Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03110692
• Collaborator: (none)
• Enrollment: 1,188
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 49.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Default initiation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1188 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Health Services Research
• Official Title: Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment
• Actual Study Start Date: Feb 10, 2016
• Actual Primary Completion Date: Oct 9, 2017
• Actual Study Completion Date: Feb 9, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percent of Patients Receiving Daily Imaging [3 months post arm crossover]

   Radiology tests including x-rays and CT scans

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Justin Bekelman, MD, University of Pennsylvania
• Principal Investigator: Mitesh Patel, MD, MBA, MS, University of Pennsylvania

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 17, 2017
• Study Protocol - Jan 25, 2017

More Information

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03110692
• Other Study ID Numbers: 826810
• First Posted: Apr 12, 2017
• Last Update Posted: Dec 9, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Usual Practice (Control)	Intervention
Arm/Group Description	The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017	Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation. Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. To start in Feb 2017 and continue in the intervention through Feb 2018
Period Title: Overall Study
STARTED	679	509
COMPLETED	679	509
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Usual Practice (Control)	Intervention	Total
Arm/Group Description	The usual practice group will rollover to the intervention arm after 3 months following the start of the default intervention in Feb 2017.	Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation. Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. To start in Feb 2017 and continue in the intervention through Feb 2018	Total of all reporting groups
Overall Participants	679	509	1188
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	341 50.2%	259 50.9%	600 50.5%
>=65 years	338 49.8%	250 49.1%	588 49.5%
Sex: Female, Male (Count of Participants)
Female	347 51.1%	268 52.7%	615 51.8%
Male	332 48.9%	241 47.3%	573 48.2%
Race/Ethnicity, Customized (Count of Participants)
White non-hispanic	470 69.2%	333 65.4%	803 67.6%
Black non-hispanic	147 21.6%	114 22.4%	261 22%
Other	41 6%	37 7.3%	78 6.6%
Missing	21 3.1%	25 4.9%	46 3.9%
ECOG Performance Status (participants) [Number]
0	92 13.5%	66 13%	158 13.3%
1	200 29.5%	145 28.5%	345 29%
2	206 30.3%	133 26.1%	339 28.5%
3	151 22.2%	121 23.8%	272 22.9%
4	27 4%	26 5.1%	53 4.5%
Missing	3 0.4%	18 3.5%	21 1.8%
Insurance (Count of Participants)
Medicaid	46 6.8%	54 10.6%	100 8.4%
Medicare	337 49.6%	226 44.4%	563 47.4%
Commercial	296 43.6%	229 45%	525 44.2%
Target Type (Count of Participants)
Bone	345 50.8%	275 54%	620 52.2%
Brain	104 15.3%	82 16.1%	186 15.7%
Soft Tissue	133 19.6%	103 20.2%	236 19.9%
Multiple Sites	97 14.3%	49 9.6%	146 12.3%
Prior Radiation (Count of Participants)
Count of Participants [Participants]	381 56.1%	268 52.7%	649 54.6%
Number of Patients Receiving Fractions (Count of Participants)
2-5 total fractions per course	156 23%	162 31.8%	318 26.8%
6-10 total fractions per course	403 59.4%	277 54.4%	680 57.2%
11-15 total fractions per course	104 15.3%	51 10%	155 13%
15+ total fractions per course	16 2.4%	19 3.7%	35 2.9%
Number of patients receiving dose per fraction (Count of Participants)
Less than or equal to 200 doses per fraction	26 3.8%	38 7.5%	64 5.4%
201-300 doses per fraction	509 75%	308 60.5%	817 68.8%
301-400 doses per fraction	137 20.2%	154 30.3%	291 24.5%
Greater than 400 doses per fraction	7 1%	9 1.8%	16 1.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Practice (Control)	Intervention
Arm/Group Description	The usual practice group will rollover to the intervention arm after 3 months from start of the default intervention in Feb 2017.	Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation. Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. To start in Feb 2017 and continue in the intervention through Feb 2018
Measure Participants	679	509
Count of Participants [Participants]	679 100%	509 100%

Adverse Events

Time Frame	Through study completion (1 year from study start)
Arm/Group Title	Usual Practice (Control)		Intervention
Arm/Group Description	The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017		Default initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation. Default initiation: A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. To start in Feb 2017 and continue in the intervention through Feb 2018
All Cause Mortality
	Usual Practice (Control)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/679 (0%)		0/509 (0%)
Serious Adverse Events
	Usual Practice (Control)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/679 (0%)		0/509 (0%)
Other (Not Including Serious) Adverse Events
	Usual Practice (Control)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/679 (0%)		0/509 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.