Surgical Advanced Care PlanningNCT06090552
I CAN DO Surgical ACP
A study testing Letter, AD and PREPARE website in people with Surgical Advanced Care Planning, run by University of California, San Francisco at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Surgical Advanced Care Planning
- What is being tested?
- Letter, AD and PREPARE website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Feb 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older Adults (age 65+) referred for surgical evaluation
Who cannot join
- ACP on file within 3 years prior to surgery (UCSF and UCI) and 5 years (UMN)
- Was previously randomized into intervention for a prior surgery during the 18-month study period
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California, Irvine
Irvine, California, 92697
Jeein Kim, 949-697-9706, jeeink2@hs.uci.edu
Neika Saville, nsaville@hs.uci.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Erin Linden, MPH, linde491@umn.edu
Genevieve Melton-Meaux
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Irina Gorodetskaya, 415-514-7430, Irina.Gorodetskaya@ucsf.edu
Sandra P Oreper, sandra.martinez2@ucsf.edu
About this study
Official title: I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) 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.
Read the detailed 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).
- Conditions
- Surgical Advanced Care Planning
- Being tested
- Letter, AD, PREPARE website, reminders, healthcare navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
Letter about ACP
ADBehavioural
PREPARE advanced directive (AD)
PREPARE websiteBehavioural
PREPARE website
remindersBehavioural
reminders to complete the advance directive
healthcare navigatorBehavioural
healthcare navigators provide assistance to complete the advance directive
| Study group | Role | What they receive |
|---|---|---|
| Letter, AD, PREPARE | Other | Letter about ACP, PREPARE advanced directive (AD), PREPARE website Receives: Behavioral: Letter; Behavioral: AD; Behavioral: PREPARE website |
| Letter, AD, PREPARE, reminders | Other | Letter, AD, PREPARE plus reminder messages Receives: Behavioral: Letter; Behavioral: AD; Behavioral: PREPARE website; Behavioral: reminders |
| Letter, AD, PREPARE, reminders, healthcare navigator | Other | Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome) Receives: Behavioral: Letter; Behavioral: AD; Behavioral: PREPARE website; Behavioral: reminders; Behavioral: healthcare navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start26 Feb 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Advanced Care PlanningStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 simple randomized block design stratified by enrollment site
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, University of Minnesota, National Institute on Aging (NIA), Fairview University Medical Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth Wick, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090552
- Sponsor's protocol ID
- P0562156
- Other IDs
- 1UG3AG081663-01
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data sets are available at request at the conclusion of the study
Publications
Welton L, Colley A, Sudore RL, Melton GB, Botsford C, Oreper S, O'Brien SE, Koopmeiners JS, Gibbs L, Carmichael JC, Wick EC. 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 completion in older adults in the presurgical setting. BMJ Open. 2025 Sep 23;15(9):e108850. doi: 10.1136/bmjopen-2025-108850.
PubMed 40987739
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) Trial
- ClinicalTrials.gov ID
- NCT06090552
- Acronym / sponsor ID
- P0562156
- Conditions
- Surgical Advanced Care Planning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of Minnesota, National Institute on Aging (NIA), Fairview University Medical Center
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 1:1:1 simple randomized block design stratified by enrollment site
| Arm | Type | Receives |
|---|---|---|
| Letter, AD, PREPARE | Other | Behavioral: Letter, Behavioral: AD, Behavioral: PREPARE websiteLetter about ACP, PREPARE advanced directive (AD), PREPARE website |
| Letter, AD, PREPARE, reminders | Other | Behavioral: Letter, Behavioral: AD, Behavioral: PREPARE website, Behavioral: remindersLetter, AD, PREPARE plus reminder messages |
| Letter, AD, PREPARE, reminders, healthcare navigator | Other | Behavioral: Letter, Behavioral: AD, Behavioral: PREPARE website, Behavioral: reminders, Behavioral: healthcare navigatorLetter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older Adults (age 65+) referred for surgical evaluation
Key exclusion criteria (2 listed)
- ACP on file within 3 years prior to surgery (UCSF and UCI) and 5 years (UMN)
- Was previously randomized into intervention for a prior surgery during the 18-month study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetterLetter about ACP | Behavioural | Letter, AD, PREPARE, Letter, AD, PREPARE, reminders, Letter, AD, PREPARE, reminders, healthcare navigator |
| ADPREPARE advanced directive (AD) | Behavioural | Letter, AD, PREPARE, Letter, AD, PREPARE, reminders, Letter, AD, PREPARE, reminders, healthcare navigator |
| PREPARE websitePREPARE website | Behavioural | Letter, AD, PREPARE, Letter, AD, PREPARE, reminders, Letter, AD, PREPARE, reminders, healthcare navigator |
| remindersreminders to complete the advance directive | Behavioural | Letter, AD, PREPARE, reminders, Letter, AD, PREPARE, reminders, healthcare navigator |
| healthcare navigatorhealthcare navigators provide assistance to complete the advance directive | Behavioural | Letter, AD, PREPARE, reminders, healthcare navigator |
Primary outcome
Number of participants with clinically meaningful Advanced Care Planning
Time frame: 6 months
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.
1 secondary outcome
Patient Engagement Scores
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 40987739Welton L, Colley A, Sudore RL, Melton GB, Botsford C, Oreper S, O'Brien SE, Koopmeiners JS, Gibbs L, Carmichael JC, Wick EC. 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 completion in older adults in the presurgical setting. BMJ Open. 2025 Sep 23;15(9):e108850. doi: 10.1136/bmjopen-2025-108850.
- Individual participant dataSharing planned: Yes. De-identified data sets are available at request at the conclusion of the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Wick, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter, AD and PREPARE website in people with Surgical Advanced Care Planning, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Wick, MD (415-353-2357, Elizabeth.wick@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically meaningful Advanced Care Planning (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.