Nursing Home Prevention of Injury in Dementia (NH PRIDE)

NCT04242186 | Completed Results DMC

• 2 other identifiers: IRB-2019-211R01AG062492-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to develop a consistent approach to prevent falls with injury in nursing home (NH) residents. A centralized Injury Liaison Service (ILS) will be developed and tested in four nursing home facilities (two in the Durham, North Carolina area and two in the Boston, Massachusetts area). The ILS will combine successful elements of a Fracture Liaison Service (FLS) and video telehealth staff education (ECHO) models with the goal of decreasing injurious falls in nursing home residents. The ILS Program has four main components:

1. 1.Automated identification of NH residents at high risk for falls with injury
2. 2.Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications
3. 3.Video telehealth sessions to educate staff
4. 4.Shared decision making with residents and/or families.

Conditions

Accidental Falls/Prevention and Control

Keywords

Nursing Homes; Elderly; Dementia

Outcome Measures

Primary Outcomes (10)

• Number of High-risk Residents According to the FRAiL Model

  baseline

• Number of High-risk Residents With One or More Deprescribing Recommendations

  4 months

• Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations

  4 months

• Number of Residents Who Accepted One or More Deprescribing Recommendations

  4 months

• Number of High-risk Residents With a Recommendation for Osteoporosis Treatment

  4 months

• Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations

  4 months

• Number of Residents Who Accepted Osteoporosis Treatment Recommendations

  4 months

• Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death

  6 months

• Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey

  6 months

• Number of Staff Members Who Attended One or More ECHO Sessions

  6 months

Secondary Outcomes (3)

• Average Number of Deprescribing Recommendations That Were Made for Each Resident

  4 months

• Average Number of Adverse Drug Events

  4 months

• Number of Injurious Falls

  4 months

Study Arms (1)

Nursing home residents and staff

EXPERIMENTAL

Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities

Other: Injury Liaison Service

Interventions

Injury Liaison Service OTHER

The Injury Liaison Service nurse will coordinate deprescribing of fall-related medications, osteoporosis management, staff support of behavior management using video case conferencing, and shared decision making with residents and/or families.

Nursing home residents and staff

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 80 long-stay beds
• Within 30 miles of Boston, Massachusetts or Durham, North Carolina
• Age ≥ 60 years
• NH length of stay ≥ 30 days
• Estimated 2-year risk of hip fracture ≥ 6% using FRAiL model
• The NH-PRIDE intervention will target the "usual" providers including nurses, certified nursing assistants (CNAs), physicians, nurse practitioners (NPs), and physician assistants (PAs) routinely caring for NH patients. Nurses should be providing care at a NH facility for a minimum of 2 shifts most weeks. Physicians, NPs, and PAs should spend, on average a minimum of four hours weekly in nursing home care. We estimate there will be 10 providers for the qualitative interviews on injurious falls prevention, 20 providers (4 from each facility) in the televideo sessions, and 60 providers (15 per facility) to participate in the post-intervention questionnaires.
• Additional eligibility criteria for providers include:
• Worked in the facility for ≥ 90 days
• Can communicate in English (in order to participate in interviews and questionnaires),
• Over 21 years of age.
• We will recruit 10 residents/proxies to participate in qualitative interviews on falls prevention. Residents/family must meet the following criteria:
• Affiliated resident has lived in the facility for ≥ 30 days
• Can communicate in English
• Over 21 years of age
• Able to provide informed consent to participate in the interviews

You may not qualify if:

• Population not primarily English speaking
• Evidence of institutional instability at time of recruitment
• Does not provide routine care to NH residents (e.g., visiting hospice provider)
• Does not speak English
• Is less than 21 years old
• Advanced dementia as defined by Cognitive Performance Scale (CPS) = 6
• Life expectancy \< 6 months, as indicated by Minimum Data Set (MDS) assessment
• Living in nursing home for less than 30 days
• Proxy has communicated wish to opt-out of study Residents will not be excluded from the study based on any specific diagnosis (e.g., congestive heart failure or schizophrenia); however, the algorithm used to make recommendations for medication management will consider individual co-morbidities.
• Affiliated resident has lived in the facility for \< 30 days
• Cannot communicate in English
• Less than 21 years of age
• Unable to provide informed consent to participate

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• National Institute on Aging (NIA): collaborator
• Duke University: collaborator
• Brown University: collaborator

Study Sites (2)

Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Little MO, Hecker EJ, Colon-Emeric CS, Herndon L, McConnell ES, Xue TM, Berry SD. Perspectives on Deprescribing in long-term care: qualitative findings from nurses, aides, residents, and proxies. BMC Nurs. 2023 Jan 31;22(1):27. doi: 10.1186/s12912-023-01179-y.

  PMID: 36721150 DERIVED

Related Links

• The Fracture Risk Assessment in Long term care (FRAiL) model

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: Sarah Berry, MD, MPH
• Organization: Hebrew SeniorLife

sarahberry@hsl.harvard.edu

617-971-5355

Study Officials

• Sarah D Berry, MD, MPH

  Hebrew Rehabilitation Center

  PRINCIPAL INVESTIGATOR

• Cathleen S Colón-Emeric, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Medicine

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: October 30, 2019
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)