Trial Outcomes & Findings for Hospital to Home Outcomes (NCT NCT02081846)

NCT ID: NCT02081846

Last Updated: 2019-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1500 participants

Primary outcome timeframe

30 days post-discharge

Results posted on

2019-04-16

Participant Flow

Patients hospitalized on the hospital medicine or neurosciences services (neurology/ neurosurgery) at Cincinnati Children's Hospital Medical Center (CCHMC), a freestanding tertiary care children's hospital, between 2/2015 and 4/2016 were eligible for study recruitment.

Participant milestones

Participant milestones
Measure	Home Nurse Visit Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control This arm will receive standard of care. 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.
Overall Study STARTED	751	749
Overall Study COMPLETED	749	749
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Home Nurse Visit Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control This arm will receive standard of care. 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.
Overall Study Withdrawal by Subject	1	0
Overall Study invalid consent	1	0

Baseline Characteristics

Hospital to Home Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Nurse Visit n=749 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=749 Participants This arm will receive standard of care. 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.	Total n=1498 Participants Total of all reporting groups
Age, Continuous	2.1 years n=5 Participants	1.9 years n=7 Participants	2.0 years n=5 Participants
Sex: Female, Male Female	357 Participants n=5 Participants	364 Participants n=7 Participants	721 Participants n=5 Participants
Sex: Female, Male Male	392 Participants n=5 Participants	385 Participants n=7 Participants	777 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	704 Participants n=5 Participants	709 Participants n=7 Participants	1413 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	453 Participants n=5 Participants	456 Participants n=7 Participants	909 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	219 Participants n=5 Participants	210 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian/Oriental or Pacific Islander	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown/missing	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	749 Participants n=5 Participants	749 Participants n=7 Participants	1498 Participants n=5 Participants
Length of Stay	2 days n=5 Participants	2 days n=7 Participants	2 days n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-discharge

Population: The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal).

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=749 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=749 Participants This arm will receive standard of care. 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	133 Participants	105 Participants

SECONDARY outcome

Timeframe: 14 days post-discharge

Population: The analysis population includes the total subjects completing the 14-day phone call survey. Of the total randomized (1,500: 751 intervention, 749 control), 29 were excluded from the intervention group and 26 from the control group.

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.

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=722 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=723 Participants This arm will receive standard of care. 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.
Post Discharge Coping Difficulty Scale	20.4 units on a scale Interval 19.1 to 21.8	21.2 units on a scale Interval 19.8 to 22.5

SECONDARY outcome

Timeframe: 14 days post-discharge

Population: The analysis population includes the total subjects completing the 14-day phone call survey with a response for the return to normalcy question. Of the total randomized (1,500: 751 intervention, 749 control), 30 were excluded from the intervention group and 26 from the control group with no data available for this outcome.

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).

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=721 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=723 Participants This arm will receive standard of care. 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.
Days Until Normalcy	4.16 days Interval 3.87 to 4.44	4.11 days Interval 3.82 to 4.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=722 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=723 Participants This arm will receive standard of care. 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.
Red Flags Remembered	1.91 units on a scale Interval 1.78 to 2.04	1.61 units on a scale Interval 1.5 to 1.73

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=749 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=749 Participants This arm will receive standard of care. 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 Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge	58 Participants	41 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=749 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=749 Participants This arm will receive standard of care. 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 Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge	75 Participants	54 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Home Nurse Visit n=749 Participants Families in this arm will receive a nurse home visit within 96 hours of discharge. 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	Control n=749 Participants This arm will receive standard of care. 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 Occurrence(s) of 14-day Unplanned Healthcare Utilization	132 Participants	110 Participants

Adverse Events

Home Nurse Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heidi Sucharew (Biostatistician)

Cincinnati Children's Hospital Medical Center

Phone: 513-803-1920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place