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NCT Number: NCT07664514

FOCUS 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

FOCUS Guide

Other

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

Primary outcomes

  1. Goal Discussion

    Time frame: During the surgical consultation

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

Secondary outcomes

  1. Goal Documentation

    Time frame: Immediately following the surgical consultation through 3 months

    Presence or absence of documentation of the goal for surgery in the surgical consultation note.

  2. Goal-Concordant Care

    Time frame: Immediately following the surgical consultation through 3 months

    Goal-concordant care will be assessed immediately following the surgical consultation using the Modified Health Outcome Prioritization Tool and associated alignment item

Other outcomes

  1. Patient-Reported Outcomes

    Time frame: Immediately following the surgical consultation through 3 months

    Changes from immediate post-visit assessment to 3 months in:

    • Independence
    • Frailty
    • Treatment burden
    • Health-related quality of life
  2. Surgeon Satisfaction Outcomes

    Time frame: 3 years

    Surgeon-reported acceptability, feasibility, and adoption of the FOCUS Guide assessed following completion of the final study consultation.

  3. Feasibility Outcomes

    Time frame: 3 years

    Enrollment rate: defined as number of participants enrolled/eligible participants Adherence rate: defined as the number of intervention participants with a completed FOCUS Guide divided by the number of intervention participants enrolled.

    Retention rate: defined as the number of participants who complete 3 month follow up questionnaires/number of participants who complete immediate post-visit questionnaires

  4. Exploratory Outcome: Goal Alignment Between Patient and Surgeon

    Time frame: Immediately following the surgical consultation through 3 months

    Goal alignment reflects concordance between the patient's stated treatment goal and the surgeon's stated goal for surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Johnson, MPH

CONTACT

[email protected]

801-646-7393

Sierra McNall, BS

CONTACT

[email protected]

801-213-6543

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 24, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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