Testing the feasibility of using a digital patient decision aid

ISRCTN	ISRCTN13802038
DOI	https://doi.org/10.1186/ISRCTN13802038
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	319363
Protocol serial number	CPMS 55375, NIHR204012, IRAS 319363
Sponsor	The Open University
Funder	NIHR Central Commissioning Facility (CCF)

Submission date: 14/07/2023
Registration date: 25/09/2023
Last edited: 17/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Questionnaires sent to over 70,000 NHS patients in 2020 show that people often do not feel involved in making decisions about their own healthcare. Something we want to change. Patient decision aids (PtDAs) are ‘tools’ that are proven to improve the ‘quality’ of: 1) The decisions made, and 2) The decision-making process. However, they are not often used in NHS practice. We co-created a digital PtDA, with service users, called CONNECT, for people with coronary heart disease who are considering treatment with planned coronary angioplasty. Earlier research we completed suggested that almost half of patients receiving this treatment are not fully involved in decision-making, do not understand the information they are given, and misunderstand the benefits and risks of their treatment.
We want to test CONNECT, in a larger study (trial), to see if it improves the quality of shared decision-making. But trials are expensive, so we need to do some groundwork first to understand what works best. In this preliminary fact-finding study, run over 24 months, we will ask 8 NHS Cardiac Centres, and 320 of their angina patients, about the best way to run a future trial. Six centres will use CONNECT and two will not.

Who can participate?
People aged 18 years and over with angina (chest pain/discomfort) are invited to take part. We're particularly interested in those considering planned coronary angioplasty treatment.

What does the study involve?
We want to improve how patients and doctors make decisions about treatments. In this study, we'll ask 320 patients from 8 NHS Cardiac Centres to try out a web-based tool called 'CONNECT'. This tool helps patients understand their options for treatment. Participants will complete forms, questionnaires, and interviews to help us learn what works best.

What are the possible benefits and risks of participating?
By participating, you can help improve the way decisions are made about treatments. There are no physical risks, but you might find some questions thought-provoking. Your insights will guide future research and could lead to better healthcare for others.

Where is the study run from?
The Open University (UK)

When is the study starting and how long is it expected to run for?
April 2023 to April 2025

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Prof. Felicity Astin, Felicity.Astin@open.ac.uk

Contact information

Prof Felicity Astin
Scientific

School of Health, Wellbeing and Social Care
Faculty of Wellbeing, Education and Language Studies
The Open University
Horlock Building
Walton Hall
Milton Keynes
MK7 6AA
United Kingdom

ORCID ID	0000-0002-8055-3072
Email	Felicity.Astin@open.ac.uk

Dr Emma Harris
Scientific

School of Health, Wellbeing and Social Care
Faculty of Wellbeing, Education and Language Studies
The Open University
Horlock Building
Walton Hall
Milton Keynes
MK7 6AA
United Kingdom

ORCID ID	0000-0002-7649-9763
Phone	+44 (0)1908654197
Email	Emma.Harris@open.ac.uk

Dr Rebecca Simpson
Scientific

Design, Trials, and Statistics, ScHARR
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

ORCID ID	0000-0003-1677-5938
Phone	+44 (0) 114 222 4390
Email	r.simpson@sheffield.ac.uk

Dr Dwayne Conway
Scientific

Sheffield Teaching Hospitals NHS Foundation Trust
Chesterman Wing Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

ORCID ID	0000-0001-7775-2583
Phone	+44 (0)114 243 4343
Email	dwayne.conway@nhs.net

Mr Mark Lewis
Scientific

Lay member co-investigator
-
-
United Kingdom

Email	markandsandie@hotmail.com

Dr Kristian Hudson
Scientific

Improvement Academy
Bradford Institute for Health Research
Temple Bank House
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 383966
Email	Kristian.Hudson@yhia.nhs.uk

Study information

Primary study design	Interventional
Study design	Interventional cluster randomized feasibility study
Secondary study design	Cluster randomised trial
Participant information sheet	43954_PIS_V3_06Mar23.pdf
Scientific title	Cluster randomized controlled feasibility study of CONNECT: a patient decision aid designed to improve the quality of shared decision-making for planned coronary angioplasty.
Study objectives	Given that the research is designed as a feasibility study, the primary focus of the analysis will be on descriptive assessments and confidence interval estimations, rather than formal hypothesis testing. As such, the researchers do not have a traditional hypothesis to test for statistical significance. Instead, the study aims to explore and gather valuable information to guide the planning and execution of a future large-scale evaluation (c-RCT).
Ethics approval(s)	Approved 23/04/2023, Health Research Authority, London - Brighton & Sussex Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0) 207104 8202; brightonandsussex.rec@hra.nhs.uk), ref: 23/PR/0129
Health condition(s) or problem(s) studied	Cardiovascular Disease
Intervention	CONNECT is a Patient Decision Aid (PtDA), which is a complex intervention (It is not a medical device). CONNECT is a web-based PtDA that supports individual self-directed learning at a pace set by the user. It was co-created with patients and health professionals and can be used on multiple devices (computer, iPad, tablet, or mobile phone). Like other PtDAs, CONNECT is a ‘tool’ designed to help people to take part in decision-making about treatment options. It uses multimedia (images, diagrams, animations, audio) to make patients aware of their treatment choices, associated risks and benefits and includes interactive activities (i.e., questions about angina symptoms, what matters to them and treatment choice) to clarify and communicate patients’ personal values that are associated with different aspects of each treatment option. CONNECT provides a personalised summary (see section 2 for example), which can be saved as a PDF file and gives details of patients’ angina symptoms, the impact of these on daily life, personal values, treatment preferences, worries, concerns, and any unanswered questions. This personalised summary can inform patient consultations and potentially act as a ‘primer’ for health professionals, alerting them to specific areas that the patient may wish to discuss. Following completion of two baseline questionnaires, participants on the waiting list for planned coronary angiogram/planned coronary angiogram±stenting will be invited to access a digital link to CONNECT along with instructions (sent via letter/email/mobile phone), which they can use at home ahead of a (usual care) pre-assessment consultation (30-45 minutes) with a specialist cardiac nurse. Metrics on participant engagement with CONNECT/website will be recorded. CONNECT produces a personalised summary and the researchers will record the number of summaries brought to pre-assessment consultations. After pre-assessment consultations, but before their planned angiogram/angio±stenting participants will complete four follow-up questionnaires. The researchers will use a 1:3 allocation ratio for the eight clusters (two control, six intervention). They have chosen this 1:3 allocation ratio as it maximises the number of clusters in the intervention arm so they can test the feasibility, practicality, safety and acceptability of the intervention, alongside having some clusters assigned to the control arm. The researchers will use stratified block randomisation with block size four and aim to stratify clusters by low (<400) and high (>400) volume centres. As the intervention ‘CONNECT’ is a website, there will be no blinding. (A control arm was included to evaluate the feasibility and acceptability of trial procedures such as the willingness of cardiac departments to be randomised. This study is not a ‘mini-version’ of the future large-scale trial designed to test the effectiveness of the intervention).
Intervention type	Behavioural
Primary outcome measure(s)	1. Number of cardiology departments contacted: count of departments approached, responses to 'expression of interest,' and willing participants, measured using expressions of interest sent by email 2. Recruitment rate of cardiology centres: number of cardiology centres recruited within a 4-month period, measured using the number of expression of interests completed by cardiac centres sent by email 3. Patient recruitment: count of eligible patient participants approached, consented, and recruited by clinical research nurse over 12 months 4. Patient recruitment rate per site: number of patients recruited per month, per site, recruited by clinical research nurse over 12 months 5. Retention rate: proportion completing Decisional Conflict Scale questionnaire (T2) over 16-month period 6. Attrition rate: loss of participants assigned to intervention or control, measured at study completion
Key secondary outcome measure(s)	1. Rates of major adverse cardiac events (MACE) and hospital readmission: rates within 30 days of discharge, measured using medical records at study completion 2. Cardiology department characteristics: geographical location, index of multiple deprivation (IMD), cardiology workforce size, presence/absence of on-site surgical cover, annual procedure volume, measured using expressions of interest at study completion 3. Patient demographics: age, gender, ethnicity, social support level, health and e-literacy, cardiac diagnosis, co-morbidities, measured using medical records and questionnaires at baseline 4. Non-English speaking participants: count of participants requiring interpreter services, measured using case report forms at the end of the study 5. Participants without digital technology access: count of participants lacking access to digital devices and the internet, measured using case report forms at the end of the study 6. Response rate: participants completing and returning questionnaires divided by sample size, measured at the end of the study 7. Item response rate: number of valid responses divided by total responses requested, measured at the end of the study 8. Intraclass correlation coefficient estimation for decisional conflict scale: estimation using marginal or random effects model at T2 9. Full c-RCT sample size calculation: based on effect size estimates, standard deviation, and intraclass correlation coefficient from primary outcome analysis 10. CONNECT usage: number of participants accessing CONNECT, measured using case report forms at the end of the study 11. Usage of CONNECT during pre-assessment clinic visits: percentage of visits where the CONNECT summary was utilized, measured using case report forms at the end of the study 12. Qualitative analysis of training and interviews: summarizing variations, practicalities, barriers, and enablers, from month 6 until the end of the study (month 21) 13. Reasons for cardiology department nonparticipation, measured using expressions of interest at the end of the study 14. Reasons for patient nonparticipation, measured using expressions of interest at 12 months 15. Self-reported adherence to CONNECT: how CONNECT was used by patients at home and during pre-assessment, measured using qualitative interviews from month 6 until the end of the study (month 21) 16. Barriers and enablers to recruitment and CONNECT usage: during home and pre-assessment clinic stages, measured using qualitative interviews from month 6 until the end of the study (month 21) 17. Understanding and appropriateness of questionnaire completion, measured using qualitative interviews from month 6 until the end of the study (month 21)
Completion date	30/04/2025

