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

Children's Oncology Group

Status: Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Childhood Burkitt Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Childhood Neoplasm; B-Cell Non-Hodgkin Lymphoma; Acute Lymphoblastic Leukemia; Malignant Solid Neoplasm; Childhood Acute Myeloid Leukemia

Treatments: Other: Questionnaire Administration; Other: Informational Intervention; Other: Medical Chart Review; Other: Interview

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT02847130

NCI-2016-00980 (Registry Identifier)

UG1CA189955 (U.S. NIH Grant/Contract)

ACCL15N1CD (Other Identifier)

COG-ACCL15N1CD (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 530 patients

Sex: All

Ages: Under 20 years old

Volunteers: No 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)

Trial design

530 participants in 1 patient group

Observational (chart review, focus group, interviews)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention

Other: Medical Chart Review

Other: Interview