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Trial registered on ANZCTR


Registration number
ACTRN12617000762358
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
24/05/2017
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an online diabetes education program for health care professionals improve inpatient diabetes care?
Scientific title
Competency based online diabetes education program versus face to face education vs usual education: A pilot Cluster Randomised Controlled Trial comparing different hospital staff diabetes education programs on diabetes care and patient outcomes
Secondary ID [1] 291676 0
NIL KNown
Universal Trial Number (UTN)
U1111-1195-3649
Trial acronym
Nil Known
Linked study record
Nil Known

Health condition
Health condition(s) or problem(s) studied:
Diabetes 302837 0
Condition category
Condition code
Metabolic and Endocrine 302326 302326 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Cambridge Diabetes Education Program ( CDEP) is an online competency based diabetes education for health professionals developed by expert diabetes clinicians from Addenbrookes Hospital in Cambridge,UK. It is endorsed by Diabetes UK, The Dietitian's Association of United Kingdom and Cambridge University Health Partners. There will be five topics available- time taken is determined by the student. The topics , modified to the Australian clinical and cultural context include: What is Diabetes, Hypoglycaemia, Oral Therapies, Injectable Therapies and Managing Diabetes in Hospital. Three hours of protected work time will be offered.
CDEP is a competency based diabetes online program underpinned by the UK’s national inter-professional diabetes competency frameworks. It is not a traditional online education program. CDEP takes the approach that enables health professionals to assess and demonstrate their’ knowledge’ and ‘know how’ in diabetes management. A series of quizzes are provided- when questions are answered correctly the participant progresses through the program. When questions are answered incorrectly, credible resource links are provided to assist in answering the question. Progress through the program requires 100% mastery.
AusCDEP is the Australian version of CDEP . Online access will be available on the ward or from outside the ward.

One hour of face to face education: will also be offered : Role of Nursing in the Continuum of Inpatient Diabetes Care. This power point presentation was developed by the American Association of Clinical Endocrinologists and will be presented by Credentialed Diabetes Educators on the ward for one hour only. The powerpoint slides will be made available to staff unable to attend the face to face sessions . This session has also been modified to the Australian context in relation to clinical ranges according to Australian Clinical Practice Guidelines.
Staff are asked to complete AusCDEP within 13 weeks, but will have ongoing access to program.

Comparator: Three hours of sessions developed by the National Association of Diabetes Centres( NADC) : What is Diabetes , Hypoglycemia and Medicines (Oral and Injectable therapies) will be presented to staff on the ward by a Credentialed Diabetes Educators. A further one hour :The Role of Nursing in the Continuum of Inpatient Diabetes Care ppt developed by the American Association of Clinical Endocrinologists will also be presented by Credentialed Diabetes Educators to the randomised ward receiving face to face education. All face to face presentations will be presented once

Control: Ward education as usual. This involves all educational activities scheduled on the ward. Diabetes related educational activities are provided by credentialed diabetes educators. These are provided on an ad hoc basis following a request from the ward or following an incident/event concerning diabetes safety and/or quality of care.
Intervention code [1] 297763 0
Treatment: Other
Intervention code [2] 297939 0
Behaviour
Comparator / control treatment
Comparator: Three hours of sessions developed by the National Association of Diabetes Centres( NADC) : What is Diabetes , Hypoglycemia and Medicines (Oral and Injectable therapies) will be presented to staff on the ward by a Credentialed Diabetes Educators. A further one hour :The Role of Nursing in the Continuum of Inpatient Diabetes Care ppt developed by the American Association of Clinical Endocrinologists will also be presented by Credentialed Diabetes Educators to the randomised ward receiving face to face education. There are four face to face sessions which will be presented once each. This means there are four one hour sessions presented in the comparator group.

