Clinical trial NCT02962687: Video-Enhanced Care Management for Medically Complex Veterans
Official title: Video-Enhanced Care Management for Medically Complex Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Cognitive Impairments
Keywords: Veterans
Cognitive impairments
Nursing care management
Videoconferencing
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-11
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat
timeFrame: 14 weeks
measure: Number of Scheduled Intervention Phone or Video Calls Completed by Participants
timeFrame: 14 weeks
measure: Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Hospitalizations or Emergency Department Visits
timeFrame: 14 weeks
measure: Physical Activity
timeFrame: 14 weeks
measure: Quality of Life Outcome
timeFrame: 14 weeks
measure: Depression
timeFrame: 14 weeks
measure: Social Support
timeFrame: 14 weeks
measure: Anxiety
timeFrame: 14 weeks
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD
role: PRINCIPAL_INVESTIGATOR
References: