Loneliness and Health Outcomes in the High Need Population

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Loneliness; Alcohol Use Disorder; Utilization, Health Care
• Intervention / Treatment: Behavioral: Shared Medical Visit

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FRANCIS S BALUCAN; Phone Number: 6505807643; Email: francis.g.balucan@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; On baseline screen, would be screened for depression, alcohol use, and loneliness. Loneliness screen will be checked every 3 months.
Active Comparator: Group Medical VIsits; 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.	Behavioral: Shared Medical Visit; Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of ED visits, Inpatient, Observations	ED Visits and Hospital Utilization (Inpatient, Observation Admissions)	0, 3, 6 and 9 months
Change in Depression from Baseline (0), and at 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	0, 3,6, and 9 months
Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 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.	0,3,6, and 9 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: FRANCIS S BALUCAN, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: social determinants of health; high need population; shared medical visits
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 220958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: July 2023 available for 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No