Valid Informed Consent Education Pilot Project

2nd Annual Nursing Research & Evidence-Based Practice Symposium

Sandra Knowlton-Soho, MS, RN

Sara Simeone, BSN, RN

November 5, 2010

Financial Disclosure

We do not have any conflict of interest to report in relation the information being presented today.

Objectives

1. Explain the need to educate research staff in obtaining valid informed consent

2. Describe how the Valid Informed Consent Project seeks to determine if the teach back method is effective to assess study participant understanding 

 

Background: Clinical Research

Clinical study of a drug to device to test safety and/or efficacy

Involve human subjects Obligation: Protection of Human Subjects Obligation: Choice

Informed Consent in Clinical Research

Components of informed consent1. Voluntary choice

o Free from coercion an undue influence

2. Information disclosureo Risks, benefits, burdens, alternatives

3. Decision-making capacityo Able to understand nature and consequences of

decisions

Informed Consent in Clinical Research

A Process Conversation with PI or designee such as

Research RN Review of Informed Consent Document Signature Documentation of process Ongoing assessment of consent to participate

Nursing and Clinical Research

Role of the Research Nurse

Overlap with Nursing Research

Framework

Identify Need

Understand what is already known (literature search)

Project development and implementation

Project assessment and sharing of knowledge (present/publish)

Challenge: Health Literacy

National Center for Education Statistics, 2003; Baker, 2010

Challenges: Regulations

October 2009 FDA Guidance Guidance for the Industry on Investigator

Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

Framework

Identify Need

Understand what is already known (literature search)

Project development and implementation

Project assessment and sharing of knowledge (present/publish)

Literature Review: Teach Back & Simulation Importance of a volunteer’s level of understanding when discussing

participation in study (Flory & Emanuel, 2004; Paris et al, 2010; Titus, 1996).

Different interventions have been proposed to improved the process (Davis et

al, 2002; Flowers, 2006; Kripalani et al, 2008; Lorenzen, 2008) but there is limited research on training research staff in using these interventions.

As an interactive method to improve skills, simulation training with standardized patients has been proven to be effective (Brindley & Dunn, 2009; Leeper-

Majors et al, 2003; Taekman et al, 2004). No literature describing the use of an Informed Consent Simulation Training

to improve the consent process. University of Michigan developed a training program similar to the one we

are proposing, but we were unable to find any citations for articles related to validating their project (Valid consent and refusal to participate in research, S. Goold).

A Solution: The Teach Back Method

● Asking patients to repeat in their own words what they need to know or do, in a non-shaming way.

● NOT a test of the patient, but of how well you explained a concept.

● A chance to check for understanding and, if necessary, re-teach the information.

Framework

Identify Need

Understand what is already known (literature search)

Project development and implementation

Project assessment and sharing of knowledge (present/publish)

The Intervention

An Educational Program:

Two hour class that will involve lecture, video, discussion, and role playing.

Objectives: explain the purpose of obtaining informed consent describe the components of informed consent identify issues associated with health literacy and

informed consent demonstrate the use of the teach-back method in

informed consent discussions

Study Design

Pilot study utilizing quantitative and qualitative design

Pre-intervention, immediately post-intervention, 3 months post-intervention

Assess participants: Knowledge - multiple choice test Attitude - self reported confidence Skills - observation of simulated consent process

Study Execution

Recruitment Internal staff responsible for conducting informed

consent discussions with potential clinical trial volunteers

Intervention 2 cohorts of 14-16 participants

Data analysis Quantitative: Analysis of Variance over the 3 time

points Qualitative: Participant feedback

Framework

Identify Need

Understand what is already known (literature search)

Project development and implementation

Sharing of knowledge (present/publish)

Lessons Learned Thus Far

Multidisciplinary Collaboration Regular meetings to stay on track Realistic timeline Make adjustments as needed

Acknowledgements

Project team members

Liz Bankert, Assistant Provost for Research, Dartmouth College Ann O’Hara, Human Research Analyst, Committee for the

Protection of Human Subjects, Dartmouth College Dianne Ferris, Human Research Analyst, Committee for the

Protection of Human Subjects, Dartmouth College Judi Forman, Research Associate/Program Coordinator, Clinical

Trials Unit at The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Acknowledgements

Institutional Support Dartmouth Hitchcock Patient Safety Training

Center D-H Quality Research Grant Program Dartmouth Clinical Trials Office Committee for the Protection of Human Subjects Norris Cotton Cancer Center – Office of Clinical

Research The Dartmouth Institute for Health Policy and

Clinical Practice