SummaryThe Mid America Heart Institute of Saint Luke’s Hospital developed a customized consent process based on a computer-generated consent form for cardiac catheterization and related interventional procedures (which are commonly referred to as percutaneous coronary interventions). Written at an eighth-grade level, the form uses graphics to depict hard-to-understand procedures and integrates each patient's unique health information to provide evidence-based predictions of potential risks from complications. Nurses and physicians review the consent form with patients and family members before the procedure, answering any questions and discussing options, including choice of stents. An evaluation found that the new process led to more patients reading and understanding the risks associated with the procedure, less anxiety among patients, an enhanced sense of being involved in medical decision making, and more informed decisions related to the choice of stents.Moderate: Based on a pre- and post-intervention study of 335 patients randomly assigned to the hospital's original (generic) consent form or the new customized consent process.
Developing OrganizationsMid America Heart Institute, Saint Luke's Hospital
Kansas City, MO
Date First Implemented2006
Patient PopulationMost of the patients treated by the cardiac clinic in this study were male, one-half had type 2 diabetes, and one-half had experienced previous cardiac catheterizations.
Problem AddressedEach year, more than 1 million percutaneous coronary interventions (PCIs) are performed to unblock arteries and restore blood flow to the heart. Patients undergoing these procedures discuss potential risks from the procedure with their doctors and sign a standard consent form, but this consent process often fails to fully engage the patient in this important health care decision.1 In fact, the majority of patients (69 percent) report not reading the consent form before signing it.2
- Little time or incentive for detailed explanation of risks: The busy pace of patient care leaves little time for doctors to provide detailed explanations about a patient's potential risk from a procedure. Few clinicians can quote accurate data or divorce themselves from personal biases to deliver a balanced presentation of options. Many lack the time or aptitude to consider individual patient's risk profiles, to predict preferences, or to help patients apply these factors to select the best personal choice. Low literacy and cultural barriers intensify these challenges, and clinicians receive little reimbursement for this effort.3
- Language often unintelligible to typical patient: The legal and complex verbiage commonly found in consent forms does little to inform or educate patients about their potential risks and medical choices. Consent agreements typically use college-level language, despite the fact that many Americans have lower-level reading skills. Ideally, the informed consent process should involve a two-way conversation and educational process that enhances good clinical practice and patient autonomy.4
Failure to adequately inform patients:
Several studies in elective surgery have demonstrated that, although patients believe they are adequately informed during the consent process, they cannot recall the information provided. A few studies that looked at the consent process in PCI found that patients tend to overestimate the benefits and underestimate or ignore the risks of the procedure.5
Description of the Innovative ActivityThe Mid America Heart Institute of Saint Luke’s Hospital helps patients make more informed decisions about elective (i.e., nonemergency) cardiac catheterizations and related PCI procedures through a customized and simplified consent process. The hospital uses a Web-based program, called Patient Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT), to incorporate patient-specific information to calculate the individual’s risk of death, bleeding, and reclosure (restenosis) of the artery after using either a bare metal or drug-eluting stent. The resulting information is then incorporated into an easy-to-read consent form that is used to discuss risks with the patient, make final decisions related to the procedure, and complete the consent process. Details of the customized consent process include:
- Integrating patient information into the consent form: Nursing staff in the hospital’s cardiovascular holding room collect and enter 22 patient-specific characteristics into a Web-based, Health Insurance Portability and Accountability Act–compliant server from a portable computer that can be wheeled to the patient’s bedside. Several of these characteristics, including age, gender, and laboratory results, have already been entered into the system from the hospital’s electronic medical record (EMR) system.
- Generating the customized consent form: Once the patient data are entered, the PREDICT software program uses prediction models based on a large clinical trial database to generate a graph that charts the likelihood of that patient’s possible outcomes, including inhospital mortality, bleeding, and restenosis. The program takes into account each patient’s clinical profile, including age, height, weight, current medications, lifestyle, and other medical conditions, and integrates it when assessing potential risk in the patient’s consent document. The customized consent form is printed at the local nursing station and given to the patient for review.
- Simple language and graphics used to describe procedure: The consent form is written at an eighth-grade reading level, and contains diagrams that illustrate the procedure and its risks (e.g., easy-to-understand graphs show risks as percentages). The form provides simple descriptions of the following PCI-related procedures: cardiac catheterization, coronary angiography, angioplasty, and stent placements (both bare metal and drug-eluting stents). The form also highlights the length of time that patients must be on blood-thinning medications after various stent procedures, and notes the higher costs associated with a drug-eluting stent (which require 1 year or more of blood-thinning medication, compared with 1 month with a bare metal stent). The form also provides graphs that show the likelihood of restenosis and the need for a repeat procedure within 1 year if the patient is treated with a bare metal or drug-eluting stent. Finally, the form includes easy-to-understand consent language that the patient can sign to authorize the procedure.
