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Loneliness and Health Outcomes in the High Need Population

Primary Purpose

Anxiety, Loneliness, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Medical Visit
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring high need population, shared medical visits, social determinants of health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Group Medical VIsits

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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),

Secondary Outcome Measures

Change in the number of ED visits, Inpatient, Observations
ED Visits and Hospital Utilization (Inpatient, Observation Admissions)
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
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.

Full Information

First Posted
July 27, 2022
Last Updated
September 5, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05484258
Brief Title
Loneliness and Health Outcomes in the High Need Population
Official Title
Loneliness and Health Outcomes in the High Need Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Loneliness, Depression, Alcohol Use Disorder, Utilization, Health Care
Keywords
high need population, shared medical visits, social determinants of health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
On baseline screen, would be screened for depression, alcohol use, and loneliness. Loneliness screen will be checked every 3 months.
Arm Title
Group Medical VIsits
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shared Medical Visit
Intervention Description
Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.
Primary Outcome Measure Information:
Title
Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.
Description
Using the Validated De Jong Giervald Loneliness Scale, scored from 0 (not lonely) to 11 (severely lonely),
Time Frame
0, 3, 6, and 9 months
Secondary Outcome Measure Information:
Title
Change in the number of ED visits, Inpatient, Observations
Description
ED Visits and Hospital Utilization (Inpatient, Observation Admissions)
Time Frame
0, 3, 6 and 9 months
Title
Change in Depression from Baseline (0), and at 3, 6, and 9 months
Description
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
Time Frame
0, 3,6, and 9 months
Title
Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months
Description
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.
Time Frame
0,3,6, and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCIS S BALUCAN
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
July 2023 available for 1 year

Learn more about this trial

Loneliness and Health Outcomes in the High Need Population

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