scholarly journals Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

2019 ◽  
Author(s):  
Kate Jolly ◽  
Manbinder Sidhu ◽  
Vichithranie Madurasinghe ◽  
Peter Bower
Keyword(s):  
Primary Care ◽  
Multimedia Information ◽  
Patient Information ◽  
Information Resource ◽  
Controlled Study ◽  
Multimedia Resources ◽  
Cluster Randomised ◽  
Study Within A Trial ◽  
Information Materials ◽  
Multimedia Resource

Abstract Background Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates, by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by PPI contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised. Results 9.6% of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (OR = 0.844, 95% CI 0.58 to 1.22). We also found no effects on the proportion of people response to the invitation (odds ratio1.02 95% CI 0.79 to 1.33) or retention in the trial at 6 and 12 months after randomization (odds ratios 0.84, 95% CI 0.57 to 1.22 and 0.80, 95% CI 0.54 to 1.18 respectively.) Conclusions The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population. Trial Registration: Current controlled trials ISRCTN 06710391 (21/11/2013) SWAT registration SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START) (11/01/2012).

scholarly journals Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled study-within-a-trial (SWAT) of a multimedia information resource

2019 ◽  
Author(s):  
Kate Jolly ◽  
Manbinder Sidhu ◽  
Vichithranie Madurasinghe ◽  
Peter Bower
Keyword(s):  
Primary Care ◽  
Multimedia Information ◽  
Patient Information ◽  
Information Resource ◽  
Controlled Study ◽  
Multimedia Resources ◽  
Cluster Randomised ◽  
Study Within A Trial ◽  
Information Materials ◽  
Multimedia Resource

Abstract Background: Good quality information is critical for valid informed consent to trials, but current paper-based consent procedures are potentially unwieldy and can be difficult to comprehend, which may deter people from participating. Multimedia resources may be able to provide more accessible and user-friendly information. We aimed to test whether offering access to a multimedia information resource alongside standard, printed patient information impacted on recruitment rates, by conducting a pragmatic ‘study within a trial’ (SWAT) embedding a trial of a multimedia resource within an existing trial. Methods: The PSM COPD study involved people with mild symptoms of chronic obstructive pulmonary disease (COPD) recruited from primary care being randomised to a nurse-delivered telephone health coaching intervention, or usual primary care. For the SWAT of recruitment procedures, practices recruiting participants were cluster randomised to use either the standard printed patient information materials or standard printed patient information materials with access to a multimedia information resource. The multimedia resource was developed by PPI contributors and researchers, and included study-specific information (e.g. study purpose, risks), and generic information about trials (e.g. confidentiality, randomisation). We developed a list of components and used animations as well as video clips of patients discussing their experiences of participation, matched to these components. The primary outcome was the proportion of participants randomised. Results: 9.6% of those receiving standard printed patient information materials and access to the multimedia information resource were recruited, compared to 10.8% in those receiving standard printed materials alone (OR = 0.844, 95% CI 0.58 to 1.22). We also found no effects on response to the invitation (pre-randomisation – odds ratio1.02 95% CI 0.79 to 1.33) or retention in the trial at 6 and 12 months after randomization (odds ratios 0.84, 95% CI 0.57 to 1.22 and 0.80, 95% CI 0.54 to 1.18 respectively.) Conclusions: The study suggests no benefits of access to a multimedia information resource alongside patient information materials on recruitment. This may reflect the limited engagement of patients with the multimedia resource. Further uses of multimedia resources will need to explore how content can be explicitly matched to user needs and preferences and methods to encourage engagement to see if effects can be enhanced. More SWATs of multimedia into ongoing trials will provide a more precise estimate of effect, and explore further how effects vary by trial context and recruitment process, intervention, and patient population. Trial Registration: Current controlled trials ISRCTN 06710391 (21/11/2013). SWAT registration: SWAT 23: Systematic Techniques for Assisting Recruitment to Trials (MRC START) (11/01/2012). Keywords: Recruitment; patient information; research methodology; randomized controlled trial.

scholarly journals User testing digital, multimedia information to inform children, adolescents and their parents about healthcare trials

