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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02915653
Other study ID # Pro000018813
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date November 2017

Study information

Verified date June 2018
Source Qure Healthcare, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date November 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. English-speaking 7. Community / non-academic based practice setting 8. = 40 patients under care weekly 9. Access to the internet

Exclusion Criteria:

- 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have practiced as a board-certified physician for less than 2 or greater than 30 years 4. Follow <40 patients weekly 5. Non-English speaking 6. Unable to access the internet

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational materials on a new diagnostic service
Educational materials on a new diagnostic service

Locations

Country Name City State
United States QURE Healthcare San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Qure Healthcare, LLC Applied Proteomics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Care Difference in difference of combined diagnostic and treatment CPV domain scores, including colonoscopy referral rates, in post-intervention versus baseline comparing intervention and control groups among the three patient types. 8 weeks
Secondary Intervention Impact on Care Difference in difference between the control and intervention groups in the overall quality of care for CRC screening and for adult primary prevention care measured by the combined and individual item CPV scores for the three patient types. 8 weeks
Secondary Healthcare Utilization Difference in health care utilization and/or costs in patients tested with SimpliPro Colon™ versus the control group. 8 weeks
Secondary Diagnostic Method Comparison Difference in recommendation of CRC evaluation with colonoscopy and/or flexible sigmoidoscopy, double barium enema, or CT colonography, including risk-level and urgency pre- and post-intervention, between intervention and control groups 8 weeks
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