NCT05807750

Brief Summary

Unplanned 30-day hospital readmissions are an critical healthcare quality metric, with meaningful effects on patients and health systems operations. Interventions to reduce unplanned readmissions have primarily operated within a healthcare-centric frame, with enhancements to either pre- or post-discharge care planning, medication reconciliation, or visit frequency. Associations of 30-day readmission rates with poverty status and other social factors, however, suggest that attending to unmet social needs may yield added benefits to models focused on healthcare delivery. The purpose of the present trial is to provide evidence regarding the effects on 30-day readmissions of providing a one-time post-discharge income supplement to socially vulnerable older adults with medical complexity participating in an enhanced care coordination program.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

March 23, 2023

Last Update Submit

May 31, 2024

Conditions

Keywords

Patient ReadmissionIncome

Outcome Measures

Primary Outcomes (1)

  • Unplanned 30-day readmission

    Whether a participant has an unplanned readmission within 30 days of the index hospital discharge

    Within 30 days of the index hospital discharge

Secondary Outcomes (5)

  • 30-day post-discharge medical expenditures

    Within 30 days of the index hospital discharge

  • 90-day post-discharge medical expenditures

    Within 90 days of the index hospital discharge

  • 30-day post-discharge medical readmission OR emergency department visit

    Within 30 days of the index hospital discharge

  • 90-day post-discharge medical readmission OR emergency department visit

    Within 90 days of the index hospital discharge

  • Unplanned 90-day readmission

    Within 90 days of the index hospital discharge

Other Outcomes (1)

  • Post-discharge care plan adherence

    Within 90 days of the index hospital discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

Enhanced care planning only (plus $15 as compensation for participation)

Other: Enhanced care planning

Intervention

EXPERIMENTAL

Enhanced care planning plus a one-time $300 post-discharge income supplement

Other: Post-discharge income supplementOther: Enhanced care planning

Interventions

$300 income supplement

Intervention

Enhanced care planning provided by a nurse care manager

ControlIntervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A participant in the underlying enhanced care planning program
  • aged 55 years or older
  • attending an outpatient clinic appointment as part of the underlying enhanced care planning program within 10 days of being discharged from an inpatient hospital stay
  • able to understand the study consent form (with interpretation services if needed)

You may not qualify if:

  • The candidate is not discharged from the index admission to a community setting (e.g., they will be excluded if they are discharged to a skilled nursing facility)
  • The candidate has a legal guardian with control over financial decision-making
  • The candidate has been approached about the study during a previous encounter
  • The index hospitalization was a planned admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AltaMed Health Services Corporation

Los Angeles, California, 90040, United States

Location

Related Publications (1)

  • Calvillo-King L, Arnold D, Eubank KJ, Lo M, Yunyongying P, Stieglitz H, Halm EA. Impact of social factors on risk of readmission or mortality in pneumonia and heart failure: systematic review. J Gen Intern Med. 2013 Feb;28(2):269-82. doi: 10.1007/s11606-012-2235-x. Epub 2012 Oct 6.

    PMID: 23054925BACKGROUND

Study Officials

  • Rajan A Sonik, PhD, JD, MPH

    Brandeis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 11, 2023

Study Start

June 21, 2023

Primary Completion

April 22, 2024

Study Completion

April 22, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations