MedTrace Logo

PGMP for Alberta Surgical Patients

NCT05036655 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2023-12-01

No results posted yet for this study

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%.

Conditions

Interventions

PROCEDURE

Perioperative glycemic management pathway

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-08-31
Completion
2025-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05036655 on ClinicalTrials.gov