Preventing Loss of Independence Through Exercise in Community Living Centers: An Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- MDS Section G (Resident Physical Function)
研究概览
简要总结
Approximately 40,000 older Veterans who have complex care needs (for example, a combination of severe cognitive, physical, and mental health conditions) receive long-term care in VA Community Living Centers (CLCs). However, CLC staff members rarely receive specialized training in how to best engage and interact with these Veterans, which can lead to poor care quality, worsening of symptoms, staff burnout, and low morale throughout a facility. The investigators have developed a unique, mind-body, group movement program for Veterans with cognitive impairment called Preventing Loss of Independence through Exercise (PLIÉ) and found that it has physical, cognitive, social and emotional benefits in CLC residents. The investigators recently taught 50 staff members from a variety of professions in 5 CLCs to lead PLIÉ classes. The study will enable us to test whether the PLIÉ,LC staff training program improves outcomes for residents and to learn about the success and sustainment of the training.
详细描述
Background: Preventing Loss of Independence through Exercise (PLIÉ) is a unique, mind-body, group movement program for people living with cognitive impairment and dementia that has been found to have physical, cognitive, social, and emotional benefits. The investigators received a VA Innovators Award to implement PLIÉ in the San Francisco VA Community Living Center (CLC), where it became one of their most successful and popular programs. As part of the ongoing VA HSR&D pre-implementation grant (1I01 HX002764), the investigators have developed and piloted a remote PLIÉ staff training program and have successfully trained 50 interprofessional staff members at 5 CLCs. This study will enable us to test the effectiveness and implementation of PLIÉ-CLC.
Significance: VA CLCs serve approximately 40,000 Veterans annually, most of whom have one or more severe neurocognitive, mental health or physical impairments; yet CLC staff members typically do not receive specialized training in how to best engage and interact with these Veterans. This training and knowledge gap can result in poor care quality, declines in physical function, increased distressed behaviors, staff burnout, and low morale throughout a facility.
Innovation & Impact: PLIÉ-CLC provides an efficient format for delivering high-quality care to groups of residents with cognitive impairment. Veterans with complex care needs often receive care from different providers who do not necessarily communicate with each other about the residents' needs. PLIÉ-CLC provides a structured framework for interprofessional staff members to work together to simultaneously address residents' physical, social and mental health needs. In addition, PLIÉ-CLC provides an efficient experiential training model. Staff members, trainees and family members are invited to join classes where they can learn by doing and can directly observe the beneficial impact of the classes on residents.
Specific Aims: The goals of this study are to: 1) Determine the effectiveness of PLIÉ-CLC on resident, entered outcomes (primary outcome: physical function; secondary outcomes: social engagement, mood, cognitive function, behaviors, falls, and pain); 2) Determine the effectiveness of PLIÉ-CLC on person-centered care practices and organizational culture, including staff engagement, burnout, and workplace climate; 3) Evaluate implementation of PLIÉ-CLC, including reach, adoption, external facilitation, and fidelity; 4) Examine the extent to which PLIÉ-CLC is sustained after external facilitation support has ended.
Methodology: The investigators proposed to achieve these Specific Aims by performing a Type 2 Hybrid Effectiveness%2Implementation study using a stepped wedge cluster randomized trial design. This design will enable us to assess the effectiveness of PLIÉ-CLC at the resident (Aim 1) and organizational (Aim 2) levels and the implementation process itself at the clinician and organizational levels (Aims 3, 4). The investigators will use a concurrent mixed methods approach to qualitative and quantitative data collection and analysis guided by the Practical, Robust Implementation and Sustainability Model (PRISM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CLC internal facilitators/champions Inclusion criteria:
- •Full-time CLC clinical staff member (including registered nurses, certified nursing assistants, nurse aids, recreation therapists, occupational therapists, physical therapists, mental health professionals or others)
- •Willingness to facilitate PLIÉ-CLC implementation at their site
- •Willingness to participate in initial and debrief site visit
- •PLIÉ-CLC staff instructors Inclusion criteria:
- •CLC clinical staff member or volunteer interested in learning to lead PLIÉ-CLC classes
- •Willingness to participate in remote training process
- •Willingness to lead PLIÉ classes locally, including tracking attendance and other process measures
- •Willingness to participate in initial and debrief site visits and biweekly check-ins
- •Veteran residents of Community Living Centers (CLCs) Inclusion criteria:
- •Long-stay resident (have resided at the facility for at least 45 days and are not expected to be discharged during the study period)
- •Not planning to be discharged within the next 12 months
- •Not receiving hospice care.
