Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Completed
NCT Number: NCT02081846
Hospital to Home Outcomes
Home Nurse Visit post discharge.
Completed
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Notify MeKey information
Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
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, 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
Treatment and study plan
Nurse Home Visit
OtherWe 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
Standard of care
OtherControl 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
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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 outcomes
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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.
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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).
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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.
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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.
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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
-
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
Hospital to Home Outcomes (H2O): A Study to Improve the Fluidity of Transitions Between Hospital and Home
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 7, 2014
- 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.