OPTIMAL in NH Residents With Dementia

University of Iowa

Status: Completed

Conditions: Alzheimer's Disease and Related Dementias

Treatments: Behavioral: OPTIMAL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05255068

K23AG066856

Details and patient eligibility

About

The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies.

Full description

This study developed and refined OPTIMAL, and evaluated its feasibility, fidelity, and usefulness. We used mixed methods (i.e., focus groups, a pilot single-group repeated measures) to refine and test OPTIMAL. We collected repeated measures at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3). At each time point, we assessed quality of staff engagement and resident outcomes including eating performance and BMI through collection and coding of videotaped observations of dyadic mealtime interaction (videos; Aim 2&3) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. We used Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, and assessed resident mealtime challenging behaviors including resistive behaviors and functional impairments and intake success rate using videos collected in this study.11, 25

The specific aims are:

1. Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. We will integrate evidence from literature and our prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. We will conduct separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing.
2. Determine feasibility, fidelity, and usefulness of OPTIMAL. Feasibility on participant identification, recruitment, consent, and retention will be evaluated descriptively. Fidelity will be assessed on a) delivery of treatment (staff attendance to training sessions), b) receipt of treatment (staff knowledge and self-efficacy pre- & post-training), and c) enactment of treatment skills (staff PCMC&TCMC behaviors, quality of staff engagement). We will conduct focus group interviews of staff to assess the usefulness of OPTIMAL after T3.
3. Describe resident outcomes (Exploratory). We will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics over time for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The investigators will recruit direct care staff, families of residents, and residents with dementia from NH sites following the exclusion and inclusion criteria after attrition rates are considered.

Inclusion Criteria:

Residents

• ≥ 55 years
• Diagnosed as having ADRD based on medical records
• Identified by NH staff as requiring mealtime assistance
• Having a legally authorized representative (LAR) providing informed written consent

Staffs

• ≥18 years
• English speaking
• A permanent facility employee
• Provide direct mealtime care for a resident participant at least twice a week over the previous month

Families

• ≥18 years
• English speaking
• A family member of the resident who is living at the NH study site at the time of the study
• Having experience of delivering mealtime care to their resident family members

Exclusion Criteria:

Residents

• Have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing disorder,
• Do not eat orally (e.g., parenteral/IV feedings, feeding tubes)
• Unable to hear or see staff even with glasses and/or hearing aids (e.g., uncorrected visual or hearing impairment)
• Stay in the NH study site for less than 12 weeks at the time of recruitment/consent/assent (e.g., terminally ill receiving hospice services, and/or receiving post-hospital skilled rehabilitation) that may not allow enough time for obtaining consent/assent, and scheduling days for video recording sessions across three-time points (baseline, and 6- and 12- weeks post-baseline)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Staff

Experimental group

Description:

Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.

Treatment:

Behavioral: OPTIMAL

Resident

Experimental group

Description:

Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.

Treatment:

Behavioral: OPTIMAL