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Trial registered on ANZCTR


Registration number
ACTRN12621000871842
Ethics application status
Approved
Date submitted
17/05/2021
Date registered
6/07/2021
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Pharmacist Involvement in Care - Medication Assisted Treatment for Opioid Dependence (EPIC-MATOD) Implementation Study
Scientific title
Enhancing Pharmacist Involvement in Care - Medication Assisted Treatment for Opioid Dependence (EPIC-MATOD). A hybrid-implementation-effectiveness study to assess the impact of collaborative care on treatment retention and implementation outcomes
Secondary ID [1] 304230 0
Nil
Universal Trial Number (UTN)
Trial acronym
EPIC-MATOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependence 321932 0
Condition category
Condition code
Public Health 319656 319656 0 0
Health service research
Mental Health 319970 319970 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants currently receiving medication assisted treatment for opioid dependence (MATOD, with either methadone or buprenorphine) will be enrolled to receive 26 weeks of collaborative care with a pharmacist and prescriber.

Following informed consent, a 30min-1hr induction meeting will occur with the pharmacist. prescriber and patient. Tasks to be delegated to the pharmacist will be initially agreed upon by the patient and prescriber, with parameters of the treatment to be defined within a collaborative care treatment agreement. Following induction to the model of care, a baseline research assessment will occur documenting demographic, substance use, treatment history, overdose history, health service utilisation, treatment perceptions and satisfaction with other health measures.
Treatment: MATOD (with either methadone or buprenorphine) will be provided within the collaborative care model over 26 weeks. During the treatment period, all onsite MATOD dosing and unsupervised doses (doses dispensed to be taken as a later date, provided as per the Victorian Policy) will be provided from the pharmacy-site. Treatment will occur according the current State and National Policies with a study specific protocol for procedures that fall outside the current policy (e.g. treatment review and medication reinduction by pharmacists).
As part of the model of care, prescribers will delegate ongoing monitoring of patient progress to pharmacists, in addition to optional delegation of three key clinical domains:
1) Adjusting patient’s methadone or buprenorphine dose, within a pre-specified range
2) Adjusting the number of unsupervised doses, within a pre-specified range
3) Reinduction back onto the same pharmacotherapy (i.e. back onto methadone or buprenorphine) after a pre-specified number of missed doses.
Additional clinical monitoring of physical or mental health comorbidities and ancillary medication adherence (e.g. monitoring adherence with antidepressant, antipsychotic or antiretroviral medicines) may also be included in the treatment plan, with specific flags for referral back to the prescriber. The frequency of pharmacist assessments will be defined by the prescriber in the treatment agreement, and will vary depending on the patient the minimum frequency as per the Victorian opioid policy (e.g. monthly in the first 2 years of treatment). Pharmacist assessments will occur face to face, and will be guided by a structured review form.
A baseline research assessment will occur within 7 days of the induction meeting, and then at 3- and 6- months post the baseline research assessment.
The first 60 patients that meet eligibility criteria will be enrolled in the active treatment arm.
Intervention code [1] 320563 0
Treatment: Other
Comparator / control treatment
A comparison group (matched on age, gender, treatment type and time in treatment) will also be recruited, who will be receiving MATOD outside the collaborative care model, but through the same healthcare providers. MATOD (methadone or buprenorphine) with regular dosing at the community pharmacy and provision of unsupervised doses will be provided as per the current Victorian Policy.
Control group
Active

