Promoting Positive Care Interactions (PPCI) in Assisted Living

NCT ID: NCT05618834

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2026-09-30

Brief Summary

The overall aim of this study is to pilot test Promoting Positive Care Interactions (PPCI) with the goal of establishing a feasible and culturally responsive approach to optimize care interactions between staff (nursing, activity, housekeeping, and dining service staff) and residents with ADRD in assisted living facilities (ALFs), and further improve select resident, staff, and facility outcomes. PPCI is a non- pharmacological four-step approach consisting of (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.

Detailed Description

Nearly one million individuals living in 28,900 assisted living facilities (ALFs) in the U.S. participate in daily care interactions, defined as any verbal or nonverbal exchange between staff and residents during physical and social care activities. While there are positive care interactions, poor care interactions also persist with prevalence as high as 25% in long-term care including ALFs. Individuals with Alzheimer's disease and related dementias (ADRD) are especially at risk for poor care interactions due to ineffective staff approaches such as negative touching (e.g., quickly removing clothes to bathe a resident), being overprotective (e.g., restricting activity for safety concerns), and lack of verbal or non-verbal contact during care. Persistent poor care interactions can negatively affect both residents and staff. Thus, there is a need to replace poor care interactions with positive care interactions, now more than ever given the worsening staff retention related to COVID-19 pandemic, and constant need to train new employees.

Positive care interaction refers to care interactions where staff use positive approaches such as honoring resident's abilities and preferences, recognizing resident's responses/non-verbal cues, acknowledging resident's effort, providing role modeling and verbal cues, managing self-responses, and using a calm respectful approach for appropriate delivery of care. It has been long known that use of positive approaches benefits both residents (e.g., less behavioral distress) and staff (e.g., greater competence in care). Yet, poor interactions continue in ALFs due to interlocking barriers associated with residents' ADRD-related communication and other difficulties and behaviors of distress (e.g., agitation), as well as staff's knowledge and training deficits in ADRD care; ALFs have fewer licensing and training mandates for staff. Lack of cultural concordance can also contribute to poor interactions. The ALF staff, often younger (mean age=38.3 yrs.) females (83.8%) with almost half representing racial minorities (47.6%) care for largely non-Hispanic white (81.4%) resident population >=65 years (93.4%). Additionally, there are systemic barriers including limited organizational engagement in implementing and sustaining these approaches, lack of environmental infrastructure (e.g., controlled noise and availability of augmentative devices such as pocket talker) and policies (e.g., consistent assignments) to support positive care interactions, and lack of adequate mentoring and support for staff. It is crucial to address these issues and barriers and train ALF staff on positive care interactions, particularly since prior work has targeted nursing homes and focused on social interactions or verbal communication.

Therefore, this study proposes Promoting Positive Care Interactions (PPCI), a four-step approach, based on Social Ecological Model (SEM) and Social Cognitive Theory (SCT), to optimize daily care interactions between staff and residents with ADRD in ALFs. The four steps include: 1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions. These four steps are based on prior work implementing function & behavior focused intervention studies but have never been used in a care interaction-focused intervention nor been tested for cultural responsiveness. This study will follow a cluster randomized trial in a sample of 60 residents and 60 staff in four ALFs in central PA (approx. 15 residents, 15 staff/ALF) who agree and consent to participate in this study. The treatment group will receive all four steps of PPCI while the control arm will receive education only.

Conditions

Alzheimer Disease and Related Dementias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

PPCI Arm

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 Type: EXPERIMENTAL

Promoting Positive Care Interactions (PPCI)

Intervention Type: BEHAVIORAL

The PPCI consists of four steps: (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.

A research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care will work with an identified internal champion monthly to implement the four steps of PPCI. The PPCI intervention comprehensively focuses on intrapersonal, interpersonal, organizational, and environmental/policy factors to bring together evidence and key stakeholders to optimize daily care interactions in assisted living.

PPCI-Staff Education Only Arm

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.

Group Type: ACTIVE_COMPARATOR

PPCI-Staff Education Only (EO)

Intervention Type: BEHAVIORAL

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.

Interventions

Promoting Positive Care Interactions (PPCI)

The PPCI consists of four steps: (1) stakeholder engagement in developing facility specific goals; (2) environment and policy assessments; (3) flexible staff education; and (4) ongoing mentorship, motivation, and support (in-person visits and text messages) for staff to optimize care interactions.

A research nurse facilitator (RNF), a registered nurse (RN) with prior experience in long-term care will work with an identified internal champion monthly to implement the four steps of PPCI. The PPCI intervention comprehensively focuses on intrapersonal, interpersonal, organizational, and environmental/policy factors to bring together evidence and key stakeholders to optimize daily care interactions in assisted living.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Assisted Living Facility (ALF) will be included in the study if they:

1. have at least 20 or more beds

2. are able to identify a facility champion, and

3. express a willingness to actively partner in an initiative to change practice at their institution

Staff will be included in the study if they:

1. are able to communicate in English, and

2. work at least 16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles

Residents will be included in the study if they:

1. are 65 years old or greater

2. are living at the facility at the time of recruitment, and

3. have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD

Exclusion Criteria

Assisted Living Facility (ALF) will be excluded from the study if they:

1. have less than 20 beds

2. are unable to identify a facility champion, and

3. do not express a willingness to actively partner in an initiative to change practice at their institution

Staff will be included in the study if they:

1. are unable to communicate in English, and

2. work less than16 hours a week at the facility at the time of recruitment in nursing, activities, housekeeping, or dining service roles

Residents will be included in the study if they:

1. are less than 65 years old

2. are not living at the facility at the time of recruitment, and

3. do not have a diagnosis of ADRD and Saint Louis University Mental Status Exam (SLUMS) score of 20 or less (high school education)/ 19 or less (less than high school education) suggesting ADRD

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Anju Paudel, PhD, MGS, RN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anju Paudel, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00021256

Identifier Type: -

Identifier Source: org_study_id