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Implementation of Function Focused Care in Acute Care

Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04235374
Enrollment
455
Registered
2020-01-21
Start date
2020-10-19
Completion date
2025-05-14
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Medical Event, Dementia, Hospitalization

Brief summary

Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.

Detailed description

After hospitals are recruited they will be randomized to cohort and randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder team and unit champions for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months. Timing of the intervention activities will be flexible based on the needs of the unit. The first meeting with the stakeholder team will be 1-2 hours and the remaining meetings will be approximately 30 minutes monthly to update the stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT. The majority of the time on the unit by the Research Nurse Facilitator will be spent with the champions helping and assuring that they are engaging staff in function focused care activities via the four steps of FFC-AC-EIT. Once hospitals are randomized we will set up a time to meet with the identified contact to determine the stakeholder team members and champions and organize the first stakeholder team meeting. The first meeting will provide an overview of the implementation of Steps 1 to 4 \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\] and will address the unit challenges to implementing function focused care using a Brainstorming approach. In the first two months the Research Nurse Facilitator completes the environment and policy assessments with the champions and implements appropriate changes on the units and plans and provides staff education and makes available information for patients and families/ caregivers. The education reviews function focused care. Ongoing work between the champions and the Research Nurse Facilitator focuses on motivating staff and patients to work toward achievement of patient goals and established unit goals. The stakeholder team will continue to meet with the Research Nurse Facilitator monthly (approximately 30 minutes) over the 12-month intervention period to review progress and to help champions overcome any identified multilevel challenges. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. To further facilitate implementation we will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion to attend a conference and submit an abstract focused on optimizing function and physical activity of hospitalized older adults with ADRD. Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.

Interventions

BEHAVIORALFFC-AC-EIT

The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Penn State University
CollaboratorOTHER
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants as hospitals will be randomized to treatment or control

Intervention model description

randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. are admitted into the hospital from any setting during the 12 month implementation period; 2. are 55 years of age or older; 3. are admitted onto a medical unit for any medical diagnosis; and 4. screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of \>2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).

Exclusion criteria

1. are enrolled in Hospice; 2. have been on the unit for greater than 48 hours; 3. do not have a family member/caregiver that we can contact; 4. anticipate surgery; or 5. have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.

Design outcomes

Primary

MeasureTime frameDescription
The Barthel IndexScores at hospital admission, hospital discharge, 1,6, and 12 months post dischargeA measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
The Physical Activity SurveyBaseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post dischargeThe Physical Activity Survey is a subjective measure of time spent in physical activities over 24 hours based on input from an informant. A total of 37 activities iin the following areas are included: locomotion (e.g., walking, wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and occupational therapy), recreational activity (music), and repetitive behavior (moving objects repeatedly). scores range from 0 to 37 with each activity considered as done at least once during the day. Higher scores are indicative of more physical activities done.
The Short Confusion Assessment Methodbaseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post dischargeAn assessment for evidence of delirium based on items reflective of behaviors associated with delirium. There are four areas considered: Acute onset and fluctuating course is scored as no (0) or yes (1). Inattention and disorganized thinking are each scored as absent (0 points), present in mild form (1 point), or present in severe form (2 points). Altered level of consciousness, is scored as alert or normal (0 points), vigilant or lethargic (1 point), and stupor or coma (2 points). Scores range from 0-7, with a higher score indicating greater severity of delirium.
the Brief Neuropsychiatric Inventorybaseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nbAssessment of behavioral symptoms including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating is done. The presence of each behavior is scored as present (1) or not present (0). The behaviors are then scored and range from 0 to 12. Higher scores are indicative of more behavioral and psychological symptoms associated with dementia.
Pain in Advanced Dementia Scale (PAINAD)change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post dischargeAn objective measure of 5 behaviors commonly associated with pain. Each pain behavior is scored from 0 (no evidence) to 2 (persistant behavior). Scores are then summed for a total score that ranges from 0 to 10 with higher scores indicative of more pain.

Countries

United States

Participant flow

Participants by arm

ArmCount
FFC-AC-EIT
treatment with the intervention FFC-AC-EIT
220
Education Only
Treatment with control for attention with education only
235
Total455

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath9191
Overall StudyRefused22
Overall StudyUnavailable123
Overall StudyWithdrawal by Legally Authorized Representative109
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicTotalFFC-AC-EITEducation Only
Age, Continuous82.5 years
STANDARD_DEVIATION 8.5
83.6 years
STANDARD_DEVIATION 7.8
81.4 years
STANDARD_DEVIATION 9
Barthel index51.5 units on a scale
STANDARD_DEVIATION 27
49.2 units on a scale
STANDARD_DEVIATION 27.3
54.9 units on a scale
STANDARD_DEVIATION 27.1
Delirium1.7 units on a scale
STANDARD_DEVIATION 1.7
1.5 units on a scale
STANDARD_DEVIATION 1.7
2.1 units on a scale
STANDARD_DEVIATION 1.8
Neuropsychiatric inventory1.9 units on a scale
STANDARD_DEVIATION 2.5
1.4 units on a scale
STANDARD_DEVIATION 2.7
2.4 units on a scale
STANDARD_DEVIATION 3.2
Pain.11 units on a scale
STANDARD_DEVIATION 0.4
.02 units on a scale
STANDARD_DEVIATION 0.2
.2 units on a scale
STANDARD_DEVIATION 0.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
17 Participants9 Participants8 Participants
Race (NIH/OMB)
Black or African American
141 Participants49 Participants92 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
297 Participants162 Participants135 Participants
Sex: Female, Male
Female
285 Participants135 Participants150 Participants
Sex: Female, Male
Male
170 Participants85 Participants85 Participants
The Physical Activity Survey8.8 units on a scale
STANDARD_DEVIATION 5.5
8.2 units on a scale
STANDARD_DEVIATION 5
9.6 units on a scale
STANDARD_DEVIATION 6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
91 / 22091 / 235
other
Total, other adverse events
136 / 220140 / 235
serious
Total, serious adverse events
0 / 2200 / 235

Outcome results

Primary

Pain in Advanced Dementia Scale (PAINAD)

An objective measure of 5 behaviors commonly associated with pain. Each pain behavior is scored from 0 (no evidence) to 2 (persistant behavior). Scores are then summed for a total score that ranges from 0 to 10 with higher scores indicative of more pain.

Time frame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge

Population: participants who had data collected at these time points.

ArmMeasureGroupValue (MEAN)Dispersion
FFC-AC-EITPain in Advanced Dementia Scale (PAINAD)Discharge.4 units on a scaleStandard Deviation 1.1
FFC-AC-EITPain in Advanced Dementia Scale (PAINAD)One month1.6 units on a scaleStandard Deviation 1.7
FFC-AC-EITPain in Advanced Dementia Scale (PAINAD)Six month1.5 units on a scaleStandard Deviation 1.6
FFC-AC-EITPain in Advanced Dementia Scale (PAINAD)twelve month6.4 units on a scaleStandard Deviation 1.7
FFC-AC-EITPain in Advanced Dementia Scale (PAINAD)Baseline.02 units on a scaleStandard Deviation 0.2
Education OnlyPain in Advanced Dementia Scale (PAINAD)Baseline.2 units on a scaleStandard Deviation 0.6
Education OnlyPain in Advanced Dementia Scale (PAINAD)twelve month6.4 units on a scaleStandard Deviation 1.8
Education OnlyPain in Advanced Dementia Scale (PAINAD)One month1.2 units on a scaleStandard Deviation 2
Education OnlyPain in Advanced Dementia Scale (PAINAD)Discharge1.2 units on a scaleStandard Deviation 1.8
Education OnlyPain in Advanced Dementia Scale (PAINAD)Six month1.3 units on a scaleStandard Deviation 1.8
p-value: 0.05Mixed Models Analysis
Primary

The Barthel Index

A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.

Time frame: Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge

ArmMeasureGroupValue (MEAN)Dispersion
FFC-AC-EITThe Barthel Index12 month32.0 score on a scaleStandard Deviation 12.1
FFC-AC-EITThe Barthel IndexBaseline49.2 score on a scaleStandard Deviation 27.3
FFC-AC-EITThe Barthel Indexdischarge52.0 score on a scaleStandard Deviation 28.5
FFC-AC-EITThe Barthel Indexone month58.2 score on a scaleStandard Deviation 31.7
FFC-AC-EITThe Barthel Indexsix month61.1 score on a scaleStandard Deviation 32
Education OnlyThe Barthel Indexsix month61.4 score on a scaleStandard Deviation 27.3
Education OnlyThe Barthel Indexone month58.0 score on a scaleStandard Deviation 30.6
Education OnlyThe Barthel IndexBaseline54.9 score on a scaleStandard Deviation 27.3
Education OnlyThe Barthel Index12 month30.1 score on a scaleStandard Deviation 10.8
Education OnlyThe Barthel Indexdischarge58.7 score on a scaleStandard Deviation 27.6
p-value: <0.05Mixed Models Analysis
Primary

the Brief Neuropsychiatric Inventory

Assessment of behavioral symptoms including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating is done. The presence of each behavior is scored as present (1) or not present (0). The behaviors are then scored and range from 0 to 12. Higher scores are indicative of more behavioral and psychological symptoms associated with dementia.