- Reviewing the form: The patient and any family members have 30 minutes to 4 hours to review the printed consent form before surgery. During this waiting period, the patients and his or her family members often discuss the form with the nursing staff in the unit, who are trained and ready to help explain procedures to patients.
- Formal patient and physician review, final decisions, and consent: Before the procedure, the patient and the interventional cardiologist review the consent form together. The physician answers any questions, and the patient and provider together make key decisions, such as selecting stent options. This mutual consent dialogue is valuable; in some cases, the patient comes forward with new information, such as an upcoming planned elective surgery, that may result in the need to choose a different stent procedure. Patients electing to have the procedure sign the consent form.
Context of the InnovationMid America Heart Institute at Saint Luke’s Hospital in Kansas City, MO, is a member of Saint Luke's Health System, which consists of 11 hospitals and many primary care practices located throughout the metropolitan area. Saint Luke’s Hospital is a 630-bed, not-for-profit, tertiary care facility. Mid America Heart Institute, which serves as a major referral center within a 100-mile radius area, has 4 cardiovascular operating room suites, 3 intensive care units, and 5 cardiac catheterization laboratories where more than 900 PCIs were performed during 2006. Because of the large number of PCI procedures performed there, doctors at the Mid America Heart Institute wanted to improve patient involvement in decisionmaking and use the informed consent process to promote patient participation in the health care process.
ResultsA pre- and post-evaluation of 335 patients who used the hospital's original (generic) consent form (142 patients) and the new customized consent process (193 patients) found that the new process led to more patients reading and understanding the risks associated with the procedure, less anxiety among patients, an enhanced sense of being involved in medical decisionmaking, and more informed decisions related to the choice of stents.
Moderate: Based on a pre- and post-intervention study of 335 patients randomly assigned to the hospital's original (generic) consent form or the new customized consent process.
- More patients read the form: Many more patients who received the PREDICT customized consent agreement reported reading the form than did patients who received the original consent form (72 versus 44 percent).
- Easier to understand and retain the information: Patients involved in the customized consent process found the information presented easier to understand and retain. For example, 61 percent of the patients receiving the PREDICT form found it easy to understand, compared with 50 percent of patients given the generic consent form. In addition, 66 percent of PREDICT patients found the descriptions of potential complications to be clear, compared with 53 percent of patients given the conventional consent form. Finally, a greater proportion of patients in the PREDICT group (85 versus 62 percent) were able to recall being told about the estimated risk of death.
- Less anxiety: More patients receiving the customized consent process reported not feeling nervous than did patients given the generic consent form (65 versus 45 percent).
- More informed decisions related to stents: Before the implementation of PREDICT, approximately 90 percent of patients received a drug-eluting stent, though it is recommended only for the highest risk patients, which made up 31 percent of the group. After the implementation of the new consent process, patients at low or moderate risk for restenosis were less likely to receive a drug-eluting stent than were patients given the original consent form. There was no difference among high-risk patients, as the vast majority of high-risk patients in both groups continued to receive drug-eluting stents.
- Additional refinements and introduction of Spanish-language version: Based on feedback from the initial experience, a significant upgrade was introduced in March 2007 that included the automatic incorporation of laboratory data, the restructuring of data entry fields, and the introduction of a Spanish version of the consent document. These upgrades increased nurse satisfaction with the process by automatically populating demographic and laboratory data, thereby decreasing the number of elements they need to enter for each patient.
Planning and Development ProcessKey steps included the following:
- Improving readability of consent form: In addition to including the individualized statistical risk models in the consent forms, Mid America Heart Institute simplified the language to increase patients’ overall understanding of the various PCI procedures. Educational pictures and descriptions were inserted, and the material was rewritten from college to eighth-grade level, which is understandable to most Americans.
- Legal and institutional review: Before initiating the new consent forms, they were submitted to and approved by the hospital’s Institutional Review Board and legal division. After reviewing the revised wording, legal staff were satisfied that it provided the hospital with the necessary legal protections even though it used plain language rather than "legalese."
- Creating risk models: Mid America Heart Institute used risk models based on the Personalized Risk Information Services Manager (ePRISM®) technology to estimate risks for each patient. The models predicted the following outcomes:
- Inhospital mortality following PCI
- Bleeding complications following PCI
- One-year restenosis with bare metal and drug-eluting stents
- Assembling the information in an intuitive software package: The hospital developed a software package that was simple for staff to use during preprocedural visits with patients.
