Adult Primary and Preventive Practice (APPP) Study (APPP)

June 18, 2018 updated by: Qure Healthcare, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • QURE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control: not receiving any intervention
Experimental: Intervention 1
Receiving educational materials on a new diagnostic service
Other: Educational materials on a new diagnostic service
Educational materials on a new diagnostic service
Experimental: Intervention 2
Receiving educational materials on a new diagnostic service
Other: Educational materials on a new diagnostic service
Educational materials on a new diagnostic service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Care
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Impact on Care
Time Frame: 8 weeks
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
Healthcare Utilization
Time Frame: 8 weeks
Difference in health care utilization and/or costs in patients tested with SimpliPro Colon™ versus the control group.
8 weeks
Diagnostic Method Comparison
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qure Healthcare, LLC

Collaborators

Applied Proteomics Inc

Investigators

  • Principal Investigator: John Peabody, MD, PhD, QURE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Pro000018813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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