Time frame: baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nb

Population: Participants who had data collected at these time points

ArmMeasureGroupValue (MEAN)Dispersion
FFC-AC-EITthe Brief Neuropsychiatric InventoryDischarge1.7 units on a scaleStandard Deviation 3.1
FFC-AC-EITthe Brief Neuropsychiatric InventorySix month5.7 units on a scaleStandard Deviation 5.2
FFC-AC-EITthe Brief Neuropsychiatric InventoryOne month6.6 units on a scaleStandard Deviation 5.8
FFC-AC-EITthe Brief Neuropsychiatric Inventorytwelve month3.0 units on a scaleStandard Deviation 2.4
FFC-AC-EITthe Brief Neuropsychiatric InventoryBaseline1.4 units on a scaleStandard Deviation 2.7
Education Onlythe Brief Neuropsychiatric Inventorytwelve month3.5 units on a scaleStandard Deviation 2.6
Education Onlythe Brief Neuropsychiatric InventoryBaseline2.4 units on a scaleStandard Deviation 3.2
Education Onlythe Brief Neuropsychiatric InventoryDischarge2.3 units on a scaleStandard Deviation 3.1
Education Onlythe Brief Neuropsychiatric InventoryOne month6.0 units on a scaleStandard Deviation 5.7
Education Onlythe Brief Neuropsychiatric InventorySix month6.8 units on a scaleStandard Deviation 6.1
p-value: 0.05Mixed Models Analysis
Primary

The Physical Activity Survey

The Physical Activity Survey is a subjective measure of time spent in physical activities over 24 hours based on input from an informant. A total of 37 activities iin the following areas are included: locomotion (e.g., walking, wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and occupational therapy), recreational activity (music), and repetitive behavior (moving objects repeatedly). scores range from 0 to 37 with each activity considered as done at least once during the day. Higher scores are indicative of more physical activities done.

Time frame: Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post discharge

Population: participants who had data collected at these time points.

ArmMeasureGroupValue (MEAN)Dispersion
FFC-AC-EITThe Physical Activity Surveytwelve month13.4 score on scaleStandard Deviation 6.2
FFC-AC-EITThe Physical Activity SurveyBaseline8.2 score on scaleStandard Deviation 5
FFC-AC-EITThe Physical Activity SurveyDischarge9.2 score on scaleStandard Deviation 5.7
FFC-AC-EITThe Physical Activity Surveyone month13.6 score on scaleStandard Deviation 6.7
FFC-AC-EITThe Physical Activity Surveysix month13.9 score on scaleStandard Deviation 6.6
Education OnlyThe Physical Activity Surveysix month12.9 score on scaleStandard Deviation 4.6
Education OnlyThe Physical Activity Surveyone month11.9 score on scaleStandard Deviation 5.7
Education OnlyThe Physical Activity SurveyBaseline9.6 score on scaleStandard Deviation 6
Education OnlyThe Physical Activity Surveytwelve month11.7 score on scaleStandard Deviation 4.4
Education OnlyThe Physical Activity SurveyDischarge10.1 score on scaleStandard Deviation 6.4
p-value: <0.05Mixed Models Analysis
Primary

The Short Confusion Assessment Method

An assessment for evidence of delirium based on items reflective of behaviors associated with delirium. There are four areas considered: Acute onset and fluctuating course is scored as no (0) or yes (1). Inattention and disorganized thinking are each scored as absent (0 points), present in mild form (1 point), or present in severe form (2 points). Altered level of consciousness, is scored as alert or normal (0 points), vigilant or lethargic (1 point), and stupor or coma (2 points). Scores range from 0-7, with a higher score indicating greater severity of delirium.

Time frame: baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post discharge

Population: participants who had data collected at these time points.

ArmMeasureGroupValue (MEAN)Dispersion
FFC-AC-EITThe Short Confusion Assessment MethodBaseline1.5 score on a scaleStandard Deviation 1.7
FFC-AC-EITThe Short Confusion Assessment MethodDischarge1.2 score on a scaleStandard Deviation 1.7
FFC-AC-EITThe Short Confusion Assessment MethodOne Month2.2 score on a scaleStandard Deviation 1.9
FFC-AC-EITThe Short Confusion Assessment MethodSix month2.1 score on a scaleStandard Deviation 1.7
FFC-AC-EITThe Short Confusion Assessment Methodtwelve month2.1 score on a scaleStandard Deviation 1.6
Education OnlyThe Short Confusion Assessment MethodSix month2.5 score on a scaleStandard Deviation 1.9
Education OnlyThe Short Confusion Assessment MethodBaseline2.1 score on a scaleStandard Deviation 1.8
Education OnlyThe Short Confusion Assessment MethodOne Month2.2 score on a scaleStandard Deviation 1.8
Education OnlyThe Short Confusion Assessment Methodtwelve month2.7 score on a scaleStandard Deviation 2
Education OnlyThe Short Confusion Assessment MethodDischarge1.7 score on a scaleStandard Deviation 1.6
p-value: 0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026