Opportunities to Improve Informed Consent with AHRQ Training Modules

Shoemaker, Sarah J.; Brach, Cindy; Edwards, Alrick S.; Chitavi, Salome; Thomas, Russel W.; Wasserman, Melanie

doi:10.1016/j.jcjq.2017.11.010

Cited by 10 publications

(23 citation statements)

References 17 publications

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“…Informed consent has considerable clinical, ethical, and legal implications for patient safety, liability, treatment cost and outcomes, patient-centered care, Hospital Consumer Assessment of Healthcare Providers and Systems scores, and reimbursement [1,2]. Patients may sign the consent form without a complete understanding of the indications, benefits, and risks of treatment procedures.…”

Section: Introductionmentioning

confidence: 99%

“…The lack of effective communication between the health care team and the patient is a root cause for informed consent–related sentinel events [2]. The Joint Commission (JC) and the Agency for Healthcare Research and Quality (AHRQ) urged hospitals to provide high-quality decision aids to support the informed consent process [1,2]. This paper describes a systematic approach to develop, implement, and alpha test an effective multimedia decision aid to reform the informed consent process of a peripherally inserted central venous catheter (PICC) procedure.…”

Section: Introductionmentioning

confidence: 99%

“…PtDAs should also include the appropriate level of details about treatment procedures, taking into consideration health literacy principles to help patients make informed choices about their treatments. Standards for patient comprehension and effectiveness measures should also be in place [1,2].…”

Section: Introductionmentioning

confidence: 99%

“…Despite these promising results, little information is available about the use of multimedia PtDAs in the consent process of therapeutic invasive procedures such as the PICCs. In addition, none of the available studies have designed their multimedia tools based on the patients’ information needs and the AHRQ’s comprehensive guide for informed consent, Making Informed Consent an Informed Choice [1]. To respond to these gaps in the literature, our systematic process of developing, implementing, and evaluating the multimedia PtDA program to reform the informed consent process for the PICC procedure was based on the AHRQ’s guides for informed consent [1], health literacy [18], and patient educational materials [19]; the Interprofessional-Shared Decision-Making (IP-SDM) model [20]; the PtDAs’ quality criteria developed by the International Patient Decision Aid Standards (IPDAS) Collaboration [21]; and the Multimedia Production Framework [22].…”

Section: Introductionmentioning

confidence: 99%

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Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement

Sowan¹,

Beraya²,

Carrola³

et al. 2018

JMIR Res Protoc

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BackgroundInformed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent.ObjectiveThis paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units.MethodsThe development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team.ResultsBased on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC.ConclusionsA systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the ...

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement

Sowan¹,

Beraya²,

Carrola³

et al. 2018

JMIR Res Protoc

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“…These factors should alert researchers of the need for extra time during the consent process to ensure all information is fully understood. Teach-back techniques are often used to confirm capacity when a researcher is uncertain about a participant's comprehension [23]. Given the complexity of AD genetic research, perhaps this should be done for all participants in key areas where misunderstandings are more common, such as those highlighted in this study.…”

Section: Discussionmentioning

confidence: 99%

Public Understanding and Opinions regarding Genetic Research on Alzheimer’s Disease

Kent

Bardach

Zhang

et al. 2018

Public Health Genomics

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Background: Participants willing to provide genetic samples are needed to propel the science of Alzheimer's disease (AD) treatment and prevention forward. Limited public understanding of what AD genetic research entails and participation concerns may serve as recruitment challenges. Objective: This study seeks to understand how well older adults understand AD genetic research and if understanding relates to concerns about participation or willingness to engage. Methods: Surveys included a mock AD consent with corresponding knowledge and opinion questions. Surveys were mailed to participants from the University of Kentucky Alzheimer's Disease Research Center and to a list of randomly selected individuals within the same age range from a local voter registration list. Descriptive and multivariable linear regression analyses were conducted. Results: Returned surveys (n=502) demonstrated limits in what respondents understood immediately after reading the relevant material, with mean summary knowledge scores of 74.5 out of 100. While comprehension gaps did not relate to level of concern or willingness to engage, concerns were related to willingness to engage. Concerns were greater among individuals not actively involved in research, individuals from minority groups, and those with higher levels of education. Conclusions: Focusing on concerns specifically rather than knowledge more generally may help increase participation.

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What is the Realistic Scope of Informed Consent?

Clapp¹,

Fleisher²

2018

The Joint Commission Journal on Quality and Patient Safety

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Opportunities to Improve Informed Consent with AHRQ Training Modules

Abstract: Many opportunities exist for hospitals to improve their informed consent practices. AHRQ's two training modules, have face validity, addressed demonstrated deficiencies in hospitals' informed consent policies and processes, and stimulated improvement activity in motivated hospitals.

Cited by 10 publications

References 17 publications

Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement

Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement

Public Understanding and Opinions regarding Genetic Research on Alzheimer’s Disease

What is the Realistic Scope of Informed Consent?

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