FOCUS Pre-Post Study
ConditionSurgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Surgeons with a predominantly pediatric practice
Transplant surgeons
Anticipated life expectancy <3 months.
Inability to complete study procedures.
Trial design
Design model
Sequential
Treatments tested in this trial
FOCUS Guide
Other interventionThe FOCUS Guide is a communication intervention designed to support discussion and documentation of the goal for surgery during outpatient surgical consultations.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Pre-intervention cohortNo intervention 0 interventions
Group B: Post-intervention cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Goal Discussion
Presence or absence of explicit discussion of the goal for surgery during the surgical consultation.
Time frame
During the surgical consultationSecondary outcomes
1
Goal Documentation
Presence or absence of documentation of the goal for surgery in the surgical consultation note.
Time frame
Immediately following the surgical consultation through 3 months2
Goal-Concordant Care
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 monthsOther outcomes
1
Patient-Reported Outcomes
Changes from immediate post-visit assessment to 3 months in: * Independence * Frailty * Treatment burden * Health-related quality of life
Time frame
Immediately following the surgical consultation through 3 months2
Surgeon Satisfaction Outcomes
Surgeon-reported acceptability, feasibility, and adoption of the FOCUS Guide assessed following completion of the final study consultation.
Time frame
3 years3
Feasibility Outcomes
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
3 years4
Exploratory Outcome: Goal Alignment Between Patient and Surgeon
Goal alignment reflects concordance between the patient's stated treatment goal and the surgeon's stated goal for surgery.
Time frame
Immediately following the surgical consultation through 3 monthsLocations
Sponsors and contacts
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University of Utah
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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