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)
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Sponsor: University of Iowa

Official title: 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). 
 
NCT number: NCT05255068 
 
document date: 1/17/2024 
 
 
 
 

Study protocol with statistical analysis plan  
Significance  
People with advanced Alzheimer’s Disease and Related Dementias (ADRD) commonly 
experience functional, cognitive, and behavioral symptoms that interfere with eating (mealtime 
difficulties),1-3 resulting in low intake4-6 and subsequent malnutrition and dehydration.7, 8 Among 
people living with advanced ADRD in residential care settings (residents), 94% are at risk for 
malnutrition and 66.5% are already malnourished.7, 8 Malnutrition further leads to increased 
infection, weight loss, decreased quality of life, and increased morbidity and mortality.7, 9 Mealtime 
difficulties can be ameliorated by maximizing resident independence and use of evidence-based, 
person-centered care approaches,10-13 so as to promote food intake11, 14 and further maintain 
nutrition and hydration which are fundamental health needs among the aging population with 
ADRD. 
Despite the increased risks and consequences of mealtime difficulties and inadequate intake, 
residents are not provided with optimal mealtime care.12, 15, 16 Person-centered mealtime care 
(PCMC) is individually tailored to residents based on their preferences and levels of 
independence, in contrast to task-centered mealtime care (TCMC) that focuses on completion of 
tasks regardless of resident preferences and abilities.17-19 The PCMC features individualized, 
resident-oriented care through adherence to four principles: 1) providing choices and 
acknowledging preferences, 2) showing respect, 3) supporting independence, and 4) promoting 
social interaction.10-12, 20 Our preliminary studies show that positive staff engagement and social 
interaction with residents is associated with reduced mealtime difficulties and improved intake.10-
12, 14 While PCMC is highly recommended, PCMC strategies haven’t been empirically tested using 
experimental designs.21-24 A gap exists in creating effective individualized PCMC interventions to 
optimize mealtime care quality and resident outcomes. 
 
Objectives  
This study developed and refined OPTIMAL, and evaluated its feasibility, fidelity, and 
usefulness. 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 post-training), and c) enactment of treatment skills 
(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, 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.   
 

Design  
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 
 
Methods 
Development of OPTIMAL (Aim 1). OPTIMAL is designed to teach staff to effectively manage 
mealtime difficulties and engage residents in eating to restore and maintain their highest level of 
function possible. We developed OPTIMAL following the four PCMC principles: 1) providing 
choices & acknowledging preferences (i.e., offering opportunities to make choices, providing and 
delivering food in ways personally acceptable and culturally appropriate), 2) supporting 
independence (i.e., providing appropriate technical, motivational, instrumental, and informational 
assistance based on residents’ functional ability), 3) showing respect (i.e., honoring and valuing 
residents when assisting them), and 4) promoting social interactions (i.e., making connections 
with residents, creating/fostering a social environment with low stimuli and positive 
engagement).10-12, 20 The use of these four PCMC principles in developing OPTIMAL is to manage 
challenges that staff identified as the most significant barrier in providing optimal mealtime care 
in terms of assessing residents’ preferences, interacting with residents, and modifying the over-
stimulated environment.12 While receiving formal and informal training in Year 1-2 of the K23, the 
PI developed OPTIMAL by integrating evidence from literature and our prior work.10-14, 26-28 
Specifically, the PI has conducted a systematic review synthesizing evidence on common 
mealtime difficulties and targeted behavioral strategies for residents with ADRD by searching five 
health-related electronic databases (Pubmed, CINAHL, AgeLine, PsychINFO, Cochrane Library) 
between 1990 and 2016.27 In this review, we have identified 98 unique mealtime difficulties 
categorized in four types of symptoms (behavioral, functional, cognitive, mixed), in which 48 
mealtime difficulties are most commonly described and addressed by 260 unique behavioral 
multilevel strategies. The PI developed OPTIMAL intervention protocol and training materials 
following 3 steps: 1) updating evidence based on literature from 2017 forward; 2) integrating 
findings from the updated review, our preliminary studies (see 4C1), and our current R03 study 
that examines patterns of and temporal relationships between staff PCMC&TCMC behaviors and 
resident mealtime difficulties and intake (see 2A); and 3) synthesizing all the above evidence. The 
training materials will address three components of OPTIMAL: a) Why and What: rationale, 
benefits, and PCMC principles, b) How (basic): resident common mealtime difficulties and 
targeted behavioral multilevel PCMC strategies; and c) How (advanced): establishment of 
individualized PCMC plans based on assessments of common mealtime difficulties and use of 
targeted multilevel PCMC strategies.  
Evaluation and Refinement of OPTIMAL (Aim 1). After the intervention protocol and training 
materials are developed, we conducted one focus group of NH stakeholders including leadership, 
staff, and families to prioritize the multiple mealtime difficulties identified from literature and to 
understand the acceptability of the OPTIMAL intervention following an interview guide. The focus 

