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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG062492-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Duke University | OTHER |
| Brown University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nursing home residents and staff | Experimental | Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injury Liaison Service | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of High-risk Residents According to the FRAiL Model | baseline | |
| Number of High-risk Residents With One or More Deprescribing Recommendations | 4 months | |
| Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations | 4 months | |
| Number of Residents Who Accepted One or More Deprescribing Recommendations | 4 months | |
| Number of High-risk Residents With a Recommendation for Osteoporosis Treatment | 4 months | |
| Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations | 4 months | |
| Number of Residents Who Accepted Osteoporosis Treatment Recommendations | 4 months | |
| Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death | 6 months | |
| Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey | 6 months | |
| Number of Staff Members Who Attended One or More ECHO Sessions | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Deprescribing Recommendations That Were Made for Each Resident | 4 months | |
| Average Number of Adverse Drug Events |
Adverse drug events were analyzed in residents who had one or more medications deprescribed (n=21). |
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Inclusion Criteria:
Facility inclusion criteria:
Resident inclusion criteria:
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:
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:
Exclusion Criteria:
Facility exclusion criteria:
Provider exclusion criteria:
Resident exclusion criteria:
Proxy/resident exclusion criteria for interviews:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah D Berry, MD, MPH | Hebrew Rehabilitation Center | Principal Investigator |
| Cathleen S Colón-Emeric, MD, MHS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew SeniorLife | Boston | Massachusetts | 02131 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36721150 | Derived | 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. |
| Label | URL |
|---|---|
| The Fracture Risk Assessment in Long term care (FRAiL) model | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of High-risk Residents According to the FRAiL Model | Posted | Count of Participants | Participants | baseline |
|
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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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nursing Home Residents | Adverse events were monitored in nursing home residents at high risk for injurious falls (n=46) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraventricular hemorrhage following a fall and resulting in death | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug withdrawal event | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Berry, MD, MPH | Hebrew SeniorLife | 617-971-5355 | sarahberry@hsl.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2022 | Sep 30, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Proxy ICF | Nov 19, 2019 | Sep 30, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Provider ICF | Nov 19, 2019 | Sep 30, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 4 months |
| Number of Injurious Falls | 4 months |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Participants |
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| Age, Continuous | Continuous age data are included only for nursing home residents. Continuous age data were not collected from interview participants and staff members. | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Number of High-risk Residents With One or More Deprescribing Recommendations | Posted | Count of Participants | Participants | 4 months |
|
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| Primary | Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations | 36 participants had one or more deprescribing recommendations | Posted | Count of Participants | Participants | 4 months |
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| Primary | Number of Residents Who Accepted One or More Deprescribing Recommendations | 21 residents had deprescribing recommendations accepted by their provider | Posted | Count of Participants | Participants | 4 months |
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| Primary | Number of High-risk Residents With a Recommendation for Osteoporosis Treatment | Posted | Count of Participants | Participants | 4 months |
|
|
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| Primary | Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations | 20 participants had a recommendation for osteoporosis treatment | Posted | Count of Participants | Participants | 4 months |
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| Primary | Number of Residents Who Accepted Osteoporosis Treatment Recommendations | 10 residents had osteoporosis treatment recommendations accepted by their provider | Posted | Count of Participants | Participants | 4 months |
|
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| Primary | Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death | Posted | Count of Participants | Participants | 6 months |
|
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| Primary | Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey | Posted | Count of Participants | Participants | 6 months |
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| Primary | Number of Staff Members Who Attended One or More ECHO Sessions | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Average Number of Deprescribing Recommendations That Were Made for Each Resident | Posted | Mean | Standard Deviation | number of recommendations | 4 months |
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| Secondary | Average Number of Adverse Drug Events |
Adverse drug events were analyzed in residents who had one or more medications deprescribed (n=21). | Adverse drug events were analyzed in residents who had one or more medications deprescribed (n=21). | Posted | Mean | Standard Deviation | number of events | 4 months |
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| Secondary | Number of Injurious Falls | Posted | Mean | Standard Deviation | number of injurious falls | 4 months |
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| 5 |
| 46 |
| 9 |
| 46 |
| 1 |
| 46 |
| Advanced dementia resulting in death | Nervous system disorders | Systematic Assessment |
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| Suspected cardiac event resulting in death | Cardiac disorders | Systematic Assessment |
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| Urosepsis resulting in hospitalization | Infections and infestations | Systematic Assessment |
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| Agitation and aggression resulting in hospitalization | Nervous system disorders | Systematic Assessment |
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| Acute colitis resulting in hospitalization | Gastrointestinal disorders | Systematic Assessment |
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| D001523 | Mental Disorders |