Providers
Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
Experimental: Intervention Providers
Participants in this arm are providers who were randomized to the Intervention group. Intervention providers will receive the DECIDE-PC intervention. The DECIDE PC is designed to help providers improve therapeutic alliance, patient-provider communication, continuance in care, and satisfaction with services for patients in order to improve shared decision making.
Behavioral: DECIDE-PC
The DECIDE-PC intervention trains providers in patient-centered communication techniques and encourages providers to be receptive to patients who take a more active role during the clinical encounter in order to improve shared decision making.




Primary Outcome Measures :
  1. Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores [ Time Frame: Follow-up assessment (2 months) ]
    12 items designed to assess SDM quality in medical visit. Rated on 5 point Likert scales ranging from 0 (behavior not observed) -- 4 (clinician exhibited behavior to high standard). Final scores are the sum of the rating and range from 0-44. Final scores were transformed to a scale that ranges from 0 (lowest SDM) - 100 (highest SDM).

  2. Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) [ Time Frame: End-of-intervention Assessment (5 months) ]
    Evaluates patient SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

  3. Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version [ Time Frame: Follow-up Assessment (2 months) ]
    The 10 items was developed by research team to evaluate provider SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the provider.

  4. Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) [ Time Frame: Follow-up Assessment (2 months) ]
    Evaluates provider SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).

  5. Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) [ Time Frame: End-of-intervention Assessment (5 months) ]
    Assesses patient perceptions of care in psychiatric settings. Includes 3 items, final scores are scored externally, and range from 0 (lowest quality) to 100 (highest quality).

  6. Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version [ Time Frame: End-of-intervention Assessment (5 months) ]
    The 10 items was developed by research team to evaluate patient SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the patient.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947283


Locations
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United States, Massachusetts
South Cove Community Health Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
South End Community Health Center
Boston, Massachusetts, United States, 02118
Family Services of Greater Boston
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center (Latino Mental Health)
Boston, Massachusetts, United States, 02215
Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)
Cambridge, Massachusetts, United States, 02139
Edward M Kennedy Health Center (Great Brook Valley Health Center)
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
Massachusetts General Hospital
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Margarita Alegria, Ph.D. Massachusetts General Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: September 20, 2013    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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