While complex interventions have been shown to be moderately successful in secondary prevention, implementation of such programs outside research settings has been limited (for example the large-scale EuroAction trial) [
8]. The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists (RESPONSE) 1 (2006–2009) trial (
n = 754) was designed to quantify the impact of a practical, hospital-based nurse coordinated prevention program, integrated into the routine clinical care of patients in the first year after an acute coronary syndrome (ACS) [
9]. The nurse-coordinated program consisted of up to four outpatient clinic visits focusing on (1) healthy lifestyle; (2) biometric risk factors; and (3) medication adherence, on top of usual care. At 12-months follow-up, the estimated overall impact on cardiovascular risk was a 17% relative reduction in patients in the intervention group as compared with patients receiving only usual care (
p = 0.021). This difference was largely driven by intensified medication titration [
10], with better treatment to target levels for LDL cholesterol and blood pressure. This was associated with slight increases in health-related quality of life, and a reduction in depressive symptoms in patients randomised to the nurse-coordinated program [
11]. There were only slight improvements in self-reported lifestyle parameters such as physical activity and diet, and no improvements in smoking cessation or body mass index. Surprisingly, a decrease in emergency room presentations/readmissions was observed, in favour of individuals attending the nurse-coordinated program (86 vs 132,
p = 0.023), potentially reflecting the counselling part of the nurse-coordinated program and the positive changes in quality of life and confidence, and reduced depressive symptoms. We therefore recommended that nurse-coordinated programs should be part of the usual care of patients with an ACS, a recommendation which was adopted by the ESC prevention guidelines (level of evidence IIa) [
1].
Based on the findings from RESPONSE‑1, the RESPONSE‑2 trial was designed (2013–2016) [
12]. The RESPONSE‑2 trial continued with the concept of the central role of a coordinating nurse specialist but focused specifically on lifestyle modification and partner participation. To increase the probability of successful lifestyle modification, the role of the nurse in RESPONSE‑2 was to identify risk profiles, to motivate patients and to refer both patients and their partners to readily available community-based commercial lifestyle interventions (weight reduction, smoking cessation and physical activity programs). A total of 824 patients with ACS or coronary revascularisation were randomised to either usual care, this time including RESPONSE‑1 nurse visits, or to the intervention group, which consisted of usual care and RESPONSE‑1 visits, plus coordinated referrals to external lifestyle programs for patients and their partners, if applicable. Due to the complex interplay of risk factors and risk factor modification in secondary prevention, a composite overall outcome measure was defined to take not only improvement of lifestyle-related risk factors into account, but also deterioration. Thus, a strict definition of successful lifestyle modification was used for the primary outcome: a clinically relevant improvement in ≥1 qualifying lifestyle-related risk factor at 12-months follow-up (weight, smoking, physical activity) without deterioration in the other risk factors. At 12-months follow-up, 37% of patients in the intervention group versus 26% in the usual care group (
p = 0.002) reached the primary outcome, i.e. showed a net improvement in ≥1 lifestyle-related risk factor. The effect was the most prominent in weight reduction (≥5% weight reduction was 27% for the intervention vs. 14% for usual care,
p < 0.001). Active partner participation in the intervention group was associated with a significantly greater success rate (46% in this subgroup reached the primary outcome), while the absence of a partner in the usual care group was associated with the lowest success rate (10%). These findings indicate that referral of patients with CVD and their partners to a comprehensive set of community-based lifestyle programs improves lifestyle-related factors more than guideline-based usual care alone [
12].