Multimorbidity Clinical Trial
Official title:
Video-Enhanced Care Management for Medically Complex Veterans
Verified date | September 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 12, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Hospitalizations or Emergency Department Visits | Descriptive analysis of emergency department visits and hospitalizations in the two study arms | 14 weeks | |
Other | Physical Activity | Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better) | 14 weeks | |
Other | Quality of Life Outcome | 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) | 14 weeks | |
Other | Depression | Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better) | 14 weeks | |
Other | Social Support | Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better) | 14 weeks | |
Other | Anxiety | Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better) | 14 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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