- Training: Nurses received training on how to enter the necessary information, generate the customized consent agreement, and discuss the risk factors identified by the consent agreement’s predictive analysis with patients. Physicians also received training in how to use the customized consent forms as a discussion tool to enhance patient-centered care practices.
- Pilot testing at Mid America Heart Institute: The initial pilot test at Mid America Heart Institute required numerous planning meetings with physicians and nurses working in the cardiovascular holding room. Beginning in August 2006, all outpatients with a scheduled coronary angiogram for which a PCI was possible had their informed consent customized by PREDICT. Patients were studied to gauge their satisfaction with the form, and focus groups and interviews were held with nurses, physicians, and programmers to address any issues they had with the revised process. Modifications were made to the consent form, which was adopted as the standard of care at Saint Luke’s Health System for outpatients and inpatients undergoing PCI.
- Expansion of program to area hospitals: In February 2007, the customized consent process was adopted within the four Kansas City metropolitan hospitals in the Saint Luke’s Health System. During the expansion phase of the project, planning meetings were held at each facility before introducing PREDICT. The implementation team included system-level staff to assure uniform implementation and a single standard of care. By the end of 2011, the consent form had been implemented at nine hospitals across the country.
Resources Used and Skills Needed
- Staffing: Program development required input from programmers, physicians, and private developers. Once operational, the new customized consent process requires no additional staff.
- Software: The PREDICT software must be installed and integrated with the hospital’s EMR system. Patient data should be accessible through the EMR so that certain fields can be automatically input into the consent form.
Funding SourcesAmerican Heart Association; National Heart, Lung, and Blood Institute (U.S.); Doris Duke Foundation; Mid America Heart Institute, Saint Luke's Hospital
The development of the enhanced patient consent process was funded internally by Mid America Heart Institute (which covered the costs associated with field testing and the server) and through a $300,000, 3-year grant from the Doris Duke Charitable Foundation. Because the process continues at St. Luke’s Health System as the standard of care, the process no longer requires funding.
Funding was received from the American Heart Association-Pharmaceutical Roundtable-Spina to implement the three initial sites, and from the NIH/NHLBI for an additional six sites.
Tools and Other ResourcesA sample consent form is available at: http://www.implementationscience.com/content/3/1/58/figure/F2.
PREDICT is a clinical decision support tool software that uses ePRISM® Technology developed by Health Outcomes Sciences LLC. It contains a number of predictive clinical models for patients presenting with acute coronary syndromes. Data for each of the models have been derived from large multicenter patient registries and validated using rigorous statistical techniques. Where available, references to published works are provided.
Getting Started with This Innovation
- Evaluate the adequacy of the current consent form for cardiac catheterization and PCI procedures: Key questions to be considered include the following: Does it encourage dialogue between patients and clinicians? Does it educate patients and enable them to make informed decisions about their health care? Do patients comprehend it, and can they recall the risks cited? Is the material written at an appropriate reading level for the typical patient?
- Examine the current consent process: Key questions to consider include the following: When do patients review and sign consent forms before surgeries? How much time do they and their family members have to review it? How much time do clinicians spend explaining the procedure and potential risks?
- Map patient flow en route to the cardiac catheterization laboratory or surgical unit: One key question to consider is whether patients travel through a holding area or go directly to the catheterization laboratory or surgical unit. The goal of this mapping process is to determine the best way to collect the data to be entered into the system, print out the customized consent form, and share it with the patient before surgery.
- Appoint an implementation team: The hospital should appoint a leadership group made up of administrators, clinicians, nurses, risk management experts, and a legal team member to develop the new process and customized form, implement the program, and monitor its success.
- Select an appropriate risk model program: A hospital can develop its own risk modeling software or license the PREDICT/ePRISM software to generate customized consent forms.
- Establish evaluation criteria: Measures should be selected to evaluate the impact of the new consent process and identify potential opportunities for improvement.
- Integrate the software: Key questions include the following: Can the PREDICT software be easily integrated into the hospital’s information systems? Can the hospital use existing information technology staff to install it, or are outside vendors needed? Integration with existing EMRs is helped by PREDICT's capacity to accept HL-7 interfaces from hospital's admission and laboratory data systems. Although this integration is helpful in reducing data entry, it is not necessary.
