Pediatric ALL Clinical Trial
Official title:
Peds SM-THINk (Self-Management Transition to Home INtervention): Nursing Interventions to Improve Discharge Outcomes
This study focuses on the delivery of discharge education by clinical nurses to improve parent and family self-management in the home environment. This study tests an discharge method (SM-THINk protocol) designed to improve the quality of care for hospitalized pediatric patients at the time of discharge, enhance the child's and family's experience, and decrease length of stay and health care utilization (ED visit or re-admission). The SM-THINk protocol is an enhancement to the standard clinical practice and will be implemented for all subjects on two Children's Hospital of Wisconsin (CHW) nursing units. This enhancement will require additional training of the nurses prior to implementation of the research project. This research determines the effectiveness of the training enhanced discharge method. The training is independent from the research project and will evaluate effectiveness of this training. For the enhanced discharge method, clinical nurses on the study units will be trained to deliver the Self-Management Transition to Home (SM-THINk protocol), which is based on the family self-management discharge preparation previously developed and tested by the study team.
This quasi-experimental study uses a cluster design with parents from 3 nursing units at the
Children's Hospital of Wisconsin. Implementation of the SM-THINk protocol will occur on 2
pediatric inpatient units and a third unit will serve as the usual care control unit. The
SM-THINk protocol will be implemented on the two implementation experimental units regardless
of this study as a clinical practice change. The nurses will not serve as subjects in this
study since they are expected to learn the protocol as part of their everyday jobs.
Plan to enroll 300 patients and one legal guardian per patient (parent or caregiver who has
guardianship of the patient). 300 parents of patients per unit (for a total of 900 patients
and 900 parents). A high-risk discharge assessment based on Mayo Clinic criteria is used to
identify children with complex or chronic conditions. Approximately 120 patients per unit
(40%) will have a complex or chronic condition. Parent experience related to quality of
discharge teaching and care coordination will be self-reported by parents using established,
reliable and valid scales. Child and parent characteristics, length of hospitalization,
readmission, and Emergency Department use data will be extracted from electronic medical
records.
Nurses on the three units will provide a brief information sheet to families at some point
after admission and explain that if the subjects/families have questions that they should
call the research team or ask the nurse to contact the research team on their behalf. This
information sheet includes a summary of the research purposes and what questions will be
asked. When a nurse on the implementation unit is ready to discharge a family who agree to
participate, he/she will obtain the iPad, enter the patient code and write down which code
corresponds to which patient on a log, perform the enhanced discharge method per clinical
practice, then log out of the iPad. He/she will then log into the parent questionnaires
(REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse
will indicate that if they would like to participate, they should do so after he/she leaves
the room and log out of the iPad when finished. Nurses on the control unit will perform their
usual discharge and then obtain the iPad, enter the patient code and write down which code
corresponds to which patient on a log. He/she will then log into the parent questionnaires
(REDCap), enter the patient code, and provide the iPad to the subjects/families. The nurse
will indicate that if they would like to participate, they should do so after he/she leaves
the room and log out of the iPad when finished. After approximately 10 minutes the nurse will
check to be sure the subject/family has left and if so, will pick up the iPad, ensure the
family has logged out, and return the iPad to the storage area. If the subject/family has not
left yet, the nurse will check back periodically until they have left. This design will
ensure that nursing discharge time is not affected. The research team will pick up the list
of patient codes on the next working day. There is a waiver for documentation of informed
consent and assent. If the parent and child are interested, participation will serve as
implied consent. A HIPAA waiver will be requested by the study team to abstract data from the
patient's medical record to look for outcomes over time regarding readmissions and ED visits.
Only the following data will be collected from the patient's medical record: the number of
hospitalizations in the last 1 year, date of admission/discharge, and the reason for
hospitalizations.
All units will ask the parents to complete the parent experience tools at time of discharge
using the iPad. Both groups will receive standard post-discharge follow-up care including
laboratory and clinic appointments.
The parent's age, insurance information and the child's chronic conditions will all be asked
for in the REDCap questionnaires on the iPad. If the iPad is temporarily unavailable for
subject/families, paper forms will be provided to them and they will be instructed by the
nurses to fill out the forms and seal them in an envelope when they are finished. Nursing
staff will provide the sealed envelopes to the research team.
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