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

Sponsor

Children's Oncology Group (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02847130

Collaborator

National Cancer Institute (NCI) (NIH)

694

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia B-Cell Non-Hodgkin Lymphoma Childhood Acute Myeloid Leukemia Childhood Burkitt Lymphoma Childhood Neoplasm Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Recurrent Childhood Acute Lymphoblastic Leukemia	Other: Informational Intervention Other: Interview Other: Medical Chart Review Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

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 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 Design

Study Type:

Observational

Anticipated Enrollment :

694 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 21, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

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: Informational Intervention

Participate in focus group

Other: Interview

Undergo one-on-one interviews

Other: Medical Chart Review

Review of medical chart

Other Names:

Chart Review

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes [Care delivered from January 1, 2014 through December 31, 2015 will be evaluated]
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.
The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes [Care delivered from January 1, 2014 through December 31, 2015 will be evaluated]
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).
The proportion of CPG-consistent care of fertility preservation (FP) episodes [Care delivered from January 1, 2014 through December 31, 2015 will be evaluated]
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.
Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a) [Care delivered from January 1, 2014 through December 31, 2015 will be evaluated]
Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.
Key coding categories (Aim 2) [Data collected from March 28, 2017 through October 15, 2018 will be evaluated]
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.
CPG format which is well understood by pediatric oncology healthcare providers (Aim 3) [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

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