Hospital to Home Outcomes
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|ClinicalTrials.gov Identifier: NCT02081846|
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : March 29, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Focus: Hospitalized Patients||Other: Nurse Home Visit Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
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): NCT02081846
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Samir S Shah, MD, MSCE||Children's Hospital Medical Center, Cincinnati|