scholarly journals Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeremy Horwood ◽  
Melanie Chalder ◽  
Ben Ainsworth ◽  
James Denison-Day ◽  
Frank de Vocht ◽  
...  
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Behaviour Change Techniques ◽  
Current Standard ◽  
Link Type ◽  
Implementation Period ◽  
Full Protocol ◽  
Randomised Controlled

Abstract Objectives To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. Trial design A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. Participants Setting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices. Intervention and comparator Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website (http://GermDefence.org/) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users’ personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. Main outcomes The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice Randomisation GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. Blinding (masking) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. Numbers to be randomised (sample size) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. Trial status Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. Trial registration This trial was registered in the ISRCTN registry (isrctn.com/ISRCTN14602359) on 12 August 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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 PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial

2020 ◽  
Vol 2 (7) ◽  
pp. e401-e411 ◽  
Author(s):  
Kika Konstantinou ◽  
Martyn Lewis ◽  
Kate M Dunn ◽  
Reuben Ogollah ◽  
Majid Artus ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Stratified Care ◽  
Randomised Controlled

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 Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

scholarly journals Feasibility & Efficacy of Deprescribing rounds in a Singapore rehabilitative hospital- a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Peng Yong Wong ◽  
Tan Wan Ting ◽  
Ee Jia Ming Charissa ◽  
Tan Wee Boon ◽  
Kwan Yu Heng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Total Daily Dose ◽  
Open Label ◽  
Rehabilitation Hospital ◽  
Link Type ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Deprescribing is effective and safe in reducing polypharmacy among the elderly. However, the impact of deprescribing rounds remain unclear in Asian settings. Hence, we conducted this study. Methods An open label randomised controlled trial was conducted on patients of 65 years and above, under rehabilitation or subacute care and with prespecified medications from a Singapore rehabilitation hospital. They were randomised using a computer generated sequence. The intervention consisted of weekly multidisciplinary team-led deprescribing rounds (using five steps of deprescribing) and usual care. The control had only usual care. The primary outcome is the percentage change in total daily dose (TDD) from baseline upon discharge, while the secondary outcomes are the total number of medicine, total daily cost and TDD up to day 28 postdischarge, overall side-effect rates, rounding time and the challenges. Efficacy outcomes were analysed using intention-to-treat while other outcomes were analysed as per protocol. Results 260 patients were randomised and 253 were analysed after excluding dropouts (female: 57.3%; median age: 76 years). Baseline characteristics were largely similar in both groups. The intervention arm (n = 126) experienced a greater reduction of TDD on discharge [Median (IQR): − 19.62% (− 34.38, 0.00%) versus 0.00% (− 12.00, 6.82%); p < 0.001], more constipation (OR: 3.75, 95% CI:1.75–8.06, p < 0.001) and laxative re-prescriptions (OR: 2.82, 95% CI:1.30–6.12, p = 0.009) though death and hospitalisation rates were similar. The median rounding time was 7.09 min per patient and challenges include the inconvenience in assembling the multidisciplinary team. Conclusion Deprescribing rounds can safely reduce TDD of medicine upon discharge compared to usual care in a Singaporean rehabilitation hospital. Trial registration This study is first registered at Clinicaltrials.gov (protocol number: NCT03713112) on 19/10/2018 and the protocol can be accessed on https://www.clinicaltrials.gov.

scholarly journals Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e025340 ◽  
Author(s):  
Terri R Fried ◽  
Colleen A Redding ◽  
Steven Martino ◽  
Andrea Paiva ◽  
Lynne Iannone ◽  
...  
Keyword(s):  
Usual Care ◽  
Behaviour Change ◽  
Advance Care Planning ◽  
Randomised Controlled Trials ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Care Planning ◽  
Link Type ◽  
Advance Care ◽  
Randomised Controlled

IntroductionAdvance care planning (ACP) is a key component of high-quality end-of-life care but is underused. Interventions based on models of behaviour change may fill an important gap in available programmes to increase ACP engagement. Such interventions are designed for broad outreach and flexibility in delivery. The purpose of the Sharing and Talking about My Preferences study is to examine the efficacy of three behaviour change approaches to increasing ACP engagement through two related randomised controlled trials being conducted in different settings (Veterans Affairs (VA) medical centre and community).Methods and analysisEligible participants are 55 years or older. Participants in the community are being recruited in person in primary care and specialty outpatient practices and senior living sites, and participants in the VA are recruited by telephone. In the community, randomisation is at the level of the practice or site, with all persons at a given practice/site receiving either computer-tailored feedback with a behaviour stage-matched brochure (computer-tailored intervention (CTI)) or usual care. At the VA, randomisation is at the level of the participant and is stratified by the number of ACP behaviours completed at baseline. Participants are randomised to one of four groups: CTI, motivational interviewing, motivational enhancement therapy or usual care. The primary outcome is completion of four key ACP behaviours: identification of a surrogate decision maker, communication about goals, completing advance directives and ensuring documents are in the medical record. Analysis will be conducted using mixed effects models, taking into account the clustered randomisation for the community study.Ethics and randomisationThe studies have been approved by the appropriate Institutional Review Boards and are being overseen by a Safety Monitoring Committee. The results of these studies will be disseminated to academic audiences and leadership in in the community and VA sites.Trial registration numbersNCT03137459andNCT03103828.

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