Trial Outcomes & Findings for Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation (NCT NCT03110692)
NCT ID: NCT03110692
Last Updated: 2019-12-09
Results Overview
Radiology tests including x-rays and CT scans
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1188 participants
Primary outcome timeframe
3 months post arm crossover
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
679
|
509
|
|
Overall Study
COMPLETED
|
679
|
509
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Default Options to Reduce Unnecessary Daily Imaging During Palliative Radiation
Baseline characteristics by cohort
| Measure |
Usual Practice (Control)
n=679 Participants
The usual practice group will rollover to the intervention arm after 3 months following the start of the default intervention in Feb 2017.
|
Intervention
n=509 Participants
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
n=1188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
341 Participants
n=99 Participants
|
259 Participants
n=107 Participants
|
600 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
338 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
588 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
347 Participants
n=99 Participants
|
268 Participants
n=107 Participants
|
615 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
332 Participants
n=99 Participants
|
241 Participants
n=107 Participants
|
573 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White non-hispanic
|
470 Participants
n=99 Participants
|
333 Participants
n=107 Participants
|
803 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black non-hispanic
|
147 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
261 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
41 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Missing
|
21 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
ECOG Performance Status
0
|
92 participants
n=99 Participants
|
66 participants
n=107 Participants
|
158 participants
n=206 Participants
|
|
ECOG Performance Status
1
|
200 participants
n=99 Participants
|
145 participants
n=107 Participants
|
345 participants
n=206 Participants
|
|
ECOG Performance Status
2
|
206 participants
n=99 Participants
|
133 participants
n=107 Participants
|
339 participants
n=206 Participants
|
|
ECOG Performance Status
3
|
151 participants
n=99 Participants
|
121 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
ECOG Performance Status
4
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
ECOG Performance Status
Missing
|
3 participants
n=99 Participants
|
18 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Insurance
Medicaid
|
46 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Insurance
Medicare
|
337 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
563 Participants
n=206 Participants
|
|
Insurance
Commercial
|
296 Participants
n=99 Participants
|
229 Participants
n=107 Participants
|
525 Participants
n=206 Participants
|
|
Target Type
Bone
|
345 Participants
n=99 Participants
|
275 Participants
n=107 Participants
|
620 Participants
n=206 Participants
|
|
Target Type
Brain
|
104 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Target Type
Soft Tissue
|
133 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Target Type
Multiple Sites
|
97 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Prior Radiation
|
381 Participants
n=99 Participants
|
268 Participants
n=107 Participants
|
649 Participants
n=206 Participants
|
|
Number of Patients Receiving Fractions
2-5 total fractions per course
|
156 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Number of Patients Receiving Fractions
6-10 total fractions per course
|
403 Participants
n=99 Participants
|
277 Participants
n=107 Participants
|
680 Participants
n=206 Participants
|
|
Number of Patients Receiving Fractions
11-15 total fractions per course
|
104 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Number of Patients Receiving Fractions
15+ total fractions per course
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Number of patients receiving dose per fraction
Less than or equal to 200 doses per fraction
|
26 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Number of patients receiving dose per fraction
201-300 doses per fraction
|
509 Participants
n=99 Participants
|
308 Participants
n=107 Participants
|
817 Participants
n=206 Participants
|
|
Number of patients receiving dose per fraction
301-400 doses per fraction
|
137 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
291 Participants
n=206 Participants
|
|
Number of patients receiving dose per fraction
Greater than 400 doses per fraction
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post arm crossoverRadiology tests including x-rays and CT scans
Outcome measures
| Measure |
Usual Practice (Control)
n=679 Participants
The usual practice group will rollover to the intervention arm after 3 months from start of the default intervention in Feb 2017.
|
Intervention
n=509 Participants
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
|
|---|---|---|
|
Percent of Patients Receiving Daily Imaging
|
679 Participants
|
509 Participants
|
Adverse Events
Usual Practice (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mitesh S. Patel
Perelman School of Medicine, University of Pennsylvania
Phone: 215-898-3367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place