RAND-University of Pittsburgh Health Institute

CTSI Comparative Effectiveness Research Pilot Grants

These comparative effectiveness research pilot grants were designed to provide funding for pilot studies that focus on informing health care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care. RUPHI and the University of Pittsburgh CTSI recently awarded two grants in this area to be completed in July, 2012:

University of Pittsburgh Investigator RAND Investigator Title of Project
Julie Donohue, PhD Walid Gallad, MD, MPH Health System Predictors Of Generic Drug Use And Consequences For Out-Of-Pocket Costs And Medication Adherence In Medicare Part D
Ellen Beckjord, PhD William Shadel, PhD Comparing the Effectiveness of a Single-Session Versus an Intensive Pre-Surgical Smoking Cessation Intervention for Individuals Diagnosed with Non-Small Cell Lung Cancer

These projects will begin this summer (2011).

Abstracts

Health System Predictors Of Generic Drug Use And Consequences For Out-Of-Pocket Costs And Medication Adherence In Medicare Part D

Generic drugs are available in most pharmacologic classes, and are equally effective but cost 80% less than their branded counterparts. Because generics lower costs to patients, and medication use is highly sensitive to out-of-pocket costs, greater use of generics may increase medication adherence rates and ultimately improve health outcomes. Yet, evidence suggests that generics are underused in many parts of the US health care system. For instance, generic use varies widely in Medicare Part D from 55% to 76% of prescriptions filled across regions. Underuse of generics has enormous implications for medication utilization and costs for older adults. Yet, the determinants of generic use are poorly understood. Medicare Part D provides an ideal “laboratory” for studying the impact of health system characteristics on generic use because it is administered by hundreds of private plans with varying premiums, formularies, cost-sharing (e.g., copayments/ coinsurance), and use of utilization management tools (e.g., prior authorization). Using medical and pharmacy claims for a 5% random sample of Medicare beneficiaries (approximately 1 million individuals) along with detailed data on Part D plan characteristics we will examine the association between health system factors and use of generics, and the association between generic use and out-of-pocket costs and medication adherence for chronic conditions. This project will provide data to support a larger grant application to conduct longitudinal comparative effectiveness research on health system factors associated with use of highly effective low-cost therapies and the impact of generic use on health outcomes.

Comparing the Effectiveness of a Single-Session Versus an Intensive Pre-Surgical Smoking Cessation Intervention for Individuals Diagnosed with Non-Small Cell Lung Cancer

The results of the National Lung Screening Trial (NLST) are expected to lead to insurance reimbursement for routine helical CT screening for current and former smokers. This practice change is expected to shift the detection of lung cancer towards more early stage diagnoses among current smokers. A surprisingly small amount of research has focused on smoking cessation among lung cancer patients (despite the significant risks that continued smoking pose for this population, and we therefor lack good evidence on the most effective way to deliver evidence-based smoking interventions as part of lung cancer care.

Pre-surgical smoking cessation interventions offer benefits for both surgical morbidity and long-term smoking cessation. The naturally occurring window of time between a lung cancer diagnosis and surgery represents an ideal opportunity to deliver a cessation intervention when patients may be highly motivated to quit. Successfully integrating an evidenced-based, systematic approach to smoking cessation into an oncology practice will require identifying the most minimally burdensome yet effective approach. The Specific Aims of this research are to compare the effectiveness of a single-session versus an intensive pre-surgical smoking cessation in a randomized study of 24 patients diagnosed with Stage I or ii non-small cell lung cancer. Outcomes will include: rates of pre-surgical cessation; surgical morbidity; rates of post-surgical cessation; time to post-surgical smoking relapse; post-surgical quality of life; and psychosocial outcomes (e.g., self-efficacy; cancer-specific distress).