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Evaluating a New Way to Prepare Parents of Hospitalized Children for Discharge and Management of Child at Home

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565785
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : November 17, 2015
Children's Hospital and Health System Foundation, Wisconsin
University of Wisconsin, Milwaukee
Marquette University
Information provided by (Responsible Party):
Medical College of Wisconsin

Brief Summary:
The purpose of this study is to pilot test the 'Family Self- Management Discharge Preparation Intervention [FSM-DPI]' that focuses on content and delivery methods to support an effective family transition to home self-management after a child's hospitalization.

Condition or disease Intervention/treatment Phase
Patient Discharge Behavioral: The FSM-DPI. Not Applicable

Detailed Description:

The specific aims of the study are:

  1. To estimate the effect of an intervention designed to improve family self-management after discharge of a hospitalized child on:

    1. Family self-management process (e.g., knowledge, self-regulation, and social facilitation)
    2. Proximal family self-management behavioral outcomes, (e.g., post-discharge parental coping difficulty and family impact), and unplanned use of post-discharge services (calls to family/friends, health care providers, hospital; unscheduled office visits, urgent care/ED visits, readmission).
  2. To describe nurse assessment and patient responses to the FSM-DPI.
  3. To compare nurse satisfaction with discharge teaching process when nurses perform discharge teaching using the FSM-DPI vs. the standard discharge teaching approach.

A novel discharge preparation intervention delivered by nurses to parents of hospitalized children who are being discharged home was developed based on previous research conducted by the investigators. The intervention is grounded in the individual and family self-management Theory. To test the impact of the intervention on discharge preparation process and parent outcomes, the investigators will conduct a pilot trial implementation using trained staff nurses to deliver the intervention. To measure the effects of the intervention a difference- in-differences approach with be used with selection of 200 parents with 50 in each of 4 groups: Baseline control 1 (parents assigned for usual care to study nurses before training on the use of the intervention); Baseline control group 2 ( parent assigned for usual care to other than study nurses); Implementation group ( parents assigned to study nurses who will receive the intervention); Concurrent control group ( parent assigned to other than study nurses). The study will be conducted on two nursing units and half of the sample will be selected from each unit using a random selection procedure.

Data to be collected from all parents (baseline control, implementation, concurrent control) on the day of hospital discharge include: Parent enrollment sheet for collection of parent demographics; Quality of Discharge Teaching Scale, Readiness for Hospital Discharge Scale, Care Transition Measure. In addition the CHW Synergy form will be copied from the child's medical record to provide information on child characteristics of the hospitalization. At 3 weeks post-discharge, parents will be contacted by telephone to obtain outcome data using the Post-Coping Difficulty Scale and the PedsQL™. Parents will also be asked questions about post-discharge utilization of health services.

Nurses will record process measures related to the delivery of the intervention. In addition the nurse of parents in implementation and control groups will complete assessments of patient readiness for discharge using the Readiness for Hospital Discharge Scale and will rate their experience with the discharge process on a survey developed by the research team.

Analysis will provide information about the utility of the FSM-DPI and preliminary data on which to base revisions and enhancements to the intervention and for development of a larger implementation trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-Management Guided Discharge Teaching for Parents of Hospitalized Children: A Pilot Study
Study Start Date : February 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Discharge Prepartion with The FSM-DPI
25 families on each of 2 units will receive the will receive the Family Self-Management-Discharge Preparation Intervention (FSM-DPI). This scripted theory-based intervention is delivered by the study nurse using a e-mobile device. Eight elements of discharge preparation are addressed, the nurse assesses the family status and documents the additional care provided.
Behavioral: The FSM-DPI.
Nurses will assess key elements of family self-management (home care, child's care, practice, medications, watching child, recovery, development, family adjustment and parental support) and address any deficits to facilitate effective discharge and family management of child at home after hospitalization.
Other Names:
  • Tailored
  • behavioral

No Intervention: control group
25 parents on each unit receiving standard of care in discharge preparation.

Primary Outcome Measures :
  1. Post-Coping Difficulty [ Time Frame: 3 weeks after discharge ]
    The Post-Coping Difficulty Scale is a measure of parent perception of difficulty and ability to manage their child's care at home.

Secondary Outcome Measures :
  1. Pediatric Quality of Life (parent report) [ Time Frame: 3 weeks after discharge ]
    The child quality of life (parent as reporter) is a measure with total score and 4 domain scores, physical, emotional, social and school.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parents must be at least 18 years of age, speak sufficient English to complete paper or online questionnaires, have a child who has been in the hospital for 2 days and is expected to go home on the data of data collection

Exclusion Criteria:

  • Parents will be excluded if their child is discharged home to hospice care, or if they were in the hospital less than 2 days, were admitted as a short stay, or remain in the hospital

Information from the National Library of Medicine

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 identifier (NCT number): NCT01565785

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
University of Wisconsin, Milwaukee
Marquette University
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Principal Investigator: Kathleen J Sawin, PhD Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: Marianne Weiss, DNSc, RN Marquette University
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Responsible Party: Medical College of Wisconsin Identifier: NCT01565785    
Other Study ID Numbers: 259192-1
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Medical College of Wisconsin:
Child parent home self-management