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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

Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE September 20, 2013
Results First Submitted Date  ICMJE May 1, 2017
Results First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 8, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
Shared Decision Making (SDM-Q-9, SDM-Q-Doc and OPTION) [ Time Frame: 2-6 Months in each data collection cycle (4 cycles) ]
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.
Change History Complete list of historical versions of study NCT01947283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
Perceptions of Care Survey [ Time Frame: 2-6 Months in each data collection cycle (4 cycles) ]
Patients will be asked to rate the quality of their care at baseline, after the clinical visit and at post-assessment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Official Title  ICMJE Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Mental Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: DECIDE-PA
  • 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.

    Intervention: Behavioral: DECIDE-PA
  • 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.
    Intervention: Behavioral: DECIDE-PC
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
481
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2013)
546
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947283
Other Study ID Numbers  ICMJE CD-12-11-4187
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Margarita Alegria, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Margarita Alegria, Ph.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP