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Multiple risk factor counseling to promote heart-healthy lifestyles in the chest pain observation unit: pilot randomized controlled trial
Katz DA, Graber M, Lounsbury P, Vander Weg MW, Phillips EK, Clair C, Horwitz PA, Cai X, Christensen AJ
Academic Emergency Medicine 2017 Aug;24(8):968-982
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Admission to the chest pain observation unit (CPOU) may be an advantageous time for patients to consider heart-healthy lifestyle changes while undergoing diagnostic evaluation to rule out myocardial ischemia. The aim of this pragmatic trial was to assess the effectiveness of a multiple risk factor intervention in changing CPOU patients' health beliefs and readiness to change health behaviors. A secondary aim was to obtain preliminary estimates of the intervention's effect on diet, physical activity, and smoking. METHODS: We conducted a pilot randomized controlled trial of a moderate-intensity counseling intervention that aimed to build motivation to change and problem-solving skills in 140 adult patients with at least one modifiable cardiovascular risk factor (CRF) who were admitted to the CPOU of an academic emergency department (ED) with symptoms of possible acute coronary syndrome. Study patients were randomly assigned to full counseling (face-to-face cardiovascular risk assessment and personalized counseling on nutrition, physical activity, and smoking cessation in the ED, plus two telephone follow-up sessions) or minimal counseling (brief instruction (< 5 minutes) on benefits of modifying cardiovascular risk factors) by a cardiac rehabilitation specialist. We measured Health Belief Model constructs for ischemic heart disease, stage of change, and self-reported CRF-related behaviors (diet, exercise, and smoking) during 6-month follow-up using previously validated measures. We used linear mixed models and logistic regression (with generalized estimating equations) to compare continuous and dichotomous behavioral outcomes across treatment arms, respectively. RESULTS: Approximately 20% more patients in the full counseling arm reported having received counseling on diet and physical activity during CPOU admission, compared to the minimal counseling arm; a similar proportion of patients in both counseling arms reported having received advice or assistance in quitting smoking. There were no significant differences between treatment arms for any cardiovascular health beliefs, readiness to change, or CRF-related behaviors during longitudinal follow-up. In secondary analyses in both treatment arms combined, however, patients showed significant differences between follow-up and baseline measurements: increases in the perceived benefits of improving CRF-related behaviors (27.7 versus 26.6 on a scale from 7 to 35, p = 0.0001) and increased readiness to change dietary behavior and physical activity during follow-up-intake of saturated fat (83% versus 49%), readiness to change fruit and vegetable consumption (83% versus 56%), and readiness to perform regular exercise (34% versus 14%) at 6 months and baseline, respectively (p < 0.0001 for all comparisons in both treatment arms combined). CONCLUSIONS: A multiple risk factor intervention that focused on increasing motivation to change and problem-solving skills did not significantly improve behavioral outcomes, compared to minimal counseling. Patients admitted to the CPOU demonstrated sustained changes in several cardiovascular health beliefs and risk-related behaviors during follow-up; this provides further evidence that the CPOU visit is a "teachable moment" for cardiovascular risk reduction. Future studies should evaluate the effectiveness of ED-initiated counseling interventions to engage patients in changing cardiovascular risk behaviors, in coordination with primary care.

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