CREATE Wellness: A multi-component behavioral intervention for patients not responding to traditional Cardiovascular disease management.

BACKGROUND/AIMS: Cardiovascular disease (CVD) is the leading cause of death in the US. Many patients do not benefit from traditional disease management approaches to CVD risk reduction. Here we describe the rationale, development, and implementation of a multi-component behavioral intervention targeting patients who have persistently not met goals of CVD risk factor control. METHODS: Informed by published evidence, relevant theoretical frameworks, stakeholder advice, and patient input, we developed a group-based intervention (Changing Results: Engage and Activate to Enhance Wellness; "CREATE Wellness") to address the complex needs of patients with elevated or unmeasured CVD-related risk factors. We are testing this intervention in a randomized trial among patients with persistent (i.e > 2 years) sub-optimal risk factor control despite being enrolled in an advanced and highly successful CVD disease management program. RESULTS: The CREATE Wellness intervention is designed as a 3 session, group-based intervention combining proven elements of patient activation, health system engagement skills training, shared decision making, care planning, and identification of lifestyle change barriers. Our key learnings in designing the intervention included the value of multi-level stakeholder input and the importance of pragmatic skills training to address barriers to care. CONCLUSIONS: The CREATE Wellness intervention represents an evidence-based, patient-centered approach for patients not responding to traditional disease management. The trial is currently underway at three medical facilities within Kaiser Permanente Northern California and next steps include an evaluation of efficacy, adaptation for non-English speaking patient populations, and modification of the curriculum for web- or phone-based versions. CLINICALTRIALSGOV IDENTIFIER: NCT02302612.

Examination of the Effects of an Intervention Aiming to Link Patients Receiving Addiction Treatment With Health Care: The LINKAGE Clinical Trial.

IMPORTANCE: Research has shown that higher activation and engagement with health care is associated with better self-management. To our knowledge, the linkage intervention (LINKAGE) is the first to engage patients receiving addiction treatment with health care using the electronic health record and a patient activation approach. OBJECTIVE: To examine the effects of an intervention aiming to link patients receiving addiction treatment with health care. DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized clinical trial evaluating the LINKAGE intervention vs usual care by applying an alternating 3-month off-and-on design over 30 months. Participants were recruited from an outpatient addiction treatment clinic in a large health system between April 7, 2011, and October 2, 2013. INTERVENTIONS: Six group-based, manual-guided sessions on patient engagement in health care and the use of health information technology resources in the electronic health record, as well as facilitated communication with physicians, vs usual care. MAIN OUTCOMES AND MEASURES: Primary outcomes, measured at 6 months after enrollment, were patient activation (by interview using the Patient Activation Measure), patient engagement in health care (by interview and electronic health record), and alcohol, drug, and depression outcomes (by interview using the Addiction Severity Index for alcohol and drug outcomes and Patient Health Questionnaire (PHQ) for depression). RESULTS: A total of 503 patients were recruited and assigned to the LINKAGE (n = 252) or usual care (n = 251) conditions, with no differences in baseline characteristics between conditions. The mean (SD) age of the patients was 42.5 (11.8) years, 31.0% (n = 156) were female, and 455 (90.5%) completed the 6-month interview. Compared with usual care participants, LINKAGE participants showed an increase in the mean number of log-in days (incidence rate ratio, 1.53; 95% CI, 1.19-1.97; P = .001). Similar results were found across types of patient portal use (communicating by email, viewing laboratory test results and information, and obtaining medical advice). LINKAGE participants were more likely to talk with their physicians about addiction problems (odds ratio, 2.30; 95% CI, 1.52-3.49; P < .001). Although 6-month abstinence rates were high for both conditions (≥70.0% for both) and depression symptoms improved (the proportion with scores ≥15 on the 9-item PHQ dropped from 15.1% [38 of 252] to 8.0% [18 of 225] among LINKAGE participants), there were no differences between conditions. Those who received all intervention components had significantly better alcohol and other drug outcomes than those who received fewer intervention components. CONCLUSIONS AND RELEVANCE: Findings support the feasibility and effectiveness of the LINKAGE intervention in helping patients receiving addiction treatment engage in health care and increase communication with their physicians. The intervention did not affect short-term abstinence or depression outcomes. Understanding if the LINKAGE intervention helps prevent relapse and manage long-term recovery will be important. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01621711.