Outcomes
Primary outcome [1] 327529 0
Retention (Proportion of participants still in treatment as assessed by attendance records at the pharmacy, Primary Effectiveness Outcome)
Timepoint [1] 327529 0
26 weeks after study enrolment
Primary outcome [2] 327530 0
Change in treatment capacity, determined by prescriber time required to provide treatment through collaborative care assessed using documented time to provide treatment through collaborative care in communication logs and clinical records (Primary Implementation Outcome - treatment capacity)
Timepoint [2] 327530 0
Based on cumulative data on prescriber time required to provide treatment, collected over the 26 weeks study period.
Secondary outcome [1] 395528 0
Proportion of doses collected over the study period, assessed by a review of dosing logs
Timepoint [1] 395528 0
Assessed retrospectively at the end of the 26 week treatment period
Secondary outcome [2] 395529 0
Physical health (The Australian Treatment Outcomes Profile (ATOP) Physical Health VAS Scale)
Timepoint [2] 395529 0
3- and 6-months after enrolment
Secondary outcome [3] 395530 0
Mental Health (The Australian Treatment Outcomes Profile (ATOP) Mental Health VAS Scale)
Timepoint [3] 395530 0
3- and 6-months after enrolment
Secondary outcome [4] 395531 0
Quality of Life (EUROHIS-QOL 8)
Timepoint [4] 395531 0
3- and 6-months after enrolment
Secondary outcome [5] 395532 0
Days of non-prescribed opioid use in the past month as assessed by self-reported substance use, assessed with the (The Australian Treatment Outcomes Profile (ATOP) substance use questions in the research interviews
Timepoint [5] 395532 0
3- and 6-months after enrolment
Secondary outcome [6] 395533 0
Days of non-opioid substance use in past month as assessed by self-reported substance use, assessed with the (The Australian Treatment Outcomes Profile (ATOP) substance use questions in the research interviews
Timepoint [6] 395533 0
3- and 6-months after enrolment
Secondary outcome [7] 395534 0
Proportion of healthcare professionals retained in in the model of care, assed through an audit of healthcare professionals who were recruited to the study who are still providing care after 12 months
Timepoint [7] 395534 0
12 months after commencing providing collaborative care
Secondary outcome [8] 395535 0
Patient satisfaction as measured with the Treatment Perceptions Questionnaire (TPQ)
Timepoint [8] 395535 0
3- and 6-months after enrolment
Secondary outcome [9] 395536 0
Cost per patient to deliver care, determined through a review of contact logs and healthcare professional time spent on providing care as documented in study records (e.g. the time taken to complete review forms is documented on the review form).
Timepoint [9] 395536 0
Costs determined per participant over 26 weeks
Secondary outcome [10] 395606 0
Health Service Utilisation (determined through requesting Medicare Benefits Scheme data, and through attendance records collected as part of the study.
Timepoint [10] 395606 0
Calculated retrospectively based on health service utilisation records over the 26 week study period.
Secondary outcome [11] 395607 0
Frequency of overdose, determined by self-report in research interviews
Timepoint [11] 395607 0
3- and 6-months after enrolment.
Secondary outcome [12] 396764 0
Proportion of appointments attended over the study period, assessed through an audit of appointment records
Timepoint [12] 396764 0
Assessed retrospectively at the end of the 26 week treatment period

Eligibility
Key inclusion criteria
• Aged 18 years or older
• Opioid-dependent currently receiving treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• Significant medical or psychiatric conditions which would compromise safety in the model of care
• Inability or unwillingness to provide informed consent or abide by the requirements of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Matched comparison group
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample of 60 participants will allow estimation of the retention primary endpoint with adequate precision, and evaluation of factors impacting implementation. To better understand healthcare utilisation and clinical outcomes for the current model of care, we will recruit a matched comparison group comprised of 60 participants who are receiving MATOD outside the collaborative care model, but through the same healthcare providers. The comparison group will be interviewed at the same three time points and included in the data-linkage component.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308608 0
Government body
Name [1] 308608 0
Victorian Department of Health
Address [1] 308608 0
50 Lonsdale St, Melbourne VIC 3000
Country [1] 308608 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Wellington Road, Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 309474 0
None
Name [1] 309474 0
Address [1] 309474 0
Country [1] 309474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308540 0
Monash University
Ethics committee address [1] 308540 0
Monash University Human Research Ethics Committee
Monash Research Office
Building 3d
Monash University, VIC 3800
AUSTRALIA
Ethics committee country [1] 308540 0
Australia
Date submitted for ethics approval [1] 308540 0
22/03/2021
Approval date [1] 308540 0
09/04/2021
Ethics approval number [1] 308540 0
27616

Summary
Brief summary
Medication Assisted Treatment for Opioid Dependence (MATOD) is effective for opioid dependence, yet a lack of prescribers in the community limits access to this treatment, particularly in regional and rural areas. The Enhancing Pharmacists Involvement in Care (EPIC)-MATOD study aims to evaluate clinical and implementation outcomes among people with opioid dependence receiving MATOD through a collaborative pharmacist-prescriber model of care across multiple sites in a regional-rural area of Melbourne, Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111066 0
A/Prof Suzanne Nielsen
Address 111066 0
Monash University Peninsula Campus
Level 3, Building G.
47-49 Moorooduc Hwy
Frankston VIC 3199Australia
Country 111066 0
Australia
Phone 111066 0
+61 3 9904 4641
Fax 111066 0
Email 111066 0
suzanne.nielsen@monash.edu
Contact person for public queries
Name 111067 0
A/Prof Suzanne Nielsen
Address 111067 0
Monash University Peninsula Campus
Level 3, Building G.
47-49 Moorooduc Hwy
Frankston VIC 3199Australia
Country 111067 0
Australia
Phone 111067 0
+61 3 9904 4641
Fax 111067 0
Email 111067 0
suzanne.nielsen@monash.edu
Contact person for scientific queries
Name 111068 0
A/Prof Suzanne Nielsen
Address 111068 0
Monash University Peninsula Campus
Level 3, Building G.
47-49 Moorooduc Hwy
Frankston VIC 3199Australia
Country 111068 0
Australia
Phone 111068 0
+61399044641
Fax 111068 0
Email 111068 0
suzanne.nielsen@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will contain sensitive information
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 11672 0
Study protocol
Citation [1] 11672 0
Link [1] 11672 0
Email [1] 11672 0
Other [1] 11672 0
Under review
Attachment [1] 11672 0
Summary results
No Results