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

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), which aims to improve staff interactions with residents who have Alzheimer's Disease and Related Dementias (ADRD) in assisted living facilities. The trial includes two groups: one receives PPCI-Staff Education Only (EO), while the other receives the full PPCI program, which involves setting facility goals, assessing policies, and providing ongoing support for staff. This trial suits assisted living facilities with 20 or more beds that are willing to change their care practices, and for staff who work at least 16 hours a week and can communicate in English. As an unphased trial, it offers a unique opportunity to contribute to innovative care practices for ADRD.

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.

What prior data suggests that this protocol is safe for residents and staff in assisted living facilities?

Research shows that the Promoting Positive Care Interactions (PPCI) approach is safe and well-received. Previous studies tested PPCI in care settings and found no reports of harmful effects on participants. The goal is to improve interactions between staff and residents in assisted living facilities. This method includes steps like training staff and providing ongoing support, which are generally safe. Studies of similar methods have reported no negative effects. Since PPCI does not involve medication, the risk of physical side effects remains very low. Overall, PPCI appears to be a safe way to enhance care interactions in dementia settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PPCI for Dementia trial because it offers a fresh approach to improving care in assisted living facilities and personal care homes. Unlike standard treatments that focus on medications to manage dementia symptoms, PPCI emphasizes enhancing care through staff education and environment modifications. The PPCI method is particularly unique due to its comprehensive approach, involving stakeholder engagement, policy assessments, and continuous mentorship by a research nurse facilitator. This holistic strategy aims to foster positive care interactions and create a supportive environment for dementia patients, which could lead to better outcomes and improved quality of life.

What evidence suggests that this trial's treatments could be effective for dementia?

Research has shown that Promoting Positive Care Interactions (PPCI), one of the treatments in this trial, can enhance care in assisted living facilities for people with dementia. One study found that PPCI reduces negative interactions, which often occur in long-term care settings. This approach involves training staff, setting goals, and providing ongoing support, and it has shown promise in making care interactions more positive. Early results suggest that PPCI might lead to better outcomes for both residents and staff by improving communication and support. Meanwhile, the PPCI-Staff Education Only (EO) arm, another treatment in this trial, focuses on staff education through in-service sessions and booster education. While more research is needed, these initial findings are encouraging. ^{2 4 5 6 7}

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

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8679871/

Pilot Testing of the Promoting Positive Care Interactions ... The purpose of this study was to test the feasibility and preliminary efficacy of Promoting Positive Care Interactions (PPCI)—a four step intervention ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35914082/

Pilot Testing of the Promoting Positive Care Interactions ... The current study aimed to test the feasibility and preliminary efficacy of the Promoting Positive Care Interactions (PPCI) intervention ...

3. clinicaltrial.be clinicaltrial.be/en/details/83715?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Promoting Positive Care Interactions (PPCI) in Assisted L... While there are positive care interactions, poor care interactions also persist with prevalence as high as 25% in long-term care including ALFs.

4. researchgate.net researchgate.net/publication/362406260_Pilot_Testing_of_the_Promoting_Positive_Care_Interactions_Intervention_in_Assisted_Living

Pilot Testing of the Promoting Positive Care Interactions ... The current study aimed to test the feasibility and preliminary efficacy of the Promoting Positive Care Interactions (PPCI) intervention ...

5. withpower.com withpower.com/trial/phase-caregivers-of-people-with-alzheimers-disease-or-related-dementia-adrd-1-2023-dcb12

PPCI for Dementia · Info for Participants This trial tests a program called Promoting Positive Care Interactions (PPCI) to improve how staff in assisted living facilities interact with residents who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811321/

Interventions promoting family involvement with care homes ... Improvement in resident behavioural and psychological symptoms of dementia was reported in two randomised controlled trials promoting partnership. Visit ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457224000727

The association between patient engagement and quality ... Acute care patients with dementia who receive more positive care interactions are significantly more likely to be actively engaged in the care interaction at ...