Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol)

Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. Methods A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52 weeks. Clinical endpoints will not be measured, but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year. Discussion The combined use of risk communication, a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention. Trial registration Current Controlled Trials ISRCTN5155672

What Has Been the Effect on Trial Outcome Assessments of a Decade of Patient Participation in OMERACT?

Objective.Since 2002, 58 patients have participated as collaborating partners in 6 Outcome Measures in Rheumatology (OMERACT) conferences. Little is known about how they engage with researchers and how they have influenced conference outcomes.Methods.A responsive evaluation was carried out, including a thematic document analysis of conference proceedings and gray literature, participant observation, and 38 interviews with patients and professionals representing research, industry, and regulators. Interview transcripts were subjected to an inductive content analysis.Results.The role of patients has evolved from a single focus group in 2002 to full integration in all parts of the conference in 2012. Longterm engagement has made a significant change in the scope and conduct of rheumatology research. It has enriched the research agenda by identifying previously neglected outcome domains such as fatigue, sleep disturbances, and flares, and it has contributed to more patient-relevant outcomes in clinical trials. Facilitating factors have been a strong commitment of the leadership, adequate selection procedure, inclusive conference design, interactive and encouraging moderation style, and self-organized support. The intensity of the program and doubts regarding the representativeness of the patient group were still seen as challenges for the future.Conclusion.Making patient participation an integral part of the vision and procedures of OMERACT has significantly contributed to the success of OMERACT. It has changed the perceptions and beliefs of many participants. Full use of patients’ experiential knowledge before and during the conference is still challenging.</jats:sec

Small but important errors in cardiovascular risk calculation by practice nurses: A cross-sectional study in randomised trial setting

Background Practice nurses play an increasingly important role in the prevention of cardiovascular diseases but we do not have evidence about the accuracy of their cardiovascular risk assessments during real practice consultations. Objectives To examine how nurses perform with regard to absolute 10-year cardiovascular risk assessment in actual practice. Design Cross-sectional study. Setting This study was nested in the IMPALA study, a clustered randomised controlled trial involving 24 general practices in The Netherlands. Participants 24 practice nurses, trained in 10-year cardiovascular risk assessment, calculated the risk of a total of 421 patients without established cardiovascular diseases but eligible for cardiovascular risk assessment. Methods The main outcome measure was the accuracy of risk assessments, defined as (1) the difference between the 10-year cardiovascular risk percentage calculated by nurses and an independent assessor, and (2) the agreement between the treatment categories assigned by the nurses (low, moderate or high risk) and those assigned by the independent assessor. Results Thirty-one (7.4%) of the calculated risk percentages differed by more than our preset limits, 25 (81%) being underestimations. Elderly patients (OR 1.1, 95% CI 1.0–1.1), male patients (vs. female OR 3.1, 95% CI 1.2–7.3), and smoking patients (vs. non-smoking OR 3.8, 95% CI 1.7–8.9) were more likely to have their cardiovascular risk miscalculated. Ten (28%) of the 36 patients who should be assigned to the high-risk treatment category according to the independent calculation, were missed as high-risk patients by the practice nurses. Conclusions The overall standard of accuracy of cardiovascular risk assessment by trained practice nurses in actual practice is high. However, a significant number of high-risk patients were misclassified, with the probability that it led to missed opportunities for risk-reducing interventions. As cardiovascular risk assessments are frequently done by nurses in general practice, further specific training should be considered to prevent undertreatment

Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial

Contains fulltext : 80088.pdf (publisher's version ) (Closed access)BACKGROUND: Preventive guidelines on cardiovascular risk management recommend lifestyle changes. Support for lifestyle changes may be a useful task for practice nurses, but the effect of such interventions in primary prevention is not clear. We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk. METHODS: We performed a cluster randomized controlled trial in 25 practices that included 615 patients. The intervention consisted of nurse-led cardiovascular risk management, including risk assessment, risk communication, a decision aid and adapted motivational interviewing. The control group received a minimal nurse-led intervention. The self-reported outcome measures at one year were smoking, alcohol use, diet and physical activity. Nurses assessed 10-year cardiovascular mortality risk after one year. RESULTS: There were no significant differences between the intervention groups. The effect of the intervention on the consumption of vegetables and physical activity was small, and some differences were only significant for subgroups. The effects of the intervention on the intake of fat, fruit and alcohol and smoking were not significant. We found no effect between the groups for cardiovascular 10-year risk. INTERPRETATION: Nurse-led risk communication, use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk, despite significant within-group differences

Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol)-1

N and measurements are shown in grey. This graphical method was proposed by Perera et al [76].<p><b>Copyright information:</b></p><p>Taken from "Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol)"</p><p>http://www.biomedcentral.com/1472-6963/8/9</p><p>BMC Health Services Research 2008;8():9-9.</p><p>Published online 14 Jan 2008</p><p>PMCID:PMC2267187.</p><p></p