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Tailored implementation of cardiovascular risk management in general practice: a cluster randomized trial.

ABSTRACT: 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.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.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.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.Nederlands Trial register NTR4069.

SUBMITTER: van Lieshout J

PROVIDER: S-EPMC4982017 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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Project description:Several observational studies on hypertensive patients have shown a gap between therapeutic targets recommended in guidelines and those achieved in daily practice. The ESCAPE trial aimed to determine whether a multifaceted intervention focused on general practitioners (GPs), could increase significantly the proportion of hypertensive patients at high risk in primary prevention who achieved all their recommended therapeutic targets.A pragmatic, cluster randomized trial involving 257 GPs randomized by region. The GPs in the intervention group had a one-day training session and were given an electronic blood pressure measurement device and a short recommendation leaflet. Along with usual follow-up, they focused one consultation on hypertension and other cardiovascular risk factors every six months for two years. They also received feedback at baseline and at one year on their patients' clinical and biological parameters. Main outcome measures were change in the proportion of patients achieving all their therapeutic targets and each individual therapeutic target at two years, and quality of life.1,832 high-risk hypertensive patients were included. After two years, the proportion of patients achieving all their therapeutic targets increased significantly in both groups, but significantly more in the intervention group: OR (odds-ratio) 1.89, (95% confidence interval (CI) 1.09 to 3.27, P = 0.02). Significantly more patients achieved their blood pressure targets in the intervention group than in the usual care group: OR 2.03 (95% CI 1.44 to 2.88, P < 0.0001). Systolic and diastolic blood pressures decreased significantly more in the intervention group than in the usual care group, by 4.8 mmHg and 1.9 mmHg, respectively (P < 0.0001 for both). There were no significant difference changes in physical and mental quality of life between groups.An easy-to-perform, multifaceted intervention targeting only GPs increased significantly the proportion of high-risk hypertensive patients in primary prevention achieving their recommended therapeutic targets.This trial was registered with ClinicalTrials.gov, number NCT00348855.

Project description:BackgroundThe use of cardiovascular medication for the primary prevention of cardiovascular disease (CVD) is potentially inappropriate when potential risks outweigh the potential benefits. It is unknown whether deprescribing preventive cardiovascular medication in patients without a strict indication for such medication is safe and cost-effective in general practice.MethodsIn this pragmatic cluster randomised controlled non-inferiority trial, we recruited 46 general practices in the Netherlands. Patients aged 40-70 years who were using antihypertensive and/or lipid-lowering drugs without CVD and with low risk of future CVD were followed for 2 years. The intervention was an attempt to deprescribe preventive cardiovascular medication. The primary outcome was the difference in the increase in predicted (10-year) CVD risk in the per-protocol (PP) population with a non-inferiority margin of 2.5 percentage points. An economic evaluation was performed in the intention-to-treat (ITT) population. We used multilevel (generalised) linear regression with multiple imputation of missing data.ResultsOf 1067 participants recruited between 7 November 2012 and 18 February 2014, 72% were female. Overall, their mean age was 55 years and their mean predicted CVD risk at baseline was 5%. Of 492 participants in the ITT intervention group, 319 (65%) quit the medication (PP intervention group); 135 (27%) of those participants were still not taking medication after 2 years. The predicted CVD risk increased by 2.0 percentage points in the PP intervention group compared to 1.9 percentage points in the usual care group. The difference of 0.1 (95% CI -0.3 to 0.6) fell within the non-inferiority margin. After 2 years, compared to the usual care group, for the PP intervention group, systolic blood pressure was 6 mmHg higher, diastolic blood pressure was 4 mmHg higher and total cholesterol and low-density lipoprotein-cholesterol levels were both 7 mg/dl higher (all P?<?0.05). Cost and quality-adjusted life years did not differ between the groups.ConclusionsThe results of the ECSTATIC study show that an attempt to deprescribe preventive cardiovascular medication in low-CVD-risk patients is safe in the short term when blood pressure and cholesterol levels are monitored after stopping. An attempt to deprescribe medication can be considered, taking patient preferences into consideration.Trial registrationThis study was registered with Dutch trial register on 20 June 2012 ( NTR3493 ).

Project description:Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS).In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded.Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p?=?0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p?=?0.004]).Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines.ClinicalTrials.gov, NCT01699256.

Project description:IntroductionAlcohol consumption is a leading global risk factor for ill-health and premature death. Alcohol screening and brief interventions (SBI) delivered in primary care is effective at reducing alcohol consumption, but routine implementation remains problematic. Screening all patients for excessive drinking (universal screening) is resource-intensive and may be at odds with general practitioners' (GPs') perceived professional role. This study aimed to develop a tailored, theory-based training intervention to strengthen GPs' ability to address alcohol and to manage alcohol-related health problems through a pragmatic approach based on clinical relevance.MethodsA qualitative study design involving focus group interviews and a structured questionnaire for free text replies with GPs in Norway. Behavioral analysis assessed factors influencing delivery of SBI according to the 'capability, opportunity, motivation and behavior' (COM-B) model to inform intervention development using the Behavior Change Wheel. Qualitative data were analyzed using framework analysis and an iterative approach was adopted to develop the training.ResultsA purposive sample of GPs attended the focus groups (n = 25) and completed the questionnaire (n = 55). Four areas required additional support including: understanding the link between alcohol use and health problems; opening up the conversation on alcohol use; addressing alcohol and dealing with obstacles; and following-up and maintaining change. Findings informed the development of a four-session interactive training intervention and a digital intervention for providing support for patients between consultations to address the identified needs.ConclusionThis work highlights the value of pragmatic, relevance-based clinical strategies, as opposed to universal screening approaches to addressing alcohol in primary care. A pragmatic approach is more in line with GPs existing sclinical skill set and holds the potential to improve widespread uptake and implementation of SBI in routine primary care.

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Tailored implementation of cardiovascular risk management in general practice: a cluster randomized trial.

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