Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000019808
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
13/01/2021
Date last updated
13/01/2021
Date data sharing statement initially provided
13/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study to determine the efficacy of using an actively managed discharge care plan for promoting enhanced communication for patients with diabetes.
Scientific title
A feasibility study to determine the efficacy of using an actively managed discharge care plan for promoting enhanced communication for patients with diabetes.
Secondary ID [1] 302368 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 319151 0
Condition category
Condition code
Metabolic and Endocrine 317111 317111 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a multi-centre, feasibility study conducted in Sydney, Australia for a period of 6 months. We will recruit 100 patients through the Diabetes centres at the following public hospitals in the Sydney, South Eastern Sydney Local Health District and St Vincent’s Hospital Network: namely Royal Prince Alfred Hospital, Prince of Wales Hospital and St Vincent’s Hospital. Eligible patients will be screened and explained the study in their regular visit of outpatient clinics. Interested patients will be provided with an information sheet containing details on the study (Participant Information Statement). The potential participant will give written consent before any activities are performed. All participants will be educated on the project procedures and commitments that are involved with participation in the project. Participants enrolled in the study will be registered in the National Diabetes Services Scheme (NDSS). The NDSS provides support services for practical help and guidance, diabetes and health information and resources and enables access to diabetes supplies at subsidised costs. Subsidised products include: blood glucose testing strips, urine testing strips, insulin pump consumables (for approved people with type 1 diabetes and gestational diabetes), continuous and flash glucose monitoring products (for eligible and approved people with type 1 diabetes and ‘other’ eligible conditions) and insulin syringes and pen needles. An actively managed discharge care plan with calling criteria for PCP will be developed for every patient enrolled to ensure continuity of care and shared care planning. The calling criteria allow trends in observations such as blood glucose levels and HbA1c’s to be tracked to trigger a response by the health professional to refer to the Staff specialist at the Diabetes Centre. The frequency and duration of participant clinic visits will be a maximum of 30 minutes depending on the severity of the patient’s condition and/or further diabetes education is required. Diabetes educators and Pharmacists from each diabetes centre will be utilised to support the effective self-management of diabetes. Face-to-face, telephone or videoconference will be the modes of administration for clinic visits/communication between participants and health care professionals. The total duration of the care plan will depend on the patient’s condition and how they respond to the treatment plan. Staff involved in the project will also be required to complete satisfaction surveys on months 3 and 6 of the study period for project assessment. Staff satisfaction survey questionnaires specifically designed for this study, with seven questions, will be sent through email with a specified REDCap link and will take around 10 minutes to complete. All the information collected from the study will be treated confidentially, and only the researchers named will have access to it. Results from this study may be used in future research studies, for which ethical approval will be sought from the relevant Ethics Committees. A summary of de-identified project results will be available five months after the completion of the last patient visit. Individual results will be provided via email indicated in the consent form, if possible/applicable.
Intervention code [1] 318912 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325198 0
To assess the feasibility of enhancing communication with the Primary Care Physician across the Central and Eastern Sydney Primary Health Network (CESPHN) region will be assessed by hospital readmission rates as recorded in hospital records.
Timepoint [1] 325198 0
Three and 6 months before and after the intervention.
Secondary outcome [1] 387158 0
Feasibility of administering actively managed discharge care plans will be assessed by delivering streamlined diabetes referral pathways and establishing an integrative care approach using the patient's medical records.
Timepoint [1] 387158 0
Three and 6 months before and after the intervention.
Secondary outcome [2] 389641 0
Staff satisfaction assessed using study-specific survey
Timepoint [2] 389641 0
Months 3 and 6 after the intervention.

Eligibility
Key inclusion criteria
• Aged 18 years old and over
• Have a known history of diabetes
• Reside in the CESPHN region
• Belong to the target priority population but not limited to (People experiencing homelessness, Aboriginal and Torres Strait Islander peoples and culturally and linguistically diverse people)
- all staff involved in the project
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Aged <18 years old
• Pregnant
• Do not reside within the CESPHN region

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data for the readmission outcome will be analysed using the before and after or interrupted time series analysis with a logistic model to compare the difference in readmission at 3 and 6 months before and after the intervention, controlling for the demographics factor. The secondary outcome data will be analysed using the staff satisfaction survey scores using the before and after or interrupted time series analysis with a linear model to compare the difference in scores at 3 and 6 months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/01/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17598 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 17600 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 17949 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 31343 0
2050 - Camperdown
Recruitment postcode(s) [2] 31345 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 31814 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 306798 0
Government body
Name [1] 306798 0
Central and Eastern Sydney Primary Health Network
Country [1] 306798 0
Australia
Primary sponsor type
Government body
Name
Central and Eastern Sydney Primary Health Network
Address
Tower A Level 5/197-201 Coward St, Mascot NSW 2020
Country
Australia
Secondary sponsor category [1] 307350 0
None
Name [1] 307350 0
Address [1] 307350 0
Country [1] 307350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306956 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306956 0
Ethics committee country [1] 306956 0
Australia
Date submitted for ethics approval [1] 306956 0
26/03/2020
Approval date [1] 306956 0
24/07/2020
Ethics approval number [1] 306956 0
X20-0114 & 2020/ETH00730

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

Contacts
Principal investigator
Name 105578 0
Prof Stephen Colagiuri
Address 105578 0
The Hub
D17 Level 2
Boden Collaboration
Charles Perkins Centre
The University of Sydney
Johns Hopkins Drive
Camperdown NSW 2050
Country 105578 0
Australia
Phone 105578 0
+61 2 8627 1914
Fax 105578 0
+61 2 8627 0141
Email 105578 0
[email protected]
Contact person for public queries
Name 105579 0
Mary Gail Del Olmo
Address 105579 0
The Hub
D17 Level 2
Boden Collaboration
Charles Perkins Centre
The University of Sydney
Johns Hopkins Drive
Camperdown NSW 2050
Country 105579 0
Australia
Phone 105579 0
+61 2 8627 7581
Fax 105579 0
+61 2 8627 0141
Email 105579 0
[email protected]
Contact person for scientific queries
Name 105580 0
Mary Gail Del Olmo
Address 105580 0
The Hub
D17 Level 2
Boden Collaboration
Charles Perkins Centre
The University of Sydney
Johns Hopkins Drive
Camperdown NSW 2050
Country 105580 0
Australia
Phone 105580 0
+61 2 8627 7581
Fax 105580 0
+61 2 8627 0141
Email 105580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable Study results may be disseminated at conferences/ departmental meeting and/or published in peer-reviewed journals.
When will data be available (start and end dates)?
February 2022 until February 2027
Available to whom?
Available to those beyond trial participants and personnel.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Individual results will be provided using the email address indicated by the participant in the consent form, if possible/applicable. The principal investigator can also be contacted through email: [email protected].


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.