ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1257-4784

Trial acronym

DiSCorD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Coronary Heart Disease

Condition category

Condition code

Mental Health

Depression

Cardiovascular

Coronary heart disease

Public Health

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]

Early detection / Screening

Intervention code [2]

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]

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]

18 and 24 (primary timepoint) weeks after implementation of the intervention

Secondary outcome [1]

Secondary outcome - depression severity quantified by the Patient Health Questionnaire-9

Timepoint [1]

18 and 24 weeks after implementation of the intervention

Secondary outcome [2]

Secondary outcome - Depression remission denoted by total scores <10 on the Patient Health Questionnaire-9

Timepoint [2]

18 and 24 weeks after implementation of the intervention

Secondary outcome [3]

Secondary outcome - Anxiety severity quantified by the Generalized Anxiety Disorder-7

Timepoint [3]