Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02962687
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date May 31, 2017
Completion date February 28, 2018

See also
  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
Recruiting 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
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
Completed NCT04326062 - Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study N/A
Completed NCT02816177 - Telemedicine and Nursing Home N/A