Plain English Summary
Background and study aims
UK parents continue to be concerned about the safety of the combined measles, mumps and rubella (MMR) vaccine. National uptake of the MMR vaccine is below the 95% needed to protect the population. Research shows that parents lack confidence in making an informed decision. Good methods to help parents make informed decisions are needed. We recently conducted a small study with 30 parents that explored their views on an MMR decision aid (web site). The next step was to test this decision aid with more parents. This study aimed to test whether a decision aid (web site) for MMR when compared with an MMR leaflet improved informed parental decision-making and increased uptake of the MMR vaccine. We also explored the financial cost of delivering the MMR decision aid versus the MMR leaflet, and asked parents and health professionals how useful they thought the decision aid and leaflet were.
Who can participate?
The aim was to recruit 576 first-time parents with a child aged 3 to 12 months being offered the first dose of the MMR vaccine. Parents were required to be registered with a participating GP practice in the north of England, have an email address and sufficient English language skills to participate.
What does the study involve?
The GP practices in the study were randomly allocated to one of three groups. Depending on the group their GP practice were put in, parents either received usual care for MMR from their GP practice (group 1) or usual care plus the MMR decision aid web site (group 2) or usual care plus an MMR leaflet (group 3). We measured parents informed decision-making in a questionnaire at the start of the study and then 2 weeks after the study had started. We also recorded the costs of delivering the MMR decision aid and leaflet and interviewed parents and doctors/nurses about their views on the MMR decision aid and leaflet.
What are the possible benefits and risks of participating?
This study helped us to better understand how parents make decisions about whether or not to immunise their child with the MMR vaccine. The MMR decision aid may help participants themselves and other parents in the future to make an informed decision about the MMR vaccine. There were no risks of taking part, just some demands on parents time.
Where is the study run from?
The study was run from the University of Leeds, UK. Other organisations involved in the study were the Health Protection Agency and NHS Leeds.
When is the study starting and how long is it expected to run for?
This study ran from September 2008 to the end of November 2010.
Who is funding the study?
The study was funded by the National Institute for Health Research (NIHR), Research for Patient Benefit Programme, UK.
Who is the main contact?
Dr Cath Jackson
Cath.jackson@york.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Cath Jackson
ORCID ID
Contact details
York Trials Unit
Department of Health Sciences
ARRC Building
University of York
York
YO10 5DD
United Kingdom
01904 32 1869
cath.jackson@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/H1311/23; UKCRN ID 4811
Study information
Scientific title
Supporting informed parental decision-making for MMR (the combined measles, mumps and rubella vaccine): Evaluation of a web-based decision aid
Acronym
DECIDA
Study hypothesis
1. Parents receiving the web-based MMR decision aid will exhibit increased informed decision making over time relative to parents receiving an MMR leaflet alone.
2. The rate of vaccine uptake will be greater for parents receiving the web-based MMR decision aid compared to parents receiving an MMR leaflet alone.
Ethics approval
Ethics approval was secured from York Research Ethics Committee on 4 April 2008 (Ref. 08/H1311/23)
Study design
Three-arm cluster randomised controlled trial with qualitative and economic components
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Public health - childhood immunisation
Intervention
The interventions were delivered at the individual parent level.
GROUP 1: Usual practice only (control)
Parents received the usual service provided by their GP practice. In England and Wales, parents of children registered with a GP receive an offer to have their child vaccinated for the first dose MMR at 12 to 13 months. Telephone interviews with participating GP practices indicated that usual practice included an appointment for the first dose MMR vaccination, a leaflet (usually MMR the Facts) and in some GP practices the offer of a consultation if the parent had concerns.
GROUP 2: MMR decision aid plus usual practice
Parents were sent by post the web link for the MMR decision aid with login instructions. They also continued to receive usual practice (described above) from their GP practice. The decision aid was a modified version of the Australian MMR decision aid. It can be accessed at www.leedsmmr.co.uk.
GROUP 3: MMR leaflet plus usual practice
Parents were sent the Health Scotland leaflet MMR your questions answered and also received usual practice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Decisional conflict . This assessed a parents perception that their decision was informed in accordance with their values and can be acted upon. This 16-item validated scale has five sub-sections: informed, values clarity, support, uncertainty and effective decision. Scores range from 1 (no decisional conflict) to 5 (extremely high decisional conflict). Scores lower than two are associated with implementing informed decisions, higher scores are interpreted as delaying decisions or feeling unsure about their implementation.
Secondary outcome measures
1. First dose MMR vaccination uptake data for children of participating parents (provided by GP practices)
2. Knowledge about MMR and the measles disease was measured using 11 multiple choice items.
3. MMR immunisation cognitions: The Theory of Planned Behaviour informed items to assess parents cognitions (attitude, subjective norm, perceived behavioural control) towards having their child immunised with MMR.
4. MMR immunisation trade-off beliefs were measured using a previously modified version of the Beliefs about Flu Vaccination Questionnaire to assess parents trade-off beliefs on vaccine necessity versus vaccine concerns for MMR . A single MMR immunisation trade-off beliefs score was calculated. A positive score indicates that the parent perceives that necessity outweighs the concerns.
5. Anxiety was assessed by the short form State-Trait Anxiety Index.
6. Parents engagement with the decision aid or leaflet: Data were collected in the post-intervention questionnaire. Parents in the decision aid arm were asked Did you use the MMR website? (Yes the whole website /Yes but only some of it /No). The time parents spent working through the decision aid was captured by Google analytics.
7. Parents in the leaflet arm were asked Did you read the MMR leaflet? (Yes the whole leaflet /Yes but only some of it / No).
8. All parents were asked to report how long (minutes) they had spent looking at other information about MMR before or since their child was born.
9. Qualitative component: A sub-sample of parents and health professionals were interviewed about their views on the MMR decision aid or leaflet.
10. Eonomic component: Self-reported intended and actual numbers of parent contacts with health professionals and parent MMR-related expenditure were collected. Costs of delivering the MMR interventions (decision aid and leaflet) were calculated.
Overall trial start date
01/09/2008
Overall trial end date
30/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. All 312 GP practices within five Primary Care Trusts in the North of England were eligible.
2. First-time parents with a child aged 3 to 12 months being offered the first dose of the MMR vaccine were eligible.
3. Parents were required to have an email address and sufficient English language skills to participate.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
576
Participant exclusion criteria
None
Recruitment start date
01/09/2008
Recruitment end date
30/11/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Trials Unit
York
YO10 5DD
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research, Research for Patient Benefit Programme (ref. PB-PG-0107-12048)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24148574
Publication citations
-
Results
Shourie S, Jackson C, Cheater FM, Bekker HL, Edlin R, Tubeuf S, Harrison W, McAleese E, Schweiger M, Bleasby B, Hammond L, A cluster randomised controlled trial of a web based decision aid to support parents' decisions about their child's Measles Mumps and Rubella (MMR) vaccination., Vaccine, 2013, 31, 50, 6003-6010, doi: 10.1016/j.vaccine.2013.10.025.