Evaluating a New Way to Prepare Parents of Hospitalized Children for Discharge and Management of Child at Home
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|ClinicalTrials.gov Identifier: NCT01565785|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Patient Discharge||Behavioral: The FSM-DPI.||Not Applicable|
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:
- Family self-management process (e.g., knowledge, self-regulation, and social facilitation)
- 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).
- To describe nurse assessment and patient responses to the FSM-DPI.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
No Intervention: control group
25 parents on each unit receiving standard of care in discharge preparation.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01565785
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Kathleen J Sawin, PhD||Children's Hospital and Health System Foundation, Wisconsin|
|Principal Investigator:||Marianne Weiss, DNSc, RN||Marquette University|