PGMP for Alberta Surgical Patients
Primary Purpose
Hyperglycemia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Perioperative glycemic management pathway
Sponsored by
About this trial
This is an interventional health services research trial for Hyperglycemia focused on measuring Perioperative hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Undergoing a surgical procedure, adults (older than 18 years of age), admitted to the hospital for more than 24 hours after their surgical procedure.
Exclusion Criteria:
- Under 18 years of age
Sites / Locations
- Foothills Medical CentreRecruiting
- Red Deer Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention: PGMP
Non-intervention: usual care
Arm Description
Sites will implement a perioperative glycemic management pathway based on national guidelines and current evidence, with support of an implementation scientist team.
Sites will perform usual perioperative glycemic management.
Outcomes
Primary Outcome Measures
Length of stay
Number of days that a patient stays in hospital after their surgical procedure
Secondary Outcome Measures
Readmissions
Representation to the emergency department or readmission to any hospital after the surgical procedure, for any reason
Hypoglycemia
A measure blood or capillary glucose less than 4.0 mmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05036655
Brief Title
PGMP for Alberta Surgical Patients
Official Title
Implementation of a Perioperative Glycemic Management Pathway for Albertan Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with postoperative hyperglycemia have higher complication rates and worse outcomes than patients with in-target glucose, including longer length-of-stay, more admissions to intensive care, increased readmission rates, and higher risk of infection. There are 35-40% of surgical patients at risk of postoperative hyperglycemia, including 20-30% of patients with diabetes, 10% with undiagnosed diabetes, and another 5-10% without diabetes who will have hyperglycemia. Data demonstrate significant quality and practice gaps that contribute to postoperative hyperglycemia in Alberta; 43% of patients with diabetes had no postoperative glucose measurements and two-third had postoperative hyperglycemia.
The multi-disciplinary Perioperative Glycemic Management Pathway (PGMP) has been demonstrated to reduce postoperative hyperglycemia and improve outcomes for surgical patients in pilot-testing. This project will confirm the effects of the PGMP on (1) postoperative glycemic management; (2) length-of-stay; (3) readmission rates and (4) cost savings; compared to usual care in surgical patients admitted for >24-hours postoperatively.
We will implement the PGMP in 12 services in 6 hospitals in Alberta using implementation science and an evidence-informed knowledge translation approach. Impact will be analyzed using a stepped-wedge study design and will include formal evaluation of cost-effectiveness and implementation, clinical, and patient-reported outcomes. The primary efficacy outcome is change in length-of-stay pre/post implementation. Secondary clinical outcomes include the 30-day readmission rate, surgical site infection rate, 30-day mortality, and one-year mortality.
We will implement the PGMP for 23,200 patients, and reduce postoperative hyperglycemia and associated complications for 7,665 patients, avoiding the expenditure of >$24.6 million for a return on investment of 1,810%.
Detailed Description
Study design:
This stepped-wedge study(69) will evaluate cost effectiveness and implementation, clinical, and patient-reported outcomes.
Research question:
What are the effects of the PGMP on: (1) postoperative glycemic management; (2) length-of-stay; (3) readmission rates and (4) cost; compared to usual care in surgical patients admitted for ≥24-hours postoperatively?
Population:
Surgical patients at risk of hyperglycemia, admitted for ≥24-hours postoperatively. Pre-intervention sites serve as control groups.
Outcomes:
Change in length-of-stay is the primary effectiveness outcome, stratified for patients with diabetes, with and without hyperglycemia and patients without diabetes, with and without hyperglycemia. Secondary clinical outcomes: odds of 30-day readmission, 30-day mortality, and one-year mortality.
Data Analysis:
The exposure is the PGMP. Patients will be stratified by diagnosis of diabetes (pragmatically defined using Diabetes Canada diagnostic criteria(51)) and postoperative hyperglycemia (categorical). We will use quantile regression to estimate differences in the median length-of-stay and logistic regression to estimate 30-day odds of readmission and mortality, and odds of 1-year mortality, adjusted for age, sex, surgical type, surgical urgency, hospital unit, and comorbidities. Surgical services will serve as their pre-implementation control, and sites that have not undergone implementation will serve as controls for post-implementation sites.(69) Prespecified covariates are age, HbA1c, and surgery type.
