Asthma symptom control, infrequent use of rescue medications, normalized activities, and rare/no emergency visits, hospitalizations, and deaths are realistic expectations of currently available pharmacologic treatment, but inadequate adherence compromises control, especially for minority and low income patients. A shared decision-making (SDM) management model is proposed that elicits patient preferences and barriers and involves the patient in choosing asthma therapy. The model is based on social/cognitive learning theory and behavior change theory (patients as active agents/motivational interviewing, readiness for change/feasibility), and is proposed as a means of improving adherence. A controlled trial of the SDM model, recently approved for funding, focuses on disease outcomes and (secondarily) adherence in a sample of 342 Caucasian and Asia/Pacific Island Kaiser members (Portland, Hawaii), The same team now proposes a parallel trial in 300 African American, Chinese, Latino, and other minority/low-income Kaiser members in Northern California. The primary outcome will be a pharmacy-based controller medication adherence index, with rescue medication use, asthma control, quality of life, and acute asthma health care utilization as secondary outcomes. Intervention effects will be determined among minorities and in the combined sample (n=642); disease outcomes will be analyzed in the parent study. Measures of psychosocial characteristics, potentially culturally-linked, will be added to the joint research protocol to investigate correlates of adherence and """"""""mechanistic"""""""" hypotheses re causal links between attitude change, improved adherence, and disease outcomes. In Phase I, we will use focus groups of patients and of clinicians to refine the intervention to accommodate the full diversity of the various populations. In Phase II, patients with suboptimally controlled, persistent asthma will be recruited using KP electronic databases. Eligible patients (n=300) will be randomized (1:1:1) to SDM management, national guidelines-based management, and usual care. Patients in both intervention arms will meet with a care manager in two sessions, have their management plan reviewed and modified as necessary, per their assigned model, and be phoned at 3, 6, and 9 months. All participants will be followed for 2 years and assessed at 12 and 24 mos. This is a unique opportunity to test an adherence intervention in a minority population, increase the value of a parallel trial in a predominantly Caucasian population, and understand the mechanisms linking attitudes, adherence, and asthma outcomes.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Special Emphasis Panel (ZRG1-RPHB-4 (02))
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Taggart, Virginia
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Palo Alto Medical Foundation Research Institute
Palo Alto
United States
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Ayala, Estela; Wilson, Sandra R; Ma, Jun et al. (2012) Influence of body mass index on effects of a shared asthma treatment decision-making intervention. Am J Respir Crit Care Med 185:591-3
Xiao, Lan; Lavori, Phillip W; Wilson, Sandra R et al. (2011) Comparison of dynamic block randomization and minimization in randomized trials: a simulation study. Clin Trials 8:59-69
Wilson, Sandra R; Strub, Peg; Buist, A Sonia et al. (2010) Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med 181:566-77