THE IMPACT of INFORMED CONSENT Housekeeping This webinar

THE IMPACT of INFORMED CONSENT

Housekeeping: • This webinar will be recorded and distributed afterwards • Today’s webinar is scheduled to last 45 minutes • All participants will be muted to enable speakers to present without interruption • Questions can be submitted via the Go. To. Webinar Questions section at any time – We will save all questions until the Q&A portion of our presentation, but feel free to submit questions throughout

Meet the Presenters: Tommy Hunkins Marketing Manager Tommy is a marketing professional who enjoys all things digital and automated. He spends his free time with his two chocolate labs, Booker and Hutch. If you’re reading this, say “hi!” in the chat. Robin Mc. Kee, MS, RN Director of Clinical Informatics/Solutions Robin is a registered nurse of over 20 years with experience in inpatient, outpatient and community health settings. She loves walking & hiking with her husband energetic border collie, Maisy.

THE IMPACT of INFORMED CONSENT

What is informed consent? More than the form…. It is the communication that takes place between the provider and the patient about the procedure being recommended. But the form plays an important role in documenting that the communication occurred effectively. Ultimately, the goal of informed consent is for the patient to be an educated participant in his/her healthcare decision, and to provide evidence of consent that serves to document their legal and ethical responsibility (The Joint Commission, 2016).

THE IMPACT of INFORMED CONSENT PRODUCTIVITY & QUALITY

Problem: Poor Form Processes Manual, paperbased form processes cause a lack of standardization & slow form completion. 3/4 of organizations still use paper consent forms instead of e. Consent technology (via https: //insights. cynergistek. com/document-management-best- practices/document-efficiency-healthcare)

Typical Informed Consent Process Paper consents have to be manually processed and scanned, increasing the risk of errors, misplaced forms, and archival errors. EHR

Problem: Missing Documents With a paper process, many forms get lost or improperly scanned. This affects clinician productivity, morale, risk, and 2/3 of procedures have missing consent forms (via https: //jamanetwork. com/journals/jamasurgery/fullarticle/1710508)

Problem: Low Quality & Legibility Many informed consent forms do not meet CMS guidelines for the minimum elements or a “well designed” consent. https: //www. cms. gov/Regulations-and-Guidance/Transmittals/downloads/R 37 SOMA. pdf

CMS Minimum Guidelines • • Name of the hospital Name of the specific procedure Name of the performing practitioner Statement that the procedure, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative • Signature of the patient or the patient’s legal representative • Date and time the informed consent form is signed by the patient or the patient’s legal representative

CMS Guidelines for a well-designed form • Provider who conducted the IC discussion • Witness signature including date/time • List of risks • Statement of other practitioners participating in procedure, including residents

CMS Proposed Rule: Quality of Informed Consent Documents for Hospital-Performed, Elective Procedures Measure • Supplements existing CMS guidelines • Evaluates consents using an abstraction tool • 20 points possible; threshold 10 initially How would your consents score?

State/local requirements • Required text by state, local, or organizational governing bodies • Forms Committee approval • Evidence based best practice

THE IMPACT of INFORMED CONSENT COMPLIANCE & RISK

Problem: Audit Failures Because consents are lost or incomplete, healthcare organizations often fail Joint Commission audits. 500 + healthcare organizations experienced complianc e issues with consent )

Problem: Comprehension • American Medical Association recommends a sixth-grade reading level • The National Cancer Institute suggests an eighth-grade reading level 8% of radiation therapy forms were at an • This study found only 8 th grade reading level – Only 4 met AMA guidelines

Problem: Increased Liability Inadequate consents also increase risk and liability in the instance of malpractice claims. 2/3 of malpractice cases cited lack of informed consent (via https: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 5831424/)

THE IMPACT of INFORMED CONSENT SATISFACTION

Problem: Clinician Burnout Superfluous paperwork directly contributes to clinician burnout 1/2 of clinicians “often or always experience feelings of burnout” Paperwork burdens… were the main reasons they https: //www. advisory. com/daily-briefing/2016/09/26/doctors-leavingfelt dissatisfied profession) (via

Problem: Poor Patient engagement A patient & procedure-specific consent form contributes to an optimal patient experience Proper informed consent increases knowledge retention and preparedness. The largest predictor of patient satisfaction is whether presurgical expectations are met. (via https: //onlinelibrary. wiley. com/doi/full/10. 1002/acr. 20475 & https: //www. ncbi. nlm. nih. gov/pmc/articles/PMC 3641464/)

THE IMPACT of INFORMED CONSENT FINANCIAL

Problem: Delays and Costs When clinicians have to search for missing consents, it causes delayed or postponed procedures. 14% of procedures are delayed, costing organizations over $500 K/year (via *https: //jamanetwork. com/journals/jamasurgery/fullarticle/1710508)

