I CAN DO Surgical ACP

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Surgical Advanced Care Planning

Treatments: Behavioral: healthcare navigator; Behavioral: AD; Behavioral: Letter; Behavioral: reminders; Behavioral: PREPARE website

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06090552

1UG3AG081663-01 (U.S. NIH Grant/Contract)

P0562156

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 6,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,000 participants in 3 patient groups

Letter, AD, PREPARE

Other group

Description:

Letter about ACP, PREPARE advanced directive (AD), PREPARE website

Treatment:

Behavioral: PREPARE website

Behavioral: Letter

Behavioral: AD

Letter, AD, PREPARE, reminders

Other group

Description:

Letter, AD, PREPARE plus reminder messages

Treatment:

Behavioral: reminders

Behavioral: PREPARE website

Behavioral: Letter

Behavioral: AD

Letter, AD, PREPARE, reminders, healthcare navigator

Other group

Description:

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

Treatment:

Behavioral: reminders

Behavioral: PREPARE website

Behavioral: Letter

Behavioral: AD

Behavioral: healthcare navigator