Background. Percutaneous coronary intervention (PCI) involves a complex informed consent process. Consent is sought simultaneously for a diagnostic angiography and the potential treatments that follow, including PCI, and fosters shared decision making. This process involves several healthcare providers, yet there has been limited data from the United States regarding the patient’s perspective of informed consent for PCI. Objective. To describe U.S. patients’ perception of their PCI informed consent process, and of PCI treatment risks and benefits. Methods. Patients admitted for coronary angiography were approached and if they volunteered for the study, completed a survey on their informed consent experience for PCI following their procedure. The survey asked about purpose of consent, attitudes, risks, benefits, and outcomes of PCI. Results. There were 82 participants who had undergone PCI, with a mean age of 65 years. Participants included 64 males and 17 females. The majority of participants recognized the key components of choice (88%), risks (94%), and benefits (87%), and 65% of participants were aware of the alternatives for PCI from the informed consent experience. Participants expressed a desire for more information, but also admitted that they had trouble retaining the information. Eighty-nine percent had misconceptions that PCI would prevent a future myocardial infarction. Forty percent of the participants stated that they preferred family to be present during informed consent. Conclusions. Healthcare providers can improve the informed consent experience by providing clear information, clarifying concerns, and by encouraging family questions and involvement.
Patients with suspected coronary artery disease have coronary angiography to detect the significance of their disease and decide upon treatment. Between 2013 and 2016, nearly 2 million percutaneous coronary interventions (PCI) were performed in the United States.1
Patients participate in informed consent before any medical procedure, including PCI. However, research has shown that patients are often unaware of their role in PCI informed consent and tend to take a passive role.2,3 Patients often overemphasize the benefits of PCI and perceive their treatment as a ‘fix’ for their heart disease.3,4
Informed consent for PCI can be complex due to multiple referral providers sending patients to tertiary centers. This requires several stages to the consent.5 While the procedure typically begins with coronary angiography, there are multiple treatment alternatives identified based on angiographic findings. Potential treatment options include medication optimization, coronary artery bypass surgery (CABG), or PCI.6 However, treatment possibilities at the time of consent are not always clear, as options depend upon the diagnostic angiography results. In addition, the context within which coronary angiography (± PCI) occurs, varies according to the clinical risk assessment. The risks and benefits of an angiogram ± PCI are different, depending on whether the patient has stable angina or acute coronary syndrome (ACS). Legal and ethical frameworks require that patients are fully informed and have the capacity to make a voluntary decision about their healthcare.7 To provide patient-centered care, it is important to understand the informed consent experience from the patient’s unique perspective.
This study seeks to describe the experience of informed consent from the perspective of the patient who has undergone the complex informed consent for coronary angiography with possible PCI.
This was an exploratory, descriptive study used to gather data regarding informed consent from patients after PCI from a single academic medical center in the United States. The Human Research Committee approved this protocol.
Sample. Participants were selected from the list of patients undergoing a routine or urgent coronary angiography that revealed a blockage amenable to treatment via PCI. Participants were approached after PCI, but prior to discharge. Inclusion criteria were defined as patients over 18 years of age and English-speaking.
A convenience sample of eligible patients was contacted by the principal investigator with a handout that explained the study and provided an invitation for them to participate in this research study. If the participant met study criteria and was interested, a survey was left for the patient to complete. The survey was administered over 3 months to eligible patients after PCI.
Measures. The 39-item survey was originally developed to address the lack of a survey on this topic. It is designed to collect participants’ views and understanding of the PCI informed consent purpose, their attitudes towards the experience, and views of risk versus benefit and outcomes discussions specifically for PCI.3 Each item had a 5-point Likert scale ranging from ‘completely agree’ to ‘completely disagree’, and participants were to indicate their level of agreement/disagreement. The original survey was tested and validated prior to use at sites in the United Kingdom.3 The survey was kept brief and lay terminology was used where possible to maximize comprehension, minimize user fatigue, and optimize response rates.3 Patients also provided demographic and clinical information.
Statistical analysis. Analysis was conducted using the Statistical Package for the Social Sciences (SPSS), Version 24.0 (IBM Corp.). Descriptive statistics including mean, standard deviation, frequency, and percentages, were employed to characterize the sample and to evaluate patients’ views about PCI and the consent process.
Eighty-two participants were enrolled, with sample demographics available in Table 1. Presenting symptoms of the participants in this study included chest pain in 45 participants (55%), chest discomfort in 26 participants (32%), fatigue in 45 participants (55%), and shortness of breath in 43 participants (52%). Sixty-six percent of the sample (n=54) were considered urgent cases, 31% (n=17) of the urgent cases were in the hospital, and 33% (n=27) were elective PCI. Only 22% (n=16) of 73 participants received treatment information in advance of PCI.
Participants were asked about their knowledge of the key aspects of informed consent: choice, risk versus benefit, and alternate choices. Eighty-eight percent (n=69 out of 78 who responded) felt they were informed of choice, 94% (77 out of 78 who responded) agreed that they were informed of the risks of PCI, and 87% (65 out of 75 who responded) were informed of benefits of PCI. Sixty-five percent (53 out of 75 who responded) agreed they were informed of alternatives to PCI.
Thirty percent of participants (n=34) indicated they did not remember all the information that was a part of the informed consent and 57% of participants (n=45) admitted that they did not understand all the information provided within their informed consent. Ninety-three percent (n=72) expressed a desire to know all possible risks for PCI.
Eighty-nine percent (n=70) of participants had misconceptions about the outcomes of PCI in reducing future myocardial infarction. Thirty-six percent believed that PCI was a ‘cure’ for their coronary artery disease. Over half of the participants (n=40, 53%) wished that their family was present during informed consent.