Problem: Cost of maintaining paper The average 1, 500 -bed hospital prints more than 8 million pages per month, with an average cost of four cents per printed page $3. 8 B Not including equipment & maintenance https: //www. healthcarefinancenews. com/news/hospitals-are-increasing-theirprinting-activity-resulting-drain-revenue

RIPPLE EFFECT OF POOR CONSENT PROCESSES Slow Operations and Delays Manual Form Errors Subpar Form Design/Workflow Clinician Burnout Manual Form Routing Paper Cost & Forms Mgmt Overhead Superfluous Expenditures Poor Data Collection Medical Mistakes and “Never” Events Scanning Errors Paper Consent Forms TACTICAL Unneeded Paperwork Lost Documents Poor Communication Audit Failures STRATEGIC Poor Patient Experience Limited Patient Engagement

Key features of e. Consent

e. Consent Provides: Instant Form Selection Generate forms by scanning a patient’s wristband or by patient selection Improved Risk Management & Compliance Features standardized content and required fields. Faster Form Completion Expedite completion with pre-fill and speech-to-text.

Mobile Informed Consent Process Mobile e. Forms are instantly added to the EHR after completion, preventing lost documents. EHR

e. Consent = High Quality Solution Procedure-Specific Forms • Provides typed details including descriptions, rationale, risks, & alternatives for the procedure. Improved Document Workflow • Digital consents are electronically routed throughout the care community to expedite form completion and ensure consents are document before the day of the procedure. Required Fields and Time Stamps • Ensure that all signatures are collected and that dates are accurately documented

Making the Change How to initiate your e. Consent project

Opportunity for Optimization Organize Simplify • Collect & review all forms • Forms assessments – what is in use? What needs to be updated? • Eliminate unnecessary tasks and complexity Standardize Automate • Use a common template • Deliver the forms electronically to ensure document compliance • Streamline form routing, completion, and archival • Accelerate workflows • Improve data collection

Forms Strategy Audit Common Challenges for Health Systems • Informed Consents Pre-Registration Forms PGHD – SDo. H, SBIRT, Assessments Admission/Nursing/Downtime Forms Post-Care Documents Clinical Support Documents – (Rounding, Checklists, etc. ) • Operational Forms • • •

ID the Problems Leverage knowledge experts • Use informatics leaders, the HIM team, & forms committee to better understand the role of forms in your organization Look for manual processes and paper consents • Every department likely has “gaps” to fill Conduct a root-cause analysis • Are forms impacting your tactical workflows? • How do they hinder strategic goals? Talk to departmental leaders • Get feedback from the CMO, CNO, Director of Patient Access, HIM Managers, Director of Risk/Compliance, and others

Avoid Pitfalls Common e. Consent Strategy Mistakes • Replicating a bad process – Use the opportunity to consider ways to improve the workflow • Building eforms in a vacuum – There are impacts to process and compliance • Creating eforms from scratch – Technology exists to use the form designs already approved by the forms committee

Finding the Best Solution Leading Technology Healthcare Expertise • Integration with EHR via FHIR or HL 7 • Understands integration with EHRs and ECM • Pre-fill and collect data • Understands HIPAA and TJC standards • Mobile-optimized forms • Understands healthcare processes • Remote forms completion • History of working with healthcare organizations • Visual workflow design Scope Services and Support • Can be used enterprise-wide • • Clinical, non clinical Quick form conversion & implementation • Inpatient, ambulatory • Offers managed form services • Can leverage your form designs

e. Consent Takeaways: • Examine tactical/strategic problems with your consent process • Engage experts at the front lines • Understand workflow / expect reengineering • Consider solution from an enterprise view • Measure! Success breeds success

Questions? Contact Information: Tommy: thunkins@formfast. com Robin: rmckee@formfast. com Personalized demo: Form. Fast. com/contact

References Hobson & Company. (2017). Delivering ROI: the case for an output management solution for hospitals Rathert, C. , Porter, T. , Mittler, J. , Fleig-Palmer, M. (2017). Seven years after meaningful use: physicians’ and nurses’ experiences with electronic health records. Health Care Management Review. Missing Consent Forms in the Preoperative Area. A Single-Center Assessment of the Scope of the Problem and Its Downstream Effects Non-value-added time: the million dollar nursing opportunity. https: //formfast. com/white-paper-esignature-roi/ https: //formfast. com/white-paper-hobson-company-research-highlights-need-formfasts-outputmanagement-solution/ https: //formfast. com/infographic-delivering-roi-with-formfast-esignature-hobson-co-research/ https: //insights. cynergistek. com/document-management-best-practices/document-efficiencyhealthcare