Improving Collaborative Decision Making in Veterans With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Shared Decision-Making Coding System
研究概览
简要总结
Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery.
The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component.
Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up.
Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.
详细描述
The proposed study has three phases, each associated with an Aim. First, a small, one-arm, open-label trial will establish feasibility of Collaborative Decision Skills Training (CDST) for Veterans receiving care in Psychosocial Rehabilitation and Recovery Centers (PRRCs), identify and complete adaptations, and pilot the assessment strategy. Stakeholder feedback will be collected via the Dynamic Adaptation Process in order to identify whether aspects of CDST or service delivery need to be adapted before conducting the RCT. Second, an RCT will compare CDST with an active control (AC) among 72 Veterans with serious mental illness (SMI). These two phases will address two key aspects of evaluating promising interventions: 1) whether CDST could feasibly be integrated into usual care practices in the VA San Diego Healthcare System (VASHDS) PRRC and other PRRCs nationwide, and 2) whether CDST leads to significant improvements in important domains for the target population. Third, findings from the first two phases will inform the design of a subsequent merit study and the completion of two primary products a CDST Clinician Manual and CDST Service Delivery Manual.
Aim 1: Conduct a small, one-arm, open-label trial to identify and complete any adaptations needed to successfully integrate CDST into PRRC settings. The Dynamic Adaptation Process will be used to produce a CDST Clinician Manual and a CDST Service Delivery Manual. The existing CDST Clinical Manual from the pilot study will be modified as needed during Aim 1 based on findings from this project. A new CDST Service Delivery Manual will be developed during Aim 1 and honed during Aim 1 and Aim 2 study activities.
An Adaptation Resource Team (ART) will be formed including 2 Veterans with SMI currently receiving services in the VASDHS PRRC, 2 clinicians who provide treatment in the VASDHS PRRC, and 2 administrators whose duties include administration of the VASDHS PRRC Veterans will be enrolled via: 1) referrals from clinicians, and 2) print advertisements in the PRRC waiting room. Clinicians and administrators will be solicited directly. Written informed consent will be obtained from each participant.
Each ART member will receive a copy of the Clinician Manual and a description of the purpose of the Service Delivery Manual. They will be asked to review these materials and make notes of their perceptions, including components that are not relevant, may not resonate with the Veteran population or would not be feasible within the PRRC context. Approximately 2 weeks later, each participant will complete an individual interview, accompanied by the research assistant, using a semi-structured interview approach. These interviews will systematically work through the CDST content and service delivery aspects of the intervention. These interviews will be analyzed, compiled, and presented back to the ART for discussion. The ART will come to consensus about adaptations with supervision from the CDST developers to ensure fidelity to CDST's active ingredients.
The open trial will occur following initial adaptation. Twelve Veterans will participate. There will not be a comparison group for the open trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistant who completes the assessments will be blind to condition, and will not attend any clinical team meetings or otherwise participate in any non-study related PRRC activities to maintain blindness. No study participants will be blinded. No other staff will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently receive services in the VASDHS PRRC
- •i.e., seen in the clinic in the past month and/or completed a PRRC group during the past trimester
- •have an SMI diagnosis per the electronic medical record
- •e.g., schizophrenia, schizoaffective disorder, delusional disorder, and major depressive disorder with psychotic features
- •agree to have a subset of treatment appointments audiotaped
排除标准
- •having primary substance use or organic neurological disorder diagnosis
- •are determined by PRRC and/or study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation
- •have a history and/or current risk of violence that PRRC and/or study staff determine to be too high risk to manage effectively at the PRRC's outpatient clinic location (which has less police presence than the primary VASDHS hospital location)
结局指标
主要结局
Shared Decision-Making Coding System
时间窗: Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5)
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers.The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
次要结局
- Goal Attainment Scaling(Change in goal attainment from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Social Skills Performance Assessment(Change in symptom severity from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Service Engagement Scale(Change in service engagement from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Situational Motivation Scale for Schizophrenia Research(Change in treatment motivation from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Collaborative Decision Making Approach Measure(Change in involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Shared Decision Making Questionnaire for Mental Health(Change in involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Client Satisfaction Questionnaire(Change in client satisfaction from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Maryland Assessment of Recovery in Serious Mental Illness(Change in personal recovery from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Brief Psychiatric Rating Scale(Change in symptom severity from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Personal and Social Performance scale(Change in social functioning from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Interest in adjunctive rehabilitative approaches(Change in interest in adjunctive rehabilitative approaches from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Canadian Occupational Performance Measure- Performance subscale(Change in goal attainment from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Decision Skills Questionnaire(Change in targeted skills from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Treatment attendance(Change in treatment attendance from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
- Decision Skills Checklist(Change in targeted skills from from baseline (month 0) to follow-up at 3-months post-intervention (month 5).)
- Qualitative interviews(follow-up at 3-months post-intervention (month 5))
- Problem-Solving Decision-Making Scale for Mental Health(Change in preferences about involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5))