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Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04242186
Acronym
NH PRIDE
Enrollment
140
Registered
2020-01-27
Start date
2019-10-30
Completion date
2022-05-20
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls/Prevention and Control

Keywords

Nursing Homes, Elderly, Dementia

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.

Interventions

OTHERInjury 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Duke University
CollaboratorOTHER
Brown University
CollaboratorOTHER
Hebrew SeniorLife
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Staff Members Who Attended One or More ECHO Sessions6 months
Number of Residents Who Accepted Osteoporosis Treatment Recommendations4 months
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death6 months
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey6 months
Number of High-risk Residents According to the FRAiL Modelbaseline
Number of High-risk Residents With One or More Deprescribing Recommendations4 months
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations4 months
Number of Residents Who Accepted One or More Deprescribing Recommendations4 months
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment4 months
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations4 months

Secondary

MeasureTime frameDescription
Average Number of Adverse Drug Events4 months1. 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 Falls4 months
Average Number of Deprescribing Recommendations That Were Made for Each Resident4 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Nursing Home Residents and Staff
Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities. Participants included 46 nursing home residents, 28 qualitative interview participants, and 66 facility staff members. 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.
140
Total140

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath5

Baseline characteristics

CharacteristicNursing Home Residents and Staff
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
46 Participants
Age, Categorical
Between 18 and 65 years
94 Participants
Age, Continuous88 years
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
140 participants
Sex: Female, Male
Female
122 Participants
Sex: Female, Male
Male
18 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
5 / 46
other
Total, other adverse events
1 / 46
serious
Total, serious adverse events
9 / 46

Outcome results

Primary

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsAttrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death6 Participants
Primary

Number of High-risk Residents According to the FRAiL Model

Time frame: baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of High-risk Residents According to the FRAiL Model46 Participants
Primary

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

Time frame: 4 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of High-risk Residents With a Recommendation for Osteoporosis Treatment20 Participants
Primary

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

Time frame: 4 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of High-risk Residents With One or More Deprescribing Recommendations36 Participants
Primary

Number of Residents Who Accepted One or More Deprescribing Recommendations

Time frame: 4 months

Population: 21 residents had deprescribing recommendations accepted by their provider

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of Residents Who Accepted One or More Deprescribing Recommendations21 Participants
Primary

Number of Residents Who Accepted Osteoporosis Treatment Recommendations

Time frame: 4 months

Population: 10 residents had osteoporosis treatment recommendations accepted by their provider

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of Residents Who Accepted Osteoporosis Treatment Recommendations10 Participants
Primary

Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations

Time frame: 4 months

Population: 36 participants had one or more deprescribing recommendations

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of Residents Whose Provider Accepted One or More Deprescribing Recommendations21 Participants
Primary

Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations

Time frame: 4 months

Population: 20 participants had a recommendation for osteoporosis treatment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations10 Participants
Primary

Number of Staff Members Who Attended One or More ECHO Sessions

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsNumber of Staff Members Who Attended One or More ECHO Sessions21 Participants
Primary

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nursing Home ResidentsProportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey17 Participants
Secondary

Average Number of Adverse Drug Events

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).

Time frame: 4 months

Population: Adverse drug events were analyzed in residents who had one or more medications deprescribed (n=21).

ArmMeasureValue (MEAN)Dispersion
Nursing Home ResidentsAverage Number of Adverse Drug Events0.05 number of eventsStandard Deviation 0.22
Secondary

Average Number of Deprescribing Recommendations That Were Made for Each Resident

Time frame: 4 months

ArmMeasureValue (MEAN)Dispersion
Nursing Home ResidentsAverage Number of Deprescribing Recommendations That Were Made for Each Resident2.2 number of recommendationsStandard Deviation 1.3
Secondary

Number of Injurious Falls

Time frame: 4 months

ArmMeasureValue (MEAN)Dispersion
Nursing Home ResidentsNumber of Injurious Falls0.07 number of injurious fallsStandard Deviation 0.25

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026