Hospital to Home Outcomes

April 11, 2019 updated by: Children's Hospital Medical Center, Cincinnati

Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home

Home Nurse Visit post discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To identify barriers to successful transitions that are most meaningful to patients and families, and use these identified barriers to iteratively adapt an existing nurse home visit program to address these barriers. This study will also test the efficacy of a nurse home visit intervention in improving post-discharge outcomes through a randomized controlled trial.

Study Type

Interventional

Enrollment (Actual)

1500

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
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

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

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is under 18 years of age Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, community pediatrics, adolescent medicine, neurology or neurosurgery.

Exclusion Criteria:

  • Patient to be discharged someplace other than home (e.g., residential facility, psychiatric facility)
  • Patient's home residence is outside the home nursing service area
  • Patient is eligible for "traditional" home nursing services
  • Caregiver is non-English speaking

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home Nurse Visit
Families in this arm will receive a nurse home visit within 96 hours of discharge.
Other: Nurse Home Visit
We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home
ACTIVE_COMPARATOR: Control
This arm will receive standard of care.
Other: Standard of Care
Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge
Time Frame: 30 days post-discharge
The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization and/or any emergency department/urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and complex versus noncomplex teams) included in the model.
30 days post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Discharge Coping Difficulty Scale
Time Frame: 14 days post-discharge
Post-Discharge Difficulty Coping Scale (Weiss, et. al) measured at 14 day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11 point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.
14 days post-discharge
Days Until Normalcy
Time Frame: 14 days post-discharge
Number of days until normalcy: measured at post discharge phone call. Parents asked to recall the number of days it took to "return to a 'normal' routine" including the return to work and school (with option of not yet be back to normal).
14 days post-discharge
Red Flags Remembered
Time Frame: 14 days post-discharge
This was measured at the 14 day post-discharge phone call survey. Parents were asked to recall "any red flags or warning signs" to indicate the "child's condition was getting worse." The number of red flags recalled could range from 0-10 depending on the template used. The template was a home visit guideline for nurses to use that was specific to the child's illness. For example, if the child had bronchiolitis the nurse would use the template "bronchiolitis/croup/pneumonia" to guide them through the visit. Higher values (i.e., the greater number of red flags remembered) represent a better outcome.
14 days post-discharge
Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge
Time Frame: 30 days
Occurrence(s) of an unplanned readmission within 30 days post-discharge.
30 days
Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge
Time Frame: 30 days
Occurrence(s) of an ED visit within 30 days post-discharge
30 days
Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization
Time Frame: 14 days post-discharge
Occurrence(s) of 14-day unplanned healthcare utilization defined by unplanned re-hospitalization and/or any emergency/urgent care visit within 14 days or parent report of an unplanned visit to one of these places. Parent report is collected at the 14 day follow-up phone call.
14 days post-discharge

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Samir S Shah, MD, MSCE, Children's Hospital Medical Center, Cincinnati

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 2, 2015

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 7, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H2O

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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