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Hospital to Home Outcomes

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. Identifier: NCT02081846
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : March 29, 2019
Last Update Posted : April 16, 2019
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Home Nurse Visit post discharge.

Condition or disease Intervention/treatment Phase
Focus: Hospitalized Patients Other: Nurse Home Visit Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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

  6. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02081846

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Patient-Centered Outcomes Research Institute
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Principal Investigator: Samir S Shah, MD, MSCE Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Study Protocol  [PDF] September 20, 2018
Statistical Analysis Plan  [PDF] September 20, 2018


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT02081846    
Other Study ID Numbers: H2O
First Posted: March 7, 2014    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Children's Hospital Medical Center, Cincinnati:
transitions of care
home nurse visit
focus groups
quality improvement