Control: Ward education as usual. This involves all educational activities scheduled on the ward. Diabetes related educational activities are provided by credentialed diabetes educators. These are provided on an ad hoc basis following a request from the ward or following an incident/event concerning diabetes safety and/or quality of care.
Control group
Active

Outcomes
Primary outcome [1] 301736 0
Mean length of stay (LOS): There will be a daily census undertaken tracking all patients on the ward with diabetes. The data will be obtained post discharge from electronic data or ward records where electronic data are not available. A two week period collecting baseline data is followed by a 20 week intervention period
Timepoint [1] 301736 0
On discharge
Secondary outcome [1] 333704 0
Glycaemic control for ward patients with diabetes as evidence by
- Percentage of days with good glycaemic control ( defined as : appropriate frequency of tests and no more than one Blood glucose reading > 11.0 mmol/L and < 4,0 mmol/L hypoglycaemia events. Data collected by chart review
Timepoint [1] 333704 0
On discharge.

Secondary outcome [2] 333705 0
Patient experience of diabetes care. This information is collected by using the Patient Experience of Diabetes Services (PEDS) survey that is part of the NHS National Diabetes Audit and measures patient experiences in primary care and specialist services. We have adapted the survey to use as a telephone survey post discharge to enable the patients to discuss their inpatient diabetes care whilst no longer under the care of clinicians.
Timepoint [2] 333705 0
Daily census will be undertaken . All patients with diabetes will be invited to participate in a post discharge telephone survey seven days after their discharge asking about their experience of diabetes care whilst they were an inpatient.
Secondary outcome [3] 334344 0
Feasibility
1) proportion of audits undertaken (80% patient audits undertaken)
2)proportion of patient telephone surveys undertaken(80% patient telephone surveys undertaken)
Timepoint [3] 334344 0
At 22 weeks
Secondary outcome [4] 334345 0
Adherence
1) proportion of staff 40% of staff register with AusCDEP
2) proportion of staff complete an AusCDEP topic (30% of staff complete a AusCDEP topic)
Timepoint [4] 334345 0
At 22 weeks
Secondary outcome [5] 334346 0
Fidelity
1) Protected time available to undertake AusCDEP and Face to Face education
2) Available computer access

A post discharge survey will be undertaken asking questions relating to barriers and facilitators of undertaking AusCDEP from an operational point of view in relation to available time and computer access both on the ward and outside the ward.
Timepoint [5] 334346 0
At 22 weeks
Secondary outcome [6] 334428 0
Number of medication errors. This information will be obtained by manual chart review audit. The audit identifies different types of medication errors relating to prescribing and administration.
Timepoint [6] 334428 0
On discharge
Secondary outcome [7] 334446 0
Number of hypoglycaemic events ( Blood glucose level < 4mmol/L ). Data collected by chart review
Timepoint [7] 334446 0
On discharge
Secondary outcome [8] 334672 0
Proportion of appropriate referral to inpatient Diabetes Specialists services of patients who should be referred according to the Think Glucose Criteria. Checking against this criteria is part of the inpatient audit
Timepoint [8] 334672 0
On discharge

Eligibility
Key inclusion criteria
Adult patients on the ward with diabetes.
All nursing staff rostered on the three wards will be included in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For the patient experience telephone survey, only people who cannot speak English will be excluded.

Medical and allied health staff are excluded from participation in this study to avoid contamination of results because of likelihood of mobility between wards of these health professionals..

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Education intervention is by ward.
Randomisation of the three wards will be undertaken by placing the names of the interventions in three sealed envelopes in no order. An independent researcher not involved in the trial will place one envelope next to the name of each ward and then open the envelopes, thereby allocating the intervention to each.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher not involved in the trial will place one envelope next to the name of each ward and then open the envelopes, thereby allocating the intervention to each
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be by intention to treat (ITT) approach and with supplementary per protocol analysis. The reduction of lengths of stay (LOS) in in-patient with diabetes between intervention and control groups will be assessed using two independent samples t-test and regression analysis, adjusted for clustering. We will report the results for 2-sided 5% tests for the primary trial outcome. Since multiple observations per participant are obtained correlation between measurements in the same participant is expected and not independent of each other. For regression analysis of such multilevel data, random cluster and/or subject effects can be added into the regression model to account for the correlation of the data. The model will be able to test the relationship between in-patient with diabetes and reduction of LOS, accounting for baseline characteristics and other variables. Model assumptions will be checked and appropriate adjustments to the analysis will be made where necessary. STAT(Registered Trademark) software version 14 (Stata Corporation, College Station, TX, USA) will be used for all analyses, with xtmixed command to fit linear mixed models and xtmelogit command to fit mixed-effects models for binary outcomes/responses. All tests will be two-sided, and p-value <0.05 will be considered statistically significant. Furthermore, because this is a pilot study with small number of clusters and double check our findings, second analysis will be conducted using two independent samples t-test and regression analysis by ignoring the effect of clustering.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/05/2017
Actual
5/06/2017
Date of last participant enrolment
Anticipated
3/11/2017
Actual
30/03/2018
Date of last data collection
Anticipated
28/12/2018
Actual
Sample size
Target
400
Accrual to date
Final
860
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7823 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 15765 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 296111 0
Government body
Name [1] 296111 0
South Western Sydney Local Health District
Country [1] 296111 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
LIVERPOOL NSW 2170
Country
Australia
Secondary sponsor category [1] 295078 0
University
Name [1] 295078 0
Western Sydney Universtiy
Address [1] 295078 0
Locked Bag 1797

