Condition category
Not Applicable
Date applied
10/09/2018
Date assigned
10/10/2018
Last edited
24/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The AC DC Study, is a pilot feasibility study, observing patients consulting in general practice and completing an automated check-in screen prior to their booked appointment, to confirm their attendance. The main aim of this study is to assess patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen.

Who can participate?
Adults attending an appointment at any of the study centres who can read and speak English

What does the study involve?
Participants will be asked to complete two extra research questions whilst completing their appointment check-in at an automated check-in screen.

What are the possible benefits and risks of participating?
The potential benefit for the patient of participation is the ability to take control of their choices and how their personal data are managed. There are no known risks to participants taking part in this study.

Where is the study run from?
Research Institute for Primary Care and Health Sciences at Keele University and 11 GP practices in the UK (unknown at present, but they will be within the NIHR Clinical Research Network: West Midlands)

When is the study starting and how long is it expected to run for?
April 2018 to December 2019

Who is funding the study?
NIHR Trainees Co-ordinating Centre (TCC) (UK)

Who is the main contact?
Sarah Lawton
s.a.lawton@keele.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Sarah Lawton

ORCID ID

Contact details

Research Institute for Primary Care and Health Sciences
Keele University
Staffordshire
Keele
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03798756

Protocol/serial number

39249

Study information

Scientific title

Automated Check-in Data Collection Study

Acronym

AC DC

Study hypothesis

It is acceptable to collect brief research information from patients, whilst they are self-completing an automated check-in screen prior to any general practice consultation.

Ethics approval

London - Westminster Research Ethics Committee, 30/08/2018, ref: 18/LO/1506

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

People attending GP surgeries

Intervention

All patients are required to confirm their attendance at the general practice by using the automated check-in screen. If the patient completing the automated check-in screen is 18 years of age or over, the additional two research questions will appear for completion. The questions are as follows:
1. “How much bodily pain have you had during the past 4 weeks?”, with options for completion of: “None”, “Very mild”, “Mild”, “Moderate”, “Severe” and “Very severe”.
2. “Would you be happy for your practice to contact you about any future research studies which are relevant to your health, to improve care for patients in the NHS?”, with options for completion of: “Yes, I would be happy for you to contact me about research of relevance to me.” and “No, thank you.”
The two additional research questions will not appear on any subsequent appointment check-in screen during the recruitment period for those participants who have already completed the questions. The additional 2 questions for each patient will be a burden in terms of time (less than 1 minute), however it has been agreed that for the extra time taken to answer the questions, the patient receives the ability to take control of their choices and how their personal data are managed. Pseudonymised data only will be downloaded from participant check-in data entry, which will allow the study team to answer the research questions.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Patient acceptability for answering brief research questions in the general practice waiting room, using an automated check-in screen, assessed by observing the percentage of completed automated check-in screens with entered research data at the time of appointment check-in.

Secondary outcome measures

Check-in completion of self-reported pain and willingness to be contacted about future research studies of relevance, assessed at the time of appointment check-in. Reported severity of bodily pain experienced over the last 4 weeks and the proportion of patients agreeing to be contacted about future research studies of relevance, will be observed from data from the check-in screens.

Overall trial start date

01/04/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Attending participating general practices for a consultation with any healthcare professional
3. Registered with the participating general practice during the specified recruitment period
4. Able to read and respond in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 9800; UK Sample Size: 9800

Total final enrolment

9274

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

14/01/2019

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Institute for Primary Care and Health Sciences
Keele University
Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

University of Keele

Sponsor details

Directorate of Research
Innovation & Engagement
Innovation Centre 2
Keele University Science & Innovation Park
Staffordshire
Keele
ST5 5NH
United Kingdom
+44 (0)1782 732000
research.governance@keele.ac.uk

Sponsor type

University/education

Website

www.keele.ac.uk

Funders

Funder type

Government

Funder name

NIHR Trainees Co-ordinating Centre (TCC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal for research methodology in 2020.

IPD sharing statement:
The data sets generated during and/or analysed during the current study are pseudonymised and available upon request from Sara Muller (s.muller@keele.ac.uk). Requests will need to be made as per Keele University guidance.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/05/2019: ClinicalTrials.gov number added. 08/05/2019: The total final enrolment was added. 25/03/2019: The condition has been changed from "Specialty: Primary Care, Primary sub-specialty: Health Services Research; Health Category: Generic health relevance" to "People attending GP surgeries" following a request from the NIHR. 10/01/2019: The following changes have been made: 1. The recruitment start date has been changed from 05/11/2018 to 14/01/2019. 2. The recruitment end date has been changed from 31/03/2019 to 30/04/2019. 3. The target number of participants has been changed from 12005 to 9800. 12/10/2018: Internal review.