Importance:Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question. Objective:To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method. Design, Setting, and Participants:This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020. Interventions:Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily. Main Outcomes and Measures:The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment. Conclusions and Relevance:As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD. Trial Registration:ClinicalTrials.gov Identifier: NCT02697916.

Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type

Introduction We developed a service to identify potential study participants through electronic medical records and deliver study invitations through patient portals. Methods The service was piloted in a cohort study that used multiple recruitment methods. Results Patient portal messages were sent to 1303 individuals and the enrollment rate was 10% (n=127). The patient portal enrollment rate was significantly higher than email and post mail (4%) strategies. Conclusion Patient portal messaging was an effective recruitment strategy.

Background: Decentralization of ART services scaled up significantly with the country wide roll out of option B plus in Uganda. Little work has been undertaken to examine population level access to HIV care particularly in hard to reach areas in rural Africa. Most work on ART scale up has been done at health facility level which omits people not accessing healthcare in the community. This study describes health service usage, particularly HIV testing and care in 2/6 parishes of Lapono sub-county of northern Uganda, prior to introduction of ART services in Lira Kato Health Centre (a local lower-level health centre III), as part of ART decentralization.Methods: Household and individual questionnaires were administered to household members (aged 15-59 years). Logit random effects models were used to test for differences in proportions (allowing for clustering within villages).Results: 2124 adults from 1351 households were interviewed (755 [36 %] males, 1369 [64 %] females). 2051 (97 %) participants reported seeking care locally for fever, most on foot and over half at Lira Kato Health Centre. 574 (76 %) men and 1156 (84 %) women reported ever-testing for HIV (P < 0.001 for difference); 34/574 (6 %) men and 102/1156 (9 %) women reported testing positive (P = 0.04). 818/850 (96 %) women who had given birth in the last 5 years had attended antenatal care in their last pregnancy: 7 women were already diagnosed with HIV (3 on ART) and 790 (97 %) reported being tested for HIV (34 tested newly positive). 124/136 (91 %) HIV-positive adults were in HIV-care, 123/136 (90 %) were taking cotrimoxazole and 74/136 (54 %) were on ART. Of adults in HIV-care, most were seen at Kalongo hospital (n = 87), Patongo Health Centre (n = 7) or Lira Kato Health Centre (n = 23; no ART services). 58/87, 5/7 and 20/23 individuals walked to Kalongo hospital (56 km round-trip, District Health Office information), Patongo Health Centre (76 km round-trip, District Health Office information) and Lira Kato Health Centre (local) respectively. 8 HIV-infected children were reported; only 2 were diagnosed aged < 24 months: 7/8 were in HIV-care including 3 on ART.Conclusions: Higher proportions of women compared to men reported ever-testing for HIV and testing HIV-positive, similar to other surveys. HIV-infected men and women travelled considerable distances for ART services. Children appeared to be under-accessing testing and referral for treatment. Decentralization of ART services to a local health facility would decrease travel time and transport costs, making care and treatment more easily accessible.

Effective web-assisted tobacco interventions (WATIs) have been underutilized by smokers; moreover, despite practice guideline recommendations, clinical teams do not routinely refer smokers to WATIs. Our goal was to test a clinical practice innovation, an ePortal designed to change practice and patient behavior. Our hypotheses were that the integrated system would result in increased smoker referrals, with an automated follow-up system resulting in more smoker registrations and finally augmentations of the WATI would result in more smokers quitting at 6 months.

LBA5000 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Sunday, June 2, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Sunday edition of ASCO Daily News.