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NCT03224130: Supplement

Supplement to Hospital to Home Outcomes

Completed NA Results posted Last updated 16 April 2019
What this trial tests

NA trial testing Nurse Phone Call in Hospitalized Patients in 966 participants. Completed in 30 June 2017.

Timeline
11 May 2016
Primary endpoint
30 June 2017
30 June 2017

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment966
Start date11 May 2016
Primary completion30 June 2017
Estimated completion30 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Under 18, any sex, with Hospitalized Patients. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge Primary · 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)

GroupValue95% CI
Nurse Phone Call77
Standard of Care63
Post-Discharge Coping Scale Secondary · 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).

GroupValue95% CI
Nurse Phone Call14.312.8 – 15.8
Standard of Care15.213.7 – 16.7
Number of Days Until Normalcy Secondary · 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).

GroupValue95% CI
Nurse Phone Call3.93.5 – 4.2
Standard of Care4.23.8 – 4.6
Red Flags Remembered Secondary · 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 outc

GroupValue95% CI
Nurse Phone Call1.81.7 – 2.0
Standard of Care1.51.4 – 1.6
Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge Secondary · 30 days

Occurrence(s) of an unplanned readmission within 30 days post-discharge.

GroupValue95% CI
Nurse Phone Call32
Standard of Care27
Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge Secondary · 30 days

Occurence(s) of an ED visit within 30 days post-discharge

GroupValue95% CI
Nurse Phone Call35
Standard of Care35
Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization Secondary · 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.

GroupValue95% CI
Nurse Phone Call71
Standard of Care72

Sponsor's own description

Post-discharge nurse phone call

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hospitalized Patients

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03224130.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing