The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial.

BACKGROUND: The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. METHODS: A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. RESULTS: The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. CONCLUSIONS: Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular risk factors. In the present era of cardiovascular therapy and with the increasing numbers of overweight and physically inactive patients, this study confirms the importance of risk factor control through lifestyle modification as a supplement to more intensified drug treatment in patients with CVD. TRIAL REGISTRATION: ISRCTN69776211 at http://www.controlled-trials.com.

Revision of the Dutch clinical algorithm for assessing patient needs in cardiac rehabilitation based on identified implementation problems.

BACKGROUND: Despite all available evidence of its effectiveness, cardiac rehabilitation and secondary prevention (CRSP) is still insufficiently implemented in current clinical practice. Based on an analysis of implementation problems, recently the Dutch clinical algorithm for the assessment of patient's CRSP needs was revised. The purpose of this paper is to describe the revision process and its results to improve CRSP guideline implementation. METHODS: The National Institute for Health and Clinical Excellence (NICE) guidelines manual for conducting guideline revisions was followed. Information on the use of the algorithm in practice was collected from electronic medical records and by conducting semi-structured interviews. Next, an expert advisory group identified the problems for use in daily practice and defined the scope for the revision. A multidisciplinary guideline development group subsequently wrote the revised algorithm. RESULTS: A large variation in assessed patient needs was observed between CRSP clinics. Assessment based on clinical judgement was found to be a source of practice variation and is therefore avoided in the revised algorithm. It was decided to add assessment instruments for anxiety and depression, cardiovascular risk factors, stress, attitude of partner and lifestyle parameters. CONCLUSION: The Dutch clinical algorithm for assessing patient needs for CRSP was revised using a combination of patient data from routine practice, knowledge from academic experts and experience from field experts. The revised algorithm is a practical tool consisting of assessment instruments to improve CRSP guideline adherence in the Netherlands. This algorithm may also be useful for other Western countries to organize their CRSP needs assessment procedure.

Design of a continuous multifaceted guideline-implementation strategy based on computerized decision support.

Implementation of clinical practice guidelines into daily care is hindered by a variety of barriers related to professional knowledge, collaboration in teams and organizations, and practicability of the guidelines. Clinical computerized decision support (CCDS) has been shown to be one of the most effective instruments to improve compliance to practice guidelines by tackling barriers related to professional knowledge. To address other barriers, however, additional interventions are needed. In this study, a continuous multifaceted guideline implementation strategy was developed which is based on CCDS but extends beyond the professional knowledge barrier. Two additional interventions were designed and embedded with CCDS in a continuous quality improvement framework. First, to address barriers within teams and organizations guideline compliance data are periodically aggregated into feedback reports for care providers. Second, barriers related to practicability of the underlying guidelines are addressed in a guideline-maintenance cycle. A case study in the field of cardiac rehabilitation is presented to demonstrate the feasibility of the developed strategy.

The effect of computerized decision support on barriers to guideline implementation: a qualitative study in outpatient cardiac rehabilitation.

CONTEXT: Computerized decision support systems (CDSSs) can be used to improve the implementation of clinical practice guidelines by changing the behaviour of care professionals. While the influence of system characteristics on the effectiveness of CDSSs is studied, little is known about the relation between cognitive, organizational and environmental factors, and CDSSs' effectiveness. OBJECTIVE: To assess the effect of CDSSs on cognitive, organizational, and environmental factors that hamper guideline implementation. DESIGN: In-depth, semi-structured interviews with care professionals, on reasons for improved adherence or persistent non-adherence to the prevailing guideline after successful adoption of a CDSS. All remarks regarding guideline implementation were extracted and classified using the conceptual framework from Cabana et al. SETTING: Outpatient cardiac rehabilitation clinics. PARTICIPANTS: Care professionals that used the CARDSS decision support system for therapeutic decision making in cardiac rehabilitation. RESULTS: Twenty-nine rehabilitation nurses and physiotherapists from 21 Dutch clinics were interviewed. CARDSS improved guideline adherence by increasing its users' familiarity with the guidelines' recommendations and decision logic, by overcoming users' inertia to previous practice, and by reducing guideline complexity for example by facilitating calculation and interpretation of data. If the system's recommendations were shared with patients, refusal to participate in therapies reduced. CARDSS never incited users to target barriers related to organizational or environmental constraints. CONCLUSION: Our results suggest that computerized decision support can improve guideline implementation by increasing the knowledge of preferred practice, by reducing inertia to previous practice, and by reducing guideline complexity. However, computerized decision support is not effective when organizational or procedural changes are required that users consider to be beyond their tasks and responsibilities.

