Population effectiveness of opportunistic chlamydia testing in primary care in Australia: a cluster-randomised controlled trial

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.

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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 ◽

10.1136/bmjopen-2020-045444 ◽

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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Adolescent seasonal allergic rhinitis and the impact of health-care professional training: cluster randomised controlled trial of a complex intervention in primary care

npj Primary Care Respiratory Medicine ◽

10.1038/npjpcrm.2014.12 ◽

2014 ◽

Vol 24 (1) ◽

Cited By ~ 1

Author(s):

Victoria S Hammersley ◽

Rob A Elton ◽

Samantha Walker ◽

Christian H Hansen ◽

Aziz Sheikh

Keyword(s):

Primary Care ◽

Health Care ◽

Allergic Rhinitis ◽

Randomised Controlled Trial ◽

Professional Training ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Randomised Controlled ◽

The Impact

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Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason – GET UP: study protocol for a cluster randomised controlled trial

Trials ◽

10.1186/s13063-018-2947-2 ◽

2018 ◽

Vol 19 (1) ◽

Author(s):

Marie Barais ◽

Hélène Vaillant Roussel ◽

David Costa ◽

Jérémy Derriennic ◽

Bruno Pereira ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Usual Care ◽

Premature Ejaculation ◽

Controlled Trial ◽

Communication Strategies ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Male Patients ◽

Randomised Controlled

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Primary care Identification and Referral to Improve Safety of women experiencing domestic violence (IRIS): protocol for a pragmatic cluster randomised controlled trial

BMC Public Health ◽

10.1186/1471-2458-10-54 ◽

2010 ◽

Vol 10 (1) ◽

Cited By ~ 15

Author(s):

Alison Gregory ◽

Jean Ramsay ◽

Roxane Agnew-Davies ◽

Kathleen Baird ◽

Angela Devine ◽

...

Keyword(s):

Primary Care ◽

Domestic Violence ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Randomised Controlled

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NHS Direct versus general practice based triage for same day appointments in primary care: cluster randomised controlled trial

BMJ ◽

10.1136/bmj.38226.605995.55 ◽

2004 ◽

Vol 329 (7469) ◽

pp. 774 ◽

Cited By ~ 18

Author(s):

David A Richards ◽

Lesley Godfrey ◽

Jane Tawfik ◽

Mike Ryan ◽

Joan Meakins ◽

...

Keyword(s):

Primary Care ◽

General Practice ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Randomised Controlled ◽

Nhs Direct

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Effectiveness of policy to provide breastfeeding groups (BIG) for pregnant and breastfeeding mothers in primary care: cluster randomised controlled trial

BMJ ◽

10.1136/bmj.a3026 ◽

2009 ◽

Vol 338 (jan30 1) ◽

pp. a3026-a3026 ◽

Cited By ~ 40

Author(s):

P. Hoddinott ◽

J. Britten ◽

G. J Prescott ◽

D. Tappin ◽

A. Ludbrook ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Randomised Controlled

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The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

10.1101/2021.09.16.21263674 ◽

2021 ◽

Author(s):

Lisa Hynes ◽

Andrew W Murphy ◽

Nigel Hart ◽

Collette Kirwan ◽

Sarah Mulligan ◽

...

Keyword(s):

Primary Care ◽

Decision Making ◽

Pilot Study ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Definitive Trial ◽

Cluster Randomised ◽

Medication Reviews ◽

Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

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