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Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials

BACKGROUND: Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There...

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Autores principales: Man, Mei-See, Rick, Jo, Bower, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4506607/
https://www.ncbi.nlm.nih.gov/pubmed/26187378
http://dx.doi.org/10.1186/s13063-015-0820-0
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author Man, Mei-See
Rick, Jo
Bower, Peter
author_facet Man, Mei-See
Rick, Jo
Bower, Peter
author_sort Man, Mei-See
collection PubMed
description BACKGROUND: Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. METHODS: The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). RESULTS: In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61). CONCLUSIONS: Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population. TRIAL REGISTRATION: Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-45066072015-07-19 Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials Man, Mei-See Rick, Jo Bower, Peter Trials Research BACKGROUND: Patient understanding of study information is fundamental to gaining informed consent to take part in a randomised controlled trial. In order to meet the requirements of research ethics committees, patient information materials can be long and need to communicate complex messages. There is concern that standard approaches to providing patient information may deter potential participants from taking part in trials. The Systematic Techniques for Assisting Recruitment to Trials (MRC-START) research programme aims to test interventions to improve trial recruitment. The aim of this study was to investigate the effect on recruitment of optimised patient information materials (with improved readability and ease of comprehension) compared with standard materials. The study was embedded within two primary care trials involving patients with long-term conditions. METHODS: The Healthlines Study involves two linked trials evaluating a telehealth intervention in patients with depression (Healthlines Depression) or raised cardiovascular disease risk (Healthlines CVD). We conducted two trials of a recruitment intervention, embedded within the Healthlines host trials. Patients identified as potentially eligible in each of the Healthlines trials were randomised to receive either the original patient information materials or optimised versions of these materials. Primary outcomes were the proportion of participants randomised (Healthlines Depression) and the proportion expressing interest in taking part (Healthlines CVD). RESULTS: In Healthlines Depression (n = 1364), 6.3 % of patients receiving the optimised patient information materials were randomised into the study compared to 4.0 % in those receiving standard materials (OR = 1.63, 95 % CI = 1.00 to 2.67). In Healthlines CVD (n = 671) 24.0 % of those receiving optimised patient information materials responded positively to the invitation to participate, compared to 21.9 % in those receiving standard materials (OR = 1.12, 95 % CI = 0.78 to 1.61). CONCLUSIONS: Evidence from these two embedded trials suggests limited benefits of optimised patient information materials on recruitment rates, which may only be apparent in some patient populations, with no effects on other outcomes. Further embedded trials are needed to provide a more precise estimate of effect, and to explore further how effects vary by trial context, intervention, and patient population. TRIAL REGISTRATION: Current Controlled Trials: Healthlines Depression (ISRCTN27508731) on 26 June 2012; and Healthlines CVD (ISRCTN14172341) on 5 July 2012 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0820-0) contains supplementary material, which is available to authorized users. BioMed Central 2015-07-19 /pmc/articles/PMC4506607/ /pubmed/26187378 http://dx.doi.org/10.1186/s13063-015-0820-0 Text en © Man et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Man, Mei-See
Rick, Jo
Bower, Peter
Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title_full Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title_fullStr Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title_full_unstemmed Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title_short Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
title_sort improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4506607/
https://www.ncbi.nlm.nih.gov/pubmed/26187378
http://dx.doi.org/10.1186/s13063-015-0820-0
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