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Behavioral and Recovery Support for 30 Day Post-Discharge Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05431894
Recruitment Status : Completed
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
NorthShore University HealthSystem
Information provided by (Responsible Party):
Laguna Health, Inc

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Laguna Coach Intervention Group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches for 30 days, the control group did not receive any support from Laguna coaches.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Behavioral and Recovery Support for 30 Day Post-Discharge Care in Participants With Cardiovascular Diseases
Actual Study Start Date : February 18, 2021
Actual Primary Completion Date : February 24, 2022
Actual Study Completion Date : June 13, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Unplanned All Cause Readmission Rate [ Time Frame: 30 Days Post-Discharge ]
    Unplanned All-Cause 30 Day Readmission Rate

  2. Unplanned Readmission Total Cost [ Time Frame: 30 Days Post-Discharge ]
    Billed facility charges for readmissions hospitalization stays


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431894


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Laguna Health, Inc
NorthShore University HealthSystem
Investigators
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Principal Investigator: Alfonso Tafur, MD NorthShore University HealthSystem
More Information
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Publications:

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Responsible Party: Laguna Health, Inc
ClinicalTrials.gov Identifier: NCT05431894    
Other Study ID Numbers: EH21-092
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laguna Health, Inc:
Readmissions
Cardiovascular
Post-Discharge
Behavioral Health
Readmission Cost
 30 Day Readmission
Heart Failure
Care Management
Barriers to Care
Contextualizing Healthcare
Additional relevant MeSH terms:
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Cardiovascular Diseases