Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847130
• Other study ID #: ACCL15N1CD
• Secondary ID: NCI-2016-00980AC
• Status: Completed
• Start date: November 21, 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• B-Cell Non-Hodgkin Lymphoma
• Burkitt Lymphoma
• Childhood Acute Myeloid Leukemia
• Childhood Burkitt Lymphoma
• Childhood Neoplasm
• Hematopoietic and Lymphoid Cell Neoplasm
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Malignant Solid Neoplasm
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	San Jorge Children's Hospital	San Juan
Puerto Rico	University Pediatric Hospital	San Juan
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Blank Children's Hospital	Des Moines	Iowa
United States	Sanford Broadway Medical Center	Fargo	North Dakota
United States	Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan
United States	BI-LO Charities Children's Cancer Center	Greenville	South Carolina
United States	Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada
United States	Summerlin Hospital Medical Center	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Children's Hospital New Orleans	New Orleans	Louisiana
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Nemours Children's Hospital	Orlando	Florida
United States	Nemours Children's Clinic - Pensacola	Pensacola	Florida
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota
United States	Mary Bridge Children's Hospital and Health Center	Tacoma	Washington
United States	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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