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My Anesthesia Choice for Hip Fracture
N/A
Waitlist Available
Led By Mark Neuman, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50 and older
Planned surgery to treat a hip fracture
Must not have
Contraindication to spinal anesthesia: critical aortic stenosis
Contraindication to spinal anesthesia: skin infection over the lumbar spine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study months 12-27
Awards & highlights
Summary
This trial aims to evaluate a strategy to improve shared decision-making between doctors and patients regarding anesthesia options for hip fracture surgery at 6 US hospitals. The strategy involves using a 1-page conversation aid and
Who is the study for?
This trial is for patients with different types of hip fractures who are about to undergo surgery. The study aims to include a diverse group, but specific eligibility details aren't provided.
What is being tested?
The study tests a new approach called 'My Anesthesia Choice-HF Model' designed to improve discussions between doctors and patients about anesthesia options before hip fracture surgery at six hospitals in the US.
What are the potential side effects?
Since this intervention involves communication strategies rather than medications or medical procedures, there are no direct side effects associated with it.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I am scheduled for surgery to fix a broken hip.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have spinal anesthesia due to severe aortic valve narrowing.
Select...
I do not have a skin infection on my lower back.
Select...
I cannot have spinal anesthesia due to blood thinners or bleeding disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study months 12-27
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study months 12-27
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention reach (primary implementation outcome)
Shared Decision-Making Process scale score (SDMP; primary effectiveness outcome)
Secondary outcome measures
CollaboRATE shared decision making scale score (secondary effectiveness outcome).
Other outcome measures
Anesthesia type received
Decisional conflict
Fidelity of intervention delivery
+5 moreTrial Design
2Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Usual care will be delivered at each site during the pre-intervention phase. Patients treated in this arm will undergo pre-anesthesia care discussions as per existing clinical routine at each site.
Group II: My Anesthesia Choice- HFActive Control1 Intervention
During the intervention and sustainment phases, site clinicians will receive standardized in-personal or virtual training on shared decision making theory and approaches. The My Anesthesia Choice-HF tool will be made available for use during preoperative conversations. Clinicians will receive encouragement to use the tool on study-eligible patients based on their assessment of clinical appropriateness.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,882,163 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,253 Previous Clinical Trials
1,007,384 Total Patients Enrolled
University of FloridaOTHER
1,354 Previous Clinical Trials
709,798 Total Patients Enrolled
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