FOCUS Pre-Post Study

Official title

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

Overview

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

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

Primary outcome measures

• Goal Discussion [Time frame: During the surgical consultation]

Secondary outcome measures (2)

• 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]

Eligibility criteria

Inclusion criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07664514 · 00200672 · 5K23AG080059

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