Adult Primary and Preventive Practice (APPP) Study

Study Overview
=================
Brief 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.

Official Title
-----------------
Adult Primary and Preventive Practice (APPP) Study

Conditions
-----------------
Preventive Care

Intervention / Treatment
-----------------
* Other: Educational materials on a new diagnostic service


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Healthcare Utilization | Difference in health care utilization and/or costs in patients tested with SimpliPro Colon™ versus the control group. | 8 weeks | 
| 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 |