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Trial registered on ANZCTR


Registration number
ACTRN12617000827336
Ethics application status
Approved
Date submitted
28/05/2017
Date registered
6/06/2017
Date last updated
6/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The RMH Pro-Diab Perioperative Study: a new structured diabetes medication management plan to improve diabetes care in patients undergoing planned surgical procedures.
Scientific title
The RMH Pro-Diab Perioperative Study: investigating the effect of a structured perioperative diabetes management plan on appropriate medication usage
Secondary ID [1] 291995 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 303350 0
Condition category
Condition code
Metabolic and Endocrine 302778 302778 0 0
Diabetes
Surgery 302896 302896 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new structured perioperative diabetes management plan (PDMP)

A single double-sided A4 sheet.

The front page outlines the details of the surgery, a brief summary of the patient's diabetes history, and the regular diabetes medications taken by the patient at the time of the preadmission clinic appointment. It also includes the plan for any changes to these regular medications prior to the surgical procedure, including instructions regarding changes prior to the day of the surgery, on the day of surgery, and in the post-procedure recovery period. Instructions regarding glucose monitoring and dextrose use are also outlined on the front page of this plan.

The back page has the details of the recommendations for changes to the various diabetes medications in the perioperative setting. It divides these medications into insulin and non-insulin groups and provides recommendations according to the likely time of procedure (AM vs PM). It also provides details of blood glucose values to be aimed at achieving and maintaining, and methods of correcting any abnormalities in blood glucose levels.

This PDMP is to be filled out by a doctor, either a Hospital Medical Officer or Anaesthetist, during an appointment at the Preadmission Clinic, which occurs prior to the day of surgery. The relevant details of the PDMP are communicated to the patient during their appointment at the Preadmission Clinic, but the method of communicating this information is left at the discretion of the doctor (photocopy of the plan given to patient, verbal communication, details written on separate document and given to patient). The PDMP itself is kept with the other appointment documents, to be used during the admission.
Intervention code [1] 298116 0
Treatment: Other
Comparator / control treatment
The patient population that attended the Level 3East Preadmission Clinic at the Royal Melbourne Hospital between the dates of 1st February 2016 and 31st May 2016 were used as the pre-intervention group. These patients did not have the PDMP in their preadmission clinic pack. Therefore, there was no specific guidance in terms of appropriate diabetes medication use in the perioperative setting. Whether there was appropriate recommendation, prescription, and administration of diabetes medications was all dependent on the clinicians at the preadmission clinic. Communication of this information to the patient was also dependent on the clinicians.
Control group
Historical

Outcomes
Primary outcome [1] 302168 0
Appropriate medication usage - the correct recommendation, prescription, and administration of medications used to treat Diabetes in the perioperative setting according to the PDMP

Definition of optimal medication usage:
-Non-insulin diabetes medications withheld on the day of surgery according to the PDMP
-Insulin medications:
-Basal insulin recommended, prescribed, and administered according to the PDMP
-Prandial insulin dose withheld or altered according to the PDMP
-Premixed insulin used or substituted according to the PDMP
Timepoint [1] 302168 0
During hospitalisation
Secondary outcome [1] 335036 0
Adverse clinical outcome: Hypoglycaemic event (BGL<4mmol/L) - review of medical records
Timepoint [1] 335036 0
During hospitalisation
Secondary outcome [2] 335037 0
Adverse clinical outcome: Hyperglycaemic event (BGL>15mmol/L) - review of medical records
Timepoint [2] 335037 0
During hospitalisation
Secondary outcome [3] 335038 0
Adverse clinical outcome: Acute Kidney Failure - review of medical records
Timepoint [3] 335038 0
During hospitalisation
Secondary outcome [4] 335039 0
Adverse clinical outcome: Urinary tract infection - review of medical records
Timepoint [4] 335039 0
During hospitalisation
Secondary outcome [5] 335040 0
Adverse clinical outcome: Hospital acquired pneumonia - review of medical records
Timepoint [5] 335040 0
During hospitalisation
Secondary outcome [6] 335041 0
Appropriate blood glucose monitoring prior to surgery (2-hourly) - review of medical records
Timepoint [6] 335041 0
Every 2 hours from admission on day of surgery to the start of the procedure
Secondary outcome [7] 335042 0
Appropriate blood glucose monitoring after surgery at the post-anaesthesia care unit (hourly) - review of medical records
Timepoint [7] 335042 0
Every hour for the duration of admission to the post-anaesthesia care unit until discharge from the post-anaesthesia care unit
Secondary outcome [8] 335043 0
Population blood glucose level (all measures during admission) - review of medical records
Timepoint [8] 335043 0
During hospitalisation
Secondary outcome [9] 335044 0
Patient-day weighted mean glucose - review of medical records
Timepoint [9] 335044 0
During hospitalisation
Secondary outcome [10] 335045 0
Adverse glycaemic days - proportion of patient-days with unstable glucose levels (defined as BGL < 4.0mmol/L or > 15mmol/L) - review of medical records
Timepoint [10] 335045 0
During hospitalisation
Secondary outcome [11] 335048 0
Patient-weighted mean glucose level in the preoperative period (admission area) - review of medical records
Timepoint [11] 335048 0
From admission on day of surgery to surgery
Secondary outcome [12] 335341 0
Patient-weighted mean glucose level in the post-anaesthesia care unit (recovery area) - review of medical records
Timepoint [12] 335341 0
For duration of stay in the post-anaesthesia care unit
Secondary outcome [13] 335614 0
First admission glucose - review of medical records
Timepoint [13] 335614 0
From admission on day of surgery to surgery
Secondary outcome [14] 335615 0
Patient-weighted perioperative glucose (including pre-operative, intra-operative, and post-operative measures) - review of medical records
Timepoint [14] 335615 0
From admission on day of surgery until discharge from the post anaesthesia care unit (recovery area)
Secondary outcome [15] 335616 0
Overall patient mortality - review of medical records
Timepoint [15] 335616 0
During hospitalisation
Secondary outcome [16] 335617 0
Readmission back to hospital - review of medical records
Timepoint [16] 335617 0
From time of discharge until 2 weeks post-discharge
Secondary outcome [17] 335618 0
Appropriate IV fluid use in the preoperative period according to the PDMP - review of medical records
Timepoint [17] 335618 0
From admission on the day of surgery until the surgery
Secondary outcome [18] 335619 0
Appropriate IV fluid use in the postoperative period according to the PDMP - review of medical records
Timepoint [18] 335619 0
From admission to the post anaesthesia care unit (recovery area) until discharge from the post anaesthesia care unit

