scholarly journals EnTraP: A factorial randomised controlled trial embedded within world hip trauma evaluation eight COPAL investigating the effect of an enhanced trainee principal investigator package and digital nudge on recruitment rates

2022 ◽  
pp. 263208432110612
Author(s):  
NR Agni ◽  
C Fairhurst ◽  
C McDaid ◽  
MR Reed ◽  
DJ Torgerson
Keyword(s):  
Positive Reinforcement ◽  
Controlled Trial ◽  
Open Cluster ◽  
Education Programme ◽  
Content Delivery ◽  
Factorial Trial ◽  
Hip Trauma ◽  
Set Up ◽  
Randomised Controlled ◽  
Ongoing Support

Background Randomised controlled trials (RCTs) often struggle with various aspects of participant recruitment, including engaging clinicians to recruit effectively, and subsequently fail to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. The RCTs embedded into the World Hip Trauma Evaluation (WHiTE) cohort study use Trainee Principal Investigators (TPIs) to help manage and drive recruitment at trial sites. No formalised training or support is provided by central trials units to the TPIs. Additionally, trial recruiters receive a generic automated email confirming randomisation to the trial with no other communication to influence or incentivise their behaviour to further recruit. The primary aim of this factorial trial was to evaluate the effectiveness of an educational intervention to TPIs and a positive reinforcement intervention via an email (digital) nudge on increasing recruitment. Secondary aims included feasibility of implementing the interventions and surveying TPIs on the educational package quality of content, delivery and ongoing support. Design This was a multicentre, open, cluster, 2x2 factorial RCT embedded in the WHiTE 8 COPAL RCT, in which research sites were randomised 1:1:1:1 to receive the enhanced TPI package, the digital nudge intervention, both, or neither. Results 1215 patients were recruited to the WHiTE 8 COPAL trial across 20 sites during the SWAT between August 2018 and March 2019. There was a statistically significant interaction between the interventions (IRR 2.09, 95% CI 1.64 to 2.68, p < 0.001). There was a statistically significant benefit on recruitment (IRR 1.23 95% 1.09 to 1.40, p=0.001) from utilizing an enhanced TPI education intervention. The digital nudge intervention had no significant impact on recruitment (IRR 0.89 95% CI 0.79 to 1.01, p=0.07). Within enhanced TPI package sites, the digital nudge had a beneficial effect, while in the standard practice TPI sites it had a detrimental effect. Feasibility analysis showed the median time to site digital nudge and enhanced TPI set up were one day and 17 days, respectively. 353 digital nudges were created taking an average of 12 min to construct, log the activity and then disseminate to recruiters. Median induction time for enhanced TPI was 32 min and 100% of the groups were extremely satisfied with the induction content, delivery and ongoing support. Discussion An education and support programme targeted at surgical TPIs involving a digital education package, 1:1 telephone induction and subsequent support package was effective in increasing recruitment in the first 6 months of trial commencement. There was no evidence for the effectiveness of the digital nudge intervention in isolation, although our results show that when combined with an education programme, it leads to enhanced effectiveness of that programme.

scholarly journals Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations—a protocol for a single-blinded randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e022685 ◽  
Author(s):  
Tiago Maricoto ◽  
Jaime Correia-de-Sousa ◽  
Luís Taborda-Barata
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
The Elderly ◽  
Education Programme ◽  
Data Safety Monitoring Board ◽  
Chronic Obstructive ◽  
Clinical Control ◽  
Set Up ◽  
Randomised Controlled ◽  
The Impact

IntroductionChronic Obstructive Pulmonary Disease (COPD)and asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.Methods and analysisA multicentre single-blinded Randomised Controlled Trial (RCT) will be set up, comparing an inhaler education programme with a teach-to-goal placebo-device training versus usual care, with a 1-year follow-up, in patients above 65 years of age with asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions χ² test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.Ethics and disseminationEvery participant will sign a written consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor early stopping criteria. Identity of all participants will be protected. This protocol was approved on 22 November 2017 by the local Ethics Committee of University of Beira Interior, with the reference number CE-UBI-Pj-2017–025. Results will be presented in scientific meetings and published in peer-reviewed journals.Trial registration numberNCT03449316; Pre-Results.

