FOCUS Guide
OtherThe FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations.
NCT Number: NCT07664514
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For surgeons
For patients:
Exclusion criteria
For surgeons
For patients
The FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations.
Time frame: During the surgical consultation
Presence or absence of explicit discussion of the goal for surgery during the surgical consultation.
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.
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
Time frame: Immediately following the surgical consultation through 3 months
Changes from immediate post-visit assessment to 3 months in:
Time frame: 3 years
Surgeon-reported acceptability, feasibility, and adoption of the FOCUS Guide assessed following completion of the final study consultation.
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
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.
Contact information is provided by the study sponsor or research team.
Jordan Johnson, MPH
CONTACT
Sierra McNall, BS
CONTACT
University of Utah
Other
Facilitating Goal-based Conversations for Understanding Surgery (FOCUS) Guide: Pre-Post Study
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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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