Video-Enhanced Care Management for Medically Complex Veterans
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with cognitive impairment, delivered via telephone or videoconferencing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedResults Posted
Study results publicly available
September 13, 2019
CompletedSeptember 13, 2019
September 1, 2019
9 months
October 25, 2016
February 15, 2019
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat
Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
14 weeks
Number of Scheduled Intervention Phone or Video Calls Completed by Participants
Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.
14 weeks
Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI
Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).
14 weeks
Other Outcomes (6)
Number of Participants With Hospitalizations or Emergency Department Visits
14 weeks
Physical Activity
14 weeks
Quality of Life Outcome
14 weeks
- +3 more other outcomes
Study Arms (2)
Videoconference care management
EXPERIMENTAL12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing
Telephone care management
ACTIVE COMPARATOR12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Interventions
12-week nurse care management for medically complex Veterans with CI delivered via videoconference
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Eligibility Criteria
You may qualify if:
- Receive primary care from a Durham Veterans Affairs Medical Center (VAMC) affiliated primary care clinic (1 visit within the previous 12 months)
- Age \> or = 65
- CAN score \> or = 90
- Valid telephone number in the medical record
- Identifies a friend or family member that we may contact for study participation as the Care Partner
- Telephone Instrument for Cognitive Status - modified (TICS-m) score 20-31
You may not qualify if:
- Cognitive impairment or dementia (identified via ICD diagnosis codes or Primary Care Provider note in previous 2 years)
- Enrolled in or have an active consult for a special population Patient Aligned Care Teams (PACT), e.g.:
- GeriPACT
- Home Based Primary Care
- Mental Health
- Post-Deployment, etc.
- Serious mental illness defined as diagnosis of psychosis of any type:
- schizophrenia
- bipolar disorder
- psychiatric hospitalization in the previous year
- or current high-risk suicide flag in their Computerized Patient Record System (CPRS) medical record
- Active substance abuse, documented in the medical record within the previous year
- Eligible for hospice, palliative care, or prognosis of less than 6 months to live
- Lacks decision-making capacity, documented in the medical record
- Referred to institutional care or residing in nursing home
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Perceived value associated with each delivery method was removed as an outcome on 2/13/19 because data are being analyzed as qualitative data; there are no quant data to report.
Results Point of Contact
- Title
- Susan N Hastings
- Organization
- Durham VA HSR&D
Study Officials
- PRINCIPAL INVESTIGATOR
Susan N. Hastings, MD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
November 11, 2016
Study Start
May 31, 2017
Primary Completion
February 12, 2018
Study Completion
February 28, 2018
Last Updated
September 13, 2019
Results First Posted
September 13, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
A de-identified, anonymized dataset will be available upon request. 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. The study statistician will create de-identified, publication-specific datasets that includes all variables presented in the study publication. 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.