VA Desert Pacific Mental Illness Research, Education, and Clinical Center (MIRECC), San Diego, CA, USA.
Department of Psychiatry, University of California San Diego, 9500 Gilman Drive 0804, La Jolla, CA, 92093, USA.
Trials. 2024 Jun 6;25(1):363. doi: 10.1186/s13063-024-08127-4.
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.
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.
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.
ClinicalTrials.gov NCT04324944. Registered on March 27, 2020. Trial registration data can be found in Appendix 1.
患者参与治疗决策是康复导向护理的一个支柱,与增强权能和幸福感的改善有关。尽管有严重精神疾病的退伍军人对更多参与治疗决策的需求很高,但参与率却很低。协作决策技能培训(CDST)是一种以康复为导向、基于技能的干预措施,旨在支持患者有意义地参与治疗决策。一项针对精神病退伍军人的开放试验支持了 CDST 的可行性,并初步表明了其有效性。需要进行一项随机对照试验(RCT)来测试 CDST 与积极对照相比的有效性,并进一步评估实施的可行性。
计划中的 RCT 是一种混合类型 1 试验,将使用混合方法系统评估 CDST 在南加州退伍军人事务部心理社会康复和康复中心(PRRC)参与的退伍军人中的有效性和实施可行性。第一个目标是通过主要结局,即退伍军人与其退伍军人事务部心理健康临床医生之间在常规护理预约期间的协作决策行为,以及次要结局(即治疗参与度、满意度和结果),来评估 CDST 与积极对照相比的有效性。第二个目标是使用实用稳健实施和可持续性模型框架来描述 CDST 在退伍军人事务部 PRRC 中的实施可行性,包括 PRRC 背景下的障碍和促进因素,以支持未来的实施。
如果 CDST 被证明是有效和可行的,那么在整个研究过程中收集的实施决定因素可以用于确保该 PRRC 和其他 PRRC 以及全国类似环境中的持续和成功实施。
ClinicalTrials.gov NCT04324944。于 2020 年 3 月 27 日注册。试验注册数据可在附录 1 中找到。