Clinical trial NCT01947283: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Official title: Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Patient-Provider Relationship
Shared Decision Making
Therapeutic Alliance
Mental Health
Minority Health
Patient Activation
Communication
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2013-09-20
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores
timeFrame: Follow-up assessment (2 months)
measure: Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)
timeFrame: End-of-intervention Assessment (5 months)
measure: Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version
timeFrame: Follow-up Assessment (2 months)
measure: Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)
timeFrame: Follow-up Assessment (2 months)
measure: Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)
timeFrame: End-of-intervention Assessment (5 months)
measure: Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version
timeFrame: End-of-intervention Assessment (5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: South Cove Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: South End Community Health Center
state: Massachusetts
city: Boston
country: United States
facility: Family Services of Greater Boston
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (Latino Mental Health)
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)
state: Massachusetts
city: Worcester
country: United States
facility: Edward M Kennedy Health Center (Great Brook Valley Health Center)
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margarita Alegria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.