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Optimizing Function and Independence Through iHI-FIVES

Primary Purpose

Functional Impairment, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iHI-FIVES
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Functional Impairment focused on measuring Caregiver, Veterans, Skills training, Informal care, Days at home

Eligibility Criteria

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

Inclusion Criteria:

Inclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services:

  • Homemaker home health aide services
  • Home based primary care
  • Adult day health care
  • Respite care
  • Veteran directed care

Inclusion here apply to subset of caregivers providing consent for telephone interviews:

  • Able and willing to provide informed consent

Exclusion Criteria:

Exclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services:

  • Hospice care

Exclusion here apply to subset of caregivers providing consent for telephone interviews:

  • Difficulty with or unable to communicate on the telephone, or no telephone access
  • Caregiver is a professional without pre-existing personal relationship with Veteran patient and receives payment for caregiving services (e.g. formal care provider)
  • Their care recipient (the Veteran) is currently in hospital or institution
  • Their care recipient (the Veteran) is currently receiving hospice care
  • Caregiver is a member of the Durham HSR&D Veteran and Family Input Initiative (VAFII), where members have advised and provided input towards the development of iHI-FIVES intervention materials

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES

Pre-implementation before iHI-FIVES program

Outcomes

Primary Outcome Measures

Patient number of days in the community
Count of number of days in the community (e.g. days not in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report)

Secondary Outcome Measures

Caregiver satisfaction with Veteran's VA care
Analysis of satisfaction with care will be measured by the 1-item CAHPS global satisfaction measure
Caregiver satisfaction with Veteran's VA care
Analysis of satisfaction with care will be measured by the 1-item CAHPS global satisfaction measure
Caregiver subjective burden
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument
Caregiver subjective burden
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument
Caregiver depressive symptoms
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression.
Caregiver depressive symptoms
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression.

Full Information

First Posted
February 15, 2018
Last Updated
April 27, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03474380
Brief Title
Optimizing Function and Independence Through iHI-FIVES
Official Title
Optimizing Function and Independence Through iHI-FIVES (QUE 16-170)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Optimizing Function and Independence Through iHI-FIVES aims to implement the iHI-FIVES caregiver skills training program at 8 VAMC sites in a stepped- wedge design and evaluate caregiver and patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.
Detailed Description
Background/Purpose. Although the VHA has the most extensive system of home and community-based services, most Veterans who need care in their home receive it exclusively through family and friends. For Veterans living with cognitive and/or functional limitations, even though family or friend caregivers help avoid or delay nursing home entry, caregivers are faced with a greater risk of depression and burnout. These caregivers often lack training and support needed to perform high-quality caregiving duties, and critical gaps remain in VA-system wide approaches to addressing caregiver skills training and support. iHI-FIVES is an evidence-based skills training program for family or friend caregivers of Veterans referred to home care services. iHI-FIVES is adapted from a randomized control trial (HI-FIVES) funded by the VHA Office of Research and Development and conducted at the Durham VAMC with evaluation results shown to increase satisfaction with VHA care and reduce caregiver feelings of isolation. The iHI-FIVES curriculum that will be delivered by clinical staff consists of four in-person group classes that address caregiver clinical, psychological, and support-seeking skills. iHI-FIVES is part of the investigators' Optimizing Function and Independence QUERI (the other sub-project is STRIDE QUX-16-015). For the iHI-FIVES sub-project, the investigators plan to implement the iHI-FIVES caregiver skills training program (hereafter called "clinical program") at 8 VAMC sites in a stepped-wedge design with sites randomized to implementation strategy and start date. Objectives. The investigators plan to conduct an evaluation to examine the impact of iHI-FIVES on patient independence and caregiver functioning. Key questions: Do patients have higher number of days in the community following iHI-FIVES implementation? Do caregivers have higher satisfaction with VA care, lower depressive symptoms and lower subjective burden following IHI-FIVES implementation? What is the value of iHI-FIVES from the caregiver's perspective? The investigators also plan to conduct a mixed method evaluation that examines implementation outcomes and provider team experience that will not be reported here. Methodology. For patients referred to home care services, the investigators will compare the number of days in the community before and after the iHI-FIVES program is implemented (approx. n=400). In addition, the investigators will compare a subset of caregivers of Veterans referred to home care services before and after the iHI-FIVES program is implemented to assess satisfaction with VA care, depressive symptoms, and subjective burden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Impairment, Cognitive Impairment
Keywords
Caregiver, Veterans, Skills training, Informal care, Days at home

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Stepped Wedge Cluster Randomized Trial (where clusters are VAMC sites) - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each VAMC site undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of VAMC sites that will start the intervention at each period are determined by random allocation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Pre-implementation before iHI-FIVES program
Intervention Type
Behavioral
Intervention Name(s)
iHI-FIVES
Intervention Description
Implementation of iHI-FIVES caregiver skills training
Primary Outcome Measure Information:
Title
Patient number of days in the community
Description
Count of number of days in the community (e.g. days not in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report)
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Caregiver satisfaction with Veteran's VA care
Description
Analysis of satisfaction with care will be measured by the 1-item CAHPS global satisfaction measure
Time Frame
Baseline
Title
Caregiver satisfaction with Veteran's VA care
Description
Analysis of satisfaction with care will be measured by the 1-item CAHPS global satisfaction measure
Time Frame
3-month follow up
Title
Caregiver subjective burden
Description
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument
Time Frame
Baseline
Title
Caregiver subjective burden
Description
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument
Time Frame
3-month follow up
Title
Caregiver depressive symptoms
Description
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression.
Time Frame
Baseline
Title
Caregiver depressive symptoms
Description
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression.
Time Frame
3-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services: Homemaker home health aide services Home based primary care Adult day health care Respite care Veteran directed care Inclusion here apply to subset of caregivers providing consent for telephone interviews: Able and willing to provide informed consent Exclusion Criteria: Exclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services: Hospice care Exclusion here apply to subset of caregivers providing consent for telephone interviews: Difficulty with or unable to communicate on the telephone, or no telephone access Caregiver is a professional without pre-existing personal relationship with Veteran patient and receives payment for caregiving services (e.g. formal care provider) Their care recipient (the Veteran) is currently in hospital or institution Their care recipient (the Veteran) is currently receiving hospice care Caregiver is a member of the Durham HSR&D Veteran and Family Input Initiative (VAFII), where members have advised and provided input towards the development of iHI-FIVES intervention materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan N. Hastings, MD MHSc
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Courtney H Van Houtven, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginia Wang, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Requests can be made for a de-identified, anonymized dataset. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.
IPD Sharing Time Frame
Available upon request.
IPD Sharing Access Criteria
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
Citations:
PubMed Identifier
35849430
Citation
Ma JE, Grubber J, Coffman CJ, Wang V, Hastings SN, Allen KD, Shepherd-Banigan M, Decosimo K, Dadolf J, Sullivan C, Sperber NR, Van Houtven CH. Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis. JMIR Form Res. 2022 Jul 18;6(7):e35623. doi: 10.2196/35623.
Results Reference
derived
PubMed Identifier
33952263
Citation
Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.
Results Reference
derived
PubMed Identifier
29678137
Citation
Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3.
Results Reference
derived
Links:
URL
https://www.durham.hsrd.research.va.gov/Function_Independence_QUERI.asp
Description
Function QUERI program website

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Optimizing Function and Independence Through iHI-FIVES

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