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

Trial Summary

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 data supports the effectiveness of the treatment Increasing intensity of ACP-related messaging prior to surgical visit?

Research shows that using advance care planning (ACP) videos in surgical settings can be integrated without harm and is considered helpful by patients, although it did not significantly change the content of ACP discussions. Increasing the intensity or modifying the content of ACP interventions might enhance their effectiveness in future studies. ^{1 2 3 4 5}

Is the Surgical Advance Care Planning Technology for Major Elective Surgery safe for humans?

The research articles do not provide specific safety data for the Surgical Advance Care Planning Technology or related interventions. They focus on the use of risk calculators and advance care planning in surgical settings, but do not address safety concerns directly. ^{1 3 4 6 7}

How does the Surgical Advance Care Planning Technology for Major Elective Surgery differ from other treatments?

This treatment is unique because it integrates advance care planning (ACP) into the surgical process, using video-based tools to help patients discuss and document their medical care preferences before surgery. Unlike traditional approaches, this method emphasizes patient-centered communication and decision-making, potentially improving patient satisfaction and preparedness for surgery. ^{1 2 7 8 9}

What is the purpose of this trial?

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.

Research Team

Elizabeth Wick, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative Advance Care Planning for Older Adults Undergoing Major Abdominal Surgery. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating Advance Care Planning Videos into Surgical Oncologic Care: A Randomized Clinical Trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Missed Opportunities and Health Disparities for Advance Care Planning Before Elective Surgery in Older Adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Use of the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator During Preoperative Risk Discussion: The Patient Perspective. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Promoting perioperative advance care planning: a systematic review of advance care planning decision aids. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Report of a Quality Improvement Program for Reducing Postoperative Complications by Using a Surgical Risk Calculator in a Cohort of General Surgery Patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Case Discussions in Advanced Care Planning. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Frequency of Preoperative Advance Care Planning for Older Adults Undergoing High-risk Surgery: A Secondary Analysis of a Randomized Clinical Trial. [2022]