Sustaining This Innovation
- Continually monitor the program's impact: Ongoing monitoring helps to identify opportunities for improvement, both within the consent form and in the overall consent process, including its impact on the patient and clinician workflow. Evidence of success can also be used to spread the idea throughout the organization and/or to other hospitals. Once staff members are trained and the PREDICT program is implemented, the process should be monitored for areas of improvement from a consent form content basis and an evaluation of the consent process to see if it works from a patient perspective and workflow perspective.
- Plan regular updates to software modeling: As new and better models become available (e.g., the American College of Cardiology has developed a new periprocedural mortality risk model), the PREDICT software easily incorporates the updates to apply the latest, most accurate scientific evidence. A business model was developed to support and disseminate the ePRISM software, Health Outcomes Sciences (http://www.h-outcomes.com).
- Build in time for patient discussions: Because the consent form is now more intuitive, patients now ask clinicians more questions. As a result, Saint Luke's has had to build in more time for physicians to talk to patients before the procedure.
Spreading This InnovationSeveral hospitals in the original study opted to buy the commercially available software and continue to use the customized consent process. Nationally, there are currently 11 sites utilizing the software for risk modeling and decision support.
- Nurses at Mid America Heart Institute have been strong supporters of the customized informed consent process. Although the new process requires additional work, nurses report enjoying participating in this kind of quality improvement project and discussing the consent form with patients and family members.
- Some surgeons at Saint Luke's are interested in adapting this model for other, noncardiac common surgeries. However, obtaining outcomes data on these procedures to allow for the development of a validated risk model has proved to be difficult. By contrast, the high volume of cardiac catheterization and PCI procedures has allowed for the development of validated risk models.
Contact the InnovatorJohn A. Spertus, MD, MPH
Medical Director, Outcomes Research
Mid America Heart Institute
Saint Luke’s Hospital
4401 Wornall Road
Kansas City, MO 64111
Phone: (816) 932-8270
Fax: (816) 932-5613
Carole Decker, RN, PhD
Mid America Heart Institute
Saint Luke's Hospital
4401 Wornall Road
Kansas City, MO 64111
Phone: (816) 932-5440
Innovator DisclosuresIn addition to the organizations that have financially supported this program listed in the Funding Sources section, Dr. Spertus reported having an equity stake in, and being a board member of, Health Outcomes Sciences, a for-profit company that promotes dissemination of this program and holds several patents on Personalized Risk Information Services Manager (PRISM) technologies. He also reported the following financial relationships that are relevant (but not directly related) to this program: receiving consulting fees from United Healthcare, Amgen, Genetech, and St. Jude Medical; receiving royalty payments as the copyright owner for the Seattle Angina Questionnaire (SAQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), and the Peripheral Artery Questionnaire (PAQ); and his employer, Mid America Heart Institute of Saint Luke's Hospital, receiving grant funding from the American Heart Association, the National Heart Lung and Blood Institute, Genetech, Lilly, Evaheart, and Amorcyte. Dr. Decker has not indicated whether she has financial interests or business/professional affiliations relevant to the work described in this profile.
References/Related ArticlesDecker C, Spertus J, Arnold S, et al. Implementing an innovative consent form: the PREDICT experience. Implement Sci. 2008;3:58. [PubMed]
Arnold SV, Decker C, Ahmad H, et al. Converting the informed consent from a perfunctory process to an evidence based foundation for patient decision making. Circ Cardiovasc Qual Outcomes. 2008;1:21-8. [PubMed]
Institute of Medicine. Crossing the Quality Chasm: a New Health System for the Twenty-First Century. Washington DC: National Academy Press, 2001. Available at: http://www.nap.edu/catalog.php?record_id=10027#toc.
Woolf S, Chan E, Harris R, et al. Promoting informed choice: transforming health care to dispense knowledge for decision making. Ann Intern Med. 2005;143:293-300. [PubMed] Available at: http://www.annals.org/content/143/4/293.abstract.
Lavelle-Jones C, Byrne DJ, Rice P, et al. Factors affecting quality of informed consent. BMJ. 1993;306:885-90. [PubMed]
Decker C, Spertus J, Arnold S, et al. Implementing an innovative consent form: the PREDICT experience. Implement Sci 2008;3:58. [PubMed]
Arnold S, Spertus J, Decker C, et al. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. Circ Cardiovasc Qual Outcomes. 2008;1:21-8. [PubMed]
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Original publication: July 07, 2008.
Original publication indicates the date the profile was first posted to the Innovations Exchange.
Last updated: July 30, 2014.
Last updated indicates the date the most recent changes to the profile were posted to the Innovations Exchange.
Date verified by innovator: June 27, 2014.
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