Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial

IntroductionIn our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care.Methods and analysisThe ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness.Ethics and disseminationThe protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences.Trial registration numberThis trial is registered at the Netherlands Trial Register (NTR5532).

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Effectiveness and cost effectiveness of syndromic sexually transmitted infection packages in South African primary care: cluster randomised trial

Sexually Transmitted Infections ◽

10.1136/sti.2005.019240 ◽

2006 ◽

Vol 82 (4) ◽

pp. 290-294 ◽

Cited By ~ 6

Author(s):

M Colvin

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

South African ◽

Sexually Transmitted Infection ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Transmitted Infection ◽

Sexually Transmitted ◽

Cluster Randomised

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Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors

BMJ Open ◽

10.1136/bmjopen-2019-032616 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032616 ◽

Cited By ~ 1

Author(s):

Yvonne L Luigjes-Huizer ◽

Marije L van der Lee ◽

Niek J de Wit ◽

Charles W Helsper

Keyword(s):

Primary Care ◽

The Netherlands ◽

Medical Research ◽

Randomised Trial ◽

Intervention Group ◽

Cancer Recurrence ◽

Fear Of Cancer Recurrence ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Fear Of Cancer

IntroductionMany successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated.Methods and analysisA two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive–behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group.Ethics and disseminationThe Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations.Trial registration numberNL7573 in the Netherlands Trial Register on 25-02-2019.

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Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-030110 ◽

2020 ◽

Vol 10 (1) ◽

pp. e030110 ◽

Cited By ~ 1

Author(s):

Joanna Thorn ◽

Mei-See Man ◽

Katherine Chaplin ◽

Peter Bower ◽

Sara Brookes ◽

...

Keyword(s):

Primary Care ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Usual Care ◽

Randomised Trial ◽

Mean Difference ◽

Secondary Outcome ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

The Cost

ObjectivePatients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.DesignEconomic evaluation conducted alongside a pragmatic cluster-randomised trial.SettingGeneral practices in three centres in England and Scotland.Participants797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care.InterventionThe 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments.Primary and secondary outcome measuresThe primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost–consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses.ResultsVery small increases were found in both QALYs (adjusted mean difference 0.007 (−0.009 to 0.023)) and costs (adjusted mean difference £126 (£−739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY).ConclusionsThe small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal.Trial registration numberISCRTN06180958

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Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice

British Journal of General Practice ◽

10.3399/bjgp18x699809 ◽

2018 ◽

Vol 68 (677) ◽

pp. e844-e851

Author(s):

Tim A Holt ◽

Andrew RH Dalton ◽

Susan Kirkpatrick ◽

Jenny Hislop ◽

Tom Marshall ◽

...

Keyword(s):

Atrial Fibrillation ◽

Risk Assessment ◽

General Practice ◽

Process Evaluation ◽

Oral Anticoagulants ◽

Qualitative Interviews ◽

Randomised Trial ◽

Software Tool ◽

Cluster Randomised Trial ◽

Cluster Randomised

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.

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Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

BMC Family Practice ◽

10.1186/s12875-016-0473-4 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 8

Author(s):

Hélène Vaillant-Roussel ◽

Catherine Laporte ◽

Bruno Pereira ◽

Marion De Rosa ◽

Bénédicte Eschalier ◽

...

Keyword(s):

Heart Failure ◽

Primary Care ◽

Chronic Heart Failure ◽

Patient Education ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

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Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

BMJ Open ◽

10.1136/bmjopen-2015-010892 ◽

2016 ◽

Vol 6 (8) ◽

pp. e010892 ◽

Cited By ~ 8

Author(s):

Dorota Juszczyk ◽

Judith Charlton ◽

Lisa McDermott ◽

Jamie Soames ◽

Kirin Sultana ◽

...

Keyword(s):

Primary Care ◽

Electronic Health Records ◽

Respiratory Infections ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Antibiotic Prescribing ◽

Health Records ◽

Multicomponent Intervention ◽

Cluster Randomised ◽

Electronically Delivered

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Using mHealth tools to improve access, coverage and treatment of uninsured people with high cardiovascular disease risk in Argentina: a study protocol for a pragmatic cluster randomised trial

BMJ Innovations ◽

10.1136/bmjinnov-2017-000255 ◽

2018 ◽

Vol 4 (3) ◽

pp. 135-141 ◽

Cited By ~ 2

Author(s):

Shafika Abrahams-Gessel ◽

Andrea Beratarrechea ◽

Vilma Irazola ◽

Laura Gutierrez ◽

Daniela Moyano ◽

...

Keyword(s):

Cardiovascular Disease ◽

Primary Care ◽

High Risk ◽

Randomised Trial ◽

Text Messages ◽

Cluster Randomised Trial ◽

Cvd Risk ◽

High Risk Patients ◽

Cluster Randomised ◽

Risk Patients

IntroductionCardiovascular disease (CVD) accounts for approximately one-third of Argentina’s deaths. Despite government provision of free primary care health services to the uninsured population, with a focus on non-communicable diseases, screening and management of those with high CVD risk at primary care clinics (PCCs) remain low.Methods and analysisThis pragmatic cluster randomised trial will take place in two provinces of Argentina and will recruit 740 participants. Eight PCCs will be randomised to either the intervention or current practice arm. Community health workers (CHWs) in the intervention arm will be trained to use a set of integrated mHealth tools (a validated risk screening tool mobile application; electronic scheduling system using wireless access to PCCs; and educational text messages) to screen for CVD and to schedule appointments with primary care providers for persons with high CVD risk (≥10%). The primary aims of this study are to determine if the use of mHealth tools will (1) increase attendance of first appointments scheduled by CHWs for persons determined to have high risk for CVD during screening and, (2) lead to an increase in follow-up visits at PCCs by high risk patients. Secondary outcomes include assessing the proportion of high-risk patients receiving appropriate medications and a cost-effective analysis of the intervention.Ethics and disseminationThis study has been approved by the Institutional Review Boards at Partners/Brigham and Women’s Hospital (USA) and the Hospital Italiano de Buenos Aires (Argentina). The open-source software for the mHealth tools will be made publicly available at the end of the study.Trial registration numberNCT02913339.

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