Video-Enhanced Care Management for Medically Complex Veterans
Primary Purpose
Multimorbidity, Cognitive Impairments
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care management via videoconference
Care management via telephone calls
Sponsored by

About this trial
This is an interventional health services research trial for Multimorbidity focused on measuring Veterans, Cognitive impairments, Nursing care management, Videoconferencing
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Unable to communicate on the telephone, or no telephone access for duration of study
- Currently hospitalized or incapacitated
- Enrolled in a study that prohibits participation in another study
Sites / Locations
- Durham VA Medical Center, Durham, NC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Videoconference care management
Telephone care management
Arm Description
12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02962687
First Posted
October 25, 2016
Last Updated
September 12, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02962687
Brief Title
Video-Enhanced Care Management for Medically Complex Veterans
Official Title
Video-Enhanced Care Management for Medically Complex Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
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
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.
Detailed Description
BACKGROUND Older adults with complex care needs constitute a large and rapidly expanding group of Veterans receiving care within Veterans Health Administration (VHA). Medically complex older Veterans, who often have multiple chronic conditions (MCC) as well as interacting functional and psychosocial challenges, account for a disproportionate amount of health care resources. Importantly, these Veterans also experience a disproportionate amount of suffering; they have worse functional status, higher symptom burden, and spend more of their time in acute care settings such as the hospital and emergency department.
The investigators' experience and recent studies suggest that a substantial proportion of older medically complex Veterans have unrecognized cognitive impairment (CI), and this contributes to their disproportionate need for care and adverse outcomes. The Cumulative Complexity model posits that complexity results from accumulating and interacting clinical and social factors that each contribute to a patient's workload (e.g. making appointments and managing complicated medicine regimens) as well as impact a patient's capacity to perform everyday tasks including those related to health care. Imbalance between the two- i.e. workload that exceeds capacity-is a primary driver of disruptions in care and negative outcomes. Older patients with MCC, high health care utilization, and CI often find themselves in the perfect storm of complexity, simultaneously experiencing escalated workload demands in the setting of reduced capacity.
OBJECTIVES
The primary objectives of this pilot study are to:
Examine the feasibility and acceptability of a 12-week care management program for medically complex Veterans with CI, delivered via telephone or through video visits.
Feasibility will be examined by calculating overall rates of eligibility and enrollment, as well as rates of attrition, adherence to nurse calls or video visits, and interview completion.
Acceptability will be assessed using in-depth interviews with study participants (Veterans and Care Partners), primary care providers, and study staff.
Assess the usability and perceived value of video-enhanced care management, compared to telephone-based, among older Veterans with medical complexity and CI.
Usability of the video-enhanced program will be examined using the System Usability Scale (SUS).
Perceived value associated with each delivery method will be explored through questionnaires and in-depth interviews with study participants and study staff.
METHODS Veterans aged 65 or older with high medical complexity based on Care Assessment Need (CAN) score will be screened for CI using a reliable and valid instrument developed for use over the telephone. Veterans with CI, and a self-identified Care Partner, will participate in a nurse-led care management program designed to provide structured cognitively-appropriate information and support in two key areas: (1) care coordination (reduce workload) and (2) protecting cognitive health (build capacity). Evidence-based strategies to improve care coordination and promote cognitive health are enhanced by video visits that allow for improved communication between the nurse and Veteran/Care Partner, and facilitate expanded assessments of the Veteran and his/her home environment. Study measures will include the SUS, participant feedback, and measures of intervention effectiveness including health and physical function (PROMIS 29), physical activity levels (PASE), depression (PHQ-9), anxiety (GAD-7), and acute care days (hospital and ER).
ANTICIPATED IMPACT Results from this preliminary study will be used to inform the development of a randomized clinical trial to evaluate the impact of a 12-month video-enhanced care management program for medically complex older adults with CI. Given the large number of medically complex Veterans affected by unrecognized CI, it is essential that interventions targeting this population be scalable, and technology-enhanced interventions offer a way to expand the reach of new care models. Proactive recognition and management of medically complex patients is a high priority for VHA, and medically complex Veterans with CI constitute one such high risk group. The results of this study will be of high relevance to VHA, and outside VA, given the urgent need to develop innovative means of improving care for medically complex older adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multimorbidity, Cognitive Impairments
Keywords
Veterans, Cognitive impairments, Nursing care management, Videoconferencing
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videoconference care management
Arm Type
Experimental
Arm Description
12-week nurse care management for medically complex Veterans with CI delivered via videoconferencing
Arm Title
Telephone care management
Arm Type
Active Comparator
Arm Description
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Intervention Type
Behavioral
Intervention Name(s)
Care management via videoconference
Intervention Description
12-week nurse care management for medically complex Veterans with CI delivered via videoconference
Intervention Type
Behavioral
Intervention Name(s)
Care management via telephone calls
Intervention Description
12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
Primary Outcome Measure Information:
Title
Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat
Description
Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
Time Frame
14 weeks
Title
Number of Scheduled Intervention Phone or Video Calls Completed by Participants
Description
Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.
Time Frame
14 weeks
Title
Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI
Description
Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).
Time Frame
14 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Hospitalizations or Emergency Department Visits
Description
Descriptive analysis of emergency department visits and hospitalizations in the two study arms
Time Frame
14 weeks
Title
Physical Activity
Description
Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)
Time Frame
14 weeks
Title
Quality of Life Outcome
Description
Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)
Time Frame
14 weeks
Title
Depression
Description
Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
Time Frame
14 weeks
Title
Social Support
Description
Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)
Time Frame
14 weeks
Title
Anxiety
Description
Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Unable to communicate on the telephone, or no telephone access for duration of study
Currently hospitalized or incapacitated
Enrolled in a study that prohibits participation in another study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan N. Hastings, MD
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
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.
Learn more about this trial
Video-Enhanced Care Management for Medically Complex Veterans
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