Cancer
Conditions
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.
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.
Interventions
BEHAVIORALDefault initiation
A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Receiving Daily Imaging | 3 months post arm crossover | Radiology tests including x-rays and CT scans |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 679 |
| 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 | 509 |
| Total | 1,188 |
Baseline characteristics
| Characteristic | Total | Intervention | Usual Practice (Control) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 588 Participants | 250 Participants | 338 Participants |
| Age, Categorical Between 18 and 65 years | 600 Participants | 259 Participants | 341 Participants |
| ECOG Performance Status 0 | 158 participants | 66 participants | 92 participants |
| ECOG Performance Status 1 | 345 participants | 145 participants | 200 participants |
| ECOG Performance Status 2 | 339 participants | 133 participants | 206 participants |
| ECOG Performance Status 3 | 272 participants | 121 participants | 151 participants |
| ECOG Performance Status 4 | 53 participants | 26 participants | 27 participants |
| ECOG Performance Status Missing | 21 participants | 18 participants | 3 participants |
| Insurance Commercial | 525 Participants | 229 Participants | 296 Participants |
| Insurance Medicaid | 100 Participants | 54 Participants | 46 Participants |
| Insurance Medicare | 563 Participants | 226 Participants | 337 Participants |
| Number of patients receiving dose per fraction 201-300 doses per fraction | 817 Participants | 308 Participants | 509 Participants |
| Number of patients receiving dose per fraction 301-400 doses per fraction | 291 Participants | 154 Participants | 137 Participants |
| Number of patients receiving dose per fraction Greater than 400 doses per fraction | 16 Participants | 9 Participants | 7 Participants |
| Number of patients receiving dose per fraction Less than or equal to 200 doses per fraction | 64 Participants | 38 Participants | 26 Participants |
| Number of Patients Receiving Fractions 11-15 total fractions per course | 155 Participants | 51 Participants | 104 Participants |
| Number of Patients Receiving Fractions 15+ total fractions per course | 35 Participants | 19 Participants | 16 Participants |
| Number of Patients Receiving Fractions 2-5 total fractions per course | 318 Participants | 162 Participants | 156 Participants |
| Number of Patients Receiving Fractions 6-10 total fractions per course | 680 Participants | 277 Participants | 403 Participants |
| Prior Radiation | 649 Participants | 268 Participants | 381 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black non-hispanic | 261 Participants | 114 Participants | 147 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Missing | 46 Participants | 25 Participants | 21 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 78 Participants | 37 Participants | 41 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White non-hispanic | 803 Participants | 333 Participants | 470 Participants |
| Sex: Female, Male Female | 615 Participants | 268 Participants | 347 Participants |
| Sex: Female, Male Male | 573 Participants | 241 Participants | 332 Participants |
| Target Type Bone | 620 Participants | 275 Participants | 345 Participants |
| Target Type Brain | 186 Participants | 82 Participants | 104 Participants |
| Target Type Multiple Sites | 146 Participants | 49 Participants | 97 Participants |
| Target Type Soft Tissue | 236 Participants | 103 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 679 | 0 / 509 |
| other Total, other adverse events | 0 / 679 | 0 / 509 |
| serious Total, serious adverse events | 0 / 679 | 0 / 509 |
Outcome results
Primary
Percent of Patients Receiving Daily Imaging
Radiology tests including x-rays and CT scans
Time frame: 3 months post arm crossover
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Practice (Control) | Percent of Patients Receiving Daily Imaging | 679 Participants |
| Intervention | Percent of Patients Receiving Daily Imaging | 509 Participants |