Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000517471
Ethics application status
Approved
Date submitted
25/01/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising identification and management of hypoglycaemia in hospital inpatients by nurses through an online video education resource.
Scientific title
Pilot study evaluating the impact of an educational audiovisual resource on nurses’ knowledge and clinical practice in the diagnosis and management of hypoglycaemia in hospital inpatients.
Secondary ID [1] 313787 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PROTECTIVE- pilot study: imProving nuRses' hypOglycaemia managemenT through an EduCaTIon VidEo
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
hypoglycaemia 336418 0
Condition category
Condition code
Metabolic and Endocrine 332940 332940 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 13 minute educational video developed by the investigators on diagnosing and managing hypoglycaemia in hospital inpatients with diabetes mellitus and the adverse consequences of hypoglycaemia for patients.

Nurses on surgical hospital wards at Nepean Hospital will be invited to participate in the study via an invitation email sent by their Nursing Unit Manager on 3 occasions, approximately 1 week apart.
The study design is a pre and post- intervention observational design.

Nurses who consent to participate will provide written informed consent via a REDCap data base and complete an online baseline questionnaire on their knowledge and clinical practice in diagnosing and managing hypoglycaemia. They will be directed on questionnaire completion through a weblink to the online education video. They will also receive an email containing the link to the video on questionnaire completion, so that they can watch it at another time or refer back to it. They can access it from any place. It is hosted on the Hospital You Tube channel. Participating nurses will be emailed a follow up questionnaire 1 month after completing the baseline questionnaire, to assess their knowledge of diagnosing and managing hypoglycaemia. The follow-up questionnaire will contain the same clinical questions as the baseline questionnaire. In addition, nurses will be asked in the follow-up questionnaire whether they have viewed the education video or not.

From 1 week after the last email invitation to the study has been sent to nurses, a prospective audit will be conducted for 3 months, 8 months and 12 months after the intervention to determine the number of episodes of hypoglycaemia and whether they are managed according to the hospital procedure on management of hypoglycaemia or not. This will also enable determination of whether, if their is an improvement in management, it is sustained for 12 months.

A retrospective audit looking at the same information as for the prospective audit will be conducted for 3 months, 8 months and 12 months prior to the first invitation email for the study.

The management of hypoglycaemia and number of episodes will be compared between the pre-intervention and post intervention as to whether management is conducted as per the hospital hypoglycaemia procedure.

The educational video is on a private YouTube channel which does not provide individual analytics. However, the total number of views and average view time will be recorded. Participation in the project is recorded via nurses filling out the consent form and baseline questionnaire. However, we will not be able to determine whether an individual nurse has watched the video or not except by that nurse’s answer in the follow-up survey to the question asking whether they have watched the video or not.
Intervention code [1] 330375 0
Diagnosis / Prognosis
Intervention code [2] 330376 0
Treatment: Other
Intervention code [3] 330377 0
Prevention
Comparator / control treatment
The comparator groups will be
1. Baseline knowledge of nurses participating in the study.
2. Management of hypoglycaemia and number of episodes of hypoglycaemia in a retrospective audit of hypoglycaemia for 3 months, 6 months and 12 months prior to the intervention.
Data for 3 months prior to the intervention will be collected from Nepean Hospital patient records for admitted patients between 6th October 2024 to 5th January 2025; For 6 months prior to the intervention, data collection will be from 6th July to 5th January; for 12 months prior to the intervention, data collection will be from 6th January 2024 to 5th January 2025.
A separate cohort of patients who do not have diabetes will also be assessed as a comparator for this study. This cohort will consist of patients without diabetes admitted to the study surgical wards at Nepean hospital.
Control group
Historical

Outcomes
Primary outcome [1] 340472 0
Change in the number of correctly treated episodes of hypoglycaemia as determined by both the administration of pharmacy provided Hypopacks (or suitable similar treatment) and checking of Blood Glucose level (BGL) 15 mins post administration of Hypopack and 1h 15 mins afterwards or as per protocol if glucose level remains low at 15 mins.
Timepoint [1] 340472 0
This will be assessed for 3 months, 6 months and 12 months starting from 1 week after the date that the 3rd study invitation email is sent to nurses.
Primary outcome [2] 340473 0
Proportion of questionnaires with all answers correct post video exposure compared with proportion of questionnaires with all answers correct at baseline prior to video exposure for participating nurses.
Timepoint [2] 340473 0
This will be assessed one week after the time that all participants have been emailed an invitation to complete the follow up questionnaire and have received 2 further weekly emails if not completed at the first request.
Secondary outcome [1] 444198 0
Change in the mean questionnaire score on follow - up compared with mean baseline questionnaire score.
Timepoint [1] 444198 0
This will be completed 1 month after all participants have been sent the 2nd of the weekly reminders to complete the follow-up questionnaire.
Secondary outcome [2] 444199 0
Change in the number of correctly treated episodes of hypoglycaemia as determined by both the administration of pharmacy provided Hypopacks (or suitable similar treatment) and checking of Blood Glucose level (BGL) 15 mins post administration of Hypopack and 1h 15 mins afterwards or as per protocol if glucose level remains low at 15 mins. episodes occurring in patients with an initial episode of hypoglycaemia during 3 months, 6 months and 12 months prior to the intervention and the 3 months, 6 months and 12 months post intervention.
Timepoint [2] 444199 0
The pre intervention audit will be performed retrospectively from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [3] 444200 0
Length of stay for patients with diabetes, with and without inpatient hypoglycaemia
Timepoint [3] 444200 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for both 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [4] 444201 0
Percentage of inpatient mortality of patients with diabetes with hypoglycaemia who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Comparison of the difference in inpatient mortality in patients with diabetes who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Both will be compared with the Inpatient mortality for people without diagnosed diabetes admitted to the same wards over the same time period.
Timepoint [4] 444201 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [5] 444202 0
Twelve month mortality, comparing those with diabetes who have at least one episode of hypoglycaemia as an inpatient and those with diabetes who do not and comparing this pre and post intervention.
Timepoint [5] 444202 0
This will be assessed from 1 year post discharge from the hospital for patients with diabetes for whom data are collected in the pre and post intervention phases
Secondary outcome [6] 444203 0
Readmission rates within 28 days of hospital discharge of patients with diabetes with hypoglycaemia who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention.
Timepoint [6] 444203 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for both 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [7] 444303 0
Change in the proportion of nurses from pre to post intervention who correctly treat a patient with hypoglycaemia, when, at 15 mins after initial treatment of hypoglycaemia the blood glucose level is 4 mmol/l or above
Timepoint [7] 444303 0
This will be assessed for the 3, 6 and 12 months pre and post intervention delivery.
Secondary outcome [8] 447746 0
Change in the proprotion of correctly treated episodes of hypoglycaemia as determined by both the administration of pharmacy provided Hypopacks (or suitable similar treatment) and checking of Blood Glucose level (BGL) 15 mins post administration of Hypopack and 1h 15 mins afterwards or as per protocol if glucose level remains low at 15 mins.
Timepoint [8] 447746 0
The pre intervention audit will be performed retrospectively from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [9] 447748 0
Percentage of inpatient mortality of patients with diabetes without hypoglycaemia who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Comparison of the difference in inpatient mortality in patients with diabetes who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Both will be compared with the Inpatient mortality for people without diagnosed diabetes admitted to the same wards over the same time period.
Timepoint [9] 447748 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [10] 447749 0
Percentage of inpatient mortality of patients without diabetes who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Comparison of the difference in inpatient mortality in patients with diabetes who have at least 1 episode of hypoglycaemia in the 3 months, 6 months and 12 months pre and post intervention. Both will be compared with the Inpatient mortality for people without diagnosed diabetes admitted to the same wards over the same time period.
Timepoint [10] 447749 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [11] 447750 0
Length of stay for a separate cohort of patients who do not have diabetes will also be assessed as a comparator for this study. This cohort will consist of patients without diabetes admitted to the study surgical wards at Nepean hospital. These comparator groups have been added to Step 3 of the form.
Timepoint [11] 447750 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for both 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [12] 447757 0
Readmission rates within 28 days of hospital discharge of patients with diabetes without hypoglycaemia
Timepoint [12] 447757 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for both 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.
Secondary outcome [13] 447758 0
Readmission rates within 28 days of hospital discharge of patients without diabetes
Timepoint [13] 447758 0
The pre intervention audit will be performed retrospectively for 3 months, 6 months and 12 months from the day before the first invitation email for the study was sent to nurses. The post intervention audit will be performed prospectively for both 3 months, 6 months and 12 months starting from 1 week after the 3rd and final invitation to participate is sent to nurses.

Eligibility
Key inclusion criteria
Being a registered nurse working on one of the surgical wards in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Being a health care practitioner other than a registered nurse.
Working on a hospital ward which is not one of the specified study wards.

Study design
Purpose of the study
Educational / counselling / training
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
Other
Other design features
Study groups:
- Patients with diabetes who have hypoglycaemia.
- patients with diabetes without hypoglycaemia
- patients without diabetes
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The power calculation is based on data from a 2018 audit of treatment of hypoglycaemia in the study hospital. In that audit only 15% of incidences of hypoglycaemia had a follow up blood glucose level (BGL) rechecked at the recommended 15 minutes post initial treatment, There was no improvement in this percentage after ward nurses received face to face educational sessions on hypoglycaemia management with credentialed diabetes educator nurses on management of hypoglycaemia. By introducing an educational video on hypoglycaemia diagnosis and management, we aim to increase this percentage of correctly treated episodes to 30%. For 80% power, a total of 121 hypoglycaemic events are required in each time period (baseline and post intervention) in order to detect an increase from 15% to 30%. For 80% power to detect an increase in correct treatment from 15% to 40%, a total of 50 events are required in each time period. From the previous audit of hypoglycaemia, 50-70 episodes of hypoglycaemia occurred per month in the 2 wards combined. Thus, 3 months of pre and post intervention data should allow us to include at least 121 episodes of hypoglycaemia in each of the pre and post intervention time periods.
Questionnaires pre and post intervention to be completed by nurses: We will compare the number of correct responses to the questionnaire pre and post-intervention and analyse if there is a statistical difference between questionnaire scores using paired sample T test if the data are normally distributed and the Wilcoxon Signed-Ranks Test if the data are not normally distributed.
Other data will be analysed by logistic regression analysis.
This will accounting for potential bias, confounding factors and missing data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
24/04/2025
Date of last participant enrolment
Anticipated
Actual
24/04/2025
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
100
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27514 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 43626 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 318252 0
University
Name [1] 318252 0
University of Sydney
Country [1] 318252 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320638 0
None
Name [1] 320638 0
Address [1] 320638 0
Country [1] 320638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316893 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 316893 0
Ethics committee country [1] 316893 0
Australia
Date submitted for ethics approval [1] 316893 0
01/12/2019
Approval date [1] 316893 0
07/06/2021
Ethics approval number [1] 316893 0
2019/ETH13806

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139342 0
A/Prof Emily Hibbert
Address 139342 0
Nepean Clinical School, 62 Derby St, Kingswood NSW 2747 or PO Box 63, Penrith NSW 2751.
Country 139342 0
Australia
Phone 139342 0
+61 2 4734 3294
Fax 139342 0
Email 139342 0
[email protected]
Contact person for public queries
Name 139343 0
Ms Laura Conway
Address 139343 0
Nepean Clinical School, 62 Derby St, Kingswood NSW 2747 or PO Box 63, Penrith NSW 2751.
Country 139343 0
Australia
Phone 139343 0
+61 24738 4574
Fax 139343 0
Email 139343 0
[email protected]
Contact person for scientific queries
Name 139344 0
Emily Hibbert
Address 139344 0
Nepean Clinical School, 62 Derby St, Kingswood NSW 2747 or PO Box 63, Penrith NSW 2751.
Country 139344 0
Australia
Phone 139344 0
+61 24738 4574
Fax 139344 0
Email 139344 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Available to other researchers on request.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentifed questionnaire results completed by nurses from the study.

What types of analyses could be done with individual participant data?
• Analyses related to management of hypoglycaemia.

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the principal investigator via email [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.