NCT07664514

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable surgery

Timeline
33mo left

Started Aug 2026

Typical duration for not_applicable surgery

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 16, 2026

Last Update Submit

June 23, 2026

Conditions

Surgery

Keywords

SurgeryGoalsCommunication guide

Outcome Measures

Primary Outcomes (1)

  • Goal Discussion

    Presence or absence of explicit discussion of the goal for surgery during the surgical consultation.

    During the surgical consultation

Secondary Outcomes (2)

  • Goal Documentation

    Immediately following the surgical consultation through 3 months

  • Goal-Concordant Care

    Immediately following the surgical consultation through 3 months

Other Outcomes (4)

  • Patient-Reported Outcomes

    Immediately following the surgical consultation through 3 months

  • Surgeon Satisfaction Outcomes

    3 years

  • Feasibility Outcomes

    3 years

  • +1 more other outcomes

Study Arms (2)

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.

Other: FOCUS Guide

Interventions

FOCUS GuideOTHER

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

Post-intervention cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For surgeons
  • \. 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.

You may not qualify if:

  • For surgeons
  • Surgeons with a predominantly pediatric practice
  • Transplant surgeons
  • For patients
  • Anticipated life expectancy \<3 months.
  • Inability to complete study procedures.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jessica Cohan, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sierra McNall, BS

CONTACT

801-213-6543Sierra.McNall@hsc.utah.edu

Jordan Johnson, MPH

CONTACT

801-646-7393jordan.esplin@hsc.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 24, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share