Loneliness and Health Outcomes in the High Need Population

NCT ID: NCT05484258

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-09-01

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.

Conditions

Anxiety; Loneliness; Depression; Alcohol Use Disorder; Utilization, Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Care

On baseline screen, would be screened for depression, alcohol use, and loneliness. Loneliness screen will be checked every 3 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Shared Medical Visit

Intervention Type: BEHAVIORAL

Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.

Interventions

Shared Medical Visit

Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Francis Balucan

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FRANCIS S BALUCAN

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

220958

Identifier Type: -

Identifier Source: org_study_id