Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol

<p>Abstract</p> <p>Background</p> <p>The non-pharmacological approach to cholesterol control in patients with hyperlipidemia is based on the promotion of a healthy diet and physical activity. Thus, to help patients change their habits, it is essential to identify the most effective approach. Many efforts have been devoted to explain changes in or adherence to specific health behaviors. Such efforts have resulted in the development of theories that have been applied in prevention campaigns, and that include brief advice and counseling services. Within this context, Motivational Interviewing has proven to be effective in changing health behaviors in specific cases. However, more robust evidence is needed on the effectiveness of Motivational Interviewing in treating chronic pathologies -such as dyslipidemia- in patients assisted by general practitioners. This article describes a protocol to assess the effectiveness of MI as compared with general practice (brief advice), with the aim of improving lipid level control in patients with dyslipidemia assisted by a general practitioner.</p> <p>Methods/Design</p> <p>An open, two-arm parallel, multicentre, cluster, controlled, randomized, clinical trial will be performed. A total of 48-50 general practitioners from 35 public primary care centers in Spain will be randomized and will recruit 436 patients with dyslipidemia. They will perform an intervention based either on Motivational Interviewing or on the usual brief advice. After an initial assessment, follow-ups will be performed at 2, 4, 8 and 12 months. Primary outcomes are lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) and cardiovascular risk. The study will assess the degree of dietary and physical activity improvement, weight loss in overweight patients, and adherence to treatment guidelines.</p> <p>Discussion</p> <p>Motivational interview skills constitute the primary strategies GPs use to treat their patients. Having economical, simple, effective and applicable techniques is essential for primary care professionals to help their patients change their lifestyle and improve their health. This study will provide scientific evidence on the effectiveness of Motivational interviewing, and will be performed under strict control over the data collected, ensuring the maintenance of therapeutic integrity.</p> <p>Trials Registration</p> <p>ClinicalTrials.gov (<a href="http://www.clinicaltrials.gov/ct2/show/NCT01282190">NCT01282190</a>).</p

Is the Scale for Measuring Motivational Interviewing Skills a valid and reliable instrument for measuring the primary care professionals motivational skills?: EVEM study protocol

Abstract Background Lifestyle is one of the main determinants of people’s health. It is essential to find the most effective prevention strategies to be used to encourage behavioral changes in their patients. Many theories are available that explain change or adherence to specific health behaviors in subjects. In this sense the named Motivational Interviewing has increasingly gained relevance. Few well-validated instruments are available for measuring doctors’ communication skills, and more specifically the Motivational Interviewing. Methods/Design The hypothesis of this study is that the Scale for Measuring Motivational Interviewing Skills (EVEM questionnaire) is a valid and reliable instrument for measuring the primary care professionals skills to get behavior change in patients. To test the hypothesis we have designed a prospective, observational, multi-center study to validate a measuring instrument. –Scope: Thirty-two primary care centers in Spain. -Sampling and Size: a) face and consensual validity: A group composed of 15 experts in Motivational Interviewing. b) Assessment of the psychometric properties of the scale; 50 physician- patient encounters will be videoed; a total of 162 interviews will be conducted with six standardized patients, and another 200 interviews will be conducted with 50 real patients (n=362). Four physicians will be specially trained to assess 30 interviews randomly selected to test the scale reproducibility. -Measurements for to test the hypothesis: a) Face validity: development of a draft questionnaire based on a theoretical model, by using Delphi-type methodology with experts. b) Scale psychometric properties: intraobservers will evaluate video recorded interviews: content-scalability validity (Exploratory Factor Analysis), internal consistency (Cronbach alpha), intra-/inter-observer reliability (Kappa index, intraclass correlation coefficient, Bland & Altman methodology), generalizability, construct validity and sensitivity to change (Pearson product–moment correlation coefficient). Discussion The verification of the hypothesis that EVEM is a valid and reliable tool for assessing motivational interviewing would be a major breakthrough in the current theoretical and practical knowledge, as it could be used to assess if the providers put into practice a patient centered communication style and can be used both for training or researching purposes. Trials registration Dislip-EM study NCT01282190 (ClinicalTrials.gov)</p