- •Cognitive impairment
- •Ability to sit in a standard chair or wheelchair unaided for a 1-hour class
- •English language fluency
- •CLC directors Inclusion criteria:
- •Recommended by VHA leader as likely to be 'early adopter' based on successful implementation of program such as STAR-VA OR
- •g based on patient population (primarily palliative care or long stay maintenance/custodial care
排除标准
- •CLC internal facilitators/champions exclusion Criteria:
- •- Planning to leave the facility in next 12 months
- •PLIÉ-CLC staff instructors exclusion criteria:
- •- Planning to leave the facility in next 12 months
- •Veteran residents of Community Living Centers (CLCs) exclusion Criteria:
- •Severe hearing, visual or communication challenges (i.e., unable to hear, see or understand well enough to participate)
- •Limited life expectancy (e.g., eligible for hospice)
- •Lack of ability to consent/assent to study procedures
- •CLC Directors exclusion criteria:
- •- Lack of willingness or interest in participating
研究组 & 干预措施
PLIE-CLC
Preventing Loss of Independence through Exercise (PLIÉ) is a multi-domain, mind-body, group movement program for people with dementia that improves quality of life. A stepped wedge cluster randomized trial design includes: 1) a baseline data collection phase where no clusters are exposed to the intervention; 2) sequential randomized crossover to the intervention (PLIÉ-CLC); and 3) analyses that account for time trends and correlations within clusters. Randomization of facilities to PLIÉ-CLC will simply delay rollout to sites randomized later in the sequence (like a wait-list control condition).
干预措施: Preventing Loss of Independence through Exercise (PLIE) (Behavioral)
结局指标
主要结局
MDS Section G (Resident Physical Function)
时间窗: -6 to 0 months (baseline), 0-6 months, 9 months, 2 months
The investigators will assess change in resident physical function using the Minimum Data Set (MDS) 3.0. The MDS has nearly 400 data elements, including cognitive function, physical functioning, behavioral symptoms, mood symptoms, pain and falls. Facility MDS coordinators (typically RNs) complete assessments for all Veterans in CLCs on admission, quarterly, and with changes in status. Reliability of the MDS is "very good" to "excellent" on most data items and scales. The investigators are using an 17-item MDS physical function measure that combines items from sections G1 (assistance needed with bed mobility, transferring, walking in room, walking in facility, and locomotion) and G3 (balance in standing, walking, turning around, getting on and off the toilet, and transferring) to create a continuous score that ranges from 0 (fully independent and steady at all times) to 136 (unable to do with or without assistance).
次要结局
- PLIE Clinical Note(0-6 months, 9 months, 12 months)
- PLIE Experience Scale for Staff(0-6 months, 9 months, 12 months)
- Clinical Sustainability Assessment Tool (CSAT)(0, 6, 12 months)
- RISE (Staff)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- MDS (Behavior)(-6 to 0 months (baseline), 0-6 months, 9 month, 12 months)
- MDS (Cognition)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- MDS (Mood)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- MDS (Pain)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- MDS (Falls)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- PC-PAL (Staff)(-6 to 0 months (baseline), 0-6 months, 9 months, 12 months)
- AES (Staff)(-6 to 0 months (baseline), 0-6, 9, 12 months)
- Reach(1-6, 9, 12 months)
- Qualitative Interviews(2, 4, 6, 12 months)
- NoMAD - Survey(0, 6, 12 months)
- Adoption(3-6, 9, 12 months)
- Staff level fidelity to PLIE Protocol(5, 6, 9, 12 months)
- PLIE Class Experience for Residents(6, 12 months)