Nursing Home Prevention of Injury in Dementia (NH PRIDE) (NH PRIDE)

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

The central hypothesis of this study is that the ILS model will reduce injurious falls by changing care delivery in two areas: deprescribing psychoactive and cardiometabolic drugs to reduce falls, and increasing osteoporosis treatment to prevent injury in the setting of a fall.

Qualitative interviews will be conducted with nursing home staff to gain a better understanding of effective and non-effective injury prevention strategies. Information from these interviews will be incorporated into the study design. Outcome measures will focus on acceptability, demand, practicality, and feasibility of the program, as well as safety.

Study Overview

• Status: Completed
• Conditions: Accidental Falls/Prevention and Control
• Intervention / Treatment: Other: Injury Liaison Service

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Hebrew SeniorLife
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Facility inclusion criteria:

1. More than 80 long-stay beds
2. Within 30 miles of Boston, Massachusetts or Durham, North Carolina

Resident inclusion criteria:

1. Age ≥ 60 years
2. NH length of stay ≥ 30 days
3. Estimated 2-year risk of hip fracture ≥ 6% using FRAiL model

Provider inclusion criteria:

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:

1. Worked in the facility for ≥ 90 days
2. Can communicate in English (in order to participate in interviews and questionnaires),
3. Over 21 years of age.

Proxy/resident inclusion criteria:

We will recruit 10 residents/proxies to participate in qualitative interviews on falls prevention. Residents/family must meet the following criteria:

1. Affiliated resident has lived in the facility for ≥ 30 days
2. Can communicate in English
3. Over 21 years of age
4. Able to provide informed consent to participate in the interviews

Exclusion Criteria:

Facility exclusion criteria:

1. Population not primarily English speaking
2. Evidence of institutional instability at time of recruitment

Provider exclusion criteria:

1. Does not provide routine care to NH residents (e.g., visiting hospice provider)
2. Does not speak English
3. Is less than 21 years old

Resident exclusion criteria:

1. Advanced dementia as defined by Cognitive Performance Scale (CPS) = 6
2. Life expectancy < 6 months, as indicated by Minimum Data Set (MDS) assessment
3. Living in nursing home for less than 30 days
4. 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.

Proxy/resident exclusion criteria for interviews:

1. Affiliated resident has lived in the facility for < 30 days
2. Cannot communicate in English
3. Less than 21 years of age
4. Unable to provide informed consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing home residents and staff; Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities	Other: Injury Liaison Service; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Number of Deprescribing Recommendations That Were Made for Each Resident		4 months
Average Number of Adverse Drug Events	Escalating behaviors, worsening depression, or functional decline following psychoactive medication deprescribing; Unplanned medical visits for hypertension, tachycardia, or hyperglycemia following cardiometabolic deprescribing; New gastroesophageal reflux disease or esophagitis following bisphosphonate prescription Adverse drug events were analyzed in residents who had one or more medications deprescribed (n=21).	4 months
Number of Injurious Falls		4 months

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife
• Collaborators: Brown University; Duke University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sarah D Berry, MD, MPH, Hebrew Rehabilitation Center; Principal Investigator: Cathleen S Colon-Emeric, MD, MHS, Duke University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Dementia; Nursing Homes
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: IRB-2019-21; 1R01AG062492-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No