I CAN DO Surgical ACP

University of California, San Francisco6,000 enrolled

Overview

The goal of the Advanced Care Planning (ACP) study is to encourage patients aged 65 or older who are referred for elective surgery to have advanced care planning.

ACP is also a critical way to support older adults in participating actively with clinicians in making real-time, complex medical decisions so that the medical care they receive is aligned with their goals. Our team has designed and tested a theory-based, interactive ACP patient-facing technology solution (PREPARE) based on the new ACP paradigm of preparing people for communication and medical decision-making. The study team hypothesizes that by including PREPARE into the EHR-centric pre-surgery workflow for older adults and including automated patient reminders, easy-to-read materials, and, in Arm 3, directed support from a healthcare navigator (HCN), they can empower patients and surgical teams to engage in ACP discussions. They also hypothesize that ACP documentation will increase more with increasing resource intensity (i.e., Arm 3 more than Arm 2 more than Arm 1). Participants will be randomized to Arms: (1) Letter about ACP, PREPARE advanced directive (AD), PREPARE website; (2) Letter, advanced directive (AD), PREPARE plus reminder messages; (3) Letter, advanced directive (AD,) PREPARE plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome). All patients randomized to the intervention will be sent a patient-reported ACP engagement survey (secondary outcome).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

6,000

Conditions

Surgical Advanced Care Planning

Interventions

LetterBEHAVIORAL

Letter about ACP

ADBEHAVIORAL

PREPARE advanced directive (AD)

PREPARE websiteBEHAVIORAL

PREPARE website

reminders

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Older Adults (age 65+) referred for surgical evaluation Exclusion Criteria: 1. ACP on file within 3 years prior to surgery (UCSF and UCI) and 5 years (UMN) 2. Was previously randomized into intervention for a prior surgery during the 18-month study period

Locations (3)

University of California, Irvine

Irvine, California, United States

RECRUITING

University of California, San Francisco

San Francisco, California, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants with clinically meaningful Advanced Care Planning

clinically meaningful ACP documentation (ACP-specific clinical notes, problem lists, Epic Smartforms or Smartphrases, advanced directives, Physician Orders for Life Sustaining Treatment, out of hospital do-not-resuscitate order, living wills, or CPT billing codes) available in the HCS EHR within 6 months of intervention.

Time frame: 6 months

Secondary Outcomes

Patient Engagement Scores

Patient-centered outcomes will be derived from the validated 4-item ACP Engagement Survey.The survey will be administered 2 weeks after the pre-surgical clinic visit and a follow up survey will be sent 6 months later.

Time frame: 6 months

Central Contacts

Elizabeth Wick, MD

CONTACT

415-353-2357 Elizabeth.wick@ucsf.edu

Irina Gorodetskaya

CONTACT

415-514-7430 Irina.Gorodetskaya@ucsf.edu

Data from ClinicalTrials.gov

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