Using Training Modules to Move Informed Consent to Informed Choice Cindy Brach Health Literacy Annual Research Conference October 13, 2016
Overview • Why create informed consent modules • Leaders Module • Health Care Professionals Module • Baseline findings from 4 pilot sites • Implementation experience at PinnacleHealth • Pilot findings • Your questions answered 2
Presenters • Cindy Brach, Agency for Health Care Research and Quality • Salome Chitavi, The Joint Commission • Alrick Edwards, Abt Associates • Kathryn Shradley, PinnacleHealth • Sarah Shoemaker, Abt Associates 3
Informed Consent: The Problem Patients Clinicians • Misunderstanding • Just a form • Don’t offer choices ► Benefits, harms, risks, • Malpractice top 10 alternatives • Don’t know they can say no 4
Informed Consent OK, you can choose regal equine therapy, OR fragment adhesion cranioplasty. Which would you prefer? 5
Why Two Modules? • Ingredients for successful quality improvement: ► Leadership support ► Prepared workforce • Leaders module – for C-suite and other execs • Health care professionals module – teach skills to clinical teams • Health literacy relevance: informed consent requires clear communication about choices Both modules will be available to Joint Commission-accredited Institutions for free continuing medical education credit 6
Leaders Module Components • Principles of informed consent • Policy • Supportive Systems • Worksheets throughout • 34 new and existing resources – e.g., Championing Change, AHRQ HL Universal Precautions Toolkit. HCP module also has resource section. 7
Principles of Informed Consent • Clarify patients’ rights • Legal and patient safety implica- tions • Patient capacity for decision making Toni Cordell 8
Policy • Purpose • Compliance • Who can obtain IC • Enforcement • When • Dissemination • Content • Review • Documentation • Exceptions • Clear communications policy (plain language, using teach-back, accommodating communication needs) 9
Informed Consent Policy Worksheet 10
Picture of slide 42 Building Systems to Improve the Informed Consent Process 11
Making Informed Consent and Informed Choice: Training for Health Care Professionals Module Salome O. Chitavi The Joint Commission
Purpose and Objectives • Strategies and Tools to Improve the Informed Consent process • Four Key Objectives Principles of Informed Consent 1. Strategies for Clear Communication 2. Strategies for Presenting Choices 3. Informed Consent as a Team Process 4.
Approach: Enduring and Interactive Modules • Video recordings • Patient friendly forms • Provider illustrations • Model conversation • Knowledge checks • Multiple resources • Illustrative scenarios • Patient stories
Strategies for Clear Communication • Prepare for the Informed Consent Discussion • Use Health Literacy Universal Precautions • Remove Language Barriers • Use Teach-Back
The Teach-Back Process Chunk and teach information. If patient teaches back correctly and there’s more to explain Ask patients to teach back in their own words. Allow patients to consult material. If patient doesn’t teach back correctly Re-teach using different words
Teach-Back Examples
Strategies for Presenting Choices • Offer choices • Engage patients, families and friends • Elicit patient goals and values • Show high-quality decision aids • Explain benefits, harms and risks of all options • Help patients choose
Informed Consent as a Team Process • Confirming Understanding • Ensuring Appropriate Documentation • Team Roles and Responsibilities
Team Roles and Responsibilities
Baseline Findings from Implementation at Four Hospitals Alrick Edwards Abt Associates Inc.
