Improving lifestyle adherence in patients with high risk for cardiovascular diseases in general practice. Costs and effects of patient involvement in cardiovascular risk management.
Projectomschrijving
Mensen met een verhoogde bloeddruk, een te hoog cholesterol gehalte, overgewicht of een ongezonde levensstijl (roken, weinig bewegen) hebben een verhoogde kans op hart- en vaatziekten. Daarom krijgen zij van hun (huis)arts het advies gezonder te gaan leven (meer bewegen, minder (vet) eten). Ook krijgen zij vaak medicijnen voorgeschreven die de bloeddruk en het cholesterolgehalte van het bloed verlagen. Veel mensen vinden het moeilijk deze adviezen (langdurig) op te volgen. Ook nemen zij de medicijnen vaak niet (altijd) in. In Maastricht is onderzocht of extra uitleg en ondersteuning door een praktijkverpleegkundige mensen met een hoog risico op hart- en vaatziekten stimuleert de leefadviezen beter op te volgen en de medicijnen trouw in te nemen. Dit bleek niet het geval. Zowel de mensen die extra voorlichting en ondersteuning kregen als de mensen die op de gebruikelijke manier werden voorgelicht hadden een jaar na het begin van de studie een gezondere leefwijze.
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Auteur: Koelewijn - van Loon MS, van Steenkiste B, Ronda G, Wensing M, Stoffers HE, Elwyn G, Grol R, van der Weijden T.
Magazine: BMC Health Services Research
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Eindverslag
Samenvatting van de aanvraag
. objective(s) / research question(s): Practice guidelines on cardiovascular disease recommend optimal drug treatment and a healthy lifestyle, but adherence to these recommendations is in about half of the patients less than optimal. Additional interventions are needed to improve adherence. Patient involvement in decision-making on cardiovascular prevention is likely to increase patients' adherence with lifestyle advice. The aim of this study is to determine costs and effects of strategies that enhance patient involvement in decisions on cardiovascular prevention, on adherence to lifestyle recommendations and medical treatment, and on estimated absolute risk on cardiovascular events in 10 years. . study design: We propose a RCT in 20 large general practices. . study population(s)/ datasets: A total of 720 patients with high risk for (recurrent) cardiovascular diseases will be prospectively recruited. It concerns patients with established CVD, with diabetes, or with a modifiable high risk according to the available risk charts for absolute 10-year risk in CVD. Measurements will be executed at baseline, 12 and 52 weeks. With expected drop out of 20% 600 patients will be available for final analysis. . intervention: The intervention is a mix of strategies with the underlying goal to facilitate patient involvement in the decisions to be taken on cardiovascular risk management. The components are: decision aid, risk communication tool, task delegation to a nurse trained in adapted motivational interviewing, and a follow-up consultation. The decision aid and the follow-up consultation have already been evaluated in a recent trial in Maastricht. The new components of the intervention are the risk communication tool, and delegation of this task to a practice nurse, who is trained in motivational interviewing. Practice nurses are increasingly important in delivering care to patients with high risk of cardiovascular diseases and they may be able to provide the strategy cost-effectively, which would fit well in current developments in primary care. In the first consultation the risk will be clarified by use of the risk communication tool, and the patient's preferences will be explored. In the second consultation, after the patient has read the decision aid at home, the nurse will help the patient to formulate his/her own goals for behaviour change. . outcome measures: Primary behavioural outcome is self-reported adherence to smoking, diet, physical exercise, or alcohol intake. One standardised adherence score will be constructed, which expresses to what extent the behaviour change goal was accomplished. If applicable, adherence to drug treatment will also be measured. Clinical endpoints will not be measured, but the absolute risk on cardiovascular events in 10 years will be estimated for each patient. Secondary outcomes are risk perception, anxiety, satisfaction with the decision, self-efficacy, and intention to change. Data will be measured by use of validated questionnaires. A more objective instrument, the pedometer, will also be applied to measure physical exercise. The adherence of the nurse to the working protocol will be measured by means of a process evaluation. . power/data analysis: We expect a 15% increase in adherence rate and a 5% reduction in absolute 10-year cardiovascular risk. The data will be analysed by hierarchical modelling in regression analysis, to account for clustering of data per practice. . economic evaluation: Costs will be estimated; costs of the intervention (the patient materials, training of practice nurses, time used by practice nurse for patient contacts) and cost consequences related to the use of health care services for cardiovascular diseases by patients (hospital admission, visits to GP, use of medication, etc.). An incremental cost-effectiveness ratio will be calculated for the observed costs and effects (cost related to absolute risk on cardiovascular events in 10 years) as well as estimated for patient full lives, estimating cost per life year gained. . time schedule: - 1-6: Elaboration of working protocol for the nurse and of the trial protocol. - 7-12: Recruitment of practices, preparation of measurements, training of GPs and practice nurses - 13-28: Patient inclusion, evaluation of effects, costs and process - 29-36: Data-analysis and report.