Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/04/2015
Date assigned
20/04/2015
Last edited
20/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Sebastian Potthoff

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Newcastle University

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes