Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Not Applicable

Completed

Conditions: Accidental Falls/Prevention and Control

Interventions: Other: Injury Liaison Service

Registration Number: NCT04242186

Lead Sponsor: Hebrew SeniorLife

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. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

Inclusion Criteria

Facility inclusion criteria:

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

Resident inclusion criteria:

Age ≥ 60 years
NH length of stay ≥ 30 days
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:

Worked in the facility for ≥ 90 days
Can communicate in English (in order to participate in interviews and questionnaires),
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:

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

Exclusion Criteria

Facility exclusion criteria:

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

Provider exclusion criteria:

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

Resident exclusion criteria:

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.

Proxy/resident exclusion criteria for interviews:

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nursing home residents and staff	Injury Liaison Service	Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Average Number of Deprescribing Recommendations That Were Made for Each Resident	4 months
Average Number of Adverse Drug Events	4 months	1. Escalating behaviors, worsening depression, or functional decline following psychoactive medication deprescribing 2. Unplanned medical visits for hypertension, tachycardia, or hyperglycemia following cardiometabolic deprescribing 3. 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).
Number of Injurious Falls	4 months