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
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Mr Sebastian Potthoff
Scientific

Baddiley-Clark Bldg
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom

Study information

Study designAn 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleImplementation intentions to facilitate habit formation in clinicians in type 2 diabetes care: a randomised controlled trail
Study objectivesClinicians 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) studiedType 2 diabetes
Intervention1. 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 typeBehavioural
Primary outcome measureSelf-reported number of information prescriptions provided at 6 month follow-up.
Secondary outcome measuresSelf-reported levels of automaticity of using the information prescriptions.
Overall study start date14/04/2015
Completion date17/02/2017
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Health professional
Age groupMixed
SexBoth
Target number of participants128 at 6 months follow-up
Key inclusion criteria1. 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 criteriaNo experience with delivering advice to patients with the help of the information prescriptions.
Date of first enrolment14/04/2015
Date of final enrolment15/12/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Newcastle PCT
Benfield Road
Newcastle Upon Tyne Tyne and Wear
NE6 4PF
United Kingdom

Sponsor information

Newcastle University
University/education

Faculty of Medical Sciences
Framlington Place
University of Newcastle
Newcastle Upon Tyne
NE2 4HH
England
United Kingdom

ROR logo "ROR" https://ror.org/01kj2bm70

Funders

Funder type

Charity

The Health Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan
IPD sharing plan

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.