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	340
Key inclusion criteria	1. CLUSTERS/CARDIOLOGY DEPARTMENTS Any NHS centre in England providing care for patients treated with planned (i.e. non-urgent) coronary angiogram query proceed, or coronary angioplasty, will be eligible to participate. The inclusion criteria for Cardiology Departments are: 1.1. NHS Trust is in England 1.2. Pre-assessment clinics embedded in the patient pathway. 1.3. Has the capacity to recruit 40 patient participants within 12 months. 1.4. Willing to be randomised to the intervention or control arm and adhere to arm allocation. 1.5. Cardiology teams are willing to participate in a 2-3-hour training session about the intervention CONNECT. 2. PATIENT PARTICIPANTS Patient participants scheduled for planned coronary angiogram query proceed, or coronary angioplasty will be eligible to participate. Eligible patient participants will be: 2.1. Adult patients (>=18 years) presenting with stable angina. 2.2. Suspected or diagnosed chronic coronary artery disease. 2.3. On the waiting list for planned coronary angioplasty or angiogram ± coronary angioplasty. 2.4. Capacity to give informed consent. 3. HEALTH PROFESSIONAL PARTICIPANTS Eligible NHS staff participants will be: 3.1. Working, or have worked, in the cardiology department delivering care for people scheduled for coronary angioplasty or coronary angiogram ± coronary angioplasty. 3.2. Have had direct involvement in the delivery of CONNECT and/or the feasibility study procedures.
Key exclusion criteria	1. Clusters/Cardiology Departments who do not fulfil the inclusion criteria will be excluded. 2. Patient participants who are clinically unstable, scheduled for urgent or emergency coronary angioplasty, or lack capacity to give informed consent at the time of recruitment will be excluded. 3. Health professionals not involved in the CONNECT study or 'angioplasty' patient care will be excluded.
Date of first enrolment	25/09/2023
Date of final enrolment	30/04/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Northern General Hospital

Herries Road
Sheffield
S5 7AU
United Kingdom

Calderdale Royal Hospital

Godfrey Road
Salterhebble
Halifax
HX3 0PW
United Kingdom

Luton and Dunstable University Hospital

Lewsey Road
Luton
LU4 0DZ
United Kingdom

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Royal United Hospital

Combe Park
Bath
BA1 3NG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The datasets generated during and/or analyzed during the current study will be stored in a publicly available repository: ORDO (Open Research Data Online), https://ordo.open.ac.uk/, which is the Open University’s research data repository. Data sharing will be postponed for 12 months after the end of the study to allow time for publication of the study findings. The data will be anonymous and available on ORDO for 10 years. Participants will have provided written informed consent for their anonymous data to be uploaded to a public repository.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 3	06/03/2023	22/09/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 0.4		23/10/2023	No	No
Statistical Analysis Plan	version 1	21/02/2024	23/04/2024	No	No

Additional files

43954_PIS_V3_06Mar23.pdf: Participant information sheet
ISRCTN13802038_PROTOCOL_V0.4_ConciseVersion.pdf: Protocol file
ISRCTN13802038_SAP_V1_21Feb24.pdf: Statistical Analysis Plan

Editorial Notes

17/09/2024: The recruitment end date was changed from 25/09/2024 to 30/04/2025.
02/09/2024: Contact details updated.
07/08/2024: The recruitment end date was changed from 31/08/2024 to 25/09/2024.
23/04/2024: Statistical analysis plan uploaded.
23/10/2023: Protocol file uploaded.
14/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).