2018 ◽  
Vol 23 (3) ◽  
pp. 468-482 ◽  
Author(s):  
Rebecca Sheridan ◽  
Jacqueline Martin-Kerry ◽  
Ian Watt ◽  
Steven Higgins ◽  
Simon R Stones ◽  
...  
Keyword(s):  
Multimedia Information ◽  
Insulin Pump ◽  
User Testing ◽  
Promising Alternative ◽  
Digital Multimedia ◽  
Multimedia Resources ◽  
Fit For Purpose ◽  
Information Materials ◽  
Information Comprehension ◽  
Participant Information

Digital, multimedia information resources (MMIs) containing text, video, animation and pictures are a promising alternative to written participant information materials designed to inform children, adolescents and parents about healthcare trials, but little research has tested whether they are fit for purpose. This study employed a consecutive groups design and user testing questionnaire to assess whether participants were able to find and understand key information in multimedia resources. Two rounds of testing were completed. In each round, seven children aged 7–11 tested the MMI with a parent; six adolescents aged 12–17 and seven parents tested the MMI independently. After round 1, the resources were revised based on participant scores, behaviour and feedback. Round 1 identified problems with 2/10 information items (length of trial and use of insulin pump); only 3/20 participants could locate all information items without difficulty. After revisions, 14/20 participants scored a clear round. Information comprehension was high: 96% understood in round 1 and 99% in round 2. Participant feedback on the multimedia resources was positive, although presentation preferences varied. User testing was employed successfully with children, adolescents and parents to identify issues with, and improve, multimedia resources developed to inform potential healthcare trial participants.

scholarly journals Effectiveness of educational interventions in improving detection and management of dementia in primary care: cluster randomised controlled study

BMJ ◽  
2006 ◽  
Vol 332 (7543) ◽  
pp. 692-696 ◽  
Author(s):  
Murna Downs ◽  
Stephen Turner ◽  
Michelle Bryans ◽  
Jane Wilcock ◽  
John Keady ◽  
...  
Keyword(s):  
Primary Care ◽  
Educational Interventions ◽  
Controlled Study ◽  
Cluster Randomised ◽  
Randomised Controlled Study ◽  
Randomised Controlled

scholarly journals User testing a patient information resource about potential complications of vaginally inserted synthetic mesh

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nikolina Angelova ◽  
Louise Taylor ◽  
Lorna McKee ◽  
Naomi Fearns ◽  
Tracey Mitchell
Keyword(s):  
Lived Experience ◽  
Patient Information ◽  
Pelvic Organ ◽  
Synthetic Mesh ◽  
Information Resource ◽  
User Testing ◽  
Structured Interviews ◽  
Convenience Sample ◽  
Asking Questions ◽  
Direct Guidance

Abstract Background Vaginal mesh implants are medical devices used in a number of operations to treat stress urinary incontinence and pelvic organ prolapse. Although many of these operations have delivered good outcomes, some women have experienced serious complications that have profoundly affected their quality of life. To ensure that evolving patient information is up-to-date, accurate and appropriate, the Transvaginal Mesh Oversight Group ‘user-tested’ a newly developed Scottish patient resource, the first to focus exclusively on the issue of complications. The aim of this research was to gather feedback on usability, content, language and presentation to inform the development of the resource from a user perspective. Methods The experience of using the patient resource was captured through semi-structured interviews that followed a ‘think-aloud’ protocol. The interviewer observed each participant as they went through the resource, asking questions and making field notes. Participants’ comments were then categorised using a validated model of user experience and subsequently analysed thematically. Results Thirteen people participated in the user testing interviews, including women with lived experience of mesh implants (n = 7), a convenience sample of staff working for Healthcare Improvement Scotland (n = 5) and a patient’s carer (n = 1). The majority of participants considered the resource as clear and helpful. Respondents reported that some presentational aspects promoted usability and understandability, including the use of a font that is easy to read, bullet lists, coloured headings and simple language. Barriers included the reliance on some technical language and an explicit anatomical diagram. Participants endorsed the valuable role of health professionals as co-mediators of patient information. Conclusions The findings illustrate the value of undertaking in-depth user-testing for patient information resources before their dissemination. The study highlighted how the direct guidance or navigation of a patient information resource by a health professional could increase its salience and accuracy of interpretation by patients, their families and carers. These insights may also be useful to other developers in improving patient information.

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.

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