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Completed

NCT Number: NCT03224130

Supplement to Hospital to Home Outcomes

Post-discharge nurse phone call

Completed

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Key information

Conditions

Hospitalized Patients

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

Previous work has identified barriers to successful transitions that are most meaningful to patients and families. Investigators used these learnings to iteratively adapt an existing nurse home visit program to address these barriers, and have been studying the effectiveness of the redesigned nurse home visit in a randomized control trial (NCT02081846).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Nurse Phone Call

Other

We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home

Standard of care

Other

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 outcomes

  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, ED or 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 state)

Secondary outcomes

  1. Post-Discharge Coping 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. Differences between intervention and control groups on this outcome at 14-day post-discharge are evaluated using a linear regression model with the stratification variables (census tract poverty and state of residence).

  2. Number of 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

    Occurence(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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: Supplement

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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