Accidental Falls/Prevention and ControlNH PRIDENCT04242186
Nursing Home Prevention of Injury in Dementia (NH PRIDE)
A study testing Injury Liaison Service in people with Accidental Falls/Prevention and Control, run by Hebrew SeniorLife at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls/Prevention and Control
- What is being tested?
- Injury Liaison Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2019to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Facility inclusion criteria:
- More than 80 long-stay beds
- Within 30 miles of Boston, Massachusetts or Durham, North Carolina
- Resident inclusion criteria:
- Age ≥ 60 years
- NH length of stay ≥ 30 days
Show all 19Show fewer
- 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:
- Worked in the facility for ≥ 90 days
- Can communicate in English (in order to participate in interviews and questionnaires),
- 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:
- Affiliated resident has lived in the facility for ≥ 30 days
- Can communicate in English
- Over 21 years of age
- Able to provide informed consent to participate in the interviews
Who cannot join
- Facility exclusion criteria:
- Population not primarily English speaking
- Evidence of institutional instability at time of recruitment
- Provider exclusion criteria:
- Does not provide routine care to NH residents (e.g., visiting hospice provider)
- Does not speak English
Show all 17Show fewer
- Is less than 21 years old
- Resident exclusion criteria:
- Advanced dementia as defined by Cognitive Performance Scale (CPS) = 6
- Life expectancy < 6 months, as indicated by Minimum Data Set (MDS) assessment
- Living in nursing home for less than 30 days
- 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:
- Affiliated resident has lived in the facility for < 30 days
- Cannot communicate in English
- Less than 21 years of age
- Unable to provide informed consent to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hebrew SeniorLife
Boston, Massachusetts, 02131
Duke University
Durham, North Carolina, 27710
About this study
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:
Read more
- Automated identification of NH residents at high risk for falls with injury
- Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications
- Video telehealth sessions to educate staff
- 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.
- Conditions
- Accidental Falls/Prevention and Control
- Being tested
- Injury Liaison Service
- Keywords
- Nursing Homes, Elderly, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury Liaison ServiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nursing home residents and staff | Experimental | Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities Receives: Other: Injury Liaison Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of High-risk Residents According to the FRAiL Model
Measured: baseline
Number of High-risk Residents With One or More Deprescribing Recommendations
Measured: 4 months
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
Measured: 4 months
Number of Residents Who Accepted One or More Deprescribing Recommendations
Measured: 4 months
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
Measured: 4 months
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
Measured: 4 months
Number of Residents Who Accepted Osteoporosis Treatment Recommendations
Measured: 4 months
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
Measured: 6 months
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
Measured: 6 months
Number of Staff Members Who Attended One or More ECHO Sessions
Measured: 6 months
Secondary outcomes (3)
Average Number of Deprescribing Recommendations That Were Made for Each Resident
Measured: 4 months
Average Number of Adverse Drug Events
- Escalating behaviors, worsening depression, or functional decline following psychoactive medication deprescribing
- Unplanned medical visits for hypertension, tachycardia, or hyperglycemia following cardiometabolic deprescribing
- 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).
Measured: 4 months
Number of Injurious Falls
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start30 Oct 2019
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental Falls/Prevention and ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Duke University, Brown University
- Responsible party
- Principal investigator, Sarah Berry, Hebrew SeniorLife
- Investigators
- Sarah D Berry, MD, MPH, Principal investigator, Hebrew Rehabilitation CenterCathleen S Colón-Emeric, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242186
- Sponsor's protocol ID
- IRB-2019-21
- Other IDs
- 1R01AG062492-01
- Acronym
- NH PRIDE
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2020
- Last updated
- 27 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Little MO, Hecker EJ, Colon-Emeric CS, Herndon L, McConnell ES, Xue TM, Berry SD. Perspectives on Deprescribing in long-term care: qualitative findings from nurses, aides, residents, and proxies. BMC Nurs. 2023 Jan 31;22(1):27. doi: 10.1186/s12912-023-01179-y.
PubMed 36721150
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Home Prevention of Injury in Dementia (NH PRIDE)
- ClinicalTrials.gov ID
- NCT04242186
- Acronym / sponsor ID
- NH PRIDE / IRB-2019-21
- Conditions
- Accidental Falls/Prevention and Control
- Keywords
- Nursing Homes, Elderly, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Duke University, Brown University
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 27 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Automated identification of NH residents at high risk for falls with injury
- Recommendations by the ILS nurse to manage medications, including deprescribing medications associated with falls and a prescription for osteoporosis medications
- Video telehealth sessions to educate staff
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing home residents and staff | Experimental | Other: Injury Liaison ServiceNursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- More than 80 long-stay beds
- Within 30 miles of Boston, Massachusetts or Durham, North Carolina
- Age ≥ 60 years
- NH length of stay ≥ 30 days
- Estimated 2-year risk of hip fracture ≥ 6% using FRAiL model
Key exclusion criteria (17 listed)
- Population not primarily English speaking
- Evidence of institutional instability at time of recruitment
- Does not provide routine care to NH residents (e.g., visiting hospice provider)
- Does not speak English
- Is less than 21 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injury Liaison ServiceThe 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. | Other | Nursing home residents and staff |
Primary outcome
Number of High-risk Residents According to the FRAiL Model
Time frame: baseline
Number of High-risk Residents With One or More Deprescribing Recommendations
Time frame: 4 months
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
Time frame: 4 months
Number of Residents Who Accepted One or More Deprescribing Recommendations
Time frame: 4 months
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
Time frame: 4 months
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
Time frame: 4 months
Number of Residents Who Accepted Osteoporosis Treatment Recommendations
Time frame: 4 months
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
Time frame: 6 months
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
Time frame: 6 months
Number of Staff Members Who Attended One or More ECHO Sessions
Time frame: 6 months
3 secondary outcomes
Average Number of Deprescribing Recommendations That Were Made for Each Resident
Time frame: 4 months
Average Number of Adverse Drug Events
Time frame: 4 months
Number of Injurious Falls
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36721150Little MO, Hecker EJ, Colon-Emeric CS, Herndon L, McConnell ES, Xue TM, Berry SD. Perspectives on Deprescribing in long-term care: qualitative findings from nurses, aides, residents, and proxies. BMC Nurs. 2023 Jan 31;22(1):27. doi: 10.1186/s12912-023-01179-y.
- The Fracture Risk Assessment in Long term care (FRAiL) modelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah D Berry, MD, MPH principal investigator
Hebrew Rehabilitation Center
Cathleen S Colón-Emeric, MD, MHS principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injury Liaison Service in people with Accidental Falls/Prevention and Control, run by Hebrew SeniorLife at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of High-risk Residents According to the FRAiL Model (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.