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Trial registered on ANZCTR


Registration number
ACTRN12620001306909
Ethics application status
Approved
Date submitted
28/08/2020
Date registered
2/12/2020
Date last updated
2/12/2020
Date data sharing statement initially provided
2/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Depression Screening and Care in Coronary Heart Disease Patients
Scientific title
Evaluation of depression screening on the uptake of collaborative depression care in Coronary Heart Disease Patients: A Stepped-Wedge Randomized Controlled Trial
Secondary ID [1] 302004 0
None
Universal Trial Number (UTN)
U1111-1257-4784
Trial acronym
DiSCorD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 318562 0
Coronary Heart Disease 318563 0
Condition category
Condition code
Mental Health 316576 316576 0 0
Depression
Cardiovascular 316577 316577 0 0
Coronary heart disease
Public Health 317230 317230 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of collaborative care, coordinated by a nurse care manager specific to each site (i.e. outpatient cardiology clinic at a tertiary hospital). Clusters who cross-over to the intervention will implement collaborative care for eligible participants, with the initial intervention dependent on each participants baseline depression severity. Level 1) initiation of antidepressant pharmacotherapy or cognitive behavioural therapy for moderate depressive symptoms, Level 2) active antidepressant pharmacotherapy and/or cognitive behavioural therapy for moderately severe depressive symptoms, Level 3) antidepressant pharmacotherapy and cognitive behavioural therapy for severe depressive symptoms. Citalopram will be recommended as first-line therapy based on high tolerance, low drug-drug interactions, and efficacy in prior collaborative care interventions in medical and cardiac patients. The dose recommendations for selective serotonin reuptake inhibitors, starting and maximum dose are: Citalopram 20–40 mg/day, Escitalopram 10–20 mg/day, Sertraline 50–100 mg/day, Paroxetine 20–40 mg/day, Fluoxetine 20–40 mg/day. For, The dose recommendations for serotonin-norepinephrine reuptake inhibitors and atypical antidepressants starting and maximum dose are: Venlafaxine 75–150 mg/day, Duloxetine 40–60 mg/day, Mirtazapine 15–30 mg/qhs. For patients requiring cognitive behavioural therapy, this is made available through the Better Access Initiative and private providers external to the research setting. Cognitive behavioural therapy typically concerns a goal-centred approach to depression over 8-12 weeks, targeting common thoughts and behaviours. Nurse care managers will liaise with each patient’s general physician and cardiologist to help coordinate antidepressant and/or cognitive behavioural therapy.

A baseline assessment serves to establish the level of stepped-treatment required (Level 1-3). At an interim review 6 and 12 weeks into active treatment, the intervention will be stepped-up a level of care when a patient’s total depression score (Patient Health Questionnaire-9) does not reduce by 4 points (or alternatively does not reduce below the moderate threshold). If a patient is already receiving the highest level of stepped care, antidepressant therapy will be increased but no higher than maximum doses. The intervention per patient is 18 weeks duration.

Fidelity to the intervention will be monitored by auditing Nurse Care Manager's clinical notes and an audit of eligible patients against a set of collaborative care criteria - rated by blinded auditors as either not met, partially met, fully met. Patient adherence will be monitored via a service-use questionnaire.
Intervention code [1] 318303 0
Early detection / Screening
Intervention code [2] 318304 0
Treatment: Other
Comparator / control treatment
In this stepped-wedge RCT, patients at clusters not yet exposed to the intervention serve as the control group, and consists of usual care. There is no restriction on usual care, which may consist of depression management by general physician, such as through antidepressant medication and/or psychological counselling.
Control group
Active

Outcomes
Primary outcome [1] 324719 0
The primary outcome is the uptake of collaborative depression care, derived from the proportion of eligible patients with depression symptoms (identified from screening), who receive- vs. do not receive- collaborative depression care. This outcome is adjudicated by assessors blinded to hospital and time-period, from a complete case audit of medical records and nurse care manager records.
Timepoint [1] 324719 0
18 and 24 (primary timepoint) weeks after implementation of the intervention
Secondary outcome [1] 385551 0
Secondary outcome - depression severity quantified by the Patient Health Questionnaire-9
Timepoint [1] 385551 0
18 and 24 weeks after implementation of the intervention
Secondary outcome [2] 385552 0
Secondary outcome - Depression remission denoted by total scores <10 on the Patient Health Questionnaire-9
Timepoint [2] 385552 0
18 and 24 weeks after implementation of the intervention
Secondary outcome [3] 386285 0
Secondary outcome - Anxiety severity quantified by the Generalized Anxiety Disorder-7
Timepoint [3] 386285 0
18 and 24 weeks after implementation of the intervention at each cluster
Secondary outcome [4] 386286 0
Secondary outcome - Angina symptoms measured by the Seattle Angina Questionnaire-7
Timepoint [4] 386286 0
18 and 24 weeks after implementation of the intervention at each cluster
Secondary outcome [5] 386287 0
Secondary outcome - Dyspnoea symptoms measured by the Rose Dyspnea Scale
Timepoint [5] 386287 0
18 and 24 weeks after implementation of the intervention at each cluster
Secondary outcome [6] 386288 0
Secondary outcome - Quality of life measured by the Short Form 12 dimensions
Timepoint [6] 386288 0
18 and 24 weeks after implementation of the intervention at each cluster
Secondary outcome [7] 386289 0
Secondary outcome - Cost utility quantified by the 5-level EuroQol 5 dimensions (EQ-5D-5L)
Timepoint [7] 386289 0
18 and 24 weeks after implementation of the intervention at each cluster
Secondary outcome [8] 386290 0
Secondary outcome - Major adverse cardiac events, defined as a fatal event, hospital readmission, or emergency department contact for any; myocardial infarction, unstable angina, coronary revascularisation procedure, stroke, heart failure, arrhythmia, sudden-cardiac death. This outcome is adjudicated by data linkage to patient's medical records, adjudicated by an assessor blinded to whether a patient did or did not receive any component of collaborative depression care.
Timepoint [8] 386290 0
24 weeks after implementation of the intervention
Secondary outcome [9] 386291 0
Secondary outcome - Psychiatric cause hospital admission defined as a fatal or non-fatal or unplanned hospital admission for; suicide attempt/ deliberate self-harm (ICD X71-X83) or psychiatric cause (ICD range F01-99). This outcome is adjudicated by data linkage to patient's medical records, adjudicated by an assessor blinded to whether a patient did or did not receive any component of collaborative depression care.
Timepoint [9] 386291 0
24 weeks after implementation of the intervention

