Patients decision making for primary prevention cardiac devices
Research type
Research Study
Full title
An exploratory study of adult patients decision making for primary prevention cardiac rhythm management device (CRMD) therapy
IRAS ID
194017
Contact name
Alison Malecki-Ketchell
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Some people are considered to be at greater risk than the average population of death due to sudden heart rhythm abnormality which is called sudden cardiac death (SCD). An important treatment approach is to implant devices to detect and correct heart rhythm abnormality. This is called primary cardiac rhythm management device (CRMD) therapy. The benefit of CRMD in preventing death is well established however CRMD implantation is associated with significant potential complications and patient and partner physical and psychosocial concerns. The enormity and uncertainty of benefits and harms present challenges for patient’s making decisions surrounding CRMD implantation. The degree of satisfaction with the decision to accept or decline CRMD implantation is complex and may influence the individuals overall acceptance, psychosocial adjustment and long term outcomes with or without the device. The aim of this research is to explore how adult patients make the decision to accept or decline primary preventative CRMD. It will focus upon whether an association exists between demographic characteristics, patterns of coping, decision style, decision reached and decisional regret. Adult patients (>16years) recommended for primary CRMD will be recruited from four implant centres in Yorkshire. The study involves two strands. Strand one involves sending a questionnaire to individuals who have made a decision about the device to assess individual characteristics, coping style, perceived level of participation, acceptance or refusal and decision regret. The second strand involves interviews with a sample of participants at the six week post implant follow up clinic or at the next cardiology clinic appointment for those who declined device implantation to explore decision making in more detail. Greater insight in to the decision process regarding CRMD among different groups may facilitate development of tailored information, communication and procedural practices to support and improve the patient experience during this part of their journey.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1164
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion