Plain English Summary
Background and study aims
A lot of money is spent on research and development of clinical guideline procedures but clinicians do not always stick to these guidelines. This means that patients do not always receive the best possible care. Recently, Diabetes UK teamed up with Newcastle University to develop three ‘information prescriptions', which are a way of giving better health and lifestyle advice to patients with type 2 diabetes. The information prescriptions cover topics including haemoglobin A1c (HbA1c) levels, high blood pressure and high cholesterol. The information prescriptions have been installed nationwide on the computer systems of primary care practices (e.g. GP practices) and clinicians will be asked to use them during patient appointments. This study aims to examine whether the addition of a short planning intervention can help clinicians to develop a habit of using the information prescriptions with patients.
Who can participate?
Health professionals familiar with the new information leaflet for type 2 diabetes.
What does the study involve?
Participants are randomly put into one of two groups. One group is given a planning intervention for using the information prescriptions, and the other group will follow standard procedure. We are measuring how often the new information prescriptions are used at three different time points over a 6 month period with the help of a planning intervention. Usage is self-reported in the form of online questionnaires.
What are the possible benefits and risks of participating?
There are no risks associated with participation in this study. The only burden to the participants is the time that they need to spend completing online questionnaires. To make this easier we are using a small number of short questions.
Where is the study run from?
Newcastle PCT (UK)
When is the study starting and how long is it expected to run for?
April 2015 to February 2017
Who is funding the study?
The Health Foundation (UK)
Who is the main contact?
Mr S Potthoff
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Implementation intentions to facilitate habit formation in clinicians in type 2 diabetes care: a randomised controlled trail
Acronym
Study hypothesis
Clinicians who form both action and coping plans at baseline will provide more information prescriptions at 6 months follow-up.
Ethics approval
Ethics Committee Newcastle University, Faculty of Medical Sciences, 29/01/2015, ref: 00849.
Study design
An online randomised controlled trial looking at the usage of a new information prescription in type 2 diabetes care. Information prescriptions are designed to give people with diabetes the information they need to understand and improve on their health targets. This study is designed to investigate whether the addition of a short planning intervention improves the uptake of the information prescriptions.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Not Specified
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Type 2 diabetes
Intervention
1. Questions prompting forming an action plan (AP) for using the information prescriptions
2. Questions prompting forming a coping plan (CP) for using the information prescriptions
3. Questions prompting forming an AP and CP for using the information prescriptions
4. Control group
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Self-reported number of information prescriptions provided at 6 month follow-up.
Secondary outcome measures
Self-reported levels of automaticity of using the information prescriptions.
Overall trial start date
14/04/2015
Overall trial end date
17/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical staff member within primary care
2. Access and experience with administering the new information leaflet
3. Male and female
4. Age 18 to 75
Participant type
Health professional
Age group
Mixed
Gender
Both
Target number of participants
128 at 6 months follow-up
Participant exclusion criteria
No experience with delivering advice to patients with the help of the information prescriptions.
Recruitment start date
14/04/2015
Recruitment end date
15/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle PCT
Benfield Road
Newcastle Upon Tyne Tyne and Wear
NE6 4PF
United Kingdom
Funders
Funder type
Charity
Funder name
The Health Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list