Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12615001165572p
Ethics application status
Submitted, not yet approved
Date submitted
15/10/2015
Date registered
2/11/2015
Date last updated
2/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Detecting depression in cardiac patients: exploring the implementation of National Heart Foundation recommendations for depression screening in the hospital setting.
Scientific title
Detecting depression in acute coronary syndrome patients: exploring the practice of depression screening as recommended by the National Heart Foundation in the acute care environment.
Secondary ID [1] 287674 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute coronary syndromes (ACS) 296508 0
Depression 296509 0
Condition category
Condition code
Cardiovascular 296768 296768 0 0
Coronary heart disease
Mental Health 296769 296769 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a translational research project exploring the recommended depression screening practice in the acute setting. 6 RNs will be screening participants with ACS for depression using the Patient Health Questionnaire-9 (PHQ-9) during their admission in a Coronary Care Unit. The nurses will screen patients in the time that they would perform usual care. Following 6 months, focus group discussions will explore the practical aspects of screening, potential barriers to implementation and the capability, opportunity and motivation of staff to change practice.
Intervention code [1] 293069 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296378 0
Qualitative data regarding the practical aspects of depression screening in the acute coronary care setting. The outcome is assessed through the analysis of qualitative data obtained from focus groups of the nurses who administered the PHQ-9 to participants.
Timepoint [1] 296378 0
6 months
Secondary outcome [1] 318293 0
Qualitative data regarding the motivation, opportunity and capability of staff to change practice. The outcome is assessed through the analysis of qualitative data obtained from focus groups of nurses, allied health and medical staff who work in the Cardiovascular Medicine Department.
Timepoint [1] 318293 0
Focus groups of nurses, allied health and medical staff will be conducted over a 6 month period. Therefore, anlaysis will be undertaken between 6 and 12 months.

Eligibility
Key inclusion criteria
Participants group 1: A purposive sample of 6 RNs who work in the CCU at the study site who will be performing depression screening during their normal nursing duties.
Participant group 2: Purposive sample of nursing, allied health and medical staff who work in the Cardiovascular Medicine Department at the study site who have expertise in the care of coronary patients.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Purposive sampling therefore only members of the Cardiovascular Medicine Department
may participate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The qualitative data generated will be analysed using Framework Analysis. This method of analysis has been specifically designed for applied policy research where the aim is to gather information with a potential to create actionable outcomes. Its primary objective is to describe and interpret what is happening in a particular setting. The prinicple of Data Saturation will determine the sample size. In keeping with qualitative research methods, no sample size calculation was performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2015
Actual
Date of last participant enrolment
Anticipated
30/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4474 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 292232 0
Charities/Societies/Foundations
Name [1] 292232 0
Sir Charles Gairdner Hospital Foundation
Country [1] 292232 0
Australia
Primary sponsor type
Individual
Name
Prof Sean Hood
Address
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 290907 0
None
Name [1] 290907 0
Address [1] 290907 0
Country [1] 290907 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293699 0
Sir Charles Gairdner Hospital and Obsbourne Park HREC
Ethics committee address [1] 293699 0
Sir Charles Gairdner Hospital
Department of Research
2nd Floor, A block
SCGH
Hospital Ave
Nedlands
WA 6009
Ethics committee country [1] 293699 0
Australia
Date submitted for ethics approval [1] 293699 0
29/09/2015
Approval date [1] 293699 0
Ethics approval number [1] 293699 0

Summary
Brief summary
This study is a translational research project that will generate qualitative data to inform changes to clinical practice in a Cardiovascular acute care setting.
Aims: 1 To explore the practical aspects of applying a depression screening protocol
2. To conduct behavioural analysis using the COM-B theorectical model to explore capability, opportunity and motivation of staff to change practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60998 0
Prof Sean Hood
Address 60998 0
School of Psychiatry
University of Western Australia
QE II Medical Centre
Nedlands
WA 6009
Country 60998 0
Australia
Phone 60998 0
61 8 93462393
Fax 60998 0
Email 60998 0
[email protected]
Contact person for public queries
Name 60999 0
Jo Crittenden
Address 60999 0
School of Psychiatry
University of Western Australia
QE II Medical Centre
Nedlands
WA 6009
Country 60999 0
Australia
Phone 60999 0
61 8 9346 1176
Fax 60999 0
Email 60999 0
[email protected]
Contact person for scientific queries
Name 61000 0
Jo Crittenden
Address 61000 0
School of Psychiatry
University of Western Australia
QE II Medical Centre
Nedlands
WA 6009
Country 61000 0
Australia
Phone 61000 0
61 8 9346 1176
Fax 61000 0
Email 61000 0
[email protected]

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
No additional documents have been identified.