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Patient DischargeNCT01565785

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

A study testing The FSM-DPI. in people with Patient Discharge, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Patient Discharge
What is being tested?
The FSM-DPI.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteUnited States
Study dates
Feb 2012to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53201

Other trials in United States

About this study

Official title: Self-Management Guided Discharge Teaching for Parents of Hospitalized Children: A Pilot Study

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.

Read the 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:
  2. Family self-management process (e.g., knowledge, self-regulation, and social facilitation)
  3. 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).
  4. To describe nurse assessment and patient responses to the FSM-DPI.
  5. 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.

Being tested
The FSM-DPI.
Keywords
Child parent home self-management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The FSM-DPI.Behavioural

    Also called Tailored, behavioral

    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.

Study groups in NCT01565785
Study groupRoleWhat they receive
Discharge Prepartion with The FSM-DPIExperimental25 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.
Receives: Behavioral: The FSM-DPI.
control groupNo intervention25 parents on each unit receiving standard of care in discharge preparation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 weeks after discharge

Secondary outcomes (1)
  1. 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.

    Measured: 3 weeks after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01565785
Sponsor's protocol ID
259192-1
Status last verified
Nov 2015
First submitted
26 Mar 2012
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing The FSM-DPI. in people with Patient Discharge, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Coping Difficulty (time frame: 3 weeks after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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