group was audio-recorded, and facilitated by the PI experienced in conducting focus group 
interviews. Data obtained were analyzed and used to refine the intervention protocol and training 
materials before pilot testing.  
 
Inclusion/Exclusion Criteria (Aim 2 and 3). Participants including staff, residents, and families 
were recruited from nursing homes. Staff are eligible if they are 18 years old or above, English 
speaking, a permanent facility employee, provide informed consent, and provide direct mealtime 
care for a resident participant at least twice a week over the previous month. Families are 
eligible if they are 18 years old or above, English speaking, a family member of the resident who 
is living at the NH study site at the time of the study, having experiences of delivering mealtime 
care to their resident family members, and providing informed consent.  
Residents are eligible if they: 1) are ≥ 55 years, 2) diagnosed as having ADRD based on 
medical records, 3) identified by NH staff as requiring mealtime assistance, and 4) having a 
legally authorized representative (LAR) providing informed written consent. Whether the 
resident needs mealtime assistance is based on medical record review as well as proxy report 
from the NH staff who has recently cared for the resident at mealtimes using the “feeding” item 
of the Katz ADL Index. Specifically, residents who need varied levels of assistance with feeding 
(limited, extensive, total assistance) are eligible, and those who get food from plate into mouth 
without help are excluded regardless of who prepares food. Residents will be excluded if they: 
1) have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing 
disorder, 2) do not eating orally (e.g., parenteral/IV feedings, use of feeding tubes), 3) unable to 
hear or see staff even with glasses and/or hearing aids  (e.g., uncorrected visual or hearing 
impairment), or 4) 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). 
 
Recruitment and Consent (Aim 2 and 3). To enroll staff and families, we will adapt a standard 
consent protocol for NH dementia mealtime research developed based on our prior study.12 To 
enroll residents, we will use a consent& assent protocol for research involving NH residents with 
dementia and their legally authorized representatives (LARs).29 Briefly, proxy informed consent 
will be obtained from the eligible resident’s LAR, and assent from the resident afterwards. Detailed 
plan is described in the PHS HSCTI, 2.5 Recruitment and Retention Plan.  
 
OPTIMAL intervention (Aim 2 and 3). A research assistant (OPTIMAL interventionist) will be 
trained by the PI to facilitate and implement the OPTIMAL intervention. To assure sustainability 
of OPITMAL care, we will identify a staff champion (a staff participant who is a lead nursing 
assistant or licensed practical nurse) in each NH to work with the OPTIMAL interventionist during 
the intervention period. The interventionist will train all staff participants to implement OPTIMAL 
through 3 phases: I) one training session, II) ongoing mentoring to establish/refine PCMC plans, 
and III) two biweekly facilitations of OPTIMAL care delivery. Phases will be implemented 
sequentially, although they will overlap in that, once initiated, they will continue throughout the 
intervention period.  
      In Phase I, all staff participants from one NH will attend an in-person 2-hour group training 
session led by the OPTIMAL interventionist in the format of didactic lectures, role 
modeling/playing, practicing with each other, and demonstration and application of skills in 

