Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
NCT Number: NCT02962687
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
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.
Assess the usability and perceived value of video-enhanced care management, compared to telephone-based, among older Veterans with medical complexity and CI.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 14 weeks
Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.
Time frame: 14 weeks
Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.
Time frame: 14 weeks
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
Descriptive analysis of emergency department visits and hospitalizations in the two study arms
Time frame: 14 weeks
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
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
Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)
Time frame: 14 weeks
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
Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)
VA Office of Research and Development
Fed
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