scholarly journals Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m3208
Author(s):  
Steven B Uittenbogaart ◽  
Nicole Verbiest-van Gurp ◽  
Wim A M Lucassen ◽  
Bjorn Winkens ◽  
Mark Nielen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Care Group ◽  
Opportunistic Screening ◽  
Cluster Randomised ◽  
Care Practices ◽  
Randomised Controlled

AbstractObjectiveTo investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.DesignCluster randomised controlled trial.Setting47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.ParticipantsIn each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.InterventionsOpportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.Main outcome measuresDifference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.ResultsFollow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.ConclusionsOpportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.Trial registrationNetherlands Trial Register No NL4776 (old NTR4914).

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial

2019 ◽  
Vol 53 (4) ◽  
pp. 1801530 ◽  
Author(s):  
Jenifer Liang ◽  
Michael J. Abramson ◽  
Grant Russell ◽  
Anne E. Holland ◽  
Nicholas A. Zwar ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Lung Function ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Smoking Abstinence ◽  
Model Of Care ◽  
Cluster Randomised ◽  
Randomised Controlled

We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI –0.89–5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19–10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.

scholarly journals TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial

2019 ◽  
Author(s):  
Jessica Frost ◽  
J Athene Lane ◽  
Nikki Cotterill ◽  
Mandy Fader ◽  
Lucy Hackshaw-McGeagh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their General Practitioner (GP) in the first instance, with conservative therapies recommended as initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care. Methods TRIUMPH is a 2-arm cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) General Practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and health care professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post-consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis. Discussion It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care therefore holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic cluster RCT will provide robust evidence in a primary care setting to inform future guidelines.

scholarly journals Cost of childhood acute otitis media in primary care in the Netherlands: economic analysis alongside a cluster randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rick T. van Uum ◽  
Roderick P. Venekamp ◽  
Clémence T. B. Pasmans ◽  
G. Ardine de Wit ◽  
Alies Sjoukes ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Cluster Randomised Controlled Trial ◽  
Productivity Losses ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Cost ◽  
Trial Intervention

Abstract Background Acute otitis media (AOM) is among the most common paediatric conditions managed in primary care. Most recent estimates of the cost of AOM date from a decade ago and lack a full societal perspective. We therefore explored the societal cost of childhood AOM in the Netherlands within the setting of a trial comparing the effectiveness of an intervention aimed at educating general practitioners (GPs) about pain management in AOM compared to usual care. Methods Economic analysis alongside a cluster randomised controlled trial conducted between February 2015 and May 2018 in 37 practices (94 GPs). In total, 224 children with AOM were included of which 223 (99%) completed the trial (intervention: n = 94; control: n = 129). The cost of AOM due to health care costs, patient and family costs, and productivity losses by parent caregivers were retrieved from study diaries and primary care electronic health records, during 28-day follow-up. We calculated mean cost (€ and $) per AOM episode per patient with standard deviations (SD, in €) regardless of study group assignment because there was no clinical effect of the trial intervention. In sensitivity analysis, we calculated cost in the intervention and usual care group, after exclusion of extreme outliers. Results Mean total AOM cost per patient were €565.93 or $638.78 (SD €1071.01); nearly 90% of these costs were due to productivity losses experienced by parents. After exclusion of outliers, AOM cost was €526.70 or $594.50 (SD €987.96) and similar in the intervention and usual care groups: €516.10 or $582.53 (SD €949.69) and €534.55 or $603.36 (SD €920.55) respectively. Conclusions At €566 or $639 per episode, societal cost of AOM is higher than previously known and mainly driven by productivity losses by children’s parents. Considering its high incidence, AOM poses a significant economic burden that extends beyond direct medical costs. Trial registration Netherlands Trial Register no. NTR4920: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4920.

scholarly journals An External Pilot Cluster Randomised Controlled Trial of a Theory-based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care (Polyprime): Study Protocol

2020 ◽  
Author(s):  
Audrey Rankin ◽  
Cathal A Cadogan ◽  
Heather E Barry ◽  
Evie Gardner ◽  
Ashley Agus ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Retention Data ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background: The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI).Methods: Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: 1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient; and 2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action.Discussion: This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT.Trial registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019, https://doi.org/10.1186/ISRCTN41009897. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019, https://clinicaltrials.gov/ct2/show/NCT04181879.

scholarly journals Opportunistic screening versus usual care for diagnosing atrial fibrillation in general practice: a cluster randomised controlled trial

2020 ◽  
Vol 70 (695) ◽  
pp. e427-e433 ◽  
Author(s):  
Femke Kaasenbrood ◽  
Monika Hollander ◽  
Steven HM de Bruijn ◽  
Carlijn PE Dolmans ◽  
Robert G Tieleman ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Screening Methods ◽  
Opportunistic Screening ◽  
Newly Diagnosed ◽  
Randomised Controlled

BackgroundAtrial fibrillation (AF) increases the risk of stroke, heart failure, and all-cause mortality. AF may be asymptomatic and therefore remain undiagnosed. Devices such as single-lead electrocardiographs (ECGs) may help GPs to diagnose AF.AimTo investigate the yield of opportunistic screening for AF in usual primary care using a single-lead ECG device.Design and settingA clustered, randomised controlled trial among patients aged ≥65 years with no recorded AF status in the Netherlands from October 2014 to March 2016.MethodFifteen intervention general practices used a single-lead ECG device at their discretion and 16 control practices offered usual care. The follow-up period was 1 year, and the primary outcome was the proportion of newly diagnosed cases of AF.ResultsIn total, 17 107 older people with no recorded AF status were eligible to participate in the study. In the intervention arm, 10.7% of eligible patients (n = 919) were screened over the duration of the study year. The rate of newly diagnosed AF was similar in the intervention and control practices (1.43% versus 1.37%, P = 0.73). Screened patients were more likely to have comorbidities, such as hypertension (60.0% versus 48.7%), type 2 diabetes (24.3% versus 18.6%), and chronic obstructive pulmonary disease (11.3% versus 7.4%), than eligible patients not screened in the intervention arm. Among patients with newly diagnosed AF in intervention practices, 27% were detected by screening, 23% by usual primary care, and 50% by a medical specialist or after stroke/transient ischaemic attack.ConclusionOpportunistic screening with a single-lead ECG at the discretion of the GP did not result in a higher yield of newly detected cases of AF in patients aged ≥65 years in the community than usual care. For higher participation rates in future studies, more rigorous screening methods are needed.

scholarly journals Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045444
Author(s):  
Sophie Ansems ◽  
Marjolein Berger ◽  
Patrick van Rheenen ◽  
Karin Vermeulen ◽  
Gina Beugel ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Cluster Randomised Controlled Trial ◽  
Referral Rate ◽  
Faecal Calprotectin ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

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