Aims of Baseline Assessments To: • Understand patient and provider perspectives on informed consent practices at hospitals. • Identify opportunities for improvement
Methods/Data Sources Data Collection Method Respondents Research Domains • Baseline Assessment Hospital Liaisons Informed consent • Survey Unit Leads practices & attitudes Informed consent • Baseline Assessment Hospital Liaisons practices & attitudes; • Interview Unit Leads policies and process Health Care Professional Informed consent • HCP/hospital staff Survey practices & attitudes
Hospital Characteristics Hospital A Hospital B Hospital C Hospital D (Northeast) (Northeast) (South) (Northwest) Integrated care Academic, integrated Academic, Teaching, for- Type system, teaching, not care system, teaching, teaching, not for- profit profit for-profit not for-profit, safety net Average 750 205 285 105 Census Director, Hospital Nurse Professional Regulatory liaison’s Development Quality Analyst Risk manager Affairs, Corporate position Specialist Compliance Had issue related to Enthusiastic; Readiness Broad support from informed consent from wanted to assessme Prepared; formal the hospital implement in their stroke review by nt leadership entire hospital Joint Commission
Informed Consent Process Workflow Confirm patient understanding Consent Signed consent Procedure before of Discussion Documentation procedure Confirm patient Transfer Unsigned Signed consent understanding Documentation to Documentation before Procedure Unit procedure Challenging workflow for hospital staff
Opportunities for Improvement - 1 Process • Streamline or standardize the Informed Consent process across units • Better clarify roles of nurses and physicians in Informed Consent • Increase focus of Informed Consent on patient understanding • Provide patients more time to consider treatment options
Opportunities for Improvement - 2 Documentation • Better document the Informed Consent discussion • Obtain signed Informed Consent forms prior to arriving for surgery • Be more consistent with witness and interpreter documentation
Opportunities for Improvement - 3 Consent Form • Improve consent forms which can be confusing, cumbersome, difficult to understand and follow • Translate form into common languages represented in patient population • Integrate consent forms into electronic health record systems
To what extent do clinician obtaining consent in your hospital/unit agree with the following statements Chief purpose of IC is to comply with regulations Getting signature is most critical part of informed consent Refusing a life-saving procedure demonstrates patient is not capable of making a decision Staff attitudes Clinicians are in a better position to make decisions than (n=235) patients Clinicians should not present less effective alternatives Leaders' perception of Clinicians should encourage patients to talk about values clinician attitudes (n=22) Informed consent process is worth the time Lack of patient understanding of IC is safety problem Clinicians are responsible for ensuring that patients undertstand their options 0% 20% 40% 60% 80% 100% Percentage 'Agree' or 'Strongly Agree’ (%)
How frequently do clinicians do the following when obtaining informed consent? Use decision aids Teach-back to confirm understanding Leaders' Elicit Goals and Values perception of Informed Consent Practices clinician IC Confirm consent before procedure practices (n=22) Offer choices Staff's perception of clinicians' IC Engage patients/family in discussion practices (n=235) Neutral Explanation Clinicians' self- report (n=45) Encourage Questions Call for Qualified Interpreters Assess decision-making capacity 0% 20% 40% 60% 80% 100% Percentage 'Usually' or 'Always' (%)
How well does your unit/do you ensure patients are making an informed choice? Unit Self 1 to 3 1 to 3 2% 0.5% 4 to 7 1 to 3 16% 4 to 7 22% 4 to 7 8 to 10 8 to 10 8 to 10 76% 84% Average: 8.6 Median: 9 Average: 8.2 Median: 8
How confident are you in your ability to use teach-back in an informed consent discussion? Self 1 to 3 4% 1 to 3 4 to 7 4 to 7 34% 8 to 10 62% 8 to 10 Average: 7.8 Median: 8
Implementation at PinnacleHealth Harrisburg, PA Kathryn Shradley PinnacleHealth 34
Director, Director, Nurse Professional Customer Relations & Nursing Practice & Development Specialist Regulatory Research 36
Why Did We Join? • Ownership Issues • Demonstrated Lack of Knowledge • Distinct Patient Events ► Delayed Surgical Times • Health Literacy Education • Concurrent Interest . ...because our Medical Librarian told us to! 37
Clinical Teams Unit Team Members 60 RN’s Med/Surg ICU 1 Pulmonologist 40 RN’s Cath Lab 1 Cardiologist 46 RN’s Perianesthesia 1 General Surgeon 66 RN’s Post-Op Surgical 1 Orthopedic Surgeon 38
Project Timeline Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul 15 15 15 15 15 15 15 15 15 15 16 16 16 16 16 16 16 Project Support Baseline Survey Patient Surveys Leader Module HCW Survey HCW Module Monthly Reviews On-Site Visits Patient Surveys Project Debriefing 39
Communication Plan 40
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