Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology
4 other identifiers
observational
530
2 countries
33
Brief Summary
This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 19, 2023
April 1, 2023
6.4 years
July 25, 2016
July 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes
FN will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent versus (vs.) CPG inconsistent care for each FN episode.
Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes
CINV will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each CINV episode (separately for high and moderate emetogenicity risk chemotherapy).
Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
The proportion of CPG-consistent care of fertility preservation (FP) episodes
FP will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each FP episode.
Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a)
Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.
Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Key coding categories (Aim 2)
Will be identified by the Framework for Clinical Practice Guideline Implementability. Operational definitions of each category will be determined. The implementation barriers and facilitators identified by focus group members will be coded using these categories independently by two investigators. New categories and sub-categories will be used to code concepts that do not fall within the pre-determined categories. Themes of commonality will be sought especially within the newly developed categories that fall outside the framework adapted from Gagliardi et al. Facilitators of and barriers to CPG implementation will be described.
Data collected from March 28, 2017 through October 15, 2018 will be evaluated
CPG format which is well understood by pediatric oncology healthcare providers (Aim 3)
The issues identified via the interviews, changes made to the formatting, and rationale for the changes will be documented between each round in a tracking matrix. The proportion of interviewees who select the correct course of action when presented with four possible courses of action will be described for each iteration of the CPG format including the final version. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
Data collected from a minimum of 25 interviews starting from February 1, 2019 to the timepoint where a format that is well understood by participants is developed will be evaluated
Study Arms (1)
Observational (chart review, focus group, interviews)
AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia \[FN\], chemotherapy induced nausea and vomiting \[CINV\], fertility preservation \[FP\]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs. AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed. AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.
Interventions
Participate in focus group
Review of medical chart
Ancillary studies
Eligibility Criteria
Patients \< 21 years old at cancer diagnosis who received care as an inpatient or outpatient at a participating COG NCORP site between January 1, 2014 and December 31, 2015
You may qualify if:
- Site willingness to participate in all 3 aims
- Received care as an inpatient or outpatient at a participating COG NCORP site during the time period between January 1, 2014 and December 31, 2015
- Ever enrolled on any COG trial (episode does not have to occur while on trial and the COG trial may be therapeutic or non-therapeutic)
- Has at least one episode eligible for FN, CINV or FP review
- CPG-Specific Eligibility
- Has any of the following diagnoses:
- Newly diagnosed acute lymphoblastic leukemia
- Relapsed acute lymphoblastic leukemia
- Any acute myeloid leukemia
- Burkitt's or mature B cell non-Hodgkin's lymphoma
- Any myeloablative autologous or allogeneic hematopoietic stem cell transplantation
- Developed FN at least once
- CINV
- Diagnosis of cancer
- Received moderately emetogenic chemotherapy as an inpatient
- +7 more criteria
You may not qualify if:
- Trainees are excluded
- Previous participation in this study either for Aim 2 or Aim 3
- Each health care provider can only be involved in one event (focus group or interview)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (33)
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Blank Children's Hospital
Des Moines, Iowa, 50309, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
San Jorge Children's Hospital
San Juan, 00912, Puerto Rico
University Pediatric Hospital
San Juan, 00926, Puerto Rico
Related Publications (1)
Sugalski AJ, Lo T, Beauchemin M, Grimes AC, Robinson PD, Walsh AM, Santesso N, Dang H, Fisher BT, Wrightson AR, Yu LC, Sung L, Dupuis LL. Facilitators and barriers to clinical practice guideline-consistent supportive care at pediatric oncology institutions: a Children's Oncology Group study. Implement Sci Commun. 2021 Sep 16;2(1):106. doi: 10.1186/s43058-021-00200-2.
PMID: 34530933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
L. Lee Dupuis
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 28, 2016
Study Start
November 21, 2016
Primary Completion
March 31, 2023
Study Completion
June 30, 2023
Last Updated
July 19, 2023
Record last verified: 2023-04