OPTIMAL in NH Residents With Dementia

Study Overview
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Brief Summary
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The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies. The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. First, the investigators will develop OPTIMAL through systematic integration of four PCMC principles, prior work on multilevel facilitators and barriers to engaging residents in eating, and our systematic review of mealtime difficulties and targeted behavioral strategies. The investigators will use mixed methods (i.e., focus groups, a pilot two-group parallel cluster RCT) to refine and test OPTIMAL. The investigators will enroll staff (N=20), families of residents (N=20), and residents (N=20) in nursing homes (NHs). Participants will be randomly assigned to one of two treatment groups: 1) OPTIMAL (i.e., training sessions, ongoing mentoring, biweekly facilitations), and 2) education control (i.e., training sessions only). In each treatment group, data will be collected 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, the investigators will assess the quality of staff engagement and resident outcomes and collect videotaped observations of dyadic mealtime interaction (videos) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. The investigators will use Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, to assess a) staff PCMC&TCMC behaviors, b) resident mealtime difficulties and intake success rate using videos collected in this study. The specific aims are: Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. The investigators will integrate evidence from literature and prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. Separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials will be conducted before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing. 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). Focus group interviews of staff to assess the usefulness of OPTIMAL will be conducted after T3. Describe resident outcomes (Exploratory). The investigators will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics overtime for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.

Official Title
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Optimizing Mealtime Care (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents With Alzheimer's Disease and Related Dementias (ADRD)

Conditions
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Alzheimer's Disease and Related Dementias

Intervention / Treatment
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* Behavioral: OPTIMAL


Participation Criteria
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Eligibility Criteria
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The investigators will recruit direct care staff (N=20), families of residents (N=20), and residents with dementia (N=20) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br>OPTIMAL | Behavioral: OPTIMAL<br>* A person-centered mealtime care intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of OPTIMAL | One separate focus group interview of staff and families, respectively, in each NH will be conducted following an interview guide to prioritize the multiple mealtime difficulties identified from literature and to explore their perceptions of the acceptability and areas of refinement of the intervention protocol and training materials. | After recruitment of staff and families of resident participants, before T1 (baseline) | 
| Feasibility data on identification, recruitment, consent, and retention of staff, residents, and family participant | 19 questions will be asked to assess the feasibility data on identification, recruitment, consent, and retention. | From recruitment/consent throughout the study completion, up to 12-weeks post baseline | 
| Staff attendance to training sessions | Delivery of training, tracking staff's attendance at the group or individual training sessions using a checklist | During each OPTIMAL training session (within 2 weeks post baseline) | 
| Changes of staff PCMC-related knowledge and self-efficacy between pre- and post-OPTIMAL training | Training receipt, indicated by a total score of ≥ 75% on the staff PCMC-related knowledge & self-efficacy test post-training with or without booster sessions | Right before and after OPTIMAL training session (within 2 weeks post baseline) | 
| Change from baseline staff use of PCMC-related strategies at 6 weeks and 12 weeks | The validated Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme capturing both verbal and nonverbal behaviors that address staff person-centered and task-centered mealtime care strategies will be used to code video-recorded observations collected from the proposed study. Briefly, codes for verbal behaviors in CUED include 8 positive behaviors and 4 negative behaviors. Nonverbal behaviors include 7 negative behaviors and 13 positive behaviors in 3 categories: 1) modification of resident eating ability represented by 5 behaviors (e.g., adjusting pace), 2) modification of care approaches represented by 3 behaviors (e.g., adjusting proximity), and 3) modification of dining environment represented by 5 behaviors (e.g., reducing clutter). | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 
| Usefulness of OPTIMAL | Staff perceived usefulness of the OPTIMAL intervention (OPTIMAL group) or OPTIMAL training session (education control group) will be assessed using semi-structured focus group interviews. | After T3 data collection time point (12-weeks post baseline) | 
| Change from baseline resident mealtime difficulties at 6 weeks and 12 weeks | Videos will be coded using CUED that have codes for resident mealtime difficulties grouped in three categories: 1) chewing or swallowing difficulties represented by 4 nonverbal behaviors, 2) functional impairment represented by 5 nonverbal behaviors, and 3) resistive behaviors represented by 6 nonverbal behaviors. | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 
| Change from baseline resident eating performance at 6 weeks and 12 weeks | Level of Eating Independence Scale, a 9-item scale assessing the ability of independence with eating and drinking activities during cycles of verbal prompts, will be used to measure. | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 
| Change from baseline resident intake success rate at 6 weeks and 12 weeks | Videos will be coded using CUED to track whether the resident or staff initiates/completes each intake attempt and whether there is a subsequent intake after each attempt. Resident intake success rate will be calculated by dividing the number of intake attempts initiated/completed by the resident with subsequent intake by the total number of intake attempts coded during one meal. | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of staff engagement | Quality of staff engagement will be assessed by Mealtime Engagement Scale developed by the PI with evidence of reliability and validity. | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 
| Resident body weight in killograms | Bodyweight will be measured in the early morning before breakfast with each individual resident dressing casual indoor clothes without shoes using the same digital body scale throughout the study. The investigators will assess body weight twice in one early morning of each time point and calculate the average of the two assessments. | T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating, Alzheimer's Disease and Related Dementias, Mealtime, Behavioral Symptoms, Food Intake, Function, Nutrition, Nursing Homes