individualized PCMC care planning. All staff participants will be provided with training materials 
to be developed by completion of Aim 1(see 4C4). If a staff is not able to attend the group session, 
we will record reasons of no attendance and schedule a make-up individual training session led 
by the interventionist. By completion of the training session, staff participants are expected to be 
able to 1) assess common mealtime difficulties and describe the use of targeted PCMC strategies, 
and 2) develop PCMC plans to address observed mealtime difficulties with targeted strategies. 
Staff will complete a PCMC-related knowledge and self-efficacy test to be developed based on 
training materials pre- and post-training session.  Adequate receipt of the OPTIMAL training is 
indicated by a total test score of ≥ 75% post-training.30, 31 Individual staff with a total test score of 
<75% post-training will attend booster training sessions (in group or individual format) until the 
individual staff receive a total test score of ≥ 75%. 
      The OPTIMAL interventionist will initiate Phase II, individualized PCMC planning, working 
closely with staff and resident participants. The interventionist will assess each resident’s eating 
independence and mealtime difficulties as well as staff use of PCMC&TCMC strategies during 
the first week of the OPTIMAL intervention. After assessment, the interventionist will record major 
mealtime difficulties demonstrated by the resident, strategies used that do (not) work, and any 
barriers to implementing specific strategies. The interventionist will then develop a PCMC care 
plan for each resident by working with staff participants based on assessments of common 
mealtime difficulties. The primary goal is to engage residents to be actively involved in eating and 
initiate each intake attempt by themselves with minimum assistance using appropriate PCMC 
strategies. For example, a care plan for a resident demonstrating prolonged chewing may include 
offering food bites of smaller size, offering drinks frequently to flush food down, and giving short, 
simple verbal cues. Another example is that for a resident with difficulty using utensil properly, the 
care plan may include preloading utensils, offering finger food, and providing adaptive utensils. 
The interventionist will work with the staff participants to identify possible solutions to eliminate 
any barriers to implement specific PCMC strategies, the best places to store/locate the care plans, 
as well as the best way for staff participants to review residents’ updated care plans in each NH.  
      After individualized PCMC care plans are established, Phase III, biweekly facilitations of 
OPTIMAL care, will be provided to each staff participant twice over 4 weeks by the OPTIMAL 
interventionist. The interventionist will coach staff participants in implementing care plans for 
resident participants. In each facilitation, the interventionist will observe each staff participant in 
providing care to a resident during one meal, and provide role modeling as well as feedback on 
how well the staff follows and implements the care plan. In this phase, individualized PCMC care 
plans will be updated continuously based on assessments of resident mealtime difficulties. 
 
Data Collection Procedures (Aim 1, 2, 3; Table 1). In each NH, immediately after written 
consents of staff and family participants are obtained, separate focus groups for staff and families 
will be scheduled and conducted (see 4C4b. Aim 1), and participants’ characteristics will be 
collected using a demographic survey (4C7) before T1. Residents will be recruited with written 
assents/consents from residents and their LARs. Resident characteristics will be collected by 
reviewing medical records. Feasibility data about identification, recruitment, consent, and 
retention of all participants will be gathered throughout the study (see 4C8a, Aim 2). A trained 
research videographer will schedule a 1-day practice recording session for each resident 
participant using a mini handheld digital video recorder. Adequate quality recordings for 
behavioral analyses have been obtained with a mini digital camera in prior research.32, 33 After the 
practice session, the videographer will schedule a 2-day formal recording session for each 
resident participant at baseline (T1), and at 6- (T2) and 12-week post baseline (T3), respectively 
(Aim 2&3). We will videotape mealtime only in the scheduled days of all recording sessions. Staff 
participants will complete a knowledge & self-efficacy test pre- and post- OPTIMAL training 

sessions (Aim 2). At each time point, in addition to mealtime video recording, a trained data 
collector will collect body mass index (BMI) of each resident, and complete observational 
measures on quality of staff engagement and resident eating performance for each of the 6 meals 
in 2 days in the NH (Aim 2&3). After T3, we will conduct one focus group in each NH (Aim 3), 
lasting 50-60 minutes, audio-recorded, and facilitated by the PI experienced in focus group 
interviews.  
 