Effect of guideline based computerised decision support on decision making of multidisciplinary teams: cluster randomised trial in cardiac rehabilitation.

OBJECTIVE: To determine the extent to which computerised decision support can improve concordance of multidisciplinary teams with therapeutic decisions recommended by guidelines. DESIGN: Multicentre cluster randomised trial. PARTICIPANTS: Multidisciplinary cardiac rehabilitation teams in Dutch centres and their cardiac rehabilitation patients. INTERVENTIONS: Teams received an electronic patient record system with or without additional guideline based decision support. MAIN OUTCOME MEASURES: Concordance with guideline recommendations assessed for two standard rehabilitation treatments-exercise and education therapy-and for two new but evidence based rehabilitation treatments-relaxation and lifestyle change therapy; generalised estimating equations were used to account for intra-cluster correlation and were adjusted for patient's age, sex, and indication for cardiac rehabilitation and for type and volume of centre. RESULTS: Data from 21 centres, including 2787 patients, were analysed. Computerised decision support increased concordance with guideline recommended therapeutic decisions for exercise therapy by 7.9% (control 84.7%; adjusted difference 3.5%, 95% confidence 0.1% to 5.2%), for education therapy by 25.7% (control 63.9%; adjusted difference 23.7%, 15.5% to 29.4%), and for relaxation therapy by 25.5% (control 34.1%; adjusted difference 41.6%, 25.2% to 51.3%). The concordance for lifestyle change therapy increased by 3.2% (control 54.1%; adjusted difference 7.1%, -2.9% to 18.3%). Computerised decision support reduced cases of both overtreatment and undertreatment. CONCLUSIONS: In a multidisciplinary team motivated to adopt a computerised decision support aid that assists in formulating guideline based care plans, computerised decision support can be effective in improving the team's concordance with guidelines. Therefore, computerised decision support may also be considered to improve implementation of guidelines in such settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36656997.

Is the MacNew quality of life questionnaire a useful diagnostic and evaluation instrument for cardiac rehabilitation?

PURPOSE: The MacNew health-related quality of life questionnaire is internationally used as a standard for psychosocial assessment in many cardiac rehabilitation centres. This study investigates its discriminating capacity between diagnostic disease categories, sex and age at entry (T1) and at the end (T2) of cardiac rehabilitation as well as the responsiveness of the MacNew during this period. METHOD: Data were used from 6,749 cardiac rehabilitation patients at T1 and 1,654 at T2. RESULTS: Results show that the global MacNew as well as the three (physical, emotional, social) subscales have high internal consistencies, and differentiate well and in the expected direction at T1 between diagnostic groups (heart surgery, myocardial infarction with and without percutaneous coronary intervention, stable angina with and without percutaneous coronary intervention, implantable cardioverter defibrillator, and heart failure patients), sex and age. The MacNew also proves to be an adequate evaluation instrument for cardiac rehabilitation, as all scales are responsive enough to capture changes from T1 to T2. At T2, however, the MacNew seems to lose some of its discriminating power, partly because of ceiling effects. CONCLUSION: It is suggested to complement the use of the MacNew both at T1 and T2 with a brief anxiety and depression measure, which is valid and responsive for different groups of cardiac rehabilitation patients.

Motives for (not) participating in a lifestyle intervention trial.

BACKGROUND: Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial, and explored the motives and barriers underlying the decision to participate or not. METHODS: We collected data on participants (n = 50) and non-participants (n = 50) who were eligible for inclusion in a comprehensive CVD lifestyle interventional trial. Questionnaires and a hospital patient records database were used to assess socio-demographic, health-related and lifestyle behavioral variables. Univariate and multivariate logistic regression was used to describe the relationship between explanatory variables and study participation. Furthermore, motives and barriers that underlie study participation were investigated by means of questionnaires. RESULTS: Participants were younger, single, had a higher level of education and were employed. No statistically significant differences were found in health measures and behavioral variables. The motives for participation that were most frequently reported were: the perception of being unhealthy and willingness to change their lifestyle. The main barriers reported by non-participants were financial arguments and time investment. CONCLUSION: The differences between participants and non-participants in a lifestyle intervention trial are in mainly demographic factors. The participants consent in order to alter their lifestyle, and/or because they want to improve their health. To minimize non-participation, it is recommended that access to a lifestyle intervention program should be easy and cause no financial restraints. TRIAL REGISTRATION: ISRCTN69776211.