Patients do understand the general components of informed consent for PCI, yet recall of information provided during informed consent is poor post PCI. This is consistent with previous studies.2,3,8-10 Patients want to know both common and uncommon risks of PCI, which adds to the complexity of informed consent. Providing information about all potential risks may be prohibitive, and overwhelm the patient and family with health information during decision making.11
Most patients were overly positive about the potential outcomes of PCI, such as expressing expectation of reduction in myocardial infarction.12 A U.K. study reported that 60% of patients treated with PCI believed that PCI cured their coronary disease.3 In contrast, only a third of U.S. participants thought PCI cured their disease.3 This finding surrounding patients’ hopefulness regarding treatment benefits reflects findings reported in previously published literature.3,9,10,13,14
Participants requested greater family involvement in the informed consent experience and desired information in advance that would help them to understand and remember the key informed consent elements. This reflects the findings reported in a similar U.K. study.3 In other studies, the presence of family members has been shown to improve the quality of discussions about PCI.15
This study enrolled participants who had a previous PCI. Due to previous experience with PCI, they could have a better understanding of options and expected outcomes, even if the information was not included in this consent experience. This group of participants did not include acutely ill patients having ST-segment elevation myocardial infarction (STEMI) and therefore, findings cannot be generalized to all PCI patients.
Implications for Practice
Healthcare providers can use the results of this study to improve the PCI informed consent process in order to make it more patient centered. Only 22% of participants reported receiving information regarding PCI ahead of their procedure, identifying an opportunity to provide information in advance for elective patients who may require PCI. Providing advanced information with a standardized core content about PCI can encourage patients and their families to take part in a shared informed consent process, and to underline the value of their participation. There is a need for additional training for healthcare providers, as well as a supportive environment that allows the patient and family to focus on the information presented, with encouragement to ask questions.2,3,16 The healthcare team must provide and clarify information, and answer questions during the informed consent experience. Therapeutic communication techniques, such as incorporation of a repeat-back process with patients,5 can help reinforce understanding and shared decision making.13
Contact the authors via Howard T. Blanchard, DNP, MEd, MS, RN, ACNS-BC, at firstname.lastname@example.org.
- Alkhouli M, Alqahtani F, Kalra A, et al. Trends in characteristics and outcomes of hospital inpatients undergoing coronary revascularization in the United States, 2003-2016. JAMA Network Open. 2020 April; 3(2): e1921326. doi: 10.1001/jamanetworkopen.2019.21326
- Probyn J, Greenhalgh J, Holt J, et al. Percutaneous coronary intervention patients’ and cardiologists’ experiences of the informed consent process in Northern England: a qualitative study. BMJ Open. 2017; 7(6): e015127.
- Astin F, Stephenson J, Probyn J, et al. Cardiologists’ and patients’ views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty: a survey study. Eur J Cardiovasc Nurs. 2020 Mar; 19(3): 260-268. doi: 10.1177/1474515119879050.
- Rothberg MB, Sivalingam SK, Kleppel R, et al. Informed decision making for percutaneous coronary intervention for stable coronary disease. JAMA Internal Medicine. 2015; 175(7): 1199-1206.
- Van Der Heijden, M. The nurse’s role in the informed consent process. Abstracts of EuroPCR: in collaboration with EuroIntervention. 2015: 205. Available online at https://www.pcronline.com/content/download/344626/8117105/version/2/file/EuroPCR-Abstracts-Book-2015.pdf. Accessed October 20, 2020.
- Sapontis J, Salisbury AC, Yeh RW, et al. Early procedural and health status outcomes after chronic total occlusion angioplasty: a report from the OPEN-CTO registry (outcomes, patient health status, and efficiency in chronic total occlusion hybrid procedures). JACC Cardiovasc Interv. 2017; 10(15): 1523-1534.
- Astin F. Do patients take angioplasty seriously? Eur J Cardiovasc Nurs. 2018 Mar; 17(3): 194-195. doi: 10.1177/1474515117737767.
- Dathatri S, Gruberg L, Anand J, et al. Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods. Ann Thorac Surg. 2014; 97(5): 1505-1502.
- Kawasuji M. Clinical evidence versus patients’ perception of coronary revascularization. Surg Today. 2013; 43(4): 347-352.
- Kureshi F, Jones PG, Buchanan DM, et al. Variation in patients’ perceptions of elective percutaneous coronary intervention in stable coronary artery disease: cross sectional study. BMJ (Clinical Research ed.) 2014; 349: g5039.
- Monteleone PP, Yeh RW. Management of complications. Interv Cardiol Clin. 2016; 5(2): 201-209.
- Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007; 356(15): 1503-1516.
- Whittle J, Fyfe R, Iles RD, Wildfong J. Patients are overoptimistic about PCI: they should be equal partners in our efforts to improve understanding. BMJ (Online). 2014; 349: g5613.
- Spertus JA, Bach R, Bethea C, et al. Improving the process of informed consent for percutaneous coronary intervention: patient outcomes from the Patient Risk Information Services Manager (ePRISM) study. Am Heart J. 2015; 169(2): 234-241.e1.
- Goff SL, Mazor KM, Ting HH, Kleppel R, Rothberg MB. How cardiologists present the benefits of percutaneous coronary interventions to patients with stable angina: a qualitative analysis. JAMA Intern Med. 2014; 174(10): 1614-1621.
- Espinosa ML, Tannenbaum AM, Kilaru M, et al. Bundle consent in US intensive care units. Am J Crit Care. 2020; 29: e44-e51.