Condition category
Not Applicable
Date applied
07/12/2015
Date assigned
23/12/2015
Last edited
22/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In recent years, the use of online tools for patients has increased dramatically. NHS England has been working with GP practices across the country to develop services for patients online, within the programme “Patient Online”. These services allow patients to book appointments, order repeat prescriptions and access to summary information in records. There are plans to further expand the online services on offer, by allowing patients detailed record access (DRA) online. The Department of Health Behavioural Insights Team is a purpose-built team which draws on research into the behavioural sciences in order to help with policymaking in the public services. The aim of this study is to find out the best way of encouraging GPs to encourage their patients to register for online services (given the GPs have already enabled the IT functionality of the service), using a letter developed by the Department of Health Behavioural Insights team.

Who can participate?
GP practices in England who are currently working with the clinical systems supplier EMIS (primary healthcare computer software) and have less than 10% of their patients registered with online services.

What does the study involve?
Participating GP practices are randomly allocated into groups. The first group (the control group) do not receive a letter. Those in the other groups receive letters written by the Department of Health Behavioural Insights team using approaches from current behavioural science literature, including social norming, gain-framed messaging, highlighting deadlines and simplifying information. These letters differ slightly, however the key message in all of the letters is to encourage GPs to enable patients to access DRA online.

What are the possible benefits and risks of participating?
Benefits of taking part in the study could involve increased patient satisfaction as well as improved patient safety and medication adherence, if practices do choose to enable DRA. Risks of participating are minimal, however offering DRA could lead to an increased workload for practices due to additional phone/email queries about notes or online access. The possibility of offending patients or providing inappropriate information is also a risk and so GPs are advised to develop strategies to avoid this.

Where is the study run from?
Department of Health, Richmond House (UK)

When is the study starting and how long is it expected to run for?
May to August 2016

Who is funding the study?
Department of Health (UK)

Who is the main contact?
1. Ms Clare Ebberson (public)
2. Ms Jo Chandler (public)

Trial website

https://www.england.nhs.uk/ourwork/pe/patient-online/

Contact information

Type

Public

Primary contact

Ms Clare Ebberson

ORCID ID

Contact details

Department of Health
Richmond House
Whitehall
London
SW1A 2NS
United Kingdom

Type

Public

Additional contact

Ms Jo Chandler

ORCID ID

Contact details

Quarry House
Leeds
LS2 7UA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Using behavioural insight approaches to encourage GPs to encourage their patients to register with online services: a randomised controlled trial

Acronym

Study hypothesis

Current hypothesis as of 22/04/2016:
Using a behavioural insights approach in letters to GPs encouraging them to encourage their patients to register with available online services will have a greater impact than the assumption that GPs will encourage patients based on previous information they have received (NHS England Patient Online team requested GPs to enable the IT functionality for patient access to online service)

The research questions are:
1. Is a letter to GPs (informed by behavioural insights) encouraging them to increase the number of patients registered with online services effective in increasing the proportion of patients registered with online services?
2. Which behavioural science messages are most effective in encouraging GPs to increase the number of patients registered with online services?

Previous hypothesis:
Using a behavioural insights approach in letters to GPs encouraging them to enable access to detailed records online will have a greater impact than standard letter writing approaches.

Ethics approval

Ethics approval is not required for this study because no patients are involved in the intervention, which is focused on encouraging GP practices to modify behaviour to encourage patients to register with an existing service

Study design

Two to four-arm randomised controlled trial (final number will be dependent upon sample size and experimental power)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

No specific participant information sheet available, please use the contact details below to request a further information.

Condition

The trial is focused on the offer to patients in primary care to access their personal GP notes online.

Intervention

Current interventions as of 22/04/2016:
The intervention will include all GP practices in England who have less than 10% of their patients registered with online services. Two or three versions of a behavioural insight-based letter will be sent to approximately 3663 GP Practices across England (number may be expanded to those with more than 10% of patients currently registered if there is not sufficient power from the sample size). The control group will receive no letter. It is planned that once the most effective letter to GPs is identified, this could be rolled out to control practices and possibly also practices with more than 10% of patients currently registered with online services. There is no existing letter in use for the intervention as it relates to a new contractual requirement.

Previous interventions:
The intervention consists of a letter that will be sent to approximately 4136 GP Practices across England. There will be four versions of the letter sent, including a control and three behavioural insight-based letters.

The control letter (letter A) will be written by the NHSE Patient Online team following usual practice including the professionals who are asked to contribute to and sign off the letter. Each of the behavioural insights letters (letters B – D) will simplify and shorten the information including highlighting a deadline for action in bold at the top. Letter C will also contain a social norm based message, stating that “hundreds of GPs have already enabled online DRA for their patients” and letter D will contain a testimony from another GP in Leeds that have already enabled DRA and had a positive experience.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 22/04/2016:
Proportion of GP Practices in each trial arm who:
1. Make an appointment with the patient online implementation team
2. Click through to an available weblink for information and online resources for their patients

Previous primary outcome measures:
Proportion of GP Practices that enable the function to allow patients access to their medical notes online.

Secondary outcome measures

Added 22/04/2016:
Proportion of patients registered with online services in each trial arm

Overall trial start date

01/05/2016

Overall trial end date

01/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Current exclusion criteria as of 22/04/2016:
GP practices in England who have less than 10% of their patients registered for online services.

Previous exclusion criteria:
GP practices with the clinical systems supplier EMIS who currently offer the functionality to enable online access to detailed records.

Participant type

Health professional

Age group

Not Specified

Gender

Not Specified

Target number of participants

3663 practices

Participant exclusion criteria

All practices not currently using EMIS as their system supplier

Added 22/04/2016:
Practices who already have over 10% of their patients registered with online services

Recruitment start date

01/05/2016

Recruitment end date

31/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health
Richmond House Whitehall
London
SW1A 2NS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom

Sponsor type

Government

Website

https://www.gov.uk/government/organisations/department-of-health

Funders

Funder type

Government

Funder name

Department of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Aim to publish an article in a health service related journal (to be determined).

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 22/04/2016 the following changes were made to the trial record: 1. The scientific title was changed from 'Using behavioural insights approaches to encourage GPs to offer patients access to online records: A randomised controlled trial' to 'Using behavioural insight approaches to encourage GPs to encourage their patients to register with online services: a randomised controlled trial'. 2. The study design was changed from 'Four-arm randomised controlled trial' to 'Two to four-arm randomised controlled trial (final number will be dependent upon sample size and experimental power)'. 3. The overall trial start date was changed from 07/12/2015 to 01/05/2016. 4. The overall trial end date was changed from 31/03/2016 to 01/08/2016. 5. The target number of participants was changed from 4136 practices to 3663 practices. 6. The recruitment start date was changed from 07/12/2015 to 01/05/2016. 7. The recruitment end date was changed from 18/12/2015 to 31/05/2016.