NCT04242186: NH PRIDE

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Completed NA Results posted Last updated 27 April 2023

What this trial tests

NA trial testing Injury Liaison Service in Accidental Falls/Prevention and Control in 140 participants. Completed in 20 May 2022.

Timeline

30 October 2019

Primary endpoint
20 May 2022

20 May 2022

Quick facts

Lead sponsor	Hebrew SeniorLife
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	140
Start date	30 October 2019
Primary completion	20 May 2022
Estimated completion	20 May 2022
Sites	2 locations across United States

Drugs / interventions tested

• Injury Liaison Service

Conditions studied

• Accidental Falls/Prevention and Control — all drugs for Accidental Falls/Prevention and Control →

Sponsor

Hebrew SeniorLife — full company profile →

Who can join

60 and older, any sex, with Accidental Falls/Prevention and Control. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of High-risk Residents According to the FRAiL Model Primary · baseline

Group	Value	95% CI
Nursing Home Residents	46

Number of High-risk Residents With One or More Deprescribing Recommendations Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	36

Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	21

Number of Residents Who Accepted One or More Deprescribing Recommendations Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	21

Number of High-risk Residents With a Recommendation for Osteoporosis Treatment Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	20

Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	10

Number of Residents Who Accepted Osteoporosis Treatment Recommendations Primary · 4 months

Group	Value	95% CI
Nursing Home Residents	10

Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death Primary · 6 months

Group	Value	95% CI
Nursing Home Residents	6

Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey Primary · 6 months

Group	Value	95% CI
Nursing Home Staff	17

Number of Staff Members Who Attended One or More ECHO Sessions Primary · 6 months

Group	Value	95% CI
Nursing Home Staff	21

Average Number of Deprescribing Recommendations That Were Made for Each Resident Secondary · 4 months

Group	Value	95% CI
Nursing Home Residents	2.2	± 1.3

Average Number of Adverse Drug Events Secondary · 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).

Group	Value	95% CI
Nursing Home Residents	0.05	± 0.22

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nursing Home Residents

Serious: 9/46 (20%)

Deaths: 5/46

Serious adverse events (6 terms)

Reaction	System	Nursing Home Residents
Advanced dementia resulting in death	Nervous system disorders	—
Urosepsis resulting in hospitalization	Infections and infestations	—
Intraventricular hemorrhage following a fall and resulting in death	Infections and infestations	—
Suspected cardiac event resulting in death	Cardiac disorders	—
Agitation and aggression resulting in hospitalization	Nervous system disorders	—
Acute colitis resulting in hospitalization	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Nursing Home Residents
Adverse drug withdrawal event	Psychiatric disorders	—

Most-reported serious reactions: Advanced dementia resulting in death, Urosepsis resulting in hospitalization, Intraventricular hemorrhage following a fall and resulting in death, Suspected cardiac event resulting in death, Agitation and aggression resulting in hospitalization, Acute colitis resulting in hospitalization.

Data from ClinicalTrials.gov NCT04242186 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Perspectives on Deprescribing in long-term care: qualitative findings from nurses, aides, residents, and proxies.
   Little MO, Hecker EJ, Colon-Emeric CS, Herndon L, et al · · 2023 · cited 3× · PMID 36721150 · DOI 10.1186/s12912-023-01179-y