Loneliness and Health Outcomes in the High Need Population

Not Applicable

Completed

• Conditions: Anxiety; Loneliness; Alcohol Use Disorder; Depression; Utilization, Health Care
• Interventions: Behavioral: Shared Medical Visit

• Registration Number: NCT05484258
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-02
• Study Start: 2022-08-15
• Primary Completion: 2023-06-30
• Status Verified: 2023-09
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Medical VIsits	Shared Medical Visit	For this arm, patients will have three visits of a shared medical visit, wherein a physician/APP will partner with a social worker to give a discussion about topics relevant to the high need population, including managing multiple medications, managing stress, and also palliative care.

Primary Outcome Measures

Name	Time	Method
Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.	0, 3, 6, and 9 months	Using the Validated De Jong Giervald Loneliness Scale, scored from 0 (not lonely) to 11 (severely lonely),

Secondary Outcome Measures

Name	Time	Method
Change in the number of ED visits, Inpatient, Observations	0, 3, 6 and 9 months	ED Visits and Hospital Utilization (Inpatient, Observation Admissions)
Change in Depression from Baseline (0), and at 3, 6, and 9 months	0, 3,6, and 9 months	Will be using PHQ 9 to evaluate depression in the population, 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months	0,3,6, and 9 months	he AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States