Cardiovascular Disease Circulatory System
Conditions
Interventions
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
Sponsors
The Open University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, | — |
Countries
England, United Kingdom
Outcome results
None listed