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Trials ; 25(1): 363, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38840160

ABSTRACT

BACKGROUND: Patient participation in treatment decision making is a pillar of recovery-oriented care and is associated with improvements in empowerment and well-being. Although demand for increased involvement in treatment decision-making is high among veterans with serious mental illness, rates of involvement are low. Collaborative decision skills training (CDST) is a recovery-oriented, skills-based intervention designed to support meaningful patient participation in treatment decision making. An open trial among veterans with psychosis supported CDST's feasibility and demonstrated preliminary indications of effectiveness. A randomized control trial (RCT) is needed to test CDST's effectiveness in comparison with an active control and further evaluate implementation feasibility. METHODS: The planned RCT is a hybrid type 1 trial, which will use mixed methods to systematically evaluate the effectiveness and implementation feasibility of CDST among veterans participating in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) in Southern California. The first aim is to assess the effectiveness of CDST in comparison with the active control via the primary outcome, collaborative decision-making behavior during usual care appointments between veterans and their VA mental health clinicians, and secondary outcomes (i.e., treatment engagement, satisfaction, and outcome). The second aim is to characterize the implementation feasibility of CDST within the VA PRRC using the Practical Robust Implementation and Sustainability Model framework, including barriers and facilitators within the PRRC context to support future implementation. DISCUSSION: If CDST is found to be effective and feasible, implementation determinants gathered throughout the study can be used to ensure sustained and successful implementation at this PRRC and other PRRCs and similar settings nationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT04324944. Registered on March 27, 2020. Trial registration data can be found in Appendix 1.


Subject(s)
Patient Participation , Psychotic Disorders , Randomized Controlled Trials as Topic , Veterans , Humans , Psychotic Disorders/therapy , Psychotic Disorders/psychology , Veterans/psychology , Cooperative Behavior , Clinical Decision-Making , Physician-Patient Relations , Decision Making, Shared , United States , Feasibility Studies , California , Decision Making , United States Department of Veterans Affairs
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