SurgeryNCT07664514
FOCUS Pre-Post Study
A study testing FOCUS Guide in people with Surgery, run by University of Utah at 1 site in United States.
Trial summary
The Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- FOCUS Guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2026to May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For surgeons
- 1. Surgeons who have regular outpatient clinics at the University of Utah and Huntsman Cancer Institute
- For patients:
- Age ≥65 years.
- Presenting for in-person outpatient consultation regarding major non-urgent surgery with an enrolled surgeon.
- Ability to provide informed consent.
- English-speaking.
Who cannot join
- For surgeons
- Surgeons with a predominantly pediatric practice
- Transplant surgeons
- For patients
- Anticipated life expectancy <3 months.
- Inability to complete study procedures.
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- Patients presenting for minor procedures or non-operative consultations.
- Telehealth consultation
- Any clinical, cognitive, communication, or logistical factor that, in the opinion of the treating surgeon or investigator, would substantially interfere with participation or completion of study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Jessica N Cohan, MD, 805-441-7886, jessica.cohan@hsc.utah.edu
Sierra McNall, BS, 801-213-6543, sierra.mcnall@hsc.utah.edu
About this study
Official title: Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide: Pre-Post Study
The Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. The purpose of this study is to assess the efficacy of the FOCUS guide in prompting discussion of the goal for surgery.
Read the detailed description
More than 300,000 older adults undergo major non-urgent surgery annually in the United States. Older adults often prioritize independence, quality of life, and preservation of function over life prolongation when making treatment decisions. However, surgical consultations rarely include explicit discussion or documentation of the goal for surgery.
Existing surgical communication often focuses on disease-centered or "fix-it" models of care, emphasizing surgical correction of structural disease rather than discussion of outcomes that matter most to patients. As a result, patients may develop unrealistic expectations regarding surgical outcomes and may experience postoperative distress when outcomes do not align with expectations.
The Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. By facilitating explicit discussion of the goal for surgery, the intervention seeks to align surgical care with patient priorities and improve patient-centered care.
- Conditions
- Surgery
- Being tested
- FOCUS Guide
- Keywords
- Surgery, Goals, Communication guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUS GuideOther
The FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention cohort | No intervention | Patients in the pre-intervention group will undergo surgical consultations according to usual care. |
| Post-intervention cohort | Experimental | Patients in the post-intervention group will undergo surgical consultations using the FOCUS Guide. Receives: Other: FOCUS Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Discussion
Presence or absence of explicit discussion of the goal for surgery during the surgical consultation.
Measured: During the surgical consultation
Secondary outcomes (2)
Goal Documentation
Presence or absence of documentation of the goal for surgery in the surgical consultation note.
Measured: Immediately following the surgical consultation through 3 months
Goal-Concordant Care
Goal-concordant care will be assessed immediately following the surgical consultation using the Modified Health Outcome Prioritization Tool and associated alignment item
Measured: Immediately following the surgical consultation through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start29 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study includes: * Pre-intervention (usual care) cohort * Surgeon training period * Post-intervention (FOCUS Guide) cohort Patients in the pre-intervention group will undergo surgical consultations according to usual care. Patients in the intervention group will undergo surgical consultations using the FOCUS Guide. All patients will undergo assessments immediately following the consultation and again at 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jessica Cohan, University of Utah
- Investigators
- Jessica Cohan, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664514
- Sponsor's protocol ID
- 00200672
- Other IDs
- 5K23AG080059
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide: Pre-Post Study
- ClinicalTrials.gov ID
- NCT07664514
- Acronym / sponsor ID
- 00200672
- Conditions
- Surgery
- Keywords
- Surgery, Goals, Communication guide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Jun 2026 (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 Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. The purpose of this study is to assess the efficacy of the FOCUS guide in prompting discussion of the goal for surgery.
Detailed description
More than 300,000 older adults undergo major non-urgent surgery annually in the United States. Older adults often prioritize independence, quality of life, and preservation of function over life prolongation when making treatment decisions. However, surgical consultations rarely include explicit discussion or documentation of the goal for surgery.
Existing surgical communication often focuses on disease-centered or "fix-it" models of care, emphasizing surgical correction of structural disease rather than discussion of outcomes that matter most to patients. As a result, patients may develop unrealistic expectations regarding surgical outcomes and may experience postoperative distress when outcomes do not align with expectations.
The Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. By facilitating explicit discussion of the goal for surgery, the intervention seeks to align surgical care with patient priorities and improve patient-centered care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study includes: * Pre-intervention (usual care) cohort * Surgeon training period * Post-intervention (FOCUS Guide) cohort Patients in the pre-intervention group will undergo surgical consultations according to usual care. Patients in the intervention group will undergo surgical consultations using the FOCUS Guide. All patients will undergo assessments immediately following the consultation and again at 3 months.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention cohort | No intervention | –Patients in the pre-intervention group will undergo surgical consultations according to usual care. |
| Post-intervention cohort | Experimental | Other: FOCUS GuidePatients in the post-intervention group will undergo surgical consultations using the FOCUS Guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For surgeons
- 1. Surgeons who have regular outpatient clinics at the University of Utah and Huntsman Cancer Institute
- Age ≥65 years.
- Presenting for in-person outpatient consultation regarding major non-urgent surgery with an enrolled surgeon.
- Ability to provide informed consent.
Key exclusion criteria (9 listed)
- For surgeons
- Surgeons with a predominantly pediatric practice
- Transplant surgeons
- For patients
- Anticipated life expectancy <3 months.
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 |
|---|---|---|
| FOCUS GuideThe FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations. | Other | Post-intervention cohort |
Primary outcome
Goal Discussion
Time frame: During the surgical consultation
Presence or absence of explicit discussion of the goal for surgery during the surgical consultation.
2 secondary outcomes
Goal Documentation
Time frame: Immediately following the surgical consultation through 3 months
Goal-Concordant Care
Time frame: Immediately following the surgical consultation through 3 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 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
Jessica Cohan, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS Guide in people with Surgery, run by University of Utah at 1 site 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 7 inclusion and 9 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Sierra McNall, BS (801-213-6543, Sierra.McNall@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Discussion (time frame: During the surgical consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.