Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation

Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment

The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Default initiation

Detailed Description

The goal of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment in which a pre-planned quality improvement default option for radiation treatment prescriptions will be introduced throughout the network of Penn Radiation Oncology. This study is a prospectively designed, observational trial with two comparison groups: (1) a usual practice group (control group) and (2) a default radiation treatment prescription group (intervention group), in which the usual practice group will subsequently rollover from control to intervention so that all sites and physicians in the practice network of Penn Radiation Oncology are exposed to intervention. The purpose of this study is to reduce preference sensitive, unnecessary daily imaging during radiation treatment with the implementation of a quality improvement initiative within 5 sites of Penn Radiation Oncology. We aim to leverage the introduction of a default prescription option to reduce the use of daily imaging in palliative intent cases where it has limited clinical benefit and adds to cost burden. Our objective is to encourage more patient-centric clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 1188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Radiation treatment courses with palliative intent
• Palliative treatment of bone, soft tissue, and intracranial metastases
• Photon radiation with 3D conformal therapy (3DCRT) only

Exclusion Criteria:

• Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as radiation treatment modality
• Retreatment to same site
• Proton radiation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual practice (control); The usual practice group will rollover to the intervention arm after 3 months.
Experimental: Intervention; Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.	Behavioral: Default initiation; A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Receiving Daily Imaging	Radiology tests including x-rays and CT scans	3 months post arm crossover

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Justin Bekelman, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Sharma S, Guttmann D, Small DS, Rareshide CAL, Jones J, Patel MS, Bekelman JE. Effect of Introducing a Default Order in the Electronic Medical Record on Unnecessary Daily Imaging During Palliative Radiotherapy for Adults With Cancer: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1220-1222. doi: 10.1001/jamaoncol.2019.1432.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2016
• Primary Completion (Actual): October 9, 2017
• Study Completion (Actual): February 9, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 826810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No