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Trial registered on ANZCTR


Registration number
ACTRN12620000577910
Ethics application status
Approved
Date submitted
9/04/2020
Date registered
18/05/2020
Date last updated
24/07/2020
Date data sharing statement initially provided
18/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge): Randomised Controlled Trial
Scientific title
A cluster randomised controlled trial of a pharmacist-led intervention for people living with severe and persistent mental illness to support medication adherence, physical health and psychological wellbeing
Secondary ID [1] 298080 0
Australian Government (GO1182)
Universal Trial Number (UTN)
U1111-1232-4723
Trial acronym
PharMIbridge
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe and persistent mental illness 312592 0
Schizophrenia 312594 0
Bipolar disorder 312595 0
Severe depression 313183 0
Schizoaffective disorder 313184 0
Condition category
Condition code
Mental Health 311101 311101 0 0
Schizophrenia
Mental Health 311102 311102 0 0
Psychosis and personality disorders
Mental Health 311644 311644 0 0
Depression
Mental Health 311645 311645 0 0
Other mental health disorders
Public Health 311646 311646 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Cluster Randomised Controlled Trial (C-RCT) focuses on Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) for people living with Severe and Persistent Mental Illness (SPMI). The PharMIbridge RCT will be conducted in two regions of Western Australia (WA), one region in New South Wales (NSW; Hunter New England) and the Australian Capital Territory (ACT). For each study arm, six community pharmacy sites will be recruited in each trial region (n=48).
The PharMIbridge intervention involves a pharmacist-led, in-depth support service for consumer participants living with SPMI delivered over six-months. The PharMIbridge intervention is goal-oriented, flexible and individualised. Goals will be guided by various self-assessment questionnaires and tools and be tailored to meet individual needs (with a specific focus on medication adherence and addressing physical health concerns). The PharMIbridge service will be delivered by trained community pharmacists who work in a community pharmacy randomised to the intervention group (IG).
Prior to delivering the intervention, pharmacists from IG pharmacies will undertake two days of training. During the first day of training, pharmacists (and additional pharmacy support staff such as pharmacy assistants) will complete Blended-Mental Health First Aid (B-MHFA; 6-8 hours online modules + 4 hours interactive session with a MHFA instructor) training and become accredited MHFAiders. They will also receive training in research processes, including participant recruitment, service delivery and using the electronic platform (GuildCare NG) to record pre- and post-service outcomes and follow-up consultations. GuildCare NG is currently used in the community pharmacy setting for the delivery of professional pharmacy programs. The second day of training focuses on the PharMIbridge training package, which includes training on communication, motivational interviewing and goal setting, complex issues relating to psychotropic medication, physical health issues for consumers living with SPMI and evidence-based strategies to address medication adherence and physical health care. Each training session will be facilitated by a local pharmacist and mental health consumer mentor pair.
The pharmacist and consumer mentor pairs will provide ongoing assistance to IG pharmacies providing the PharMIbridge intervention during the entire trial duration. The mentors will personally visit IG pharmacies up to two times during the six-month intervention period while participant recruitment and intervention delivery is ongoing. In addition to these visits, mentors will provide regular support through phone calls, emails and any other mechanisms agreed upon with the pharmacist involved. Pharmacies will also be supported with dedicated trial resources, such as a service delivery manual, information resources to promote trial participation from consumers living with SPMI, and fact sheets and information about the trial evaluation.
Each pharmacy will recruit up to 10 consumer participants. Consumer participants will be required to complete the same survey at Baseline and at the six-months follow-up consultation, with their pharmacist. This survey will include a range of validated and widely reported measurement instruments such as: the Insomnia Severity Index (ISI), Kessler Psychological Distress Scale (K6), Assessment of Quality of Life (AQoL-6D), Brief Illness Perception Questionnaire (BIPQ), Drug Attitude Inventory (DAI-10), Reported Adherence Medication Survey (RAMS), Physical Activity Vital Signs (PAVS), ten items from the Living with Medicines Questionnaire (LMQ version 3), Alcohol, Smoking and Substance Involvement Screening Test (ASSIST v3.1) or ASSIST-Y for participants aged 16-17 years, Dietary Behaviour Questions from Australian National Health Surveys and physical measurements (e.g. Blood Pressure, Weight, Height).
Based on their responses to the Baseline survey, IG participants will also complete more detailed assessments through an Initial Health Review to help pharmacists identify their main concerns relating to their medicines and medical conditions, and to set goals to resolve these concerns. The Initial Health Review may include some or all of the following tools:
• My Medicines and Me Questionnaire (M3Q)
• Fragerstrom Test for Nicotine Dependence
• Simple Physical Activity Questionnaire (SIMPAQ)
• The Pittsburgh Sleep Quality Index (PSQI)
• Brief Pain Inventory (BPI)
The Initial Health Review for IG participants is expected to take approximately 75 minutes. At a minimum, consumer participants will have at least three consultations with IG pharmacists: upon recruitment and Initial Health Review (75 minutes), a follow-up consultation, and at the six-month follow-up consultation for Final Health Review (30 minutes). However, as many follow-up consultations as required can occur during the study period (for example, one follow-up consultation each month).