Smoking abstinence-related expectancies among American Indians, African Americans, and women: potential mechanisms of tobacco-related disparities.

Research has documented tobacco-related health disparities by race and gender. Prior research, however, has not examined expectancies about the smoking cessation process (i.e., abstinence-related expectancies) as potential contributors to tobacco-related disparities in special populations. This cross-sectional study compared abstinence-related expectancies between American Indian (n = 87), African American (n = 151), and White (n = 185) smokers, and between women (n = 231) and men (n = 270) smokers. Abstinence-related expectancies also were examined as mediators of race and gender relationships with motivation to quit and abstinence self efficacy. Results indicated that American Indians and African Americans were less likely than Whites to expect withdrawal effects, and more likely to expect that quitting would be unproblematic. African Americans also were less likely than Whites to expect smoking cessation interventions to be effective. Compared with men, women were more likely to expect withdrawal effects and weight gain. These expectancy differences mediated race and gender relationships with motivation to quit and abstinence self-efficacy. Findings emphasize potential mechanisms underlying tobacco-related health disparities among American Indians, African Americans, and women and suggest a number of specific approaches for targeting tobacco dependence interventions to these populations.

The Smoking Abstinence Questionnaire: measurement of smokers' abstinence-related expectancies.

AIMS: To develop and validate a measure of smokers' expectancies for the abstinence process upon quitting smoking: the Smoking Abstinence Questionnaire (SAQ). DESIGN: Principal component analysis and other psychometric analyses of self-report data. SETTING: San Francisco, California. PARTICIPANTS: A total of 507 adult smokers of at least 10 cigarettes per day diverse in gender, sexual orientation and ethnoracial status. MEASUREMENTS: The primary measure was a draft version of the SAQ. Additional measures assessed a variety of other smoking-related constructs. FINDINGS: Analyses yielded 10 scales of the SAQ: Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use and Weight Gain. The SAQ scales demonstrated internal consistencies ranging from 0.62 to 0.85 and were associated with tobacco dependence, motivation to quit, abstinence self-efficacy, withdrawal symptoms, dietary restraint, shape and weight concern and tobacco use expectancies. The SAQ predicted smoking-related constructs above and beyond tobacco use expectancies, suggesting that abstinence-related expectancies and tobacco use expectancies are distinct from one another. CONCLUSIONS: A newly developed questionnaire, the Smoking Abstinence Questionnaire, appears to capture reliably smokers' expectancies for abstinence (Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Common Reasons, Optimistic Outcomes, Coffee Use, and Weight Gain) and expectancies related to the success of a quit attempt (Treatment Effectiveness, Barriers to Treatment and Social Support). It remains to be seen how far any of these expectancies predict attempts to quit, withdrawal, treatment utilization and response and quitting success above and beyond existing measures.

Smokers' expectancies for abstinence: preliminary results from focus groups.

Smokers' expectancies regarding the effects of cigarette use are powerful predictors of smoking motivation and behavior. However, studies have not investigated the consequences that smokers expect when they attempt to quit smoking: abstinence-related expectancies. The primary goal of this qualitative study was to gain initial insight into smokers' expectancies for abstinence. Eight focus groups were conducted with 30 smokers diverse with respect to age, gender, and ethnoracial background. Content analyses indicated that smokers anticipate a variety of outcomes from abstinence. The most frequently reported expectancies included pharmacologic withdrawal symptoms, behavioral withdrawal symptoms, decreased monetary expense, and immediate improvement of certain aspects of physical functioning and health. Additional expectancies concerned weight gain, improved attractiveness, enhanced social functioning/self-esteem, long-term health outcomes, and loss of relationships. Finally, a number of relatively unheralded expectancies were revealed. These involved nicotine replacement therapy effectiveness, alcohol and other drug use, cue reactivity, cessation-related social support, aversion to smoking, and "political process" implications. This study provides a preliminary step in understanding smokers' expectancies for abstinence from cigarettes.