Table 1. Data Collection Timeline  
Aim
s 
Data/Variables 
Recruitme
nt 
T
1  
Pre-
&post-
training  
T
2 
T
3  
Pos
t T3 
1,2,3 Consent & sample characteristics  
X 
 
 
 
 
 
1 
Acceptability of OPTIMAL  
X 
 
 
 
 
 
2 
Feasibility of OPTIMAL  
X 
X 
X 
X 
X 
X 
Fidelity of OPTIMAL  
 
X 
X 
X 
X 
 
Usefulness of OPTIMAL  
 
 
 
 
 
X 
3 
Resident mealtime difficulties,  eating 
performance, intake success rate, 
BMI 
 
X 
 
X 
X 
 
 
Sample Characteristics (Aim 1, 2, 3). Resident characteristics include age, gender, race, 
ethnicity, education, dementia stage. Staff and families characteristics include age, gender, race, 
ethnicity, education, job title (staff only), and length of caregiving.  
 
Feasibility, Fidelity, and Usefulness Data (Aim 2)  
Feasibility of OPTIMAL. Descriptive data on identification, recruitment, consent, and retention 
of staff, resident, and family participants will be gathered to assess intervention feasibility34-36 (see 
Appendix 5). In addition to the number of participants screened and eligible for the study, the 
recruiter will track reasons for those unwilling to participate in the study, and whether that is 
specifically related to video recording and/or OPTIMAL intervention. We will record the number of 
participants deemed not eligible and reasons for ineligibility as a basis for planning future trials of 
OPTIMAL. The length of time it takes to obtain assents/consents from residents, staff, families, 
and LARs, as well as the number of families and LARs who don’t mail back their written consent 
within expected time period (i.e., 2 weeks after they receive blank consent forms by mail) will be 
tracked. Families/LARs will be contacted to determine barriers to return of consents and how 
processes could be changed to facilitate timely return of consent. We will track the number of 
residents and staff requiring rescheduling of video recording sessions and the reasons for 
rescheduling. We will track the number of resident and staff participants who withdraw at various 
time points (e.g., before, during, and after T1, T2, and T3), and those who withdraw will be 
contacted to determine reasons for withdrawal and how process could be changed to facilitate 
retention.  
Fidelity of OPTIMAL. We will assess three aspects of fidelity37: 1) delivery of treatment, tracking 
staff attendance at the group or individual training sessions using a checklist, 2) receipt of 
treatment, indicated by a total test score of ≥ 75% on the staff PCMC-related knowledge & self-
efficacy test post-training with or without booster sessions (we will track the number of group or 
individual booster sessions offered in each NH), and 3) enactment of treatment skills, including 
quality of staff engagement assessed by the 19-item Mealtime Engagement Scale38 developed 

by the PI with evidence of reliability and validity (each item is scored on 0-3, total score range: 0-
57, higher score = higher quality of engagement).   
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. Open-ended questions focus on experiences in delivering 
OPTIMAL care, use of PCMC-related strategies, strategies that do (not) work, and suggestions 
of refinement for OPTIMAL (see Appendix 7). 
 