The PharMIbridge intervention is purposely flexible to ensure that the service is individualized and can cater to consumer participants’ different health goals. Hence, it will not be possible to assess adherence to or fidelity of the PharMIbridge service, due to the variations in the service provided to individual consumer participants. Nonetheless, the number of follow-up consultations that each consumer participant attends will be recorded and reported to determine the uptake of the service and to conduct comparisons among participants who attended different numbers of follow-up consultations. Furthermore, analyses will be conducted to explore the completeness of data collection by IG pharmacists, as well as, the appropriateness of recommendations by IG pharmacists.
Intervention code [1] 314689 0
Treatment: Other
Intervention code [2] 314690 0
Lifestyle
Comparator / control treatment
Community pharmacists are trained medicine management experts and currently provide funded medication management services (such as MedsChecks) to identify and address medication-related problems. Pharmacists and staff from pharmacies randomised to the comparator group (CG) will undertake only one day of training. This training will include Blended-MHFA training, as well as, training in research processes, including participant recruitment, service delivery and using the electronic platform (GuildCare NG) to record pre- and post-service outcomes and follow-ups.
Each pharmacy will recruit up to 10 consumers. Consumer participants will be required to complete the same survey at Baseline and at six-months Follow-up, with their pharmacist. This survey will include a range of validated and widely reported measurement instruments such as: the Insomnia Severity Index (ISI), Kessler Psychological Distress Scale (K6), Assessment of Quality of Life (AQoL-6D), Brief Illness Perception Questionnaire (BIPQ), Drug Attitude Inventory (DAI-10), Reported Adherence Medication Survey (RAMS), Physical Activity Vital Signs (PAVS), ten items from the Living with Medicines Questionnaire (LMQ version 3), Alcohol, Smoking and Substance Involvement Screening Test (ASSIST v3.1) or ASSIST-Y for participants aged 16-17 years, Dietary Behaviour Questions from Australian National Health Surveys and physical measurements (e.g. Blood Pressure, Weight, Height).
Following Baseline data collection, participants recruited by a CG pharmacy will receive a standard MedsCheck service, and then continue to receive the standard care that their community pharmacy offers. MedsCheck was selected as the most suitable comparator service for this RCT as it is a currently funded pharmacy service. Most consumers using antipsychotics and/or mood stabilisers would be eligible for a MedsCheck. However, we believe that this hard-to-reach, vulnerable population may be missing out on this service. This trial provides an opportunity for all RCT participants to access a standard level of care and identify the impact of MedsCheck for participants living with SPMI. This is particularly important given the lack of data on the impact of MedsCheck on medicine adherence, especially among people living with SPMI. Pharmacists will schedule a second consultation with CG participants six-months after recruitment to complete the final trial outcome assessments (i.e. Follow-Up Survey).
It is expected that baseline data collection and Medscheck service will take approximately 60 minutes for CG consumers, while the final data collection (Follow-Up Survey) at six months will take approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 320351 0
Difference in medication adherence rates between the IG and CG at the RCT conclusion, as assessed by pharmacy dispensing data, PBS data and self-reported assessment using the Reported Adherence to Medication (RAM) Scale27
Timepoint [1] 320351 0
Baseline and at six-months after baseline data collection
Secondary outcome [1] 371291 0
Quality of life differences between the IG and CG at the RCT conclusion, as assessed by the AQoL-6D
Timepoint [1] 371291 0
Baseline and at six-months after baseline data collection
Secondary outcome [2] 371292 0
Psychological distress differences between the IG and CG at the RCT conclusion, as assessed by the K6
Timepoint [2] 371292 0
Baseline and at six-months after baseline data collection
Secondary outcome [3] 371293 0
Differences in medication burden between the IG and CG at the RCT conclusion, as assessed by 10 items of the LMQ
Timepoint [3] 371293 0
Baseline and at six-months after baseline data collection
Secondary outcome [4] 371294 0
Differences between IG and CG consumers attitudes to therapy at the RCT conclusion, as assessed by the DAI-10
Timepoint [4] 371294 0
Baseline and at six-months after baseline data collection
Secondary outcome [5] 371295 0
Illness beliefs differences between the IG and CG at the RCT conclusion, as assessed by the BIPQ
Timepoint [5] 371295 0
Baseline and at six-months after baseline data collection
Secondary outcome [6] 371298 0
Differences between IG and CG in alcohol, smoking, substance and non-prescribed drug use as assessed by a composite measure (ASSIST/ASSIST-Y)
Timepoint [6] 371298 0
Baseline and at six-months after baseline data collection
Secondary outcome [7] 371299 0
Differences between IG and CG in dietary behaviour as assessed by Dietary Behaviour Questions from Australian National Health Surveys
