Fostering Positive Care Interactions in Assisted Living

University of Maryland Baltimore (UMB)

Status: Begins enrollment in 1 month

Conditions: Dementia

Treatments: Behavioral: FPCI-AL; Behavioral: Education Only (EO)

Study type: Interventional

Funder types: Other

Identifiers

NCT07378800

AARG-25-1481519

Details and patient eligibility

About

The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with Alzheimer's disease or related dementias (ADRD ) by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.

Full description

Staff-resident care interactions are integral to effective care provision in assisted living communities, and especially critical for residents living Alzheimer's disease or related dementias (ADRD). The purpose of this study is to improve the quality of staff-resident care interactions particularly among residents living with ADRD by testing the Fostering Positive Care Interactions in Assisted Living (FPCI-AL) intervention. This 6 month intervention uses a four-step, theoretically based approach implemented by a research facilitator to change how staff provide care to residents living with ADRD. The research facilitator will work with a community-based stakeholder team and identified champion to implement the following four-step approach: 1) assessments of the environment and policy to facilitate positive interactions; (2) educating staff on fostering positive interactions; (3) establishing individualized positive care interaction approaches for residents and incorporating them into resident service plans; and (4) providing ongoing mentoring, motivating, and role modeling for staff to reinforce positive care interactions. Therefore, the aims of this study are to: Aim 1: Establish the feasibility of the FPCI-AL based on delivery, receipt and enactment of study activities; and establish acceptability of the FPCI-AL; Aim 2: Evaluate the preliminary efficacy of the FPCI-AL on the quality of care interactions received by residents living with ADRD; and Aim 3: Evaluate the preliminary efficacy of the FPCI-AL on behavioral symptoms of distress, resistiveness to care, and resident engagement with staff during care interactions. The investigators will use a cluster randomized controlled trial with a repeated measures design to test the feasibility and preliminary efficacy of the FPCI-AL. This study will include four assisted living communities, and a convenience sample of 25 residents per community (N = 100) will be recruited. Residents will be eligible to participate if they: (a) are 55 years of age or older; (b) are currently residing in a participating community; and (c) have evidence of ADRD based on a score ≤20 on the Saint Louis University Mental Status Examination. Residents will be excluded if they are admitted to the assisted living for short term care. The research facilitator will implement the four intervention steps over 6 months. Communities randomized to Education Only will receive education consistent with step two of the FPCI-AL. All community and resident data will be obtained by a trained research evaluator and will be measured at baseline, 4 months, and 6 months post-intervention. This study will be a critical first step in determining the sample size needed to test the efficacy of a practical approach to improving the quality of care interactions for assisted living residents living with ADRD, ultimately enhancing behavioral outcomes such as decreasing behavioral symptoms of distress, reducing resistiveness to care, and optimizing engagement in care tasks.

Enrollment: 100 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 55 years of age or older
• currently residing in a participating community
• Evidence of ADRD based on a score ≤20 on the Saint Louis University Mental Status Examination

Exclusion criteria

• Admitted to the assisted living for short term care

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

FPCI-AL

Experimental group

Description:

The FPCI-AL is implemented using a research facilitator working with a community-based champion and stakeholder group to provide the following four-steps: (1) assessments of the environment and policy to facilitate positive interactions; (2) educating staff on fostering positive interactions; (3) establishing individualized positive care interaction approaches for residents and incorporating them into resident service plans; and (4) providing ongoing mentoring, motivating, and role modeling for staff to reinforce positive care interactions.

Treatment:

Behavioral: FPCI-AL

Education Only (EO)

Active Comparator group

Description:

Communities randomized to education only will receive the same education as provided in FPCI-AL step two via an established PowerPoint. Delivery format will match community preferences (e.g., online or in-person) for pragmatic reasons and to facilitate the education process.

Treatment:

Behavioral: Education Only (EO)