Cost-effectiveness Analysis:
We will conduct a cost-utility analysis comparing current standard of care (pre-implementation)) with the PGMP (post-implementation) over a 90-day post-operative period. Costs will be based on the 2023 Alberta costs of care. Health benefits will be described as Quality-Adjusted Life Years (QALYs) using EQ-5D-3L collected from pre-and post-intervention sites. The QALYs will represent the impact of PGMP on morbidity and mortality. The resultant incremental cost-effectiveness ratio (ICER) (cost of the intervention as well as net system health service utilization costs as numerator and QALYs as the denominator) will establish the incremental cost-utility ratio of the PGMP compared to the prior standard of care. We will evaluate the cost effectiveness from a healthcare and societal perspective using the robust resources of the DON SCN for societal costs of surgical complications from diabetes.
Sample Size:
Based on the effect size seen in pilot-testing (reduction in length-of-stay, 0.6-1.1 days, variance 2.9 days) and using an estimated intraclass correlation of 0.02 (range 0.01-0.05), 3 steps (Appendix 5) and a period of 3 months, we will require 2 clusters of 75 patients each to demonstrate a significant reduction in length-of-stay with 90% power (alpha 0.05).(70) This accounts for only 35% of patients being eligible for the PGMP (Appendix 6).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Perioperative hyperglycemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Non-random stepped wedge
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: PGMP
Arm Type
Active Comparator
Arm Description
Sites will implement a perioperative glycemic management pathway based on national guidelines and current evidence, with support of an implementation scientist team.
Arm Title
Non-intervention: usual care
Arm Type
Active Comparator
Arm Description
Sites will perform usual perioperative glycemic management.
Intervention Type
Procedure
Intervention Name(s)
Perioperative glycemic management pathway
Intervention Description
The PGMP is a shared-care pathway. It starts at the decision to undergo surgery, and includes preoperative planning, intraoperative management, the postoperative inpatient stay, and post-admission coordination of care to manage patients undergoing surgery based on a logic model for postoperative hyperglycemia. The PGMP identifies patients at high-risk of postoperative hyperglycemia at the time of surgical triaging using hemoglobin A1c (HbA1c) screening, based on Diabetes Canada recommendations. HbA1c screening estimates an individual's three-month average blood glucose, and is used to screen, diagnose, and titrate medications for diabetes. The PGMP then guides team members to monitor blood glucose postoperatively using POCT, and to manage hyperglycemia in high-risk patients using standardized care plans.
Primary Outcome Measure Information:
Title
Length of stay
Description
Number of days that a patient stays in hospital after their surgical procedure
Time Frame
365 days after surgery
Secondary Outcome Measure Information:
Title
Readmissions
Description
Representation to the emergency department or readmission to any hospital after the surgical procedure, for any reason
Time Frame
30 days
Title
Hypoglycemia
Description
A measure blood or capillary glucose less than 4.0 mmol/L
Time Frame
During the inpatient hospital stay
Other Pre-specified Outcome Measures:
Title
Surgical site infections
Description
Using the Centre for Disease Control and Prevention definition
Time Frame
6 weeks after the index surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing a surgical procedure, adults (older than 18 years of age), admitted to the hospital for more than 24 hours after their surgical procedure.
Exclusion Criteria:
Under 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon M Ruzycki, MD, MPH
Phone
403-220-7370
Email
shannon.ruzycki@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rita Alemao
Phone
403-220-7370
Email
ralemao@ucalgary.ca
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Ruzycki, MD, MPH
Phone
403-210-7370
Email
shannon.ruzycki@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Rita Alemao
Phone
403-220-8382
Email
ralemao@ucalgary.ca
Facility Name
Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon M Ruzycki, MD MPH
Phone
403-220-7370
Email
shannon.ruzycki@ucalgary.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data owned by Alberta Health Services cannot be shared except in aggregate.
Learn more about this trial
PGMP for Alberta Surgical Patients
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