Clinical trial NCT01389804: Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
Official title: Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant
Keywords: transplant, pediatric
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2011-07-08
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of pediatric solid organ transplant recipients (heart, kidney, liver or lung)

Brief summary: The overall long term objective of this research is to improve health care utilization and quality of life of pediatric solid organ transplant recipients and family. Understanding the process of transition to a chronic medical condition during the acute (3 weeks after transplant) and long term (3 and 6 months) will significantly guide the development of clinical interventions aimed at maximizing adherence and family psychosocial adjustment.

Detailed description: Parents of children that have received a heart, kidney, liver or lung transplant will be invited to participate in this protocol.

Involvement in this study entails completion of questionnaires at 4 separate time points. Parents will first complete questionnaires regarding discharge teaching, care coordination and readiness for hospital discharge on the day of discharge from the hospital. Parents will subsequently complete questionnaires at 3 weeks, 3 months and 6 months after discharge. The post discharge questionnaires assess coping, family management, adherence and utilization of healthcare resources.

Currently, no research has been conducted related to readiness for hospital discharge of a parent as the primary caregiver for a child with solid organ transplant or the sequential relationships between hospitalization care and the trajectory of post-discharge outcomes. This research will fill the gap in knowledge needed for care of solid organ transplant children and parents.

The ability to identify factors in the first year after transplant that are predictive of decreased coping and non-adherence affords an opportunity to develop nursing and health interventions that have significant implications for care decisions, as well as disease activity and health care costs.

Eligibility criteria: Inclusion Criteria:

1. the parent's child has undergone a heart, kidney, liver, lung or multivisceral transplant and is being discharged home from the hospital
2. the parent is English speaking (tools being used have been validated for English participants only)
3. the parent is 18 years of age or older

Exclusion Criteria:

1. presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
2. the child has already experienced the discharge to home transition after a previous transplant.

Primary outcomes:
measure: Determine if discharge preparation has an effect on parent readiness for hospital discharge and if readiness for hospital discharge effects post-discharge outcomes following hospital discharge in parents of solid organ transplant recipients
timeFrame: 2 years
Secondary outcomes:
measure: Post transplant outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital and Medical Center of Nebraska
state: Nebraska
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin/Children's Hospital of Wisconsin
name: Stacee Lerret, PhD(c), RN
role: PRINCIPAL_INVESTIGATOR
References: