Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242186
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Duke University
Brown University
Information provided by (Responsible Party):
Sarah Berry, Hebrew Rehabilitation Center, Boston

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
Accidental Falls/Prevention and Control Other: Injury Liaison Service Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 30, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 or with a recommendation for osteoporosis treatment [ Time Frame: 4 months ]
  3. Number of residents whose provider accepted one or more medication recommendations [ Time Frame: 4 months ]
  4. Number of residents who accepted one or more medication recommendation [ Time Frame: 4 months ]
  5. Attrition of eligible residents from the NH facility due to transfer, discharge to community, or death [ Time Frame: 6 months ]
  6. Proportion of staff members who indicated they were satisfied or very satisfied with the ILS on a post-intervention survey [ Time Frame: 6 months ]
  7. Number of staff members who attended one or more ECHO sessions [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of injurious falls [ Time Frame: 4 months ]
  2. Number of adverse drug events [ Time Frame: 4 months ]
    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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Facility inclusion criteria:

  1. More than 80 long-stay beds
  2. Within 30 miles of Boston or Durham, NC

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242186


Locations
Layout table for location information
United States, Massachusetts
Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
National Institute on Aging (NIA)
Duke University
Brown University
Investigators
Layout table for investigator information
Principal Investigator: Sarah D Berry, MD, MPH Hebrew Rehabilitation Center
Principal Investigator: Cathleen S Colón-Emeric, MD, MHS Duke University
Additional Information:
Layout table for additonal information
Responsible Party: Sarah Berry, Associate Professor in Medicine, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT04242186    
Other Study ID Numbers: IRB-2019-21
1R01AG062492-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Berry, Hebrew Rehabilitation Center, Boston:
Nursing Homes
Elderly
Dementia
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders