Implementation of Function Focused Care in Acute Care

NCT04235374 | Completed Results DMC

• 2 other identifiers: 00089301R01AG065338-01
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 14

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.

Conditions

Dementia; Acute Medical Event; Hospitalization

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Study Arms (2)

FFC-AC-EIT

EXPERIMENTAL

The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion 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 to implement Steps 1 to 4 of FFC-AC-EIT \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. 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.

Behavioral: FFC-AC-EIT

Education Only

PLACEBO COMPARATOR

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.

Behavioral: FFC-AC-EIT

Interventions

FFC-AC-EIT BEHAVIORAL

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.

Also known as: FFC-AC-EO

Education Only; FFC-AC-EIT

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are admitted into the hospital from any setting during the 12 month implementation period;
• are 55 years of age or older;
• are admitted onto a medical unit for any medical diagnosis; and
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• Penn State University: collaborator

Study Sites (14)

Luminus Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

University of Maryland Baltimore Washington Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland Hospital

Baltimore, Maryland, 21201, United States

Location

Midtown Hospital

Baltimore, Maryland, 21211, United States

Location

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

University of maryland Upper Chesapeake Hospital

Perryville, Maryland, 21903, United States

Location

University of Maryland Saint Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Jefferson Abbington

Abington, Pennsylvania, 19001, United States

Location

Lancaster Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Jefferson Lansdale

Lansdale, Pennsylvania, 19446, United States

Location

Jefferson Lansdale (control);

Philadelphia, Pennsylvania, 16802, United States

Location

Hospital University of Pennsylvania - Cedar Avenue

Philadelphia, Pennsylvania, 19143, United States

Location

Jefferson Methodist

Philadelphia, Pennsylvania, 19148, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (1)

• Resnick B, Boltz M, Galik E, Kuzmik A, McPherson R, Drazich B, Kim N, Zhu S, Wells CL. Measurement of Physical Activity Among Hospitalized Older Adults Living With Dementia. Rehabil Nurs. 2024 Jul-Aug 01;49(4):115-124. doi: 10.1097/RNJ.0000000000000464. Epub 2024 Jun 20.

  PMID: 38904657 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Barbara Resnick
• Organization: University of Maryland

resnick@umaryland.edu

410 706 5178

Study Officials

• Barbara Resnick, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants as hospitals will be randomized to treatment or control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: October 19, 2020
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)