Filling In the Blanks

Similar to many healthcare facilities across the country, Chicago-based Resurrection Health Care (RHC) had a responsible and sufficient informed consent protocol. Providers throughout the eight-hospital system discussed risks, benefits and alternatives with their patients, with nurses serving as witnesses while patients signed the consent forms. To ensure the signed form was highly visible and easily accessible, RHC pre-printed the informed consent document on pink paper, hole-punched for secure binding into the medical record.

When RHC leadership performed an assessment in advance of an accreditation survey in 2006, they discovered that their accrediting organization had adopted recommendations from the Centers for Medicare and Medicaid Services (CMS) for supporting a rigorous, detail-conscious approach to informed consent. This put risk directors on high alert since the RHC certification survey was less than a year away and its informed consent protocol needed refining to meet the new CMS standards.

RHC knew it needed to upgrade its process quickly to comply with the new expectations, prepare for the survey and ensure that patients were giving genuinely “informed” consent. To that end, it implemented an automated solution that offered content already compliant with CMS guidance and ensured standardization of that process across the healthcare system.

The Problem

The language and expectations that characterized RHC’s informed consent process were replicated across the system, which mirrored the documentation used throughout Cook County. The forms included spaces for the patient name, procedure and physician delivering treatment, and were typically completed by the physician or nurse. However, there was no space provided to outline risks, benefits or alternatives, although some providers documented these elements in supplemental progress notes for the medical record.

Consent forms are far more detailed than they once were, which is especially helpful to patients and their families who appreciate documentation that is specific to them and their conditions.

The earlier forms were for verifying only that the provider discussed the relevant aspects of a planned procedure and that the patient understood what was explained.

When the Healthcare Facilities Accreditation Program (HFAP), administered by the American Osteopathic Information Association, announced it would begin using revised CMS guidelines for all upcoming surveys, RHC began exploring methods for upgrading its informed consent process.

The Solution

RHC established a multi-disciplinary task force with representatives from the medical staff, Nursing, Risk Management, Information Systems and Performance Distinction (Quality Assurance). After conducting online searches and networking with colleagues on electronic bulletin boards, the task force began evaluating automated systems. The solution that ultimately met the organization’s needs was developed primarily to support informed consent and provided pre-developed content for more than 2,100 procedures.

The Information Systems Steering Committee approved the task force’s selection in February 2007 and met with the executive team and medical staff to present the big-picture benefits of automated informed consent immediately after its purchase completed in April.

Implementation

The first step toward implementation was evaluating current informed consent processes to understand what to keep and what to change. For example, RHC could no longer print on pre-punched pink paper because it would require purchasing new printers organizationwide. In addition, the hospital system took the opportunity to update the language of its informed consent and incorporated the revised language into the template document employed by the automated system.

Keeping an aggressive timeline, RHC asked the risk directors at each hospital to serve as their site’s project manager, assisted by clinical informatics and education staff. Project leaders also relied heavily on physician champions who saw the value of automation and standardization, and who could drive adoption among their colleagues. The information services team installed the Web-based application on a single server that could support all eight hospitals, accessible via the Intranet.

RHC providers and their staff select the appropriate informed consent document from the application’s library and print it for patient discussions. Non-employee, community-based physicians who have privileges with at least one RHC hospital retrieve the documents through a secure Web portal. Resurrection Medical Center (RMC) became the pilot location since the system director of Risk Management and the RMC risk director would be onsite to oversee the initial stages and problem-solve as necessary. This proved an effective approach because the system director, charged with responsibility for the overall project, also could easily identify best practices to share with other sites.

The application was installed and ready to use in July 2007 with simultaneous rollouts at the other sites following during August and September. Throughout the transition, RHC devoted a significant amount of time to internal communication so that implementation proceeded smoothly.

Risk directors and IS personnel met with staff at all locations to discuss changes. Users reviewed procedure descriptions contained in the informed consent documents to ensure they represented surgeons’ clinical practices at RHC. The IS team also taught staff how to access the application from various locations.

While the informed consent documents were available in English and Spanish, RHC had to develop methods to better communicate with Polish patients also, a significant population treated at its facilities. To address this issue, the core sections of the informed consent form were translated into Polish within the application, and translators assisted providers in explaining the English-language procedure details to patients.

Some providers reviewed the procedure templates and wanted to know if they could set up their own versions. However, project leaders convinced them to give the new system a try, and for the most part, providers were able to adapt. This allowed RHC to meet standardization objectives, avoid customization costs and simplify maintenance when upgrades are deployed.

Results

RHC completed the conversion before the accreditation survey, which began in August 2007, and lasted until mid-December. The healthcare system had not finalized the full transition at a few hospitals, but the surveyors began their work at other locations and by the time they made it to the final sites, all was in place. Consequently, RHC earned high marks on its informed consent process during accreditation. The HFAP surveyors relayed that they were pleased that RHC had met its recently adopted standards, and were impressed with the way the organization used technology to improve the process.

Providers and staff have also shared positive feedback. They have noted that the comprehensive, procedure-specific forms prompt more detailed discussions with the patients. This enhances patients’ understanding of their condition, options and prognosis, and engages them as true partners in their care. For providers who habitually skim the informed consent discussions, this automated system reminds them about the importance of this critical step in the treatment process.

Anecdotal feedback suggests that patients are more satisfied, as well. In the past, consents were sometimes completed at the hospital just before the procedure, and patients often remarked that they felt rushed to review the form. The automated application affords patients the opportunity to complete consent forms in physician offices which, when made available during the pre-procedure verification and time-out, reduces medical errors and malpractice risk. As providers become more familiar with the automated system, the ease of documenting informed consent in physician offices will become more evident.

The Way Forward

In general, the quality of information — and therefore, the quality of care — at RHC is enhanced by the automated informed consent solution.

Consent forms are far more detailed than they once were, which is especially helpful to patients and their families who appreciate documentation that is specific to them and their conditions. Likewise, the documentation is always legible and complete — attributes that are essential to ensuring compliance with internal RHC policies, as well as with CMS and HFAP requirements.

Finally, all consent forms clearly list patient, procedure and surgical site. Thus, they serve as an essential verification tool for reducing the risk of error and enhancing patient safety.

The successful implementation of the automated informed consent application is helping pave the way for additional health IT initiatives. RHC plans to become paperless in the near future, adopting an electronic medical record for family practices, and implementing complementary functionality such as e-prescribing and digital signatures.