Automated Check-in Data Collection (AC DC) Study

ISRCTN	ISRCTN82531292
DOI	https://doi.org/10.1186/ISRCTN82531292
ClinicalTrials.gov number	NCT03798756
Secondary identifying numbers	39249

Submission date: 10/09/2018
Registration date: 10/10/2018
Last edited: 09/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Sarah Lawton
Public

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

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Automated Check-in Data Collection Study
Study acronym	AC DC
Study objectives	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(s)	London - Westminster Research Ethics Committee, 30/08/2018, ref: 18/LO/1506
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2018
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 9800; UK Sample Size: 9800
Total final enrolment	9274
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	14/01/2019
Date of final enrolment	30/04/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Research Institute for Primary Care and Health Sciences

Keele University
Staffordshire
ST5 5BG
United Kingdom

Sponsor information

University of Keele
University/education

Directorate of Research, Innovation & Engagement
Innovation Centre 2
Keele University Science & Innovation Park
Staffordshire
Keele
ST5 5NH
England
United Kingdom

Phone	+44 (0)1782 732000
Email	research.governance@keele.ac.uk
Website	www.keele.ac.uk
"ROR"	https://ror.org/00340yn33

Funders

Funder type

Government

NIHR Trainees Co-ordinating Centre (TCC)

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal for research methodology in 2020.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		19/04/2021	06/12/2021	No	No
Abstract results		01/01/2020	15/11/2022	No	No
Thesis results		01/10/2021	15/11/2022	No	No
Results article	primary outcome data	05/01/2023	09/01/2023	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

09/01/2023: Publication reference added.
15/11/2022: An abstract and a thesis have been added to the trial outputs.
06/12/2021: Added link to basic results.
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.