Multimorbidity Clinical Trial
Official title:
Video-Enhanced Care Management for Medically Complex Veterans
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05421143 -
Co-design of a Seamless Person-centered Intervention to Optimize Medication Use Across Healthcare Levels
|
||
Completed |
NCT04942613 -
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
|
N/A | |
Completed |
NCT02928939 -
Therapeutic Conflicts and Multimorbidity
|
||
Recruiting |
NCT05560451 -
Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity
|
N/A | |
Completed |
NCT03697772 -
Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients
|
||
Recruiting |
NCT03439410 -
Clinical Complexity in Internal Medicine Wards. San MAtteo Complexity Study
|
||
Active, not recruiting |
NCT05985044 -
Living With Multimorbidity: CO-ORDINATE Program
|
N/A | |
Completed |
NCT02866799 -
Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
|
N/A | |
Recruiting |
NCT05406193 -
A New Care Model for Patients With Complicated Multimorbidity
|
N/A | |
Completed |
NCT02664454 -
Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care
|
N/A | |
Not yet recruiting |
NCT04391218 -
A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients
|
N/A | |
Completed |
NCT03126565 -
Evaluation of the Philips Lifeline CareSage Risk Assessment System
|
N/A | |
Recruiting |
NCT04856202 -
ACP in Older Patients With Multimorbidity: a Randomized Pilot
|
N/A | |
Completed |
NCT03912103 -
Interdisciplinary Medication Review Interventions in an Integrated Outpatient Department.
|
N/A | |
Completed |
NCT04955600 -
Digital Technology in the Home of Elderly Patients With Multimorbidity
|
||
Completed |
NCT05893212 -
Nature Walks or Exercise as a Group Activity, the Effect Well-being, Sleep and Activity.
|
N/A | |
Recruiting |
NCT06123546 -
Effectiveness of a Patient-oriented Discharge Summary
|
N/A | |
Completed |
NCT03528005 -
Effectiveness of Integrated Care Network
|
N/A | |
Completed |
NCT03088982 -
Preventing Decompensation Among Multimorbid Outpatients in Residential Care. A Cohort Study With a Six-month Follow-up.
|
N/A | |
Not yet recruiting |
NCT06458205 -
Impact of Multi-Component Interventions on High-Risk COPD Smokers
|
N/A |