Surgical Advance Care Planning Technology for Major Elective Surgery

Recruiting at 2 trial locations

Overseen By Irina Gorodetskaya

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Acp on file, Prior randomization

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals aged 65 or older who plan to undergo elective surgery in preparing for future health care needs. It focuses on advanced care planning (ACP), which involves making decisions about the care desired if one cannot communicate. Participants will receive varying levels of support, such as letters, online tools, reminders, and possibly a healthcare navigator, to aid in creating a plan. Individuals aged 65 or older who have not established an ACP in recent years are ideal candidates for this trial. As an unphased trial, it provides a unique opportunity to proactively manage healthcare decisions with expert guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for patients undergoing major elective surgery?

Previous studies have shown that increasing the intensity of advance care planning (ACP) messages is safe for patients. The research primarily examines how well patients understand and use this information, rather than focusing on physical side effects. These studies have not reported any harm or negative effects from the messages themselves. The treatment includes sending letters, reminders, and providing access to resources like the PREPARE website, which aids patients in making informed care decisions.

Overall, participants tolerate these messages well, and they pose no known risk. If you decide to join a clinical trial involving ACP messaging, the safety data suggests you are unlikely to experience any negative effects from the intervention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance advance care planning (ACP) for patients undergoing major elective surgery. Unlike standard approaches that might involve a single discussion or written directive, this trial uses a combination of letters, advanced directives, a dedicated website, reminder messages, and even a healthcare navigator. This multi-layered approach aims to make ACP more engaging and effective, potentially leading to more meaningful and personalized care decisions. By increasing the intensity and accessibility of ACP-related communication, the trial seeks to improve how patients prepare for surgery, making sure their healthcare preferences are clearly documented and respected.

What evidence suggests that this trial's treatments could be effective for advanced care planning in elective surgery?

This trial will evaluate different strategies for advance care planning (ACP) messaging to help older adults prepare for surgery. Research has shown that ACP messages can enhance readiness for surgery. Participants will be assigned to different arms, each receiving varying levels of ACP-related messaging. Some will receive a letter, an advanced directive (AD), and access to the PREPARE website. Others will receive these materials plus reminder messages, and some will also have the support of a healthcare navigator. Studies have found that more frequent and personalized ACP messages increase the likelihood of patients completing important documents and discussing care preferences. Including reminders and a healthcare navigator boosts understanding and involvement in ACP. Previous findings suggest these strategies make meaningful conversations about care wishes more likely. Overall, increasing ACP-related messaging helps patients prepare more effectively for surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth Wick, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above, or those with a serious illness who are planning to undergo major elective surgery. It's not open to patients who already have an advanced care plan on file within the last six months or have received ACP-related messages from their primary care providers at UCSF and UCI.

Inclusion Criteria

I am over 65 or have a serious illness and need surgery.

Exclusion Criteria

I have completed an advance care plan within the last 6 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a letter about ACP, PREPARE advanced directive, and access to the PREPARE website. Some participants also receive reminder messages and/or a healthcare navigator.

6 months

Follow-up

Participants are monitored for clinically meaningful ACP documentation and patient engagement scores.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Increasing intensity of ACP-related messaging prior to surgical visit

Trial Overview The study tests different ways of encouraging Advanced Care Planning (ACP) before surgery using technology. Patients will be randomly placed in one of three groups: basic ACP information; ACP info with reminder messages; or ACP info with reminders and help from a healthcare navigator.

How Is the Trial Designed?

Group I: Letter, AD, PREPARE, reminders, healthcare navigator Experimental Treatment 5 Interventions

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

Group II: Letter, AD, PREPARE, reminders Experimental Treatment 4 Interventions

Letter, AD, PREPARE plus reminder messages

Group III: Letter, AD, PREPARE Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Fairview University Medical Center

Collaborator

Trials

7

Recruited

60+

Citations

1. withpower.com withpower.com/trial/phase-surgical-advanced-care-planning-5-2024-85b2e

Surgical Advance Care Planning Technology for Major ... What data supports the effectiveness of the treatment Increasing intensity of ACP-related messaging prior to surgical visit? Research shows that using advance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11185963/

Health Care Navigators for Perioperative Advance ... This cohort study evaluates the addition of a patient-centered intervention to an advance care planning process for older surgical patients.

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e108850

I CAN DO Surgical ACP (Improving Completion, Accuracy ... Methods and analysis This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient-facing EHR ...

4. researchgate.net researchgate.net/publication/395774395_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_

(PDF) I CAN DO Surgical ACP (Improving Completion, ... Methods and analysis This is a three-site, single-blinded, pragmatic randomised trial comparing increasing intensity of ACP-focused, patient- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932621/

Using the Perspectives of Advanced Practice Providers to ... Using the Perspectives of Advanced Practice Providers to Design Strategies to Increase Engagement of Surgical Patients in Advance Care Planning.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36001323/

Missed Opportunities and Health Disparities for Advance Care ... Data were analyzed from January to May 2022. Exposures: Elective surgery requiring an inpatient admission. Main outcomes and measures: ACP ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10512745/

Preoperative Advance Care Planning for Older Adults ... ACS NSQIP is a national, validated and risk-adjusted database created to track surgical outcomes and improve the quality of surgical care. Professionally ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0039606023002076

Experiences with targeting inpatient advance care ... A resident-led quality improvement project, including education and performance measurement, was conducted on an emergency general surgery service.

9. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2795575

Missed Opportunities and Health Disparities for Advance ... This cohort study evaluates the use of advance care planning among older, high-risk patients undergoing elective surgery.

10. journals.sagepub.com journals.sagepub.com/doi/10.1177/21582440241284445

Advance Care Planning of Patients Undergoing High-Risk ... The aim of this research was to clarify the concept of advance care planning (ACP) for patients undergoing high-risk surgery.