NCT03539978

Brief Summary

This study focuses on the delivery of discharge education by clinical nurses to improve parent and family self-management in the home environment. This study tests an discharge method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric patients at the time of discharge, enhance the child's and family's experience, and decrease length of stay and health care utilization (ED visit or re-admission). The SM-THINk protocol is an enhancement to the standard clinical practice and will be implemented for all subjects on two Children's Hospital of Wisconsin (CHW) nursing units. This enhancement will require additional training of the nurses prior to implementation of the research project. This research determines the effectiveness of the training enhanced discharge method. The training is independent from the research project and will evaluate effectiveness of this training. For the enhanced discharge method, clinical nurses on the study units will be trained to deliver the Self-Management Transition to Home (SM-THINk protocol), which is based on the family self-management discharge preparation previously developed and tested by the study team.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

April 25, 2018

Last Update Submit

December 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improved parent experience

    Parents of children with and without complex or chronic health conditions who received enhanced discharge preparation by the clinical nurse using the SM-THINk protocol would report increased parent experience (quality of discharge teaching delivered and care coordination).

    30 days

Study Arms (2)

SM-THINk Unit

Two of the three inpatient floors will use the SM-THINk enhanced discharge method. This is part of a clinical practice change and not for research. Parents will complete a questionnaire at the time of the patient's discharge from the hospital.

Other: SM-THINk

Control Unit

One of the three inpatient floors will use the usual discharge method. Parents will also complete a questionnaire at the time of the patient's discharge from the hospital.

Interventions

Patients will receive the SM-THINk enhanced discharge method.

SM-THINk Unit

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We expect to enroll 300 patients and one legal guardian per patient (parent or caregiver who has guardianship of the patient) per unit (for a total of 900 patients and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria will be used to identify children with complex or chronic conditions. Based on conversations with hospital leadership it is expected that approximately 120 patients per unit (40%) will have a complex or chronic condition. Parent experience related to quality of discharge teaching and care coordination will be self-reported by parents using established, reliable and valid scales. Child and parent characteristics, length of hospitalization, readmission, and Emergency Department use data will be extracted from electronic medical records.

You may qualify if:

  • the parent's/caregiver's child is inpatient on the selected study units
  • the parent/caregiver is English speaking (to date the tools being used have been validated for English participants only)
  • the parent/caregiver is 18 years of age or older
  • the patient is 17 years of age or younger

You may not qualify if:

  • presence of significant communication or cognitive impairment on the part of the parent/caregiver that would preclude completion of questionnaires based on self-report.
  • the patient is a ward of the state or in foster care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stacee Lerret, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 30, 2018

Study Start

August 30, 2018

Primary Completion

February 20, 2019

Study Completion

April 20, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations