Nursing Home Prevention of Injury in Dementia (NH PRIDE)

Sponsor
Hebrew SeniorLife (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04242186
Collaborator
National Institute on Aging (NIA) (NIH), Duke University (Other), Brown University (Other)
180
2
1
29
90
3.1

Study Details

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:
  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.

Condition or Disease Intervention/Treatment Phase
  • Other: Injury Liaison Service
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Actual Study Start Date :
Oct 30, 2019
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Number of high-risk residents according to the FRAiL model [baseline]

  2. Number of high-risk residents with one or more deprescribing recommendations or with a recommendation for osteoporosis treatment [4 months]

  3. Number of residents whose provider accepted one or more medication recommendations [4 months]

  4. Number of residents who accepted one or more medication recommendation [4 months]

  5. Attrition of eligible residents from the NH facility due to transfer, discharge to community, or death [6 months]

  6. Proportion of staff members who indicated they were satisfied or very satisfied with the ILS on a post-intervention survey [6 months]

  7. Number of staff members who attended one or more ECHO sessions [6 months]

Secondary Outcome Measures

  1. Number of injurious falls [4 months]

  2. Number of adverse drug events [4 months]

    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

  3. Average number of medications that were deprescribed for each resident [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
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:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hebrew SeniorLife Boston Massachusetts United States 02131
2 Duke University Durham North Carolina United States 27710

Sponsors and Collaborators

  • Hebrew SeniorLife
  • National Institute on Aging (NIA)
  • Duke University
  • Brown University

Investigators

  • Principal Investigator: Sarah D Berry, MD, MPH, Hebrew Rehabilitation Center
  • Principal Investigator: Cathleen S Colón-Emeric, MD, MHS, Duke University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sarah Berry, Associate Professor in Medicine, Hebrew SeniorLife
ClinicalTrials.gov Identifier:
NCT04242186
Other Study ID Numbers:
  • IRB-2019-21
  • 1R01AG062492-01
First Posted:
Jan 27, 2020
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Berry, Associate Professor in Medicine, Hebrew SeniorLife
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021