The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established
dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link.
The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary
perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with
certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events
that may require high cost emergency department utilization and/or inpatient care. The sustainability of the
proposed intervention after the completion of the project is integrally linked to the health economic assessment
to show the health care cost savings. By integration with a rural primary care center, with an African American
majority and households with average incomes below the state average, the study ensures that the proposed
intervention to reduce stroke disparity is applicable to this target population.
Design and Procedures
The objective of this research proposal is to compare treatment strategies currently being used to treat an uncommon condition, symptomatic CAD, by conducting a prospective longitudinal observational study using a patient-centered web-based data capture. We will conduct several comparative research protocols prioritized by CAD survivor focus groups and surveys. The prospective component of COMPASS Pilot will utilize both the i2b2 and RFA database combined with additional follow up interviews of 100 CAD survivors at 6 months and 12 months after discharge, for a combined cohort to obtain detailed information on patient ?reported outcomes.
The proposed project will use a cohort study design (N=100) with web-based data capture to acquire high quality information. Detailed observational data will be collected and used in propensity score analysis to adjust for the baseline differences in treatment groups. This includes differences arising from selection bias and measured confounders. The propensity score based adjustment of these differences will result in a better estimate of the effect size. A user friendly, web-based data capture tool will facilitate the identification of clinically significant outcomes in a larger number of patients. Once validated, the methodology can be used to obtain evidence of comparative effectiveness that will aid decision-making in treatment of other rare neurological diseases where RCTs are unfeasible.
The following are candidate outcomes of interest in COMPASS Pilot for both therapeutic areas:
? ?Home-time? (days alive and at home)
? Stroke/TIA readmission
? All-cause readmission
? Cardiovascular readmission
? Bleeding readmission
The COMPASS Pilot study plans on inclusion of a diverse study population with respect to age, gender, race, ethnicity, geography, or clinical status. Specific patient selection criteria:
1. Patients who are at least 18 years of age.
2. Extracranial carotid or vertebral artery dissection with symptom onset within the last ninety days. Patients will be included with ipsilateral TIA or stroke and ipsilateral Horner?s syndrome or neck pain with known onset.
3. Imaging evidence of definite or probable dissection on magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), computed tomography angiography (CTA) or ultrasound (patients can be initially randomized on ultrasound alone but subsequent MR or CTA confirmation is needed).
4. Patient or patient?s legally appointed representative has been informed of the nature of the study, agrees to participation, and has signed an IRB approved consent form.
1. Symptom onset more than ninety days
3. Contraindications to either antiplatelet agents or anticoagulation therapy
4. Patient refusal to consent
5. Patient unable to follow-up for the 12 month period.