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Nursing Home Prevention of Injury in Dementia (NH PRIDE) (NH PRIDE)

Primary Purpose

Accidental Falls/Prevention and Control

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injury Liaison Service
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Accidental Falls/Prevention and Control focused on measuring Nursing Homes, Elderly, Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Hebrew SeniorLife
  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nursing home residents and staff

Arm Description

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

Outcomes

Primary Outcome Measures

Number of High-risk Residents According to the FRAiL Model
Number of High-risk Residents With One or More Deprescribing Recommendations
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
Number of Residents Who Accepted One or More Deprescribing Recommendations
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
Number of Residents Who Accepted Osteoporosis Treatment Recommendations
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
Number of Staff Members Who Attended One or More ECHO Sessions

Secondary Outcome Measures

Average Number of Deprescribing Recommendations That Were Made for Each Resident
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).
Number of Injurious Falls

Full Information

First Posted
January 23, 2020
Last Updated
April 5, 2023
Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA), Duke University, Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04242186
Brief Title
Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Acronym
NH PRIDE
Official Title
Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA), Duke University, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls/Prevention and Control
Keywords
Nursing Homes, Elderly, Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nursing home residents and staff
Arm Type
Experimental
Arm Description
Nursing home residents at high risk for injurious falls, as well as nursing home staff at participating facilities
Intervention Type
Other
Intervention Name(s)
Injury Liaison Service
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of High-risk Residents According to the FRAiL Model
Time Frame
baseline
Title
Number of High-risk Residents With One or More Deprescribing Recommendations
Time Frame
4 months
Title
Number of Residents Whose Provider Accepted One or More Deprescribing Recommendations
Time Frame
4 months
Title
Number of Residents Who Accepted One or More Deprescribing Recommendations
Time Frame
4 months
Title
Number of High-risk Residents With a Recommendation for Osteoporosis Treatment
Time Frame
4 months
Title
Number of Residents Whose Provider Accepted Osteoporosis Treatment Recommendations
Time Frame
4 months
Title
Number of Residents Who Accepted Osteoporosis Treatment Recommendations
Time Frame
4 months
Title
Attrition of Eligible Residents From the NH Facility Due to Transfer, Discharge to Community, or Death
Time Frame
6 months
Title
Proportion of Staff Members Who Indicated They Were Satisfied or Very Satisfied With the ILS on a Post-intervention Survey
Time Frame
6 months
Title
Number of Staff Members Who Attended One or More ECHO Sessions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Average Number of Deprescribing Recommendations That Were Made for Each Resident
Time Frame
4 months
Title
Average Number of Adverse Drug Events
Description
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).
Time Frame
4 months
Title
Number of Injurious Falls
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah D Berry, MD, MPH
Organizational Affiliation
Hebrew Rehabilitation Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathleen S Colón-Emeric, MD, MHS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://ifar-frail.hsl.harvard.edu/web/evaluation
Description
The Fracture Risk Assessment in Long term care (FRAiL) model

Learn more about this trial

Nursing Home Prevention of Injury in Dementia (NH PRIDE)

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