Clinical trial NCT03110692: Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation
Official title: Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 1188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients Receiving Daily Imaging
timeFrame: 3 months post arm crossover
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Justin Bekelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mitesh Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.