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CompletedNCT04242186NH PRIDEUpdated Apr 27, 2023Results posted

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

An interventional study of Injury Liaison Service in Accidental Falls/Prevention and Control, sponsored by Hebrew SeniorLife. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Accidental Falls/Prevention and Control

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Keywords

  • Nursing Homes
  • Elderly
  • Dementia
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 140 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Hebrew SeniorLife is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Nursing home residents and staff

    Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities

    Other: Injury Liaison Service

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.

06

What researchers measure

Primary outcomes

  1. Number of High-risk Residents According to the FRAiL Model

    Time frame: baseline

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

    Time frame: 4 months

  3. Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations

    Time frame: 4 months

  4. Number of Residents Who Accepted One or More Deprescribing Recommendations

    Time frame: 4 months

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

    Time frame: 4 months

  6. Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations

    Time frame: 4 months

  7. Number of Residents Who Accepted Osteoporosis Treatment Recommendations

    Time frame: 4 months

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

    Time frame: 6 months

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

    Time frame: 6 months

  10. Number of Staff Members Who Attended One or More ECHO Sessions

    Time frame: 6 months

Secondary outcomes

  1. Average Number of Deprescribing Recommendations That Were Made for Each Resident

    Time frame: 4 months

  2. 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

  3. Number of Injurious Falls

    Time frame: 4 months

07

Results

Posted Apr 27, 2023

Participant flow

Participant flow — Overall Study
MilestoneNursing Home Residents and Staff
Started140
Qualitative interview participants28
Nursing home residents46
Facility staff members66
Completed135
Not completed5
Withdrew: Death5

Outcome measures

PrimaryNumber of High-risk Residents According to the FRAiL Model
Time frame:
baseline
Reported as:
Count of participants · Participants
Number of High-risk Residents According to the FRAiL Model
ParticipantsNursing Home Residents
Number of High-risk Residents According to the FRAiL Model46
PrimaryNumber of High-risk Residents With One or More Deprescribing Recommendations
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of High-risk Residents With One or More Deprescribing Recommendations
ParticipantsNursing Home Residents
Number of High-risk Residents With One or More Deprescribing Recommendations36
PrimaryNumber of Residents Whose Provider Accepted One or More Deprescribing Recommendations
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
ParticipantsNursing Home Residents
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations21
PrimaryNumber of Residents Who Accepted One or More Deprescribing Recommendations
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Residents Who Accepted One or More Deprescribing Recommendations
ParticipantsNursing Home Residents
Number of Residents Who Accepted One or More Deprescribing Recommendations21
PrimaryNumber of High-risk Residents With a Recommendation for Osteoporosis Treatment
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
ParticipantsNursing Home Residents
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment20
PrimaryNumber of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
ParticipantsNursing Home Residents
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations10
PrimaryNumber of Residents Who Accepted Osteoporosis Treatment Recommendations
Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Residents Who Accepted Osteoporosis Treatment Recommendations
ParticipantsNursing Home Residents
Number of Residents Who Accepted Osteoporosis Treatment Recommendations10
PrimaryAttrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
Time frame:
6 months
Reported as:
Count of participants · Participants
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
ParticipantsNursing Home Residents
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death6
PrimaryProportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
Time frame:
6 months
Reported as:
Count of participants · Participants
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
ParticipantsNursing Home Staff
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey17
PrimaryNumber of Staff Members Who Attended One or More ECHO Sessions
Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Staff Members Who Attended One or More ECHO Sessions
ParticipantsNursing Home Staff
Number of Staff Members Who Attended One or More ECHO Sessions21
SecondaryAverage Number of Deprescribing Recommendations That Were Made for Each Resident
Time frame:
4 months
Reported as:
Mean · number of recommendations
Average Number of Deprescribing Recommendations That Were Made for Each Resident
number of recommendationsNursing Home Residents
Average Number of Deprescribing Recommendations That Were Made for Each Resident2.2 ± 1.3
SecondaryAverage 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
Reported as:
Mean · number of events
Average Number of Adverse Drug Events
number of eventsNursing Home Residents
Average Number of Adverse Drug Events0.05 ± 0.22
SecondaryNumber of Injurious Falls
Time frame:
4 months
Reported as:
Mean · number of injurious falls
Number of Injurious Falls
number of injurious fallsNursing Home Residents
Number of Injurious Falls0.07 ± 0.25

Adverse events

Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nursing Home Residents5/46 (10.9%)9/46 (19.6%)1/46 (2.2%)
Most frequent serious events
Most frequent serious events
EventNursing Home Residents
Advanced dementia resulting in deathNervous system disorders3/46
Urosepsis resulting in hospitalizationInfections and infestations2/46
Intraventricular hemorrhage following a fall and resulting in deathInfections and infestations1/46
Suspected cardiac event resulting in deathCardiac disorders1/46
Agitation and aggression resulting in hospitalizationNervous system disorders1/46
Acute colitis resulting in hospitalizationGastrointestinal disorders1/46
Most frequent other events
Most frequent other events
EventNursing Home Residents
Adverse drug withdrawal eventPsychiatric disorders1/46

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Nursing Home Residents and Staff
<=18 years0
Between 18 and 65 years94
>=65 years46
Age, Continuous
Age, Continuous(years)Nursing Home Residents and Staff
Median88 (81 to 92)
Sex: Female, Male
Sex: Female, Male(Participants)Nursing Home Residents and Staff
Female122
Male18
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Nursing Home Residents and Staff
Region of Enrollment
Region of Enrollment(participants)Nursing Home Residents and Staff
United States140
08

Study locations

2 sites
  • Hebrew SeniorLife
    Boston, Massachusetts 02131, United States
  • Duke University
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 14, 2022
  • Informed consent form · Nov 19, 2019
  • Informed consent form · Nov 19, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04242186
Lead sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA), Duke University, Brown University
Responsible party
Sarah Berry (Associate Professor in Medicine, Hebrew SeniorLife) — Principal investigator
First posted
Jan 27, 2020
Start date
Oct 30, 2019
Primary completion
May 20, 2022
Completion
May 20, 2022
Results posted
Apr 27, 2023
Last update
Apr 27, 2023

Study contacts

Sarah D Berry, MD, MPH
principal investigator · Hebrew Rehabilitation Center
Cathleen S Colón-Emeric, MD, MHS
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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