Behavioral and Recovery Support for 30 Day Post-Discharge Care

June 20, 2022 updated by: Laguna Health, Inc

Behavioral and Recovery Support for 30 Day Post-Discharge Care in Participants With Cardiovascular Diseases

This study will provide behavioral and mental health support to a select group of participants to supplement the hospital-provided discharge and recovery plans, based on clinical guidance and dedicated post-hospitalization behavioral protocols, with the goals of reducing readmission rates and costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated clinical guidance and dedicated post-hospitalization Laguna recovery protocols, with the aims of improving health outcomes, reducing health costs, and reducing readmission rates within 30 days post-discharge.

Participants in the intervention group received support from Laguna Health via phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted to the hospital with a diagnosis of a cardiovascular disease
  • Discharged to home
  • Converse in English or Spanish
  • Uses a telephone

Exclusion Criteria:

  • Participant unable to provide informed consent
  • Participant lacks cognitive ability to participate in the study interventions as judged by the primary attending physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Group received support from Laguna Coaches
Behavioral: Laguna Coach Intervention Group
Behavioral and mental support was delivered through personal interactions with Laguna Coaches via phone, video, or web chat. Behavioral and mental support was individualized to best match each patient's needs and strengths. Support was provided to participants through human interactions over approximately 30 days.
No Intervention: Control Arm
Group received no support from Laguna Coaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unplanned All Cause Readmission Rate
Time Frame: 30 Days Post-Discharge
Unplanned All-Cause 30 Day Readmission Rate
30 Days Post-Discharge
Unplanned Readmission Total Cost
Time Frame: 30 Days Post-Discharge
Billed facility charges for readmissions hospitalization stays
30 Days Post-Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laguna Health, Inc

Collaborators

NorthShore University HealthSystem

Investigators

  • Principal Investigator: Alfonso Tafur, MD, NorthShore University Healthsystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

February 24, 2022

Study Completion (Actual)

June 13, 2022

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH21-092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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