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I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): a protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical set

Por: Welton · L. · Colley · A. · Sudore · R. L. · Melton · G. B. · Botsford · C. · Oreper · S. · O'Brien · S. E. · Koopmeiners · J. S. · Gibbs · L. · Carmichael · J. C. · Wick · E. C.
Introduction

Approximately, 20 million older adults undergo major elective surgery annually, yet less than 10% engage in advance care planning (ACP). This is a critical missed opportunity to optimally engage in patient-aligned medical decisions and communications in the perioperative setting. The PREPARE ACP programme (easy-to-read advance directives (ADs) and a patient-directed, online ACP programme) has been shown to increase ACP documentation and patient and clinician empowerment to discuss ACP. Yet, a gap remains in extending PREPARE’s use to surgical populations. We hypothesise that by delivering PREPARE in a patient-facing electronic health record (EHR) centric presurgery workflow for older adults, supported by automated patient reminders and outreach from a healthcare navigator (HCN), we can enable patients and/or surgical teams to engage in ACP discussions.

Methods and analysis

This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR messaging and HCN support. The outreach occurs prior to a new presurgical clinic visit. We will enrol 6000 patients (2000 each site) aged 65 and older and randomise them equally to the following study arms: (Arm 1) ACP-related cover letter and PREPARE URL information sent via patient portal and postal mail (includes cover letter, AD and PREPARE pamphlet); (Arm 2) Arm 1 plus reminder message via text or MyChart message and (Arm 3) Arm 2 plus HCN outreach and support. The primary outcome is clinically meaningful ACP documentation in the EHR (ie, surrogate designation, documented discussions and ADs) within 6 months of the new surgical visit. The rate of ACP documentation will be compared between treatment groups using generalised estimating equations. Secondary outcomes include a validated four-item ACP engagement survey, administered 2 weeks after the presurgical visit and 6 months later. All analyses will follow the intention-to-treat principle and recent Consolidated Standards of Reporting Trials guidelines.

Ethics and dissemination

The study will be conducted according to the Declaration of Helsinki, Protection of Human Volunteers (21 Code of Federal Regulations (CFR) 50), Institutional Review Boards (21 CFR 56) and Obligations of Clinical Investigators (21 CFR 312). The protocol and consent form were reviewed and approved by Advarra, an National Insitutes of Health (NIH)-approved, commercial, centralised Institutional Review Board (IRB). The IRB/Independent Ethics Committee of each participating centre reviewed and approved the protocol and consent and obtained reliance agreements with Advarra prior to study initiation. The study is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of the study will be disseminated to both academic and community stakeholders, complying with all applicable privacy laws.

Trial registration number

ClinicalTrials.gov ID: NCT06090552.

Protocol number

Advarra Pro 00070994.

University of California, San Francisco IRB iRIS number

23-38948.

Protocol Date: 24 October 2024. Protocol Version: 4.

Use of health equity tools in patient safety incident analyses: a scoping review

Por: Sedrak · P. · Ly · K. · Saini · G. · Hwang · M. · Welton · C. · Ginzburg · A. · Fan · L. · Sharfuddin · N.
Objectives

The aim of this study is to investigate the use and effectiveness of equity tools in current practices of patient safety incident analyses via a scoping review of the literature.

Design

Scoping review of the literature using the two main search term concepts "health equity" AND "safety review". The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist was used to report in this paper.

Data sources

Databases including but not limited to MEDLINE, Embase and PubMed were searched from inception to 16 January 2023.

Eligibility criteria

Studies that included an equity tool in patient safety reviews were included. There were no restrictions on language or setting for included studies. Review articles were excluded.

Data extraction and synthesis

Two independent reviewers used standardised methods to search and screen included articles. Data from included studies was extracted and compiled.

Results

Five studies out of 5026 screened studies were included in the final analysis, 4 were conducted in the USA and 1 in Norway. While all studies identified equity domains to guide their approach to the provision of more equitable care, only three proposed change ideas and one implemented their framework to evaluate the role of social determinants and bias in adverse events. Communication was the most common theme found across four of the five studies. Access to healthcare services and bias were included as equity domains in two of the five studies. Implicit bias training was one of the identified change ideas. Other change ideas included improving access and communication, for example, through increasing the use and availability of interpreter services. One of the studies piloted the implementation of their equity checklist and found adverse event causes rooted in equity in 50% of the cases.

Conclusions

This scoping review demonstrates that there is a gap in current patient safety incident analyses, specifically lacking the consideration of equity domains. The development of a comprehensive health equity tool is necessary to promote equitable and safe care.

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