Penrith NSW 2751
Country [1] 295078 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297365 0
South Western Sydney Local Health District (SWSLHD) Human Research Ethics Committee (EC00136)
Ethics committee address [1] 297365 0
Research and Ethics Office’
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 297365 0
Australia
Date submitted for ethics approval [1] 297365 0
27/02/2017
Approval date [1] 297365 0
15/05/2017
Ethics approval number [1] 297365 0
HE17/047

Summary
Brief summary
Background
The Cambridge Diabetes Education Program (CDEP) is an online inter-professional competency based Continuing Professional Development (CDP) programme underpinned by the UK’s national diabetes competencies frameworks and has been adapted to the Australian context as AusCDEP.

Objectives
We aim to pilot a trial comparing the effect of AusCDEP, face to face diabetes education, and ‘usual’ staff education on length of stay and management of inpatients with diabetes..

Study Plan
This is a pilot cluster randomized controlled trial(CRCT) conducted in Campbelltown Hospital over 22 weeks. The unit of randomisation is the medical ward.

Patient length of stay is the primary outcome. Secondary outcomes include glycaemic control, medication errors, patient experience, and appropriate referrals to hospital based diabetes specialist services
This pilot CRCT will also evaluate the feasibility, adherence and fidelity of undertaking in the future a larger CRCT .
Three wards will be randomized to either 1) three hours of protected time to undertake AusCDEP (and ongoing external access) with one hour of face to face education sessions 2)four hours face to face sessions or 3) professional education as usual.

A daily census of all the patients on the three wards with pre-existing diabetes will be conducted and length of stay calculated post-discharge.

The charts of all patients identified as having pre-existing diabetes in the previous week will be reviewed using the Diabetes Inpatient Audit Form.

As a pilot, no power calculations have been undertaken. Data will inform a larger RCT. We predict 400 patients (130 per group) in this pilot within this time limit. The time limit has been chosen to allow run in, implementation of the whole educational programme and sufficient time to test all components of the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73822 0
Prof David Simmons
Address 73822 0
Head of Department
Endocrinology,
Campbelltown Hospital
Therry Road,
Campbelltown, NSW 2560
Country 73822 0
Australia
Phone 73822 0
+61 2 4620 3306
Fax 73822 0
Email 73822 0
Da.Simmons@westernsydney.edu.au
Contact person for public queries
Name 73823 0
Ms Therese Fletcher
Address 73823 0
Macarthur Diabetes Service
Campbelltown Hospital
Therry Road,
Campbelltown, NSW 2560
Country 73823 0
Australia
Phone 73823 0
+61 2 4634 3699
Fax 73823 0
Email 73823 0
therese.fletcher@sswahs.nsw.gov.au
Contact person for scientific queries
Name 73824 0
Ms Therese Fletcher
Address 73824 0
Macarthur Diabetes Service
Campbelltown Hospital
Therry Road,
Campbelltown, NSW 2560
Country 73824 0
Australia
Phone 73824 0
+61 2 4634 3699
Fax 73824 0
Email 73824 0
therese.fletcher@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseThe impact of nursing staff education on diabetes inpatient glucose management: a pilot cluster randomised controlled trial.2022https://dx.doi.org/10.1186/s12902-022-00975-y
N.B. These documents automatically identified may not have been verified by the study sponsor.