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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default initiation | Behavioral | A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Receiving Daily Imaging | Radiology tests including x-rays and CT scans | 3 months post arm crossover |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Bekelman, MD | University of Pennsylvania | Principal Investigator |
| Mitesh Patel, MD, MBA, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31246224 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Practice (Control) | The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017 |
| FG001 | Intervention | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Practice (Control) | The usual practice group will rollover to the intervention arm after 3 months following the start of the default intervention in Feb 2017. |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Receiving Daily Imaging | Radiology tests including x-rays and CT scans | Posted | Count of Participants | Participants | 3 months post arm crossover |
|
Through study completion (1 year from study start)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Practice (Control) | The usual practice group will rollover to the intervention arm 3 months after the start of the default intervention group in Feb. 2017 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mitesh S. Patel | Perelman School of Medicine, University of Pennsylvania | 215-898-3367 | mpatel@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2017 | Oct 14, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Nov 19, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ECOG Performance Status | The ECOG (Eastern Cooperative Oncology Group) Performance Status is used to classify a patient according to their functional status. It assesses how the disease affects the daily living abilities of the patient, and to help determine treatment and prognosis. Scale Ranking 0- Fully active, able to carry on all pre-disease performance without restriction 1 2 3- 4-Completely disabled, cannot carry on any selfcare, totally confined to bed or chair | Number | participants |
|
| Insurance | Count of Participants | Participants |
|
| Target Type | Count of Participants | Participants |
|
| Prior Radiation | Count of Participants | Participants |
|
| Number of Patients Receiving Fractions | The measure shows the proportion of patients that received X number of fractions per course | Count of Participants | Participants |
|
| Number of patients receiving dose per fraction | The total radiation dose is divided up into several fractions. Each fraction contains a small amount of radiation that gradually accumulates to form the total dose. The measure displayed shows the proportion of patients that received the dose per fraction. | Count of Participants | Participants |
|
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| 0 |
| 679 |
| 0 |
| 679 |
| 0 |
| 679 |
| EG001 | Intervention | 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 | 0 | 509 | 0 | 509 | 0 | 509 |
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