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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Acute Lymphoblastic Leukemia; B-Cell Non-Hodgkin Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia; Childhood Burkitt Lymphoma; Childhood Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Medical Chart Review; Other: Informational Intervention; Other: Interview

Detailed Description

PRIMARY OBJECTIVES:

I. To measure the rate of adherence to selected Children's Oncology Group (COG)-endorsed supportive care clinical practice guidelines (CPG) recommendations at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites. (Aim 1) II. To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. (Aim 1a) III. To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care. (Aim 1b) IV. To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. (Aim 2) V. To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. (Aim 3)

OUTLINE:

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.

• Study Type: Observational
• Enrollment (Actual): 530

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00926
    • University Pediatric Hospital
  • San Juan, Puerto Rico, 00912
    • San Jorge Children's Hospital
• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I duPont Hospital for Children
  • Florida
    • Fort Myers, Florida, United States, 33908
      • Golisano Children's Hospital of Southwest Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic-Jacksonville
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hospital
    • Pensacola, Florida, United States, 32504
      • Nemours Children's Clinic - Pensacola
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33607
      • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Blank Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital New Orleans
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Helen DeVos Children's Hospital at Spectrum Health
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital Medical Center
    • Las Vegas, Nevada, United States, 89135
      • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Cancer Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus
    • New York, New York, United States, 10032
      • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Broadway Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • BI-LO Charities Children's Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78229
      • Methodist Children's Hospital of South Texas
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Mary Bridge Children's Hospital and Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Site willingness to participate in all 3 aims
• AIM 1 - ELIGIBILITY CRITERIA FOR INCLUSION IN RETROSPECTIVE CENTRALIZED CHART REVIEW
• 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

• FN

  • 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
  • < 12 years of age at the start of a CINV episode and received highly emetogenic chemotherapy as an in-patient

• FP

  • Newly diagnosed cancer
  • >= 15 years of age at cancer diagnosis
• Note: a single patient may contribute data for multiple episodes
• AIM 2 AND AIM 3 INCLUSION CRITERIA

• Healthcare professional currently employed at a participating COG NCORP institution

  • Eligible healthcare providers include but are not limited to: physicians, nurses, nurse practitioners, pharmacists, social workers, dieticians, psychologists, and physical therapists/physiotherapists
• Provides direct care for children with cancer as part of current position at NCORP site

Exclusion Criteria:

• AIM 2 AND AIM 3 EXCLUSION CRITERIA
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Questionnaire Administration; Ancillary studies; Other: Medical Chart Review; Review of medical chart; Other Names: Chart Review; Other: Informational Intervention; Participate in focus group; Other: Interview; Undergo one-on-one interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: L. Lee Dupuis, Children's Oncology Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimated): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; supportive care; Clinical practice guidelines
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; DNA Virus Infections; Tumor Virus Infections; Epstein-Barr Virus Infections; Herpesviridae Infections; Neoplasms; Lymphoma; Lymphoma, B-Cell; Leukemia; Burkitt Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: ACCL15N1CD (Other Identifier: CTEP); UG1CA189955 (U.S. NIH Grant/Contract); NCI-2016-00980 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); COG-ACCL15N1CD (Other Identifier: DCP)