Clinical trial NCT06972004: Preventing Loss of Independence Through Exercise in Community Living Centers
Official title: Preventing Loss of Independence Through Exercise in Community Living Centers: An Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Cognitive Dysfunction
Keywords: health-related quality of life
Social Participation
Accidental Falls
Pain
Movement
Behavior
neurocognitive disorder
nursing homes
implementation science
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-05-14
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: We propose to perform a hybrid type 2 effectiveness-implementation study with a stepped wedge cluster randomized trial (SW-CRT) design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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. We 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. We 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.

Detailed description: 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. We 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 our ongoing VA HSR\&D pre-implementation grant (1I01 HX002764), we 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: We 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). We 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).

Next Steps/Implementation: We will work with our partners in the VA Office of Geriatrics and Extended Care, Office of Patient Centered Care \& Cultural Transformation, and Mental Health \& Suicide Prevention to use the findings from this effectiveness-implementation trial to inform decisions about sustainable roll out and implementation of PLIÉ-CLC nationwide.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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:

* Comatose
* Bedbound
* 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

Primary outcomes:
measure: MDS Section G (Resident Physical Function)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 2 months
Secondary outcomes:
measure: RISE (Staff)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: MDS (Behavior)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 month, 12 months
measure: MDS (Cognition)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: MDS (Mood)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: MDS (Pain)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: MDS (Falls)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: PLIE Experience Scale for Staff
timeFrame: 0-6 months, 9 months, 12 months
measure: PLIE Clinical Note
timeFrame: 0-6 months, 9 months, 12 months
measure: PC-PAL (Staff)
timeFrame: -6 to 0 months (baseline), 0-6 months, 9 months, 12 months
measure: AES (Staff)
timeFrame: -6 to 0 months (baseline), 0-6, 9, 12 months
measure: Reach
timeFrame: 1-6, 9, 12 months
measure: Qualitative Interviews
timeFrame: 2, 4, 6, 12 months
measure: NoMAD - Survey
timeFrame: 0, 6, 12 months
measure: Adoption
timeFrame: 3-6, 9, 12 months
measure: Clinical Sustainability Assessment Tool (CSAT)
timeFrame: 0, 6, 12 months
measure: Staff level fidelity to PLIE Protocol
timeFrame: 5, 6, 9, 12 months
measure: PLIE Class Experience for Residents
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Francesca M Nicosia, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: