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FOCUS Pre-Post Study

Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide: Pre-Post Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07664514
Enrollment
180
Registered
2026-06-24
Start date
2026-08-15
Completion date
2029-05-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Surgery, Goals, Communication guide

Brief 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. 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.

Interventions

OTHERFOCUS Guide

The FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations.

Sponsors

University of Utah
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For surgeons 1\. Surgeons who have regular outpatient clinics at the University of Utah and Huntsman Cancer Institute For patients: 1. Age ≥65 years. 2. Presenting for in-person outpatient consultation regarding major non-urgent surgery with an enrolled surgeon. 3. Ability to provide informed consent. 4. English-speaking.

Exclusion criteria

For surgeons 1. Surgeons with a predominantly pediatric practice 2. Transplant surgeons For patients 1. Anticipated life expectancy \<3 months. 2. Inability to complete study procedures. 3. Patients presenting for minor procedures or non-operative consultations. 4. Telehealth consultation 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
Goal DiscussionDuring the surgical consultationPresence or absence of explicit discussion of the goal for surgery during the surgical consultation.

Secondary

MeasureTime frameDescription
Goal DocumentationImmediately following the surgical consultation through 3 monthsPresence or absence of documentation of the goal for surgery in the surgical consultation note.
Goal-Concordant CareImmediately following the surgical consultation through 3 monthsGoal-concordant care will be assessed immediately following the surgical consultation using the Modified Health Outcome Prioritization Tool and associated alignment item

Contacts

CONTACTSierra McNall, BS
Sierra.McNall@hsc.utah.edu801-213-6543
CONTACTJordan Johnson, MPH
jordan.esplin@hsc.utah.edu801-646-7393
PRINCIPAL_INVESTIGATORJessica Cohan, MD

University of Utah

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026