ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001112156

Ethics application status

Approved

Date submitted

19/07/2019

Date registered

12/08/2019

Date last updated

21/10/2022

Date data sharing statement initially provided

12/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The Assertive Cardiac Care Trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting

Scientific title

Secondary ID [1]

APP1141344

Universal Trial Number (UTN)

U1111-1220-6135

Trial acronym

ACCT

Linked study record

Health condition

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

Cardiovascular Disease

Severe mental Illness

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Hypertension

Cardiovascular

Other cardiovascular diseases

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1 BRIEF NAME:
ACCT Intervention Group

2 WHY:
People living with severe mental illnesses are at increased risk of early mortality that is largely attributable to modifiable risk factors associated with cardiovascular disease. People with SMI are over-represented in all areas of CVD risk and across all ages. CVD risk is modifiable through both pharmacological (where appropriate) and non-pharmacological means (primarily diet, behavioural, lifestyle and physical activity interventions). CVD and CVD risk factors in people with SMI are under diagnosed and under treated across all healthcare settings due to interconnected structural, individual and social reasons not limited to fragmentation between sectors, stigma associated with seeking help, unwelcoming environments and diagnostic over shadowing. Despite available interventions, uptake and ongoing adherence to interventions often remains low. The ACCT Healthy Heart Study intervention uses a virtual care model to deliver person-centred and evidence-based approaches such as motivational interviewing and the principles of assertive community treatment to support intrinsic behaviour change that can lead to improved heart health.

3 WHAT (Materials):
- Healthy Heart Check (including Absolute Cardiovascular Disease Risk (ACVDR) assessment)
- ACVDR assessment: age, gender, systolic BP, smoking status, total cholesterol, HDL cholesterol, diabetes (Yes/No), ECG (Yes/No/Unknown)
- Body Mass Index (BMI)
- HbA1c (baseline and 12 months)
- Blood pressure
- Lipids

- Healthy Heart Information sheet
A coproduced study specific information sheet was developed for the study containing general information on ways to maintain or improve cardiovascular health. The sheet was coproduced with people that have lived experience of severe mental illness to ensure that the information presented is accessible and meaningful.

- ACCT Virtual Care Platform
A bespoke telehealth platform has been designed for the ACCT study for the conduct of the Healthy Heart Action Plan Appointment. This is a long appointment with the research nurse covering risk discussion, change identification, smart goal establishment, goal identification, and commencement of the Healthy Heart Action Plan. The following coproduced tools are presented within the platform. The ACCT Virtual Care Platform has undergone several rounds of co-design to ensure that it is usable and meets the needs of end users.

- ACCT Change Identification Conversation Aid
A study specific tool has been co-designed with people that have lived experience of severe mental illness to facilitate the self-identification of lifestyle factors that could be improved. The tool covers activity, food and diet, smoking and alcohol use and psychological wellbeing and may lead to consideration of pharmacological and/or non-pharmacological management.

- SMART goal establishment:
A SMART goal setting template will be used to ensure that the goals set by study participants are Specific, Measurable, Achievable, Relevant and Time-bound.

- Goal identification sheet
A form was co-designed with people who have lived experience of severe mental illness where the goals set within the intervention can be for documentation of goals to display easily and accessibly at home as a reminder.

- Healthy Heart Action Plan (Modelled using the components of Chronic Disease Management Plan; GP management plan; Team Care Arrangements Plans)
A primary care management plan that meets the requirements of the Australian Government’s Medical Benefit Scheme for people. This plan will be developed by study participants as a component of the Intervention in consultation with the research nurse and the participant’s General Practitioner. The plan is used to establish ongoing management of the cardiovascular health of participants in the intervention group.

- Nurse Resource: Risk factor overview and treatment guide
Decision tree and resource kit. A study specific tool has been developed to provide an overview of the key CVD risks that contribute to ACVDR, and outline the key lifestyle contributors to CVD and impact of changes to these factors.

4 WHAT (Procedures):
if. A GP or practice nurse (or other qualified clinician) will conduct a Healthy Heart Check that includes:
a. an assessment of absolute CVD risk score using the National Vascular Disease Prevention Alliance formula;
b. additional measures of weight; BMI; and diastolic blood pressure and pathology derived HbA1c (baseline and 12 months); LDL cholesterol; triglycerides;.
c. Presentation of Healthy Heart Information Sheet: Following randomisation, participants in the intervention group will be presented with the heathy heart information sheet.

Participants randomised to the Intervention group will be scheduled to attend a Healthy Heart Action Plan Appointment with the research nurse. This appointment will be conducted remotely using the ACCT Virtual Care Platform or via telephone with hard copy versions of the study Action Plan Tools (Conversation Aid; Goal setting Form). The presentation medium will be determined through discussion with the participant. The Healthy Heart Action Plan Appointment is a 60-90 minute long, person-centred appointment, where the research nurse and the participant will discuss the results of the Healthy Heart Check, and potential ways to improve heart health and to reduce absolute CVD risk.

a. ACCT Change Identification Conversation Aid
Participants will be presented with the ACCT Change Identification Conversation Aid (through the ACCT Virtual Care Platform or hard copy) as a part of this discussion. The aid provides a user-friendly overview of risk factors with motivational interviewing inspired questions to guide the person to think about the areas of change that the individual would like to consider that will reduce absolute cardiovascular disease risk. The aid assists the nurse and participant to reflect on possible changes and discuss possible treatment methods. Pharmacological and non-pharmacological options will be discussed alongside each other. This will include a discussion of treatment efficacy and impact and goals will be formulated to support new treatment approaches.

b. Establishment of SMART goals
This discussion will lead to the establishment of one or two behavioural/lifestyle goals with an aim to reduce ACVDR (presented through the ACCT Virtual Care Platform or via telephone). These goals will be made by the participant with support from the research nurse. The goals will be person-centred and will reflect the abilities and capacity of the participant. The participant will be informed that they will receive ongoing support to attain these goals over the 12-month involvement in the study. The goals will be established using a SMART Goal Recording Form (i.e. they will be Specific; Measurable; Achievable; Relevant; Time-Bound). The goals will be recorded by the research nurse on the study database and a hard copy of the established goals will be provided to the participant.

The participant will take home a copy of the goals on the ACCT Take Home Goals Form.

c. Development of a Healthy Heart Action Plan (GP management plan)
A key output of the intervention session will be the development of a Healthy Heart Action Plan that employs the main components of a chronic disease management or equivalent and suitable plan. The management plan meets the Australian Government funding requirements. The Action Plan draws information from the Healthy Heart Action Plan appointment, baseline assessments and demographics to create a structured document to develop a management plan that can be used by GPs and participants to record goals and actions. The partially completed Healthy Heart Action Plan (GP management plan) will be forwarded to the participant’s GP for follow-up and integration of the GP’s clinical input and initiation of any medications.

d. General Practitioner Discussion
Following the Healthy Heart Action Plan appointment, the study employed research nurse will forward the partially completed Healthy Heart Action Plan (GP management plan) to the participant’s GP clinic and contact the GP to discuss pharmacological management options and possible referrals that are available for the participant. The GP will initiate medication where warranted, order any further tests or referrals that are indicated, and discuss these with the participant. This information will be provided from the GP clinic to the study nurse to update study records and be used to help support the participant to reach their goals through their involvement in the study. The outcomes of this process will be discussed with the participant and will be tailored to the research participant.

ii. Weekly Phone-contact
Weekly phone contact will be made alternating between a phone-call and SMS support. The purpose of these call is to provide support and to troubleshoot barriers and track progress towards the goals. These calls will utilise Motivational Interviewing techniques and will employ a structured approach that allows for the participant to guide the discussion.

The SMS messaging will be tailored to the individual and will be based on the goals that they have set. The SMS content will be supportive in tone and will provide some feedback on progress where appropriate and encouragement and motivation to continue.

iii. General Practitioner collaboration, medication monitoring/ General Practitioner management plan review
The General Practitioners of Intervention Group participants will be forwarded a summary of the Healthy Heart Check from the Baseline and 12-month assessments. General Practitioners will be involved in the in-person appointments to provide input into Healthy Heart Action Plan, review medications, initiate and monitor referrals and monitor progress.

iv. Handover to GP at 52 weeks
Following the final assessment at 52 weeks, the research nurse will conduct a full handover with the GP and participant that will review the goals set, the progress that has been made and approach that assist to maintain motivation and momentum to achieve the goals, and all Heart Health outcome measures over the course of the study. A study summary will be presented to the GP and participant.

5 WHO PROVIDED:
The intervention will be delivered by a research nurse employed by the University in collaboration with General Practitioners and GP clinic staff (practice nurses/GP registrars).
- Research Nurse: The research nurse will have professional registration and will be trained in the study protocol; general cardiovascular risk factors; the best evidence for CVD treatments; and the principles of both Motivational Interviewing and Assertive Community Treatment.
- General Practitioners: Participating General Practitioners will have professional registration and be educated in the aims and procedures of the study.
- Practice nurses/GP registrars: Participating practice nurses/GP registrars will be supervised by the participating GP and will have current professional registration.

6 HOW (MODE OF DELIVERY):

The intervention will be delivered virtually using telehealth and the telephone. Healthy Heart Checks will be conducted in-person at the participant’s usual GP clinic, but these will be conducted by clinic staff and not study employed research staff. These changes reflect the impact of COVID-19 on the original study protocol.

In-person study-related engagement will be conducted at:
- Week 0 – Baseline Healthy Heart Check (ACVDR assessment) with GP/practice staff
- Week 6 – GP review of medication (if needed)
- Week 12 – GP review of medication (if needed)
- Week 38 – GP review of medication (if needed)
- Week 52 – 12 Month Healthy Heart Check (ACVDR assessment) & In-person appointment with GP to review of Healthy Action Heart Plan, & Handover to GP with research nurse participating remotely.

Telehealth
- Week 1 – Healthy Heart Action Plan Appointment will be conducted remotely via the ACCT Virtual Care Platform or via telephone depending on the preferences of the participant.

Phone delivery will be weekly and will alternate between fortnightly phone calls and positive short text messages (SMS) on the alternate weeks. The phone calls will follow a standard script and template to document the person’s progress and any barriers to working towards the goals. The phone conversations will utilise the principles of Motivational Interviewing. The SMS contact will be individualised and will be tailored to the goals that the person has set.

7 WHERE (LOCATION):
The in-person sessions will be delivered at the participant’s General Practice Clinic or Community Health Centre. Phone contact will be made by the research nurse from the university research office.
8 WHEN and HOW MUCH:
The intervention will run for 12 months and will involve:

- 2 x Healthy Heart Checks (Baseline, 12 months).
- One Healthy Heart Action Plan Appointment (Week 1)
- In-person appointments with GP (Baseline; Week 6 (if needed); Week 12 (if needed); Week 38 (if needed); Week 52)
- 26 x Fortnightly Activation Phone Calls
- 26 x Fortnightly Activation SMS messaging
- Ongoing AE monitoring

9 TAILORING:
This will be a highly tailored and person-centred intervention. The intervention will be based on:
- the presenting CVD risks; - the participant’s health and personal capabilities;
- goals established in conjunction with the participant;
- formulation of an action plan
- progress through the goals.
The goals established will reflect the CVD risks detected in the Healthy Heart Check matched with the individual’s motivational stages for change. One or two goals will be maintained for the intervention duration with intensification to be determined by progress and discussion with the participant. Treatments and actions will be tailored to risks, and support and guidance provided to the individual to meet their goals over the intervention course. Additionally, the support will be tailored to the person’s progress through their goals and can be adjusted as required.

10 MODIFICATIONS:
The occurrence of the COVID-19 Pandemic has required that the protocol be substantially revised with a reduction in the number of in-person contacts through the study. This is also reflected in the shift to remote engagement through key intervention components.

11 HOW WELL (Planned):
Adherence to intervention delivery and fidelity will be assessed by checking audio recordings of 15% of the Tailored Assessment and Goal Setting Appointments for their adherence to all steps within discussion, goal setting, and motivational interviewing principles. Notes of follow-up appointments will also be reviewed to check for fidelity to motivational interviewing and assertive community treatment principles.

12 HOW WELL (Actual):
Not Relevant at this stage

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

1 BRIEF NAME:

ACCT Active Control Group

2 WHY:
People living with severe mental illnesses are at increased risk of early mortality that is in part attributable to modifiable risk factors associated with cardiovascular disease. The ACCT Active Control Group represents a real-world comparator to compare the ACCT Intervention group against. ACCT Active Control Group participants will complete Healthy Heart Check for data collection purposes only, and will not form the basis of an intervention.

3 WHAT (Materials):
- Healthy Heart Check (including Absolute Cardiovascular Disease Risk (ACVDR) assessment)
- ACVDR assessment: age, gender, systolic BP, smoking status, total cholesterol, HDL cholesterol, diabetes (Yes/No), ECG (Yes/No/Unknown)
- Body Mass Index (BMI)
- HbA1c (baseline and 12 months)
- Blood pressure
- Lipids

- Healthy Heart Information Sheet: A study specific information sheet developed for the study containing general information on ways to maintain or improve cardiovascular health. The sheet has been co-designed with people that have lived experience of severe mental illness to ensure that the information presented is accessible and meaningful.

4 WHAT (Procedures):
i. A GP or practice nurse (or other qualified clinician) will conduct a Healthy Heart Check that includes:
a. an assessment of absolute CVD risk score using the National Vascular Disease Prevention Alliance formula;
b. additional measures of weight; BMI; and diastolic blood pressure and pathology derived HbA1c (baseline and 12 months); LDL cholesterol; triglycerides;.
c. Presentation of Healthy Heart Information Sheet: Following randomisation, participants in the active control group will be presented with the Heathy Heart Information Sheet and will be directed to their general practitioner to follow up any heart health concerns.

ii. Monthly Phone-contact

Monthly phone contact will be made to the Active Control group to maintain study contact. These calls will follow a script and will not include any intervention.

iii. Handover to GP at 52 weeks (study completion)

Following the final assessment at 52 weeks, the research nurse will conduct a full handover with the GP that will provide a summary of all the Heart Health outcome measures over the course of the study. A study summary will be presented to the GP and participant.

5 WHO PROVIDED:

- Monthly phone contact will be made by a research assistant who is not involved in the delivery of the intervention.
- General Practitioners: Participating General Practitioners will have professional registration and be educated in the aims and procedures of the study.
- Practice nurses/GP registrars: Participating practice nurses/GP registrars will be supervised by the participating GP and will have current professional registration.
- Research Nurse will be responsible for collation of the Healthy Heart Check results, randomisation, and the GP handover at study completion. The research nurse will have professional registration and will be trained in the study protocol.

6 HOW (MODE OF DELIVERY):

In-person contacts will be conducted:
- Week 0 – Baseline Healthy Heart Check (ACVDR assessment)
- Week 52 – 12 Month Healthy Heart Check & In-person appointment with research nurse & Handover to GP (ACVDR assessment)

Phone contacts will be conducted:
The research assistant will contact Active Control participants at monthly intervals at a time suitable to participants.

7 WHERE (LOCATION):
The in-person sessions will be delivered at the participant’s General Practice Clinic or Community Health Centre.

Phone contact will be made by the research assistant from the university research office.

8 WHEN and HOW MUCH:

The intervention will run for 12 months and will involve:

- Presentation of the Healthy Heart Information Sheet x 1
- Monthly “check-in” phone contact x12
- Healthy Heart Check x 3 (Baseline, 12 months)

9 TAILORING:

This will be a generic, scripted, monitoring intervention.

10 MODIFICATIONS:

Not Relevant at this stage

11 HOW WELL (Planned):

Contacts will be recorded on the study database, and 15% of phone contact audio recordings will be reviewed to ensure that the script has been followed

12 HOW WELL (Actual):

Not Relevant at this stage

Control group

Active

Outcomes

Primary outcome [1]

Australian Absolute CVD Risk (ACVDR) Score: The estimated 5-year CVD risk using the Australian ACVDR calculator 12 months post randomization. The ACVDR calculator has been developed by the National Vascular Disease Prevention Alliance (NVDPA) and is calculated using: age, gender, systolic blood pressure (mm/Hg), smoking status, total cholesterol, HDL cholesterol, diabetes, ECG LVH – yes/no/unknown). The ACVDR calculator is based on the validated Framingham Risk Calculator.

The study has been powered to detect a two percentage point absolute difference between study groups in mean 5-year risk for cardiovascular disease using the Australian ACVDR Calculator at 12 months.

Timepoint [1]

12 months post randomisation

Secondary outcome [1]

Systolic and diastolic blood pressure: Measured in mm/hg using an automatic blood pressure monitor.

Timepoint [1]

Baseline and 12 months post randomisation

Secondary outcome [2]

Total cholesterol (Tot-c) mmol/L via serum assay

Timepoint [2]

Baseline and 12 months post randomisation

Secondary outcome [3]

Glycated haemoglobin (HbA1c) expressed as both mmol/L and % via serum assay.

Timepoint [3]

Baseline and 12 months post randomisation

Secondary outcome [4]

Body Mass Index (BMI) expressed as kg/m^2 as measured using a stadiometer and digital scale.

Timepoint [4]

Baseline and 12 months post randomisation.

Secondary outcome [5]

The Motivation and Attitudes Toward Changing Health (MATCH) Scale

Timepoint [5]