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Discharge to Home and Chronic Illness Care Pilot

Primary Purpose

Solid Organ Transplant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
myFAMI iPad application
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Solid Organ Transplant focused on measuring pediatric, solid organ transplant, parents, heart, kidney, liver

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
  • the parent is English speaking (to date the tools being used have been validated for English participants only)
  • parent is 18 years of age or older
  • patient is 17 years of age and younger.

Exclusion Criteria:

  • presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
  • parent and child has experienced the discharge to home transition from a previous transplant.

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Intervention

Arm Description

Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.

Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.

Outcomes

Primary Outcome Measures

Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
Hypothesis: Compared to parents who received standard discharge preparation (usual care), parents receiving myFAMI will report: i) Better care coordination, ii) Higher quality of discharge teaching, iii) Greater readiness for hospital discharge, iv) Improved post-discharge coping, v) Improved family functioning, vi) Better self-management of medication and treatment regimens vii) Fewer emergency department visits and hospital readmissions

Secondary Outcome Measures

Examine the acceptability of myFAMI:
2. Examine the acceptability of myFAMI: The content of the interview will focus on strengths and weaknesses of iPad® technology in preparing parents for hospital discharge utilizing both survey and qualitative questions

Full Information

First Posted
June 12, 2014
Last Updated
March 6, 2019
Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02165423
Brief Title
Discharge to Home and Chronic Illness Care Pilot
Official Title
Discharge to Home and Chronic Illness Care Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's National Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Organ Transplant
Keywords
pediatric, solid organ transplant, parents, heart, kidney, liver

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Ten parents will be randomized to the control group defined as 'usual care' and ten to the intervention group, stratified by type of transplant.
Intervention Type
Behavioral
Intervention Name(s)
myFAMI iPad application
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
Description
Hypothesis: Compared to parents who received standard discharge preparation (usual care), parents receiving myFAMI will report: i) Better care coordination, ii) Higher quality of discharge teaching, iii) Greater readiness for hospital discharge, iv) Improved post-discharge coping, v) Improved family functioning, vi) Better self-management of medication and treatment regimens vii) Fewer emergency department visits and hospital readmissions
Time Frame
30 days following enrollment
Secondary Outcome Measure Information:
Title
Examine the acceptability of myFAMI:
Description
2. Examine the acceptability of myFAMI: The content of the interview will focus on strengths and weaknesses of iPad® technology in preparing parents for hospital discharge utilizing both survey and qualitative questions
Time Frame
Enrollment plus 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital the parent is English speaking (to date the tools being used have been validated for English participants only) parent is 18 years of age or older patient is 17 years of age and younger. Exclusion Criteria: presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report parent and child has experienced the discharge to home transition from a previous transplant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacee Lerret, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Discharge to Home and Chronic Illness Care Pilot

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