Trial Outcomes & Findings for Nursing Home Prevention of Injury in Dementia (NH PRIDE) (NCT NCT04242186)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

baseline

Results posted on

2023-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Nursing Home Residents and Staff Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities 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.
Overall Study STARTED	140
Overall Study Qualitative Interview Participants	28
Overall Study Nursing Home Residents	46
Overall Study Facility Staff Members	66
Overall Study COMPLETED	135
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Nursing Home Residents and Staff Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities 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.
Overall Study Death	5

Baseline Characteristics

Continuous age data are included only for nursing home residents. Continuous age data were not collected from interview participants and staff members.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nursing Home Residents and Staff n=140 Participants 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.
Age, Categorical <=18 years	0 Participants n=140 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=140 Participants
Age, Categorical >=65 years	46 Participants n=140 Participants
Age, Continuous	88 years n=46 Participants • Continuous age data are included only for nursing home residents. Continuous age data were not collected from interview participants and staff members.
Sex: Female, Male Female	122 Participants n=140 Participants
Sex: Female, Male Male	18 Participants n=140 Participants
Region of Enrollment United States	140 participants n=140 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Number of High-risk Residents According to the FRAiL Model	46 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Number of High-risk Residents With One or More Deprescribing Recommendations	36 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 36 participants had one or more deprescribing recommendations

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=36 Participants Nursing home residents at high risk for injurious falls
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations	21 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 21 residents had deprescribing recommendations accepted by their provider

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=21 Participants Nursing home residents at high risk for injurious falls
Number of Residents Who Accepted One or More Deprescribing Recommendations	21 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment	20 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 20 participants had a recommendation for osteoporosis treatment

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=20 Participants Nursing home residents at high risk for injurious falls
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations	10 Participants

PRIMARY outcome

Timeframe: 4 months

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

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=10 Participants Nursing home residents at high risk for injurious falls
Number of Residents Who Accepted Osteoporosis Treatment Recommendations	10 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death	6 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=21 Participants Nursing home residents at high risk for injurious falls
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey	17 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=21 Participants Nursing home residents at high risk for injurious falls
Number of Staff Members Who Attended One or More ECHO Sessions	21 Participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Average Number of Deprescribing Recommendations That Were Made for Each Resident	2.2 number of recommendations Standard Deviation 1.3

SECONDARY outcome

Timeframe: 4 months

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

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).

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=21 Participants Nursing home residents at high risk for injurious falls
Average Number of Adverse Drug Events	0.05 number of events Standard Deviation 0.22

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Nursing Home Residents n=46 Participants Nursing home residents at high risk for injurious falls
Number of Injurious Falls	0.07 number of injurious falls Standard Deviation 0.25

Adverse Events

Nursing Home Residents

Serious events: 9 serious events

Other events: 1 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Nursing Home Residents n=46 participants at risk Adverse events were monitored in nursing home residents at high risk for injurious falls (n=46)
Infections and infestations Intraventricular hemorrhage following a fall and resulting in death	2.2% 1/46 • Number of events 1 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).
Nervous system disorders Advanced dementia resulting in death	6.5% 3/46 • Number of events 3 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).
Cardiac disorders Suspected cardiac event resulting in death	2.2% 1/46 • Number of events 1 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).
Infections and infestations Urosepsis resulting in hospitalization	4.3% 2/46 • Number of events 2 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).
Nervous system disorders Agitation and aggression resulting in hospitalization	2.2% 1/46 • Number of events 1 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).
Gastrointestinal disorders Acute colitis resulting in hospitalization	2.2% 1/46 • Number of events 1 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).

Other adverse events

Other adverse events
Measure	Nursing Home Residents n=46 participants at risk Adverse events were monitored in nursing home residents at high risk for injurious falls (n=46)
Psychiatric disorders Adverse drug withdrawal event	2.2% 1/46 • Number of events 1 • 4 months We used the clinicaltrials.gov definitions of adverse events. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in facility staff. They were only assessed in nursing home residents at high risk for falls (n=46).

Additional Information

Sarah Berry, MD, MPH

Hebrew SeniorLife

Phone: 617-971-5355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place