Clinical trial NCT05484258: Loneliness and Health Outcomes in the High Need Population
Official title: Loneliness and Health Outcomes in the High Need Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Loneliness
Depression
Alcohol Use Disorder
Utilization, Health Care
Keywords: high need population
shared medical visits
social determinants of health
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The high need population are patients who have three or more chronic diseases and have a functional limitation in their ability to take care for themselves. Investigators aim to understand the effects of a support group intervention, with the use of group medical visits and understand longitudinal effects in emotional wellbeing and loneliness.

Detailed description: The high need population with functional limitations are patients who have three or more chronic diseases and have a functional limitation in their ability to care for themselves (such as bathing or dressing) or perform routine daily tasks. Two-thirds of the population is female, and three-quarters of them are white non-Hispanic and half of the population were described as low income. The High Need Population with functional limitations also utilizes the emergency department at twice the rate of adults with multiple chronic diseases and more than three times more likely to be hospitalized than adults of other populations.

Loneliness is seen as a significant independent risk factor for poor health behaviors, physical health problems and psychiatric conditions. Loneliness and isolation are becoming a more recognized entity that contributes to worsening depression.

Investigators aim to compare the of effects of a Social Worker and Physician/APP-led support group intervention on loneliness at 9 months, after up to 3 group visits.

Shared Medical Visits as a form of support Group increase clinician-patient contact time and provide patients with support and prevention of chronic conditions increasing patient empowerment.

Eligibility criteria: Inclusion Criteria:

Patients who are enrolled into the VIC program. These are patients that are 18 years old and above, and have either

* HCC Score 3.0 and above
* HCC 2.0 - 3.0 and 2 or more unplanned admissions in last 12 months
* HCC 0.24 - 0.35 + ESRD OR
* Charlson Score \>3, or LACE \>30

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.
timeFrame: 0, 3, 6, and 9 months
Secondary outcomes:
measure: Change in the number of ED visits, Inpatient, Observations
timeFrame: 0, 3, 6 and 9 months
measure: Change in Depression from Baseline (0), and at 3, 6, and 9 months
timeFrame: 0, 3,6, and 9 months
measure: Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months
timeFrame: 0,3,6, and 9 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: FRANCIS S BALUCAN
role: PRINCIPAL_INVESTIGATOR
References: