Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment
Phase: NA
Conditions: Cancer
Sponsor: University of Pennsylvania

Health System Initiative to Reduce Unnecessary Daily X-
Ray Image Guidance During Palliative Radiation Treatment 
Final Study Protocol 
                January 25, 2017
ClinicalTrials.gov NCT Number: NCT03110692

 
Outline 
1. Abstract 
2. Overall objectives 
3. Aims 
 
3.1 Primary outcome 
4. Background 
 
4.1 Value-based cancer care 
 
4.2 Image-guided radiotherapy  
 
4.3 Preliminary data 
 
4.4 Default options 
 
4.5 Quality improvement initiatives in the Radiation Oncology Department  
5. Study design 
 
5.1 Design 
 
5.2 Study duration 
 
5.3 Target population 
 
5.4 Accrual 
 
5.5 Key inclusion criteria 
 
5.6 Key exclusion criteria 
6. Subject recruitment 
7. Subject compensation 
8. Study procedures 
 
8.1 Consent 
 
8.2 Procedures 
 
8.3 Coin-flip to select initial site (randomization) 
9. Analysis plan 
10. Investigators 
11. Human research protection 
 
11.1 Data confidentiality 
 
11.2 Subject confidentiality 
 
11.3 Subject privacy 
 
11.4 Data disclosure 
 
11.5 Data safety and monitoring 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
 
 
11.6.2 Potential study benefits 
 
 
11.6.3 Risk/benefit assessment 
 
 

1. Abstract 
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 pragmatic stepped wedge 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.  
 
2. Overall objectives 
The purpose of this study is to reduce preference sensitive, unnecessary daily imaging during 
radiation treatment with the implementations 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. 
 
3. Aims 
 
3.1 Primary outcome 
The primary objective of this study is to reduce unnecessary daily imaging during palliative 
radiation treatments.  
 
4. Background 
4.1 Value-based cancer care. With exponentially rising healthcare costs, providers practice 
medicine in an increasingly value conscious environment.1–5 Physicians are encouraged to reduce 
low-value care by eliminating unnecessary tests and procedures, thus, reducing healthcare costs 
at large. However, methods to optimally promote high value care are still under evaluation.   
 
Radiation oncology, in specific, has come under scrutiny for expensive treatments and rising 
costs particularly with the advent of newer treatment technologies over the past 15 years.5–7 We 
aim to reduce low value care in a multi-site radiation oncology clinical practice.  
 
4.2 Image-guided radiotherapy. Image-guided radiation therapy (IGRT) is a tool used in 
radiotherapy to ensure reproducible patient positioning during treatment. The two main 
technologies used to perform IGRT are kilovoltage x-ray images (KV), which are x-ray images 
to check patient alignment, and conebeam computed tomography (CBCT), which is a CT scan 
(also ‘x-ray’ based) done on the radiation treatment table. Regardless of whether IGRT is used, 
all patients have daily clinical positioning using immobilization devices and a calibrated 
treatment table with 3-dimensional lasers aligned to small tattoos placed on the body at the time 
of treatment planning. 
 
The role of IGRT is evolving in the field of radiation oncology. While evidence for its clinical 
utility is uncertain or even limited in certain clinical situations,8,9 IGRT is used extensively 
amongst radiation oncologists and its use is projected to increase further.10 However, daily 
imaging beyond clinical positioning adds significant additional radiation exposure and increases 
the total time on the treatment table for patients who are often in pain or have limited mobility. 

Given the limited evidence and lack of clarity regarding ideal use of IGRT, and the fact that all 
patients receive daily clinical positioning, insurance companies are increasingly denying the 
charges associated with such procedures. Furthermore, daily IGRT also places a considerable 
strain on clinic resources and efficiency.11 
 
Overuse of IGRT is particularly apparent during palliative radiation treatments. Our department 
has demonstrated that for the palliative treatment of brain metastases standard, clinical 
immobilization and setup techniques without the use of daily IGRT are sufficient for treatment in 
routine cases.8 Moreover, evidence-based guidelines clearly state that “IGRT generally is not 
medically necessary in the palliative setting.”12 Yet despite uncertain clinical need and 
decreasing reimbursements, physicians often reflexively order daily imaging for treatment. 
 
4.3. Preliminary data. At our institution, across the University of Pennsylvania Health System 
(UPHS) Radiation Oncology network, 79% of palliative intent radiation courses over the past 
year (August 2015 – August 2016) utilized daily x-ray image guidance as part of the treatment 
paradigm. As shown in Table 1, despite clinical guidelines recommending against the use of 
daily IGRT in palliative cases, 83% of bone metastases, 82% of soft tissue metastases, and 57% 
of palliative brain/ CNS cases employed daily IGRT during the associated radiation treatment 
course. 
 
Table 1: Use of Daily IGRT in Palliative Cases at UPHS by Treatment Indication  
 
*Daily IGRT defined as at least 80% (i.e., 4 of 5 days, on average) of treated fractions in a 
treatment course have IGRT 
**SBRT: Stereotactic Body Radiation Therapy 
 
As shown in Table 2, the total number of palliative courses and associated daily IGRT varies 
across our main site and satellites. Our main site, the Perelman Center for Advanced Medicine 
(PCAM), has the highest volume of cases overall, and, hence, the highest number of palliative 
courses. All sites across the UPHS radiation oncology network, however, demonstrate high 
levels of daily IGRT usage in palliative courses. Over the past year, the number of palliative 
courses treated at each department was roughly stable over time as shown in Table 3, other than 
a slight rise in the number of cases treated during the month of June.  
 
 
 
 

Table 2: Use of Daily IGRT in Palliative Cases by UPHS Radiation Oncology Department 
Location 
 
**PCAM: Perelman Center for Advanced Medicine; PAH: Pennsylvania Hospital; CHH: 
Chestnut Hill Hospital; DH: Doylestown Hospital; VF: Valley Forge 
 
Table 3: Monthly Frequency of Palliative Courses  
 
 
*PCAM: Perelman Center for Advanced Medicine 
**Non-PCAM consists of satellites at Pennsylvania Hospital, Chestnut Hill Hospital, 
Doylestown Hospital, and Valley Forge 
 
4.4. Default options. We have described how default options can be an effective means of 
reducing low-value services in cancer care and other healthcare settings.13–15 Defaults may 
promote high-value care by introducing a treatment standard indicative of evidence-based 
guidelines or institutional recommendations.15 For instance, in our own health system, a change 
in default drug prescription options in the electronic health record (EHR) has been successfully 
leveraged to reduce the prescription of low-value, brand name medications.13 Default options 
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
PCAM
37
57
57
51
43
65
48
53
51
53
64
44
Non-PCAM
12
12
13
18
23
29
11
19
15
18
13
19
0
10
20
30
40
50
60
70
Number of Palliative
Courses
Monthly Frequency of Palliative Courses
PCAM
Non-PCAM

provide a unique means of influencing decision-making while preserving physician choice; 
importantly, default prescriptions may be altered by treating physicians to best serve the needs 
of their patients.15–17  
 
At Penn Radiation Oncology, default prescriptions for radiation are the norm. These defaults 
exist currently in non-palliative settings and involve template prescription order sets that contain 
default settings. These default prescription templates improve clinic workflow and standardize 
clinical care. Importantly, as always with default prescription options, physician choice is 
preserved.  
 
In the initiative proposed herein, we aim to introduce a default prescription template in the 
palliative setting. This effort is part of the department’s overarching quality improvement 
initiative to standardize treatment approaches. With defaults, the physician has the option to alter 
default order sets to fit their clinical decisions. This is true for all other default prescription order 
sets already in use in our clinic. In other words, default options for curative, non-palliative 
treatments are currently standard of care in our clinic as a means of improving efficiency and 
standardizing care across our network, and we plan to rollout default options for palliative 
treatments in order to reduce unnecessary daily image guided radiation.  
 
4.5 Quality Improvement Initiatives in the Radiation Oncology Department: The Penn Medicine 
Department of Radiation Oncology (also called Penn Radiation Oncology) has a long history of 
excellence in quality improvement and safety initiatives. QI initiatives are typically implemented 
first at either PCAM or non-PCAM sites and then rolled out to the entire clinical practice.  
Continuous quality improvement is conducted though monitoring and comparisons of physician 
and site rates of care delivery, depending on the focus of the QI initiative, and iterative changes 
to improve initiatives are then implemented over time. In this study, we leverage the existing 
departmental processes for QI implementation, and we will choose the first site of intervention 
implementation by coin flip rather than arbitrarily as has been done in the past. 
 
Our study is sponsored and approved by our health systems partners including the Office of the 
Chair of Radiation Oncology and the Penn Medicine Nudge Unit. 
 
5. Study design 
 
5.1 Design 
In this study, we propose to leverage a pre-planned departmental initiative of default 
prescriptions to reduce unnecessary daily x-ray imaging in palliative radiation treatments. 
 
This study follows a pragmatic stepped wedge design 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. One group is comprised of physicians who practice at the Perelman Center for 
Advanced Medicine (PCAM). Another group is comprised of non-PCAM physicians at our 
network satellites (Pennsylvania Hospital, Chestnut Hill Hospital, Doylestown Hospital, and 
Valley Forge). As is standard practice for implementation of QI initiatives in our department, we 
will implement the intervention at one network site prior to implementing the intervention at all 

sites. These groups will be assigned to the intervention or usual care at the start of the study by 
coin flip. Subsequently, the usual practice group will rollover into the default intervention. 
 
Intervention. The default intervention will be started in February 2017. It will be comprised of 
default prescription order sets that do not include daily imaging for brain/ CNS, bone, and soft 
tissue metastases (See Figure 1). The defaults will be immediately preceded by a department 
wide session with intervention group physicians and therapy staff announcing the initiation of 
the intervention. Thus, as is usual practice in the department, physicians and department staff 
will be aware and educated on the QI initiative at the time of implementation. Default 
prescription order sets will be created in Aria (the radiation oncology electronic health record) 
for specific palliative treatment indications, namely brain/CNS, bone, soft tissue, and other 
palliative cases.  
 
Figure 1: Example of Default IGRT Prescription for Palliative Cases 
 
 
Figure 2: Study Framework 
  
 

*Coin flip to determine initial intervention vs. usual care group:  
Group 1: PCAM Physicians 
Group 2: Non-PCAM Physicians (Pennsylvania Hospital, Chestnut Hill Hospital, Doylestown 
Hospital, and Valley Forge) 
 
The study will involve our entire physician network across the UPHS Radiation Oncology 
network, including both PCAM and regional network facilities (Pennsylvania Hospital, Chestnut 
Hill Hospital, Doylestown Hospital, and Valley Forge).  
 
 
5.2 Study duration 
The duration of the study will be 27 months, including the 12 retrospective pre-intervention study 
period, 1 month for the intervention, 2 months for the first post-intervention study period, 1 month 
for the control to cross over to the intervention, and 2 additional months for observation in which 
all physicians are exposed. Analysis of data and dissemination of results will occur in the 9 month 
period following the 2nd post-intervention period.  
. 
 
5.3 Target population 
The study will include a total of ~29 subjects (UPHS radiation oncologists) and 5 sites across the 
UPHS network (Perelman Center for Advanced Medicine, Pennsylvania Hospital, Chestnut Hill 
Hospital, Doylestown Hospital, and Valley Forge) that treat about 800 palliative patients a year. 
The University of Pennsylvania Radiation Oncology network (both PCAM and satellites) will be 
the only site of this study.  
 
 
5.4 Accrual 
Radiation oncology physicians will be recruited from the University of Pennsylvania Health 
System.   
 
5.5 Key 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 
 
5.6 Key exclusion criteria 
- 
Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as 
radiation treatment modality  
- 
Retreatment to same site  
- 
Proton radiation  
 
6. Subject recruitment 
Not applicable. Subjects will include all UPHS radiation oncologists. As a result, no recruitment 
will be needed in this study.  
 
7. Subject compensation 
No compensation will be offered in this study. 
 
8. Study procedures 

 
8.1 Consent 
A waiver of informed consent is requested.  This is a departmental quality improvement 
initiative that will be implemented regardless of the study we propose.  The study is to evaluate 
that quality improvement initiative.  Without a waiver of the consent, the initiative would still be 
implemented by the health system, but the study would be infeasible.  Additionally, consenting 
every patient and physician would make the study impossible to conduct. As mentioned, this 
initiative would occur with or without the study of it.  Furthermore, if physician members of the 
usual care group were consented, they would know they were being studied and this could bias 
their behavior, which would make our findings difficult to interpret. Moreover, physicians are 
not being forced to change their prescription of image guidance in radiation.  Instead, they are 
being reminded of evidence-based guidelines and offered a default option which can be altered. 
The physician would continue to prescribe radiation treatment and whichever imaging they 
believe is appropriate for the patient.  The intervention is simply a default option for the 
physician and makes their care process easier to conduct.     
 
 
8.2 Procedures 
Data on use of daily imaging will be obtained from Aria. De-identified patient-level 
demographic and disease-specific data will also be obtained from EPIC, including patient age, 
race, gender, cancer diagnosis, and insurance provider. Billing information associated with the 
IGRT CPT codes used in the pre and post-intervention radiation courses will be obtained from 
our revenues department. 
 
 
8.3 Coin-flip to select initial site (randomization)  
Group 1 (PCAM physicians) and 2 (non-PCAM physicians) will be assigned to either the 
intervention or control group prior to study initiation by coin flip (rather than arbitrarily as has 
been done in past QI efforts). The control group will then rollover to the intervention arm after 2 
months.  
 
