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Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation

NCT ID: NCT03110692

Last Updated: 2019-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-10

Study Completion Date

2018-02-09

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Usual practice (control)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Default initiation

Intervention Type BEHAVIORAL

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

Interventions

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Default initiation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Bekelman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Mitesh Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31246224 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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826810

Identifier Type: -

Identifier Source: org_study_id