Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial.

Abstract Background: Globally eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services, in addition, specialist services are over utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smart phone-based screening algorithm (Peek Community Screening App). The application (App) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteer (CVs) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualizing service delivery. We hypothesize that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches. Study design: A single masked, cluster-randomised controlled trial design will be used. The unit of randomisation will be the “community unit”, defined as a dispensary or health centres with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitization, where attendance will be ascertained. During triage participants will be assessed and treated, and if necessary referred onwards to Kitale eye unit. Discussion: We aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level. Trial registration The Pan African Clinical Trials Registry (PACTR), 201807329096632. Registered 8th June 2018, https://pactr.samrc.ac.za

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Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial.

10.21203/rs.2.327/v1 ◽

2019 ◽

Author(s):

Hillary Rono ◽

Andrew Bastawrous ◽

David Macleod ◽

Emmanuel Wanjala ◽

Stephene Gichuhi ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Health System ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Eye Care ◽

Community Screening ◽

Eye Health ◽

Cluster Randomised ◽

Eye Problems ◽

Randomised Controlled

Abstract Background: Globally eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services, in addition, specialist services are over utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smart phone-based screening algorithm (Peek Community Screening App). The application (app) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteer (CVs) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients and carers and has a program dashboard for visualizing service delivery. We hypothesize that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches. Methods: A single masked, cluster-randomised controlled trial. The unit of randomisation will be the “community units”, defined as a dispensary or health centres with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitization, where attendance will be ascertained. During triage participants will be assessed and treated, and if necessary referred onwards to Kitale eye unit. Discussion: We aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level. Trial registration: The Pan African Clinical Trials Registry (PACTR), 201807329096632. Registered 8th june 2018, https://pactr.samrc.ac.za. Keywords: Eye problems, Visual Impairement, Access, Primary eye care , Community Eye Health system, Community volunteres, Peek community screening app., cluster randomised controlled trial.

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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

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00822-2 ◽

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.

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Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial

PLoS Medicine ◽

10.1371/journal.pmed.1002178 ◽

2016 ◽

Vol 13 (11) ◽

pp. e1002178 ◽

Cited By ~ 36

Author(s):

Lara R. Fairall ◽

Naomi Folb ◽

Venessa Timmerman ◽

Carl Lombard ◽

Krisela Steyn ◽

...

Keyword(s):

South Africa ◽

Primary Care ◽

Chronic Disease ◽

Chronic Disease Management ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Educational Outreach ◽

Clinical Tool ◽

Cluster Randomised ◽

Randomised Controlled

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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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