Background: Counselling on health-related lifestyles is key to the prevention and management of chronic diseases. After comprehensive study of determinants of its delivery in general practice and strategies to improve, we composed a tailored improvement program, which included communication skills training, online patient information, and a clinical protocol for managing depressive symptoms. Our aim was to assess the effectiveness of this program on professional performance and outcomes in cardiovascular patients.
Methods: A two-arm cluster randomized trial in 34 general practices involving 34 nurses was conducted. The primary outcome was an aggregated score of a positive score on lifestyle counselling delivered and an appropriate action on depressive symptoms. Secondary outcomes included the various elements of the primary outcome, vascular risk factors (extracted from patient records), and patient-reported lifestyle behaviors. Data were collected from medical records and a written survey among included patients.
Results: A sample of 1782 patients with recorded cardiovascular disease or high cardiovascular risk was available at follow-up at 6 months. No impact on the primary outcome was found; lifestyle counselling was recorded in a minority of patients (11.4 % in the intervention group and 10.3 % in the control group). An effect was found on a secondary outcome: patients' physical activity level increased (B 0.18; 95 % CI 0.02-0.35) on a seven-point scale.
Conclusions: The tailored improvement program showed no effect on the primary outcome. This challenges the methodology of tailoring. More involvement of the targeted health care professionals might offer ways to develop more effective implementation programs. Physical activity might be the lifestyle issue that can be more easily changed than smoking or dietary habits.
Trial registration: Nederlands Trial register NTR4069.
Keywords: Cardiovascular disease; Cluster randomization; Counselling; Implementation; Lifestyle; Primary care; Randomized controlled trial; Risk factors; Tailored interventions.