Resident outcomes (Aim 3) 
Resident mealtime difficulties. We will code videos using CUED that has codes for resident 
mealtime difficulties grouped into three types: 1) chewing and swallowing difficulties represented 
by 4 behaviors (e.g., holds food in mouth), 2) functional impairment represented by 5 behaviors 
(e.g., difficulty using utensil), and 3) resistiveness to care represented by 6 behaviors (e.g., 
doesn’t open mouth). Coded data will be used to calculate the number of resident mealtime 
difficulties by type in each videotaped meal.  
Resident eating performance. We will use the 9-item Level of Eating Independence scale (see 
appendix 8) to assess the ability of independence with eating and drinking activities during cycles 
of verbal prompts39. Each item is scored from 1 (total dependence) to 4 (total independence), with 
total score ranging from 9 to 36 (higher score = more independence). The inter-rater reliability 
was 0.96.39 
Resident intake success rate. We will code videos using CUED to track whether the resident or 
staff initiates/completes each intake attempt, and whether there is a subsequent intake after each 
attempt. We will calculate resident intake success rate through 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.  
Resident Body Mass Index (BMI). We will assess body weight 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. We will assess body weight twice in one early 
morning of each time point and calculate the average of the two assessments for BMI.  
Behavioral Coding Procedures for Videos. All videos will be computer archived and coded 
second-by-second by trained coders using Noldus Observer® 14.0 following a standard CUED 
coding manual established by our team. Detailed training and coding procedures are described 
in PHS HSCTI, 4.4 Statistical Design and Power. Coded data on resident mealtime difficulties 
and intake process will be exported from Noldus Observer® to excel worksheets, and then 
imported to SAS 9.440 for us to calculate the number of mealtime difficulties, and intake success 
rate. 
 
Statistical Analysis Plan.  
Develop, evaluate, and refine OPTIMAL intervention protocol and training materials (Aim 
1). We developed OPTIMAL through systematic integration of four PCMC principles,10-12, 20 our 
prior work on multilevel facilitators and barriers to engaging residents in eating, and our systematic 
review of mealtime difficulties and targeted behavioral strategies. We integrated 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 conducted focus group interviews of staff participants on the acceptability and 
appropriateness of the intervention protocol and training materials before pilot testing. Based on 

staff overall comments, the OPTIMAL components were highly evaluated as timely and fit to the 
needs of care practice. Data obtained were used to refine the intervention protocol and training 
materials before pilot testing.  
Determine feasibility, fidelity, and usefulness of OPTIMAL (Aim 2). We described feasibility 
data on participant identification, recruitment, consent and retention, including the number of and 
reasons for participants’ ineligibility, unwillingness to participate, not consenting/assenting, not 
returning written consent within expected time period, and attrition/withdrawal. We used this 
information to refine study procedures for a future larger trial to facilitate recruitment and retention. 
We described treatment fidelity, including staff attendance at training sessions and staff PCMC-
related knowledge scores pre- and post-training. Audio-recorded focus group interviews from staff 
(usefulness) were transcribed41 and coded42. We extracted codes using open coding (using staff’s 
own words)42, 43 to address the usefulness and areas of refinement of OPTIMAL.  
Describe resident outcomes (Aim 3). We described distributions of resident eating 
performance, mealtime challenging behaviors including resistive behaviors and functional 
impairments, intake success rate, and BMI using appropriate descriptive statistics (mean, median, 
mode, range, variance, SD, percentile and quartile ranks, n, %) over time. These data were used 
to inform estimates of effect sizes for sample size calculation in a future trial.   
 
Expected Outcomes and Impact for Future Trials. Using mixed methods, qualitative and 
quantitative data will be collected and analyzed to refine OPTIMAL intervention protocol, training 
materials, and study procedures, and to understand its feasibility, fidelity, and usefulness. Data 
obtained from this pilot trial will provide five critical pieces of information for a future larger efficacy 
trial. They are: 1) refined OPTIMAL intervention protocol and training materials with preliminary 
evidence of feasibility, fidelity, and usefulness; 2) refined study procedures for recruitment, 
retention, data collection, and recording and behavioral coding of videos; 3) evidence of feasibility 
for a two-group parallel cluster RCT design with three repeated measures (baseline, 6-&12-weeks 
post baseline); 4) effect size estimates of resident outcomes for sample size calculation; and 5) 
videotaped observations collected in this study to be used in future staff training sessions to 
illustrate OPTIMAL care skills.  
Limitations. As a pilot RCT, a small sample of staff and residents from 4 NHs will be enrolled. 
This is a logical first step to develop and test a new behavioral intervention, prior to a large-scale 
efficacy trial.    
 
 

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