Background And Aim: Primary cardiac rhythm management device (CRMD) provides potentially lifesaving treatment for people at risk of sudden cardiac death. Yet the enormity and uncertainty of benefits and harms present challenges for patient decision-making surrounding device implantation. There was limited international and no UK based research related to the process and influences affecting patient CRMD decision-making. The aim of this research was to explore ‘what influences adult patients' decision-making in accepting or declining primary prevention complex cardiac rhythm management devices?’
Research Methods And Analysis: A scoping review, followed by a four step, mixed methods, concurrent research design, with three strands was employed. Strand one involved completion of a structured questionnaire, administered to a convenient sample of 50 patients, across 4 implant sites. Strand two entailed concurrent semi-structured interviews with a purposive sample of 17 patients who had accepted, and 3 who had declined a cardiac device. A range of statistical testing was applied to the Strand 1 data using IBM SPSS statistical software v25. Framework analysis was used to analyse the Strand 2 narrative data. The data sets were merged and integrated into Strand 3.
Findings: A novel theoretical model of patient decision-making for primary CRMD was developed. Four types of decision-making emerged in response to a recommendation for CRMD. They are Leap Of Faith, Reinforced Acceptance, Reinforced Refusal or Reconsideration. Certain socio-demographic and situational factors appeared to predict and influence the type of decision-making. The level and accuracy of knowledge acquisition, information recall and informed consent characterised the alternate decision-making journeys.
Conclusion: An appreciation of the type of decision-making may inform the development of a framework of tailored information and communication to enable effective decision making, to meet specific needs and situations, to facilitate truly informed choices, and help acceptance and adjustment to life with this significant technology
