Condition category
Not Applicable
Date applied
13/12/2015
Date assigned
08/01/2016
Last edited
08/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We all need to make decisions about our health and treatments, and health and health research are often in the news. Information about treatments is sometimes confusing or hard to understand. To make it easier to understand for people making a decision about a treatment, we would like members of the public to test some different ways health research information can be presented. The DECIDE project is working to find ways to present information about treatments to all the people involved in making healthcare decisions, including patients and their families, healthcare managers, doctors, nurses and other health professionals. This is an important part of providing high quality healthcare.

Who can participate?
People aged over 18 who are on the SHARE online database of people in Scotland who are interested in participating in trials.

What does the study involve?
We have prepared some information on using the following treatments: antibiotics for middle ear infection; aspirin for primary prevention of cardiovascular disease; warfarin for atrial fibrillation. This information is based on the best research about treatment options for these health problems. We have prepared different ways of presenting this information. Participants are randomly allocated to be shown one of three ways of presenting information about one of these topics so that we can get their opinion on how helpful the information is. Completing the study takes around 15 minutes.

What are the possible benefits and risks of participating?
We aim to ask thousands of people to give their opinion, which will give a good idea of what works and what doesn’t. Taking part in the study won’t lead to an immediate benefit for participants personally. However, it will help organisations that produce health information improve the way they do this. This may be help people in the future when making real decisions about treatments.

Where is the study run from?
1. Health Services Research Unit at the University of Aberdeen (UK)
2. Norwegian Knowledge Centre for the Health Services (Norway)

When is the study starting and how long is it expected to run for?
November 2014 to January 2016

Who is funding the study?
The European Union (Belgium)

Who is the main contact?
Prof. Shaun Treweek
DECIDE_iSoF@icloud.com

Trial website

http://isof-trial.epistemonikos.org/

Contact information

Type

Public

Primary contact

Prof Shaun Treweek

ORCID ID

Contact details

Health Services Research Unit
University of Aberdeen
3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 775 614 4998
DECIDE_iSoF@icloud.com

Type

Scientific

Additional contact

Dr Jenny Moberg

ORCID ID

http://orcid.org/0000-0003-4931-2438

Contact details

Norwegian Knowledge Centre for the Health Services
Oslo
N-0130
Norway
+47 97 97 95 34
jmoberg@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does an interactive "Summary of Findings table", compared with standard evidence-based patient information and with a static Summary of Findings table, improve members of the public's understanding of and satisfaction with information about the benefits and harms of treatments?

Acronym

Study hypothesis

1. An interactive Summary of Findings (iSoF) table compared to evidence-based patient information, and to static SoF tables will improve participants’ understanding of, and satisfaction with, information about the benefits and harms of treatments when making a hypothetical decision
2. The initial iSoF table presentation will have an effect on understanding of, and satisfaction with, information about the benefits and harms of treatments when making a decision; and that participants will prefer interactive presentations, and certain initial presentations over the other presentations

Ethics approval

The University of Aberdeen Life Sciences and Medicine College Research Ethics Board has prepared a checklist, which classes this work as very low risk and it therefore does not need formal review by their committee. The work will be conducted in accordance with the Ethical Review and Governance Framework of the University of Aberdeen.

Study design

Internet-based parallel randomized trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Internet

Trial type

Other

Patient information sheet

https://s3.amazonaws.com/isof_pdf/Participant+Information+sheet+2015+09+21.pdf

Condition

Understanding and satisfaction with evidence-based information about the harms and benefits of treatments

Intervention

Members of the public are recruited to participate in the trial via the internet. Participants will consent and complete the trial on-line., before being randomly allocated to one six groups. Each group will see a scenario for one of two baseline risk levels for one of three different topics, and involve making a hypothetical decision about whether or not to use a treatment. The three topics are antibiotics for acute otitis media, aspirin for primary prevention of coronary heart disease, and warfarin for atrial fibrillation. For each of these six groups we will then randomly allocate participants to see either evidence-based patient information, one of six initial presentations of an interactive SoF, or of a static SoF. Using an online questionnaire participants will be asked to make a hypothetical decision whether or not to use the treatment, questions about their understanding of the balance between the benefits and harms, the sizes of effects, the certainty of the evidence; and whether they are satisfied that they have been adequately informed about the benefits and harms of the treatment. Participants will then be shown the alternative presentations for the same scenario and risk level, and ask whether they prefer the standard patient information, an interactive SoF, a static SoF, a combination of standard patient information with an interactive SoF or with a static SoF, and the reasons for their preferences.They will also be asked which initial presentation of the iSoF table they prefer and the reasons for their preferences. There is no follow up for participants after they have completed the online trial questionnaire

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Participants’ understanding of, and satisfaction with, information about the benefits and harms of treatments when making a decision is measured using a specially designed online questionnaire that they are given at the time of randomisation
2. Which presentations participants prefer is measured using a specially designed online questionnaire that they are given at the time of randomisation

Secondary outcome measures

1. The reasons for participants’ preferences, their understanding of the balance of the benefits and harms, and their hypothetical decisions is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation
2. The primary outcomes in people who would like their doctor or somebody else to make a decision for them are excluded from the comparisons is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation
3. Whether the primary outcomes vary across the six decision-making scenarios is measured using a specially designed online questionnaire that they are given at the time of randomisation (baseline) and after the presentation

Overall trial start date

25/11/2014

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Memebers of the public aged 18 or over
2. Registered on the SHARE online database of people in Scotland who are interested in participating in trials (www.registerforshare.org)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

3200

Participant exclusion criteria

1. Familiar with GRADE SoF tables (assessed by asking participants)
2. Those who have previously participated in the trial
3. Those who have research training or experience equivalent to an MSc or PhD

Recruitment start date

14/12/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Aberdeen
Health Services Research Unit 3rd Floor, Health Sciences Building Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Trial participating centre

Norwegian Knowledge Centre for the Health Services
Pilestredet Park 7
Oslo
N-0130
Norway

Sponsor information

Organisation

Health Services Research Unit at the University of Aberdeen (UK)

Sponsor details

3rd Floor
Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)775 614 4998
DECIDE_iSoF@icloud.com

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

The results will be published on the SHARE website. They will also be presented to guideline organisations and others through scientific documents, presentations and meetings. The results will be used to guide the way health information is presented in the future.

Intention to publish date

31/10/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes