CancerNCT03110692
Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation
A study testing Default initiation in people with Cancer, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Default initiation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,188 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2016to 9 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiation treatment courses with palliative intent
- Palliative treatment of bone, soft tissue, and intracranial metastases
- Photon radiation with 3D conformal therapy (3DCRT) only
Who cannot join
- Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as radiation treatment modality
- Retreatment to same site
- Proton radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Default initiation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default initiationBehavioural
A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Default initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Receiving Daily Imaging
Radiology tests including x-rays and CT scans
Measured: 3 months post arm crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start10 Feb 2016
- Primary completion9 Oct 2017
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin Bekelman, MD, Principal investigator, University of PennsylvaniaMitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110692
- Sponsor's protocol ID
- 826810
- Status last verified
- Nov 2019
- First submitted
- 29 Mar 2017
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31246224
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health System Initiative to Reduce Unnecessary Daily X-Ray Image Guidance During Palliative Radiation Treatment
- ClinicalTrials.gov ID
- NCT03110692
- Acronym / sponsor ID
- 826810
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual practice (control) | No intervention | –The usual practice group will rollover to the intervention arm after 3 months. |
| Intervention | Experimental | Behavioral: Default initiationDefault initiation: Introduce a default prescription template in the palliative setting in order to reduce unnecessary daily image guided radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiation treatment courses with palliative intent
- Palliative treatment of bone, soft tissue, and intracranial metastases
- Photon radiation with 3D conformal therapy (3DCRT) only
Key exclusion criteria (3 listed)
- Use of intensity modulated radiation (IMRT) or stereotactic body radiation (SBRT) as radiation treatment modality
- Retreatment to same site
- Proton radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default initiationA default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. | Behavioural | Intervention |
Primary outcome
Percent of Patients Receiving Daily Imaging
Time frame: 3 months post arm crossover
Radiology tests including x-rays and CT scans
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31246224Sharma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Bekelman, MD principal investigator
University of Pennsylvania
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default initiation in people with Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients Receiving Daily Imaging (time frame: 3 months post arm crossover). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03110692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.