Timepoint [7] 371299 0
Baseline and at six-months after baseline data collection
Secondary outcome [8] 371300 0
Differences between IG and CG in health service utilisation as assessed by MBS data
Timepoint [8] 371300 0
Baseline and at six-months after baseline data collection
Secondary outcome [9] 371302 0
Goal achievement among IG participants, as assessed by the Goal Attainment Scale
Timepoint [9] 371302 0
Baseline (Initial Health Review) and at six months after receiving the PharMIbridge intervention (Final Health Review)
Secondary outcome [10] 371309 0
Changes in pharmacists’ confidence in providing MHFA, as assessed by survey items developed by MHFA-Australia
Timepoint [10] 371309 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [11] 371310 0
Changes in pharmacists’ attitudes as assessed by the Social Distance Scale and Mental Illness Attitudes Scale
Timepoint [11] 371310 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [12] 371311 0
Pharmacists’ MHFA skill acquisition as assessed by simulated patient assessments among IG pharmacists
Timepoint [12] 371311 0
Post-MHFA training completion
Secondary outcome [13] 371312 0
Changes in pharmacists’ knowledge and confidence as assessed by questions adapted from the Metabolic-Barriers, Attitudes, Confidence, and Knowledge Questionnaire (M-BACK)
Timepoint [13] 371312 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [14] 371313 0
Changes in pharmacists’ willingness to provide pharmacy services to people living with SPMI
measured using an eight-item validated survey tool developed by members of the research team and previously used in published literature
Timepoint [14] 371313 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [15] 371314 0
Changes in pharmacists’ attitudes towards providing pharmaceutical care to people living with SPMI measured using a 10-item tool developed specifically for this study through adaptations of previously published literature
Timepoint [15] 371314 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [16] 381757 0
Changes to pharmacists’ responses to “incentives and barriers” questions relating to working with people living with SPMI measured using a six-item tool developed specifically for this study through adaptations of previously published literature
Timepoint [16] 381757 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [17] 381758 0
Changes in confidence in providing MHFA, among pharmacy staff, as assessed by survey items developed by MHFA-Australia
Timepoint [17] 381758 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [18] 381759 0
Changes in attitudes, among pharmacy staff, as assessed by the Social Distance Scale and Mental Illness Attitudes Scale
Timepoint [18] 381759 0
Baseline, post-PharMIbridge training and six months follow-up
Secondary outcome [19] 381760 0
MHFA skill acquisition, among pharmacy staff, as assessed by simulated patient assessments among IG pharmacy staff
Timepoint [19] 381760 0
Post-MHFA training completion
Secondary outcome [20] 382621 0
Differences between IG and CG in health care service utilisation as assessed by the frequency of GP consultations and allied health services uptake, obtained through linkage with MBS data and Guildcare data sharing between healthcare professionals
Timepoint [20] 382621 0
Baseline and at six-months after baseline data collection
Secondary outcome [21] 382622 0
Differences between IG and CG in health care service utilisation as assessed by pharmacist records within the data collection platform (GuildCare NG) which will record pharmacist service provision, recommendations, referrals and follow-up consultations during the intervention
Timepoint [21] 382622 0
Baseline and at six-months after baseline data collection
Secondary outcome [22] 382623 0
Differences between IG and CG in rates of hospitalisation as assessed by hospitalisation data
Timepoint [22] 382623 0
Baseline and at six-months after baseline data collection
Secondary outcome [23] 382624 0
Differences between IG and CG in Emergency Department presentations as assessed by hospitalisation data
Timepoint [23] 382624 0
Baseline and at six-months after baseline data collection
Secondary outcome [24] 382625 0
PharMIbridge service acceptability from the perspective of IG consumer participants as assessed by qualitative interviews (interview guide will be developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT)
Timepoint [24] 382625 0
At the conclusion of the intervention
Secondary outcome [25] 382626 0
PharMIbridge service acceptability from the perspective of IG pharmacy staff as assessed by qualitative interviews (interview guide will be developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT)
Timepoint [25] 382626 0
At the conclusion of the intervention
Secondary outcome [26] 382627 0
PharMIbridge service acceptability from the perspective of other health care professionals involved in the intervention (e.g. prescribers, nominated GPs and mental health workers) as assessed by qualitative interviews (interview guide will be developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT)
Timepoint [26] 382627 0
At the conclusion of the intervention
Secondary outcome [27] 382628 0
PharMIbridge service acceptability from the perspective of IG pharmacy staff as assessed by a questionnaire developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT
Timepoint [27] 382628 0