Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001258640
Ethics application status
Approved
Date submitted
25/09/2023
Date registered
5/12/2023
Date last updated
5/12/2023
Date data sharing statement initially provided
5/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Lily: Eating Disorder Clinical Registry
Scientific title
The Lily: Eating Disorder Clinical Registry
Secondary ID [1] 310366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medically unstable eating disorders 331105 0
Condition category
Condition code
Mental Health 327892 327892 0 0
Eating disorders
Emergency medicine 328296 328296 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
The Lily Registry will include all patients with eating disorders identified as medically unstable upon admission to the emergency department of a hospital, and if the instability is secondary to the eating disorder. These patients will be given the option to ‘opt-out’ of ongoing data collection in the Registry for their current hospital admission, once they are deemed stable by the attending clinical team. Participation is presumed unless the patient takes action to decline to participate. Data regarding the patient’s condition, cognitive-behavioural changes and general care will be obtained by the treating medical staff including attending physicians, nurses, dietitians, psychiatrists, paediatricians (if applicable), or authorised delegees. There is also an ‘opt-in’ component of the project that requires self-reporting by the patient. These questionnaires will be made available to the patient via an email link which can be accessed on a tablet, computer, or mobile phone. Those who consented to the opt-in componenet of the study will receive questionnaires at regular intervals after discharge at 3, 6 and 12 months. All participants will be closely followed up by a team at outpatient clinics, community dieticians or readmission to hospital as part of their standard course of treatment and is not related to the project itself.

Patient-identifiable information in the Registry is only visible to the treating clinical team. Data can be de-identified or re-identified based on role permissions granted to registry personnel. The collected data will be encrypted and securely stored. Thus, The Lily Registry will act as a platform to improve service quality for this very vulnerable group of patients, with the resultant learning and clinical research opportunities for clinicians and trainees. This registry will include both adult and paediatric patients. There is no defined duration or endpoint for the Registy. According to the ASCQHC National Framework for Clinical Quality Registries consultation paper, “CQRs shall support the retention of active records over 20 year periods to support longitudinal data analysis. After 20 years, records will be archived, but still be available for analysis."
Intervention code [1] 327043 0
Not applicable
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336123 0
Feasibility of 100% patient data entry (validated against administrative data using ICD-10 codes). That is, every patient considered medically unstable due to an eating disorder will be enrolled.
Timepoint [1] 336123 0
This outcome will be assessed every 12 months (at a minimum) post study commencement.
Secondary outcome [1] 426913 0
Time to haemodynamic stability: the time taken to achieve vital signs that no longer meet admission criteria. For example, no significant postural change in blood pressure or heart rate and resting heart rate >40 beats per minute. As this is an observational study, we will be collecting retrospective data. This means that the research team (who are also part of the clinical team) at respective sites will be obtaining data (i.e. change in blood pressure, heart rate, laboratory results, multi disciplinary meeting notes etc.) from Electronic Medical Records (EMR) as eligible patients who have consented are enrolled in this registry study.
Timepoint [1] 426913 0
This outcome will be assessed every 12 months (at a minimum or as needed) post study commencement.
Secondary outcome [2] 428573 0
Baseline changes in scores from the symptom inventory, ED-15.
Timepoint [2] 428573 0
Every 12 months (at a minimum or as needed) post study commencement.
Secondary outcome [3] 429032 0
Time to biochemical stability: defined as no significant abnormality for two consecutive days, demonstrated on the third day. As this is an observational study, we will be collecting retrospective data. This means that the research team (who are also part of the clinical team) at respective sites will be obtaining data (i.e. change in blood pressure, heart rate, laboratory results, multi disciplinary meeting notes etc.) from Electronic Medical Records (EMR) as eligible patients who have consented are enrolled in this registry study.
Timepoint [3] 429032 0
Every 12 months (at a minimum or as needed) post study commencement.

Eligibility
Key inclusion criteria
The participant should be diagnosed as having one of the 5 recognised eating disorder conditions and be in a medically unstable condition due to symptoms and behaviour due to eating disorder (Anorexia Nervosa, Bulimia Nervosa, Avoidant/restrictive food intake disorder, Binge Eating Disorder, OFSED (Other specified feeding or eating disorder)). The diagnosis might be new or existing.
Minimum age
9 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a). patients with an eating disorder who are not medically unstable.
(b). patients whose medical instability is not directly related to the symptoms and behaviour of their eating disorder, e.g., someone admitted for pneumonia, but also has an eating disorder, where the pneumonia is not the result of the eating disorder.
(c). patients under the age of 18 years (only applicable to sites that cater for adult patients only)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25562 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 41385 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314571 0
Other
Name [1] 314571 0
South Australian Association of Internal Medicine (SAAIM)
Country [1] 314571 0
Australia
Primary sponsor type
Other
Name
South Australian Association of Internal Medicine (SAAIM)
Address
L4 The Department of General Medicine, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316531 0
None
Name [1] 316531 0
Address [1] 316531 0
Country [1] 316531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313605 0
Central Adelaide Local Health Network (CALHN)
Ethics committee address [1] 313605 0
Port Road, Adelaide, SA 5000
Ethics committee country [1] 313605 0
Australia
Date submitted for ethics approval [1] 313605 0
05/05/2023
Approval date [1] 313605 0
16/05/2023
Ethics approval number [1] 313605 0

Summary
Brief summary
The Lily Registry will aim to:
a. collect data about inpatients with medical complications of eating disorders
b. define the practice and improve outcomes for patients with medical complications of eating disorders
c. encourage translational research, innovation, and clinical leadership in best practice care across South Australia for this important and challenging patient cohort
d. enable excellence in inpatient care of people with medical complications of eating disorders by supporting best-practice multidisciplinary care and continuous quality improvement
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128722 0
Dr Patrick Russell
Address 128722 0
The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 128722 0
Australia
Phone 128722 0
+61 404 807 880
Fax 128722 0
Email 128722 0
patrick.russell@sa.gov.au
Contact person for public queries
Name 128723 0
Dr Patrick Russell
Address 128723 0
The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 128723 0
Australia
Phone 128723 0
+61 404 807 880
Fax 128723 0
Email 128723 0
patrick.russell@sa.gov.au
Contact person for scientific queries
Name 128724 0
Dr Patrick Russell
Address 128724 0
The Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
Country 128724 0
Australia
Phone 128724 0
+61 404 807 880
Fax 128724 0
Email 128724 0
patrick.russell@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.