Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation
NCT ID: NCT01947283
Last Updated: 2019-03-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
481 participants
INTERVENTIONAL
2013-09-30
2016-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
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.
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.
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 interventions assigned to this group
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 interventions assigned to this group
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 interventions assigned to this group
Control Providers
Participants in this arm are providers who were randomized to the Control group. Control providers will not receive the DECIDE-PC intervention.
No interventions assigned to this group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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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.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Margarita Alegria, PhD
Chief, Disparities Research Unit
Principal Investigators
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Margarita Alegria, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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South Cove Community Health Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
South End Community Health Center
Boston, Massachusetts, United States
Family Services of Greater Boston
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (Ambulatory Psychiatry Unit)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (Latino Mental Health)
Boston, Massachusetts, United States
Cambridge Health Alliance (Windsor Clinic, Macht Building, Central Street, Malden Primary Care Mental Health)
Cambridge, Massachusetts, United States
Edward M Kennedy Health Center (Great Brook Valley Health Center)
Worcester, Massachusetts, United States
Countries
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References
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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.
Related Links
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Disparities Research Unit (DRU) website
Other Identifiers
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CD-12-11-4187
Identifier Type: -
Identifier Source: org_study_id
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