An interventional study of The FSM-DPI. in Patient Discharge, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
The specific aims of the study are:
To estimate the effect of an intervention designed to improve family self-management after discharge of a hospitalized child on:
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.
Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
25 parents on each unit receiving standard of care in discharge preparation.
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.
Also known as: Tailored, behavioral
Post-Coping Difficulty
The Post-Coping Difficulty Scale is a measure of parent perception of difficulty and ability to manage their child's care at home.
Time frame: 3 weeks after discharge
Pediatric Quality of Life (parent report)
The child quality of life (parent as reporter) is a measure with total score and 4 domain scores, physical, emotional, social and school.
Time frame: 3 weeks after discharge
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin