Parent Educational Discharge Support Strategies
- Conditions
- Educational Activities
- Interventions
- Other: PEDSS - symptom managementOther: PEDSS - support for the caregiver
- Registration Number
- NCT03227068
- Lead Sponsor
- Duke University
- Brief Summary
After the initial hospitalization, parents of children newly diagnosed with cancer assume responsibility for assessing and managing their care; however, parents are often overwhelmed with information received throughout the hospitalization and are apprehensive about caring for their child at home. Parents want concise, focused information on how to care for their child after the hospital discharge. Two parent education discharge support strategies (PEDSS) were created to use at hospital discharge. PEDSS consists of a symptom management intervention and a support for the caregiver intervention. A cluster randomized control trial will assess the effectiveness and feasibility of the two different interventions.
- Detailed Description
Providing education to parents of children newly diagnosed with cancer is a primary component of nursing practice, but best practices regarding delivery of information are not known. Parents often report confusion and worry with the complexity and large volume of information received during the initial hospitalization that leads to concerns in caring for their child after discharge. In addition, the amount and content of education is not standardized across institutions. This results in considerable variability in educational practices, including symptom education. During a recent qualitative study, parents described helpful discharge education strategies as having written materials, keeping information concise, and receiving anticipatory guidance so they knew what to expect. These preferences were succinctly summarized by a mother of a child newly diagnosed with leukemia who stated "...it would be nice to have one sheet of paper that just said 'these are the signs that you're looking for at home'." The purpose of this research study is to implement and evaluate parent educational discharge support strategies (PEDSS) for parents of children newly diagnosed with cancer. Findings from this study will provide a framework for nurses to deliver concise and consistent information to parents of children newly diagnosed with cancer, and will assist parents with their child after hospital discharge.
The goal of this study is to determine the effectiveness and feasibility of two parent education discharge support strategies (PEDSS - symptom management vs. PEDSS - support for the caregiver) for parents of children newly diagnosed with cancer. Specific aims of the study include:
Specific Aim 1: Explore the effects of parent education discharge support strategies on childhood cancer symptoms (fever, pain, fatigue, nausea, appetite changes, and sleep problems) and parents' perception of their ability to care for their child with a new cancer diagnosis during the first two months following the initial hospital discharge.
Specific Aim 2: Determine whether implementation of parent education discharge support strategies decreases unplanned utilization of healthcare services (unscheduled clinic visits, emergency room visits, unplanned hospitalizations), and preventable toxicity (malnutrition, sepsis) among children with cancer during the first two months following the initial hospitalization.
Specific Aim 3: Examine the feasibility and fidelity of implementing the PEDSS at the initial hospital discharge among parents of newly diagnosed children with cancer for use through the first two months following hospital discharge at participating Magnet institutions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 289
- A parent (referred to as "parent" but includes a parent or legal guardian) of a patient 3 to 17 years of age who is newly diagnosed with any type of malignant disease on an inpatient oncology unit
- Must speak English, Spanish, or Arabic
- Child will be or is receiving chemotherapy and/or radiation therapy
- A parent of a child diagnosed with histiocytosis or any hematological disease considered non-malignant
- A parent whose child received the initial cancer diagnosis and initial cancer treatment while hospitalized on a non-oncology unit (i.e., surgical ward)
- A parent of a child who is experienced a relapse of a malignant disease
- A parent who is the primary caregiver of the child with cancer and is illiterate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEDSS - symptom management PEDSS - symptom management Content for the PEDSS - symptom management includes the most commonly experienced treatment-related physical symptoms, descriptions of each symptom, strategies to reduce symptom distress, and when and how to contact the cancer care team. PEDSS - support for the caregiver PEDSS - support for the caregiver Content for the PEDSS - support for the caregiver includes five topics and suggestions on how caregivers can care for themselves during this time.
- Primary Outcome Measures
Name Time Method Change from baseline pain severity to two months At baseline and monthly for two additional months Wong-Baker Faces Scale
Change from baseline appetite changes to two months At baseline and monthly for two additional months Simplified Nutritional Appetite Questionnaire, 4-item asking about child's appetite and rated on a 5-point Likert Scale
Change from baseline fatigue severity to two months At baseline and monthly for two additional months Categorized as none to mild or moderate to severe from the Adolescent Fatigue Scale for adolescents 13-17 years of age, the Childhood Fatigue Scale for children 7-12 years of age, or the Parent Fatigue Scale to obtain proxy responses from parents of children \< 7 years of age
Change from baseline nausea severity to two months At baseline and monthly for two additional months Visual Analogue Scale in the form of a thermometer that rates the severity of nausea from 0-100
Change from baseline pain behavior to two months At baseline and monthly for two additional months PROMIS® Pediatric - Pain Behavior Short Form
Change from baseline sleep disturbances to two months At baseline and monthly for two additional months The Sleep Wake Scale
- Secondary Outcome Measures
Name Time Method Unplanned utilization of healthcare services At one and two months from start of study Combined frequency of the number of unscheduled clinic visits, emergency room visits, and unplanned hospitalizations
Change in baseline nutritional status to two months At baseline and monthly for two additional months Body mass index
Change of baseline parents' perception of their ability to care for their child with a new cancer diagnosis to two months At baseline and monthly for two additional months Seven items asking the parent to rate perceptions of the care of their child's symptoms on a 5-point Likert scale
Sepsis At one and two months from start of study Frequency of septic events over the past month
PEDSS intervention feasibility At baseline Nurse documentation of completion of PEDSS discussion and distribution of PEDSS worksheet
PEDSS intervention satisfaction At two months after intervention delivery Descriptive items asking about timing of intervention and frequency of intervention use then 6 items scored on a 5-point Likert scale asking about ease of use and satisfaction.
Trial Locations
- Locations (16)
Ann and Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Northwestern Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Cohen Children's Medical Center Northwell Health
🇺🇸New Hyde Park, New York, United States
Maine Children's Cancer Program at Maine Medical Center
🇺🇸Scarborough, Maine, United States
St. Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Health System of Texas Children's Medical Center
🇺🇸Dallas, Texas, United States
West Virginia University Medicine
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Health American Children's Hospital
🇺🇸Madison, Wisconsin, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
King Faisal Specialist Hospital and Research Centre-Riyadh
🇸🇦Riyadh, Saudi Arabia
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Medical University of South Carolina Children's Hospital
🇺🇸Charleston, South Carolina, United States