Eligibility
Key inclusion criteria
1) aged greater than or equal to 18 years.
2) able to communicate in English.
3) CHD out-patient with history of any; acute coronary syndrome [ST and non-ST elevation myocardial infarction, unstable angina], percutaneous coronary intervention or coronary artery bypass graft, or other clinical indication of CHD e.g. greater than or equal to 50% stenosis in 1 coronary artery from coronary angiography.
4) have a moderate to severe level of depression denoted as a PHQ-9 depression screening score greater than or equal to 10
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) already receiving current antidepressant, psychotherapy, or psychiatric care.
2) have a complex psychiatric comorbidity including any psychosis, bi-polar disorder, personality disorder, drug or alcohol dependence, as defined by medical records or self-report.
3) high suicide risk requiring acute psychiatric assessment via a referral to the emergency department, determined as a severe level of depression and a positive response to PHQ suicidality item “more than half the days” or higher.
4) observed cognitive impairment or dementia (e.g. donepezil use) impeding delivery of collaborative care components such as psychotherapy.
5) severe non-vascular comorbidity with life expectancy <12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves central randomisation by computer at the central administration site. In this stepped-wedge design, cluster allocation is concealed to clinicians and patients until clusters cross over to the intervention phase. Clinicians are unblinded once the intervention commences.

Patients remain blind to allocation at all phases of the intervention. Independent raters will extract data for primary and secondary outcomes, blind to stage of the trial (pre cross-over, transition, implementation, maintenance phases).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated and unmodifiable sequence of randomly permuted variable numbers (representing cluster and step) will be generated before the trial with the REDCap online program. Clusters will be randomised to the intervention in 4 steps, after determination of the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analysis will be performed according to intention-to-treat principles adjusted for calendar time, using a linear mixed effects regression with random effect for clusters and fixed effect for time and treatment indicators. Generalised linear mixed-effect regressions will be employed to assess secondary outcomes. These complications will also adjust for calendar time, using generalised linear mixed models with random effect for wedge and fixed effect for each step.

Participant level measures of utility derived from the EQ-5D-5L instrument will be integrated with survival curves using the quality-adjusted survival analysis method over the trial period. This analysis includes cost-effectiveness, acceptability, net benefit and expected net loss curves to inform decision makers of the optimal strategy at any threshold for different subgroups and the uncertainty around this decision.

Participant level measures of utility derived from the EQ-5D-5L instrument will be integrated with survival curves using the quality-adjusted survival analysis method over the trial period. This analysis includes cost effectiveness, acceptability, net benefit and expected net loss curves to inform decision makers of the optimal strategy at any threshold for different subgroups and the uncertainty around this decision.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2021
Actual
Date of last participant enrolment
Anticipated
13/01/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
756
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17248 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 17249 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 17250 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 17251 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 30959 0
5042 - Bedford Park
Recruitment postcode(s) [2] 30960 0
5011 - Woodville
Recruitment postcode(s) [3] 30961 0
5000 - Adelaide
Recruitment postcode(s) [4] 30962 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 306425 0
Charities/Societies/Foundations
Name [1] 306425 0
National Heart Foundation of Australia
Country [1] 306425 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Level 4
Rundle Mall Plaza
50 Rundle Mall
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 306951 0
None
Name [1] 306951 0
Address [1] 306951 0
Country [1] 306951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306621 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 306621 0
Ethics committee country [1] 306621 0
Australia
Date submitted for ethics approval [1] 306621 0
27/10/2019
Approval date [1] 306621 0
19/12/2019
Ethics approval number [1] 306621 0
HREC/19/CALHN/409

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

Contacts
Principal investigator
Name 104498 0
Dr Phillip Tully
Address 104498 0
C/O Freemasons Foundation Centre for Men's Health
Ground Floor
245 North Terrace
The University of Adelaide
SA 5005
AUSTRALIA
Country 104498 0
Australia
Phone 104498 0
+61 8 8313 0514
Fax 104498 0
Email 104498 0
phillip.tully@adelaide.edu.au
Contact person for public queries
Name 104499 0
Phillip Tully
Address 104499 0
C/O Centre for Men's Health
Ground Floor
245 North Terrace
The University of Adelaide
SA 5005
AUSTRALIA
Country 104499 0
Australia
Phone 104499 0
+61 8 8313 0514
Fax 104499 0
Email 104499 0
phillip.tully@adelaide.edu.au
Contact person for scientific queries
Name 104500 0
Phillip Tully
Address 104500 0
C/O Freemasons Foundation Centre for Men's Health
Ground Floor
245 North Terrace
The University of Adelaide
SA 5005
AUSTRALIA
Country 104500 0
Australia
Phone 104500 0
+61 8 8313 0514
Fax 104500 0
Email 104500 0
phillip.tully@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans to share IPD for this stepped-wedge trial, given that only 1 other stepped-wedge trial has been reported for collaborative depression care in cardiac populations.


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.