PGMP for Alberta Surgical Patients

November 29, 2023 updated by: Shannon Ruzycki, University of Calgary

Implementation of a Perioperative Glycemic Management Pathway for Albertan Surgical Patients

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4T9
        • Foothills Medical Centre
      • Red Deer, Alberta, Canada
        • Red Deer Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention: PGMP
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
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.
Active Comparator: Non-intervention: usual care
Sites will perform usual perioperative glycemic management.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 365 days after surgery
Number of days that a patient stays in hospital after their surgical procedure
365 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Readmissions
Time Frame: 30 days
Representation to the emergency department or readmission to any hospital after the surgical procedure, for any reason
30 days
Hypoglycemia
Time Frame: During the inpatient hospital stay
A measure blood or capillary glucose less than 4.0 mmol/L
During the inpatient hospital stay

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical site infections
Time Frame: 6 weeks after the index surgical procedure
Using the Centre for Disease Control and Prevention definition
6 weeks after the index surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB21-0089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data owned by Alberta Health Services cannot be shared except in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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