Attempting to set up a randomised controlled trial

2000 ◽  
Vol 14 (21) ◽  
pp. 32-36 ◽  
Author(s):  
Lorraine Ellis ◽  
Sue Davies ◽  
Sara Laker
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Set Up ◽  
Randomised Controlled

Efficacy of a self-management education programme on patients with type 2 diabetes in primary care: A randomised controlled trial

2019 ◽  
Vol 13 (2) ◽  
pp. 122-133 ◽  
Author(s):  
Estibaliz Gamboa Moreno ◽  
Maider Mateo-Abad ◽  
Lourdes Ochoa de Retana García ◽  
Kalliopi Vrotsou ◽  
Emma del Campo Pena ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomised Controlled Trial ◽  
Management Education ◽  
Controlled Trial ◽  
Education Programme ◽  
Self Management ◽  
Randomised Controlled

scholarly journals Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1153 ◽  
Author(s):  
Nickil Agni ◽  
Caroline Fairhurst ◽  
Catriona McDaid ◽  
Mike Reed ◽  
David Torgerson
Keyword(s):  
Randomised Controlled Trial ◽  
Positive Reinforcement ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Educational Programme ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Principal Investigators ◽  
Link Type ◽  
Randomised Controlled

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

scholarly journals Feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’) for patients with low back pain: protocol for a feasibility and pilot randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e056339
Author(s):  
Joshua R Zadro ◽  
Christopher Needs ◽  
Nadine E Foster ◽  
David Martens ◽  
Danielle M Coombs ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting Times ◽  
Education Programme ◽  
Low Back ◽  
Pain Education ◽  
Stratified Care ◽  
Randomised Controlled

IntroductionLong waiting time is an important barrier to accessing recommended care for low back pain (LBP) in Australia’s public health system. This study describes the protocol for a randomised controlled trial (RCT) that aims to establish the feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’), which aims to reduce waiting times for LBP.Methods and analysisWe will conduct a single-centre feasibility and pilot RCT with nested qualitative interviews. Sixty participants with LBP newly referred to a hospital outpatient clinic will be randomised to receive Rapid Stratified Telehealth or usual care. Rapid Stratified Telehealth involves matching the mode and type of care to participants’ risk of persistent disabling pain (using the Keele STarT MSK Tool) and presence of potential radiculopathy. ‘Low risk’ patients are matched to one session of advice over the telephone, ‘medium risk’ to telehealth physiotherapy plus App-based exercises, ‘high risk’ to telehealth physiotherapy, App-based exercises, and an online pain education programme, and ‘potential radiculopathy’ fast tracked to usual in-person care. Primary outcomes include the feasibility of delivering Rapid Stratified Telehealth (ie, acceptability assessed through interviews with clinicians and patients, intervention fidelity, appointment duration, App useability and online pain education programme usage) and evaluating Rapid Stratified Telehealth in a future trial (ie, recruitment rates, consent rates, lost to follow-up and missing data). Secondary outcomes include waiting times, number of appointments, intervention and healthcare costs, clinical outcomes (pain, function, quality of life, satisfaction), healthcare use and adverse events (AEs). Quantitative analyses will be descriptive and inform a future adequately-powered RCT. Interview data will be analysed using thematic analysis.Ethics and disseminationThis study has received approval from the Ethics Review Committee (RPAH Zone: X21-0221). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberACTRN12621001104842.

scholarly journals Effect of an action plan with ongoing support by a case manager on exacerbation-related outcome in patients with COPD: a multicentre randomised controlled trial

Thorax ◽  
2011 ◽  
Vol 66 (11) ◽  
pp. 977-984 ◽  
Author(s):  
J. C. A. Trappenburg ◽  
E. M. Monninkhof ◽  
J. Bourbeau ◽  
T. Troosters ◽  
A. J. P. Schrijvers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Action Plan ◽  
Controlled Trial ◽  
Case Manager ◽  
Randomised Controlled ◽  
Ongoing Support
Sign in / Sign up

Export Citation Format

Share Document