Developing Pilot Postoperative Guidelines for Improved Functional Outcomes After High-Risk Cancer Surgery
Development and Implementation of Pilot Postoperative Guidelines to Improve Functional Outcomes Following High-Risk Surgery for Cancer: A North American Prospective Feasibility Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective, feasibility, and effectiveness trial to be conducted at The University of Alabama at Birmingham. We plan to develop algorithmic guidelines focused on proactive support of surgical recovery and will then recruit surgeons who care for adults undergoing high-risk abdominal surgery for cancer to study the preliminary effectiveness of implementing the algorithmic guidelines into postoperative care workflows at 4 pre-determined timepoints. A modified Delphi process will be used to ensure an expert consensus on the algorithmic guideline content is achieved through a rigorous and consensus-driven process. Two rounds of structured online voting will be conducted to rate and refine each algorithmic guideline component.
Key feasibility outcomes include recruitment and retention rates, surgeon adherence, data completeness, and integration into routine workflows. Preliminary effectiveness will be measured using patient-reported outcomes, timeliness of referral to supportive providers and resources, use of supportive services, rates of surgical regret, and measures of functional recovery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amber N Taylor (Clinical Research Regulatory Coordinator I), BS, MA
- Phone Number: (205)996-4611
- Email: amberntaylor@uabmc.edu
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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Contact:
- Amber Taylor, BS, MA
- Phone Number: 2059964611
- Email: amberntaylor@uabmc.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Surgeons who perform abdominal surgery for cancer at the study institution
Exclusion Criteria:
- Surgeons who do not perform abdominal surgery for cancer
- Surgeons who are external to the study institution
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Surgeons
Surgeons will be given a postoperative decision support guideline for assessment of functional recovery
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This is a pilot feasibility study to test the clinical use of a novel algorithmic guideline to support patient functional recovery following cancer surgery.
To date, no algorithmic guideline exists to support functional recovery as a primary postoperative outcome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Surgeon Utilization of the Algorithmic Guidelines for Functional Recovery following Cancer Surgery
Time Frame: 6 months
|
The primary outcome is surgeon use of the novel guideline to guide the postoperative clinical care of patients recovering from GI cancer surgery.
This will be measured by in-clinic fidelity monitoring, i.e. researcher monitoring of clinical use of the developed guideline.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kimberly E Kopecky, MD,MSCI, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300016448
- UAB (Other Identifier: UAB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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