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Opportunities to Improve Informed Consent with AHRQ Training Modules.

ABSTRACT: BACKGROUND:Informed consent is a process of communication between clinician and patient that results in the patient's decision about whether to undergo a specific intervention. However, patients often do not understand the risks, benefits, and alternatives, even after signing a consent form. METHODS:Mixed-methods pilot test of two Agency for Healthcare Research and Quality (AHRQ) informed consent training modules implemented in four hospitals. Methods included staff and patient surveys, interviews, site visits, and pre- and posttests of the modules. RESULTS:A low proportion of clinicians reported using teach-back (40.0%) or high-quality decision aids (55.0%). Patients reported limited use of best practices, including being asked to teach-back (58.4%), having other options described (54.9%), viewing decision aids (37.4%), and finding the form very easy to understand (66.8%). Content of the training modules aligned well with identified deficiencies. Barriers to completing the modules included staff turnover, competing demands, and lack of accountability. Facilitators included committed champions with available time, motivation, and release time for staff to take modules. Knowledge increased for leaders (p?<0.05) and staff (p?<0.001) who completed the training modules. Hospitals reported the effects of piloting the modules included fostering dialogue and identifying opportunities for improvements, identifying and rectifying policy ambiguity and noncompliance, reinforcing the use of interpreter services, and using modules' strategies and tools to improve informed consent. CONCLUSION: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.

SUBMITTER: Shoemaker SJ

PROVIDER: S-EPMC6022821 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Opportunities to Improve Informed Consent with AHRQ Training Modules.

Shoemaker Sarah J SJ Brach Cindy C Edwards Alrick A Chitavi Salome O SO Thomas Rene R Wasserman Melanie M

Joint Commission journal on quality and patient safety 20180503 6

<h4>Background</h4>Informed consent is a process of communication between clinician and patient that results in the patient's decision about whether to undergo a specific intervention. However, patients often do not understand the risks, benefits, and alternatives, even after signing a consent form.<h4>Methods</h4>Mixed-methods pilot test of two Agency for Healthcare Research and Quality (AHRQ) informed consent training modules implemented in four hospitals. Methods included staff and patient su ...[more]

PMID: 29793885

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Project description:IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.

Dataset Information

Opportunities to Improve Informed Consent with AHRQ Training Modules.

Publications

Opportunities to Improve Informed Consent with AHRQ Training Modules.

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