NCT03110692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,188

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 9, 2019

Completed
Last Updated

December 9, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

March 29, 2017

Results QC Date

July 29, 2019

Last Update Submit

November 20, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Percent of Patients Receiving Daily Imaging

    Radiology tests including x-rays and CT scans

    3 months post arm crossover

Study Arms (2)

Usual practice (control)

NO INTERVENTION

The usual practice group will rollover to the intervention arm after 3 months.

Intervention

EXPERIMENTAL

Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation.

Behavioral: Default initiation

Interventions

Default initiationBEHAVIORAL

A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 31246224BACKGROUND

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Mitesh S. Patel
Organization
Perelman School of Medicine, University of Pennsylvania
mpatel@pennmedicine.upenn.edu
215-898-3367

Study Officials

  • Justin Bekelman, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Mitesh Patel, MD, MBA, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 12, 2017

Study Start

February 10, 2016

Primary Completion

October 9, 2017

Study Completion

February 9, 2018

Last Updated

December 9, 2019

Results First Posted

December 9, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)