Implementation intentions for creating and breaking habits in care provided to patients with type 2 diabetes: a dual process approach
| ISRCTN | ISRCTN15637399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15637399 |
| Protocol serial number | N/A |
| Sponsor | Newcastle University |
| Funder | The Health Foundation (UK) |
- Submission date
- 10/04/2015
- Registration date
- 20/04/2015
- Last edited
- 07/01/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Baddiley-Clark Bldg
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| 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. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Implementation intentions to facilitate habit formation in clinicians in type 2 diabetes care: a randomised controlled trail |
| Study objectives | Clinicians who form both action and coping plans at baseline will provide more information prescriptions at 6 months follow-up. |
| Ethics approval(s) | Ethics Committee Newcastle University, Faculty of Medical Sciences, 29/01/2015, ref: 00849. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Self-reported number of information prescriptions provided at 6 month follow-up. |
| Key secondary outcome measure(s) |
Self-reported levels of automaticity of using the information prescriptions. |
| Completion date | 17/02/2017 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 128 |
| Key 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 |
| Key exclusion criteria | No experience with delivering advice to patients with the help of the information prescriptions. |
| Date of first enrolment | 14/04/2015 |
| Date of final enrolment | 15/12/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Newcastle Upon Tyne Tyne and Wear
NE6 4PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/01/2021: The trial did not go ahead due to a failed recruitment strategy and PhD funding timeline.
21/12/2020: Internal review.
