Dataset Information

Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice - the ECSTATIC study: a cluster randomised non-inferiority trial.

ABSTRACT:

Background

The 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.

Methods

In 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.

Results

Of 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?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 registration

This study was registered with Dutch trial register on 20 June 2012 ( NTR3493 ).

SUBMITTER: Luymes CH

PROVIDER: S-EPMC5763574 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice - the ECSTATIC study: a cluster randomised non-inferiority trial.

Luymes Clare H CH Poortvliet Rosalinde K E RKE van Geloven Nan N de Waal Margot W M MWM Drewes Yvonne M YM Blom Jeanet W JW Smidt Nynke N Assendelft Willem J J WJJ van den Hout Wilbert B WB de Ruijter Wouter W Numans Mattijs E ME

BMC medicine 20180111 1

<h4>Background</h4>The 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.<h4>Methods</h4>In this pragmatic cluster randomised controlled non-inferiority trial, we recruited 46 general practices i ...[more]

PMID: 29321031

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Project description:BACKGROUND:Patients with low cardiovascular disease (CVD) risk potentially use preventive cardiovascular medication unnecessarily. Our aim was to identify various viewpoints and beliefs concerning the preventive CVD management of patients with low CVD risk using preventive cardiovascular medication. Furthermore, we investigated whether certain viewpoints were related to a preference for deprescription or the continuation of preventive cardiovascular medication. METHODS:In 2015, we purposively sampled patients from the intervention arm of the Evaluating Cessation of STatins and Antihypertensive Treatment In primary Care (ECSTATIC) trial in the Netherlands for this study. Participants made Q-sorts by ranking 43 statements concerning preventive CVD management from "totally disagree" to "totally agree". These Q-sorts were analyzed using PQMethod 2.35 software. A varimax procedure presented the distinguishing viewpoints that were favored by our participants. We used group discussion quotations to underline our findings. For validation purposes, we asked participants how well each viewpoint fitted them. RESULTS:Of 291 invited patients, 33 participated. Thirty-one Q-sorts were analyzed. The following three viewpoints were found: 1) a controlling viewpoint, in which patients held the belief that monitoring blood pressure and cholesterol levels is important (n=13, of which seven had their medication deprescribed and six continued their medication); 2) an autonomous viewpoint, in which patients showed a dislike of medication (n=8, of which seven had their medication deprescribed and one had it continued); and 3) an afraid viewpoint, in which patients were fearful of developing CVD (n=8, of which two had their medication deprescribed and six had it continued). Seventy-four percent of the participants believed that the viewpoint to which they were assigned was a good fit. CONCLUSION:Three well-discriminating viewpoints about preventive CVD management were determined. Knowing and recognizing these viewpoints is effective for general practitioners when discussing the deprescribing of preventive cardiovascular medications with patients and may be used to promote implementation of deprescription.

Project description:IntroductionManaging patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.Methods and analysisThis pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.Ethics and disseminationThis trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.Trial registration numberISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

