Trial Outcomes & Findings for Cancer Prevention Clinical Decision Support (NCT NCT02986230)
NCT ID: NCT02986230
Last Updated: 2024-01-24
Results Overview
Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35953 participants
Primary outcome timeframe
1 year post index date
Results posted on
2024-01-24
Participant Flow
Patients were accrued if they were not up to date on breast, cervical, or colorectal cancer screening, or not up to date on HPV vaccine at the index visit. Eligibility was determined using automated algorithms.
Cluster randomization of the 34 primary care clinics was done to minimize contamination. Pre-randomization balance factors included: 1) clinic urbanicity, and 2) percentage of women at each clinic up to date on breast cancer screening. The first concealed randomization scheme meeting balance criteria was selected. 35953 participants were allocated to one of three groups (i.e. Started). The number Completed reflects the number of subjects included in final analysis after exclusions and opt outs.
Unit of analysis: primary care clinics
Participant milestones
| Measure |
CP-CDS
The CP-CDS group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
CP-CDS + SDMT
The SDMT-focused group will receive the point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
Usual Care
Patients of providers practicing at clinics assigned to the usual care arm will have no access to the CP-CDS or CP-CDS + SDMTs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11402 11
|
10138 11
|
14413 12
|
|
Overall Study
COMPLETED
|
10122 11
|
9034 11
|
12960 12
|
|
Overall Study
NOT COMPLETED
|
1280 0
|
1104 0
|
1453 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cancer Prevention Clinical Decision Support
Baseline characteristics by cohort
| Measure |
CP-CDS
n=10122 Participants
Providers practicing in the PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
CP-CDS + SDMT
n=9034 Participants
Providers practicing in the SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
Usual Care
n=12960 Participants
Providers practicing at clinics assigned to the usual care arm will have no access to the CP Wizard.
|
Total
n=32116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 17.2 • n=93 Participants
|
47.9 years
STANDARD_DEVIATION 17.5 • n=4 Participants
|
47.7 years
STANDARD_DEVIATION 17.3 • n=27 Participants
|
48.0 years
STANDARD_DEVIATION 17.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
6725 Participants
n=93 Participants
|
5870 Participants
n=4 Participants
|
8532 Participants
n=27 Participants
|
21127 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3397 Participants
n=93 Participants
|
3164 Participants
n=4 Participants
|
4428 Participants
n=27 Participants
|
10989 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
116 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
397 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9917 Participants
n=93 Participants
|
8863 Participants
n=4 Participants
|
12670 Participants
n=27 Participants
|
31450 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
89 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
269 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
261 Participants
n=93 Participants
|
169 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
585 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
74 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
211 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
19 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
164 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
485 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
9459 Participants
n=93 Participants
|
8548 Participants
n=4 Participants
|
12343 Participants
n=27 Participants
|
30350 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
145 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
165 Participants
n=27 Participants
|
431 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 1 year post index datePopulation: Analysis population included adult patients ages 21-75 who had a visit at a study clinic over the accrual period, and who were due for one or more breast, cervical, or colorectal cancer screening test.
Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.
Outcome measures
| Measure |
CP-CDS
n=7987 Participants
The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
CP-CDS + SDMT
n=7105 Participants
The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
Usual Care
n=10106 Participants
Providers practicing at clinics assigned to the usual care arm will have no access to the CP Wizard.
|
|---|---|---|---|
|
Composite Cancer Screening Tests up to Date
|
3087 Participants
|
2590 Participants
|
3866 Participants
|
PRIMARY outcome
Timeframe: 1 year post index datePopulation: Young adults ages 18-26 with a visit at a study clinic during the accrual period, and not up to date on HPV vaccination.
Participants up to date on HPV vaccination at 1 year post index date.
Outcome measures
| Measure |
CP-CDS
n=1511 Participants
The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
CP-CDS + SDMT
n=1470 Participants
The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
Usual Care
n=2073 Participants
Providers practicing at clinics assigned to the usual care arm will have no access to the CP Wizard.
|
|---|---|---|---|
|
HPV Vaccination up to Date
|
90 Participants
|
69 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 1 year post index datePopulation: Adult patients with a visit at a study clinic and not up to date for lung cancer screening at index date.
Participants up to date on lung cancer screening at 1 year post index date.
Outcome measures
| Measure |
CP-CDS
n=624 Participants
The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
CP-CDS + SDMT
n=459 Participants
The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
CP-CDS: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
|
Usual Care
n=781 Participants
Providers practicing at clinics assigned to the usual care arm will have no access to the CP Wizard.
|
|---|---|---|---|
|
Lung Cancer Screening up to Date
|
200 Participants
|
104 Participants
|
198 Participants
|
Adverse Events
CP-CDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
CP-CDS + SDMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 26 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place