Diann E. Gaalema, Ph.D. - US grants

PROJECT SUMMARY (See instructions); Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) and Medicaid coverage are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we propose to examine the efficacy of using financial incentives for increasing CR participation among low-income patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study we will randomize 130 CR-eligibie low-income patients to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions or to a usual-care condition. Participants in both treatment conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Furthermore, we will model the value of the intervention based on increases in participation rates, intervention costs, long-term medical costs and health outcomes after a coronary event. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.

PROJECT SUMMARY Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10- 35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in our prior trial. For this study we will randomized 200 CR-eligible lower-SES patients to: a treatment condition where there are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a ?usual-care? condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition taking into account increases in CR participation. Furthermore, we will model the value of the interventions based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow us to test the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.

PROJECT SUMMARY - Project 1 Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10- 35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) and Medicaid coverage are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using financial incentives for increasing CR participation among low-income patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study we have randomized 130 CR-eligible, low-income patients to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions, or to a ?usual-care? condition. Participants in both treatment conditions complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health- related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Furthermore, we will model the value of the intervention based on increases in participation rates, intervention costs, long-term medical costs and health outcomes after a coronary event. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.

Affective disorders (ADs; mood and anxiety disorders) are the most common mental health conditions in the US. Over 40% of people with ADs are current smokers, and they experience disproportionately high rates of tobacco-related disease and death. A national nicotine reduction policy for cigarettes has the potential to reduce tobacco dependence and improve health in these smokers. Controlled trials in general population samples have demonstrated that switching smokers to very low nicotine content cigarettes (VLNCCs) results in reductions in cigarettes per day (CPD), cigarette dependence, and tobacco toxicant exposure, with few adverse consequences. Furthermore, our work during the current funding period indicates that smokers with ADs respond to VLNCCs with reductions in cigarette demand and other measures of addiction. However, tobacco market conditions are likely to exert considerable influence over the effectiveness of a cigarette nicotine reduction policy. During the next funding period, we will utilize principles and methods of behavioral economics and behavioral pharmacology to examine the effects of VLNCCs in smokers with ADs, either alone or while providing a substitute non-combusted source of nicotine (e-cigarettes). In separate conditions, e-cigarettes will be provided in tobacco flavors only or in appealing personalized flavors. This multi-site trial uses a four parallel group, pragmatic design. Daily smokers with ADs will be randomized to 16 weeks of: (1) normal nicotine content cigarettes (NNCCs) alone, the control condition, (2) VLNCCs alone, (3) VLNCCs + nicotinized, tobacco-flavored (TF e-cigs), or (4) VLNCCs + nicotinized, preferred-flavored e-cigs (PF e-cigs). Outcome measures include CPD, product demand, craving, appeal, psychiatric symptoms, biomarkers of brain function, and biomarkers of tobacco toxicant exposure and airway inflammation. After 16 weeks of use, participants will undergo an abstinence assessment in which we examine the effects of the study conditions on participants? ability to abstain from cigarettes and their responses to abstinence. The integrative theme of this TCORS is vulnerable populations. The proposed research is highly relevant to CTP?s scientific domains of Addiction and Behavior because it will examine whether reducing the nicotine content of cigarettes reduces cigarette use, dependence, and product appeal, and whether these effects are enhanced by the availability of e-cigarettes. It will address the Health Effects domain by assessing the effects of these conditions on biomarkers of brain function, tobacco toxicant exposure, and airway inflammation. The proposed study is significant and innovative because it will model how availability and appeal of e-cigs may moderate the effectiveness of a national reduced-nicotine policy for cigarettes in an understudied population. Finally, it is programmatic, as it will build upon the work that we accomplished during the current funding period. Overall, this proposal has the potential to continue a highly productive multidisciplinary research program and will provide FDA with critically important empirical evidence relevant to its regulatory responsibilities.