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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03110692
Other study ID # 826810
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2016
Est. completion date February 9, 2018

Study information

Verified date November 2019
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1188
Est. completion date February 9, 2018
Est. primary completion date October 9, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pennsylvania Health System Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & 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 Jun 27. doi: 10.1001/jamaoncol.2019.1432. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Patients Receiving Daily Imaging Radiology tests including x-rays and CT scans 3 months post arm crossover
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