Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04235374
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2020-01-15
Brief Title:
Implementation of Function Focused Care in Acute Care
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimers Disease and Related Dementias
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Older adults with Alzheimers 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 eg mobilitybathing 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 eg 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 motivationwillingness 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 enactment136 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 Nascocom to buy supplies for the unit to engage patients with ADRD in physical activities eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG065338-01 | NIH | None | httpsreporternihgovquickSearchR01AG065338-01 |