Clinical trial NCT04242186: Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Official title: Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls/Prevention and Control
Keywords: Nursing Homes
Elderly
Dementia
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Duke University
name: Brown University
First posted: 2020-01-27
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of High-risk Residents According to the FRAiL Model
timeFrame: baseline
measure: Number of High-risk Residents With One or More Deprescribing Recommendations
timeFrame: 4 months
measure: Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
timeFrame: 4 months
measure: Number of Residents Who Accepted One or More Deprescribing Recommendations
timeFrame: 4 months
measure: Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
timeFrame: 4 months
measure: Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
timeFrame: 4 months
measure: Number of Residents Who Accepted Osteoporosis Treatment Recommendations
timeFrame: 4 months
measure: Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
timeFrame: 6 months
measure: Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
timeFrame: 6 months
measure: Number of Staff Members Who Attended One or More ECHO Sessions
timeFrame: 6 months
Secondary outcomes:
measure: Average Number of Deprescribing Recommendations That Were Made for Each Resident
timeFrame: 4 months
measure: Average Number of Adverse Drug Events
timeFrame: 4 months
measure: Number of Injurious Falls
timeFrame: 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hebrew SeniorLife
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Hebrew Rehabilitation Center
name: Sarah D Berry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Cathleen S Colón-Emeric, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: