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

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

BMJ Open ◽

10.1136/bmjopen-2016-015510 ◽

2017 ◽

Vol 7 (9) ◽

pp. e015510 ◽

Cited By ~ 6

Author(s):

Carline J van den Dries ◽

Ruud Oudega ◽

Arif Elvan ◽

Frans H Rutten ◽

Sjef J C M van de Leur ◽

...

Keyword(s):

Atrial Fibrillation ◽

Primary Care ◽

Cost Effectiveness ◽

The Netherlands ◽

Major Bleeding ◽

Dominant Role ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Ageing Society ◽

Cluster Randomised

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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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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