I CAN DO Surgical ACP

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06090552
• Collaborator: University of California, Irvine (Other), University of Minnesota (Other), National Institute on Aging (NIA) (NIH)
• Enrollment: 25
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The goal of the Advanced Care Planning (ACP) study is to encourage patients aged 65 or older, or with serious illness, who are referred for major 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 electronic health record (HER)-centric pre-surgery workflow for older adults and including automated reminders, the study team can empower patients and surgical teams to engage in ACP discussions.

Participants will be randomized to Arms: (1) Letter about ACP, PREPARE advanced directive (AD), PREPARE website; (2) Letter, advanced directive (AD), PREPARE plus reminder text/phone messages; (3) Letter, advanced directive (AD,) PREPARE plus reminders plus a healthcare navigator on ACP documentation (discussions and careplans, primary outcome) and patient-reported ACP engagement. Using mixed methods, the study team will assess patients' and surgical care teams' experience with surgery ACP.

Condition or Disease	Intervention/Treatment	Phase
Surgical Advanced Care Planning	Behavioral: Increasing intensity of ACP-related messaging prior to surgical visit	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 1:1 randomized block design stratified by enrollment site; within enrollment site, further stratified by surgical clinic1:1 randomized block design stratified by enrollment site; within enrollment site, further stratified by surgical clinic
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) Trial
• Anticipated Study Start Date: Jun 1, 2024
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Letter, AD, PREPARE Letter about ACP, PREPARE advanced directive (AD), PREPARE website	Behavioral: Increasing intensity of ACP-related messaging prior to surgical visit; Behavioral interventions to observe how the different arms of advanced care planning helps participants aged 65 or older.
Other: Letter, AD, PREPARE, reminders Letter, AD, PREPARE plus reminder text/phone messages	Behavioral: Increasing intensity of ACP-related messaging prior to surgical visit; Behavioral interventions to observe how the different arms of advanced care planning helps participants aged 65 or older.
Other: Letter, AD, PREPARE, reminders, healthcare naviagator, patient reported engagement Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (discussions and careplans, primary outcome) and patient-reported ACP engagement	Behavioral: Increasing intensity of ACP-related messaging prior to surgical visit; Behavioral interventions to observe how the different arms of advanced care planning helps participants aged 65 or older.

Outcome Measures

Primary Outcome Measures

1. Number of participants with Advanced Care Planning [6 months]

   Advanced Directive (Living Will and Durable Power of Attorney) or out of hospital DNR or Physician Orders for Life-Sustaining Treatment or ACP note in EHR

Secondary Outcome Measures

1. Patient Engagement Scores [6 months]

   Self-assessed patient engagement levels will be measures using a 11 question survey. Participants will answer each question with responses that range from "least likely" to "most likely," with each response converted to a numerical score. Scores range from 1 to 5, with higher scores indicating higher levels of patient engagement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Older Adults (age 65+) or any patient with a serious illness referred for surgical evaluation

Exclusion Criteria:

1. ACP on file within 6 months prior to surgery

2. Prior ACP-related patient portal messages from primary care (UCSF and UCI)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• University of California, Irvine
• University of Minnesota
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Elizabeth Wick, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT06090552
• Other Study ID Numbers: P0562156; 1UG3AG081663-01
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 19, 2023