Project description:Interventions: Future Health Today (FHT) trial is testing a quality improvement (QI) program in order to reduce cardiovascular disease (CVD) risk in people with chronic kidney disease (CKD) and to facilitate earlier diagnosis of cancer in general practice. The intervention consists of: 1.Technology platform consisting of audit, point of care clinical decision support, and QI templates. Practices will generate a baseline cohort of patients using the audit tool at the beginning of the trial. The progress of the cohort will be automatically updated using the Future Health Today platform over the trial duration. Practices will be encouraged to review their progress and complete a minimum of three reviews of audit data as part of an accredited Royal Australian College of General Practitioners (RACGP) quality improvement activity. These can be carried out at any time during the trial, but we will recommend that they are conducted at least once every four months over the 12-month trial period. The point of care tool will automatically deploy when the electronic medical record of an eligible patient is opened and will provide a prompt regarding guideline-concordant care. The QI template has been developed specifically for this study, and aligns to RACGP requirements. 2.ECHO (Extension for Community Healthcare Outcomes) education activities. ECHO sessions are delivered using the zoom videoconference platform. The 60-minute sessions consist of (1) Introductions of participants (2) Delivery of a short didactic lecture (approximately 10 minutes in duration), followed by question and answer session (3) Presentation of a clinical case by a participant followed by feedback from participants and an expert panel. Each arm will receive 3 ECHO sessions based on their allocation (see below). T Primary outcome(s): Proportion of eligible patients with CKD (coded diagnosis or pathology consistent with diagnosis of CKD) that are receiving ACE inhibitors or Angiotensin receptor blockers and/or statins consistent with Kidney Health Australia, RACGP Red Book and National Vascular Disease Prevention Alliance Guidelines.[ 12 months post-baseline];Proportion of eligible patients at risk of undiagnosed prostate, oesophageal, gastric, colorectal, endometrial, lung or ovarian cancer that have been assessed and investigated according to NICE, Cancer Council Australia, Victorian Government Department of Health and Human Services, Prostate Cancer Foundation of Australia guidelines. This will be assessed utilising data extracted from electronic medical records and stored in the Department of General Practice, University of Melbourne Patron dataset. [ 12 months post-baseline] Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Financial incentives and audit plus feedback on performance are two strategies commonly used by governments to motivate general practitioners (GP) to undertake specific healthcare activities. However, in recent years, governments have reduced or removed incentive payments without evidence of the potential impact on GP behaviour and patient outcomes. This trial (known as ACCEPt-able) aims to determine whether preventive care activities in general practice are sustained when financial incentives and/or external audit plus feedback on preventive care activities are removed. The activity investigated is annual chlamydia testing for 16- to 29-year-old adults, a key preventive health strategy within this age group.ACCEPt-able builds on a large cluster randomised controlled trial (RCT) that evaluated a 3-year chlamydia testing intervention in general practice. GPs were provided with a support package to facilitate annual chlamydia testing of all sexually active 16- to 29-year-old patients. This package included financial incentive payments to the GP for each chlamydia test conducted and external audit plus feedback on each GP's chlamydia testing rates. ACCEPt-able is a factorial cluster RCT in which general practices are randomised to one of four groups: (i) removal of audit plus feedback-continue to receive financial incentive payments for each chlamydia test; (ii) removal of financial incentive payments-continue to receive audit plus feedback; (iii) removal of financial incentive payments and audit plus feedback; and (iv) continue financial incentive payments and audit plus feedback. The primary outcome is chlamydia testing rate measured as the proportion of sexually active 16- to 29-year-olds who have a GP consultation within a 12-month period and at least one chlamydia test.This will be the first RCT to examine the impact of removal of financial incentive payments and audit plus feedback on the chlamydia testing behaviour of GPs. This trial is particularly timely and will increase our understanding about the impact of financial incentives and audit plus feedback on GP behaviour when governments are looking for opportunities to control healthcare budgets and maximise clinical outcomes for money spent. The results of this trial will have implications for supporting preventive health measures beyond the content area of chlamydia.The trial has been registered on the Australian and New Zealand Clinical Trials Registry ( ACTRN12614000595617 ).

Project description:BACKGROUND: Inappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people. Inappropriate drug use may increase the risk of the occurrence of 'geriatric giants' such as immobility, instability, incontinence and cognitive impairment. There are indications that clinical medication reviews (CMR) can reduce inappropriate drug use. However, CMRs have not yet been implemented at a large scale in primary care. An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs. The aim of this study is to assess whether this CMR program is (cost-) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms. METHODS: A cluster randomised controlled trial will be performed in 20 Dutch general practices including 500 patients. Patients of 65 years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug. GP practices will be stratified by practice size and randomly allocated to control (n?=?10) or intervention group (n?=?10). The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist. Primary outcome measures are patient's quality of life and the presence of self-reported geriatric symptoms during a follow-up period of 6 months. Secondary outcomes are costs of healthcare utilisation, feasibility, number of drug related problems, medication adherence and satisfaction with medication. DISCUSSION: This study is expected to add evidence on the (cost-) effectiveness of an optimally facilitated, prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP. The strength of this study is that it will be conducted in daily clinical practice. This improves the possibilities to implement the CMRs in the primary care setting on a large scale. TRIAL REGISTRATION: Netherlands Trial register: NTR4264.

Project description:BackgroundFew patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral.MethodsA cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the softwareResultsFrom 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral.ConclusionThere was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations.

Project description:IntroductionClinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy.Methods and analysisPlanned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter.Scopegeneral practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients.Populationpatients (≥18 years) with polypharmacy (≥5 prescriptions).Sample sizeinitially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved.Interventioncomplex intervention eMMa.Follow-upat least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa.Outcomesprimary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse.Statistical analysisprimary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints.Ethics and disseminationTrial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences.Trial registrationNCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336).

Dataset Information

Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice - the ECSTATIC study: a cluster randomised non-inferiority trial.

Background

Methods

Results

Trial registration

Publications

Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice - the ECSTATIC study: a cluster randomised non-inferiority trial.

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