9. Analysis plan 
The primary analysis will use a mixed effects logistic regression model, where the unit of 
analysis is an individual patient, the outcome is use of daily x-ray imaging and the explanatory 
variables are time (pre-intervention vs. post-intervention period), dummy variable for whether 
the intervention is received, group (PCAM vs. satellite providers) and physician random effects.  
The coefficient of interest is the coefficient of whether the intervention is received.  The 
physician random effects account for the clustering by physician.  The study is analyzed at the 
physician level (patients clustered within physicians) rather than the practices site level because 
there are only two practice sites. Of the two practice sites – PCAM vs. non-PCAM sites – one 
group will be assigned to the intervention for the entire intervention period by coin flip, and the 
other group of providers will be assigned to the control for the first two months of the 
intervention period and then the intervention for the remaining four periods of the intervention. 
Randomly assigning the order of practice sites exposed to the intervention helps to blunt 
selection bias. For this analysis, we have 89% power to detect an effect of the intervention that 
reduces the probability of daily imaging by 0.2 for each physician.   
 
10. Investigators 

Sonam Sharma, MD: Principal Investigator (PI), Chief Resident, Department of Radiation 
Oncology at the Perelman School of Medicine at the University of Pennsylvania 
 
Justin Bekelman, MD: Co-investigator, Associate Professor of Radiation Oncology and Medical 
Ethics & Health Policy Faculty, Senior Fellow at the Leonard Davis Institute for Health 
Economics.  
 
Mitesh Patel, MD, MBA, MS: Director, Penn Medicine Nudge Unit, Assistant Professor of 
Medicine and Health Care Management at the Perelman School of Medicine at the University of 
Pennsylvania  
 
Greg Kurtzman, BA: Clinical Research Coordinator, Penn Medicine Nudge Unit at the Perelman 
School of Medicine at the University of Pennsylvania  
 
Dylan Small: Professor, Department of Statistics, The Wharton School at the University of 
Pennsylvania 
 
Joshua Jones, MD: Assistant Professor, Department of Radiation Oncology at the Perelman 
School of Medicine at the University of Pennsylvania 
 
David Guttmann, MD, MTR: Resident, Department of Radiation Oncology at the Perelman 
School of Medicine at the University of Pennsylvania 
 
Peter Gabriel, MD MSE: Assistant Professor, Department of Radiation Oncology at the 
Perelman School of Medicine at the University of Pennsylvania 
 
11. Human research protection 
 
11.1 Data confidentiality 
Data will be collected on HIPAA-secure UPHS computers and computer-based files will be 
password-protected and available only to study personnel. When possible, patient identifiers will 
be removed from data files. Any patient or physician level data obtained will be used only for 
research purposes. All members of the research team will complete HIPAA and CITI training to 
remain compliant with PHI protection. Only trained study staff will have access to the code that 
links the unique identifier to the subject’s identity. Electronic data will be stored on secure, 
password-protected firewalled servers at UPHS. 
 
 
11.2 Subject confidentiality 
Data on physicians and patients will be obtained from EPIC. Any information that is obtained 
will be used for research purposes only.  Information on patients will only be disclosed within 
the study team.  All study staff will be reminded of the confidential nature of the data collected 
and contained in these databases. 
 
 
11.3 Subject privacy 
All efforts will be made by study staff to ensure subject privacy.  Data will be evaluated in a de-
identified manner whenever possible. 
 

 
11.4 Data disclosure 
Information on patients will only be disclosed within the study team.  
 
 
11.5 Data safety and monitoring 
The investigator will provide oversight for the study evaluation of this intervention.  Physician 
practices will follow their standards of care to treat patients with palliative radiation. The study 
PI will be responsible for ensuring the ongoing quality and integrity of the research study. 
 
11.6 Risk/benefit  
 
 
11.6.1 Potential study risks 
The potential risks from this study and the intervention are minimal. Patients will continue to 
receive the standard of care in terms of radiation treatment as per their physician provider. 
Subjects in the study (UPHS radiation oncologists) will have minimal risk of harm. Breach of 
data is a potential risk that will be addressed as described above with the use of HIPAA 
compliant, password-protected electronic files, and secure data servers at UPHS.    
 
 
 
11.6.2 Potential study benefits 
The direct benefits of this study to the study participants (UPHS radiation oncologists) are 
minimal. The intervention to change defaults will promote evidence-based decision making. It 
will also have the indirect benefit of reducing radiation exposure for patients by decreasing the 
number of unnecessary images taken for patient positioning during treatment. Additional indirect 
benefits may include reducing costs and improving efficiency in the clinic by decreasing the use 
of daily imaging and patient time on the treatment table.  
 
 
 
11.6.3 Risk/benefit assessment 
Given the minimal risks to study participants and patients with an intervention to promote high-
value care while maintaining standard radiation treatments, the benefits of this study (reducing 
low-value care, decreasing costs, reducing patient radiation exposure, improving clinic 
efficiency) outweigh the potential, minimal risks associated with the intervention.  
 
 
 

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