PPCI for Dementia

(PPCI Trial)

Overseen By Anju Paudel, Assistant Professor

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Under 65, No ADRD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Promoting Positive Care Interactions (PPCI) to improve how staff in assisted living facilities interact with residents who have dementia. The program includes setting goals, assessing the environment, educating staff, and providing ongoing support. It aims to replace negative interactions with positive ones, benefiting both residents and staff.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on improving care interactions without using medications.

How is the PPCI treatment for dementia different from other treatments?

The PPCI treatment for dementia is unique because it focuses on educating staff to promote positive care interactions, rather than using medication. This approach aims to improve the quality of care by enhancing the skills and knowledge of caregivers, which is different from traditional treatments that often rely on drugs. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PPCI-Staff Education Only (EO), Promoting Positive Care Interactions (PPCI) for dementia?

Research on similar educational programs, like P.I.E.C.E.S., shows that staff education can improve care for dementia patients by promoting teamwork and better communication, although maintaining these improvements over time can be challenging. Additionally, interventions like the PROACTIVE Treatment Approach have shown to improve staff confidence and reduce patient hospital stays, suggesting that educational programs can positively impact dementia care. ^{5 6 7 8 9}

Who Is on the Research Team?

Anju Paudel, Assistant Professor

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for assisted living facilities with 20+ beds willing to partner in practice change, and their staff who speak English and work at least 16 hours weekly. It's also for residents aged 65+, diagnosed with Alzheimer's or dementia (ADRD), having specific scores on a mental status exam indicating ADRD.

Inclusion Criteria

My care facility is large, has a leader for change, and is open to new practices.

I am 65 or older, live in a facility, and have a diagnosis of ADRD with a low SLUMS score.

Exclusion Criteria

I am under 65, not living in a facility, and do not have a diagnosis or low SLUMS score indicating ADRD.

My care facility is small and cannot or will not commit to new health initiatives.

I work less than 16 hours a week or cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stakeholder Engagement and Goal Development

Stakeholder engagement in developing facility-specific goals

1 month

1 visit (in-person)

Environment and Policy Assessment

Assessment of environment and policies to support positive care interactions

1 month

1 visit (in-person)

Flexible Staff Education

Staff education on positive care interactions

1 month

1 visit (in-person), monthly follow-up visits

Ongoing Mentorship and Support

Ongoing mentorship, motivation, and support for staff to optimize care interactions

3 months

Monthly visits (in-person and virtual)

Follow-up

Participants are monitored for effectiveness and sustainability of care interactions

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PPCI-Staff Education Only (EO)
• Promoting Positive Care Interactions (PPCI)

Trial Overview The study tests the Promoting Positive Care Interactions (PPCI) program aiming to improve interactions between staff and residents with ADRD in assisted living. PPCI includes goal setting, assessing policies, flexible education for staff, plus ongoing mentorship through visits and texts.

How Is the Trial Designed?

Group I: PPCI Arm Experimental Treatment 1 Intervention

The ALF/PCH assigned as treatments will receive the four steps of PPCI including, stakeholder engagement and facility goal development, environment and policy assessment, staff education, and ongoing mentorship/motivation and support over a period of six-months by a research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care. The RNF will work with an identified internal/facility champion monthly to implement the four steps of PPCI.

Group II: PPCI-Staff Education Only Arm Active Control 1 Intervention

The ALF/PCH assigned as controls will receive PPCI-staff education only (EO). The EO will include a 30-45 min in-service session and monthly f/u visits for booster education. The education content and process will be the same as outlined in Step 3 of the PPCI for treatment sites.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

A study involving 170 patients with dementia in a specialized acute hospital unit (CAMIE) showed significant improvements in functional status, well-being, and reduced agitation compared to a control group of 60 patients receiving usual care over a 6-month period.

The person-centered care approach in the CAMIE unit was found to be cost-effective, with an incremental cost-effectiveness ratio of USD 23,111, suggesting that this model of care could be beneficial for broader implementation in treating patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-centered care for older people with dementia in the acute hospital. Tay, FHE., Thompson, CL., Nieh, CM., et al.[2022]

The 'Partners in Dementia Care' (PDC) program, implemented over 12 months with 148 caregivers and 84 persons with dementia, showed significant improvements in outcomes for both groups, including reduced caregiver isolation and increased confidence in caregiving.

The positive results of the PDC program in real-world settings were consistent with previous randomized controlled trials, demonstrating its effectiveness as a regular service for supporting caregivers and persons with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". Bass, DM., Hornick, T., Kunik, M., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Supporting general hospital staff to provide dementia sensitive care: A realist evaluation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Person-centered care for older people with dementia in the acute hospital. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Healthcare professionals' perceptions of P.I.E.C.E.S. education in supporting care delivery for older adults with responsive behaviours of dementia in acute care. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of an Acute Care Multicomponent Intervention for Dementia-Related Behavioral Expressions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An Education Intervention to Enhance Staff Self-Efficacy to Provide Dementia Care in an Acute Care Hospital in Canada: A Nonrandomized Controlled Study. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Findings From a Real-World Translation Study of the Evidence-Based "Partners in Dementia Care". [2022]

7. England pubmed.ncbi.nlm.nih.gov

Building capacity and resilience in the dementia care workforce: a systematic review of interventions targeting worker and organizational outcomes. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Effectiveness of Educational Interventions in Promoting Person-Centred Care in Dementia Services. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The experience of hospital staff in applying the Gentle Persuasive Approaches to dementia care. [2019]