Eligibility
Key inclusion criteria
Patients with known diabetes that attended an appointment at the Preadmission Clinic 3East at the Royal Melbourne Hospital.
Elective surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who were diet controlled.
Patients who did not have a medication chart completed - unable to determine if medications were appropriately prescribed and administered.
Patients with incomplete documentation on the electronic medical record.
Patients who underwent emergency surgery.
Patients who underwent cardiac surgery - seen in a separate clinic and subject to different guidelines

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot proof of principle study, therefore no power calculations are required.
Data will be presented as median and interquartile ranges or mean and standard deviation as appropriate.
The Mann-Whitney U-test or Kruskal-Wallis test will be applied for unpaired data analyses and the Wilcoxon-test for paired data.
All normally distributed data will be presented as mean +/- SE and parametric tests applied.
Chi square test will be used to test for differences in the proportions of the responses to the applied tests between the subject groups.
Statistical significance will be assigned at the P<0.05.
If preliminary data derived from this study confirm a positive effect of the intervention on diabetes medication handling, then these data will be used to design a larger cluster randomised controlled clinical trial across multiple hospitals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
31/07/2017
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8067 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 16110 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 296508 0
Hospital
Name [1] 296508 0
Royal Melbourne Hospital - City Campus
Country [1] 296508 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital - City Campus
Address
Department of Diabetes and Endocrinology
Level 4 West
300 Grattan Street
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 295470 0
None
Name [1] 295470 0
None
Address [1] 295470 0
None
Country [1] 295470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297730 0
Melbourne Health , Human Research Ethics Committee
Ethics committee address [1] 297730 0
PO Box
Royal Melbourne Hospital
Parkville
Victoria 3050
Ethics committee country [1] 297730 0
Australia
Date submitted for ethics approval [1] 297730 0
31/01/2017
Approval date [1] 297730 0
03/04/2017
Ethics approval number [1] 297730 0
2017.039

Summary
Brief summary
Background: The perioperative management of inpatients with diabetes is complex given carbohydrate intake and diabetes medication administration is altered. Suboptimal glycaemia in the perioperative period is well documented in the literature and is associated with increased morbidity and mortality.

Aim: This study has been undertaken to determine the effect of a structured perioperative diabetes management plan (PDMP) on the appropriate recommendation, prescription, and administration of diabetes medications in the perioperative setting.

A multidisciplinary team developed a novel structured PDMP endorsed by the Departments of Diabetes & Endocrinology and Pain & Anaesthesia. This observational study consisted of pre- and post-intervention periods, where pre-intervention care for perioperative diabetes management (non-structured) was audited for 4 months in 2016 and then re-audited for 4 months post-intervention in 2017 (structured plan). The primary outcome measure was documentation of appropriate recommendation, prescription and administration of diabetes medications in the perioperative setting according to the PDMP. Secondary outcome measures included glucose monitoring practice and glycaemic measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74962 0
Dr Spiros Fourlanos
Address 74962 0
Department of Diabetes and Endocrinology
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 74962 0
Australia
Phone 74962 0
+613 93427365
Fax 74962 0
Email 74962 0
[email protected]
Contact person for public queries
Name 74963 0
Qi Yang Damien Qi
Address 74963 0
Royal Melbourne Hospital Clinical School
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 74963 0
Australia
Phone 74963 0
+61 415 570 979
Fax 74963 0
Email 74963 0
[email protected]
Contact person for scientific queries
Name 74964 0
Qi Yang Damien Qi
Address 74964 0
Royal Melbourne Hospital Clinical School
Royal Melbourne Hospital
300 Grattan Street
Parkville, Victoria 3050
Country 74964 0
Australia
Phone 74964 0
+61 415 570 979
Fax 74964 0
Email 74964 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23528Study protocol    372976-(Uploaded-27-10-2021-09-01-53)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Pro-Diab Melbourne Perioperative Study: A structured pre-admission perioperative diabetes management plan to improve medication usage in elective surgery.2022https://dx.doi.org/10.1111/dme.14838
N.B. These documents automatically identified may not have been verified by the study sponsor.