PGMP for Alberta Surgical Patients

NCT05036655 | Unknown DMC

• 1 other identifier: REB21-0089
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 2

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%.

Conditions

Hyperglycemia

Keywords

Perioperative hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Number of days that a patient stays in hospital after their surgical procedure

  365 days after surgery

Secondary Outcomes (2)

• Readmissions

  30 days

• Hypoglycemia

  During the inpatient hospital stay

Other Outcomes (1)

• Surgical site infections

  6 weeks after the index surgical procedure

Study Arms (2)

Intervention: PGMP

ACTIVE COMPARATOR

Sites will implement a perioperative glycemic management pathway based on national guidelines and current evidence, with support of an implementation scientist team.

Procedure: Perioperative glycemic management pathway

Non-intervention: usual care

ACTIVE COMPARATOR

Sites will perform usual perioperative glycemic management.

Procedure: Perioperative glycemic management pathway

Interventions

Perioperative glycemic management pathway PROCEDURE

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.

Intervention: PGMP; Non-intervention: usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing a surgical procedure, adults (older than 18 years of age), admitted to the hospital for more than 24 hours after their surgical procedure.

You may not qualify if:

• Under 18 years of age

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 4T9, Canada

Location

Red Deer Regional Hospital

Red Deer, Alberta, Canada

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Non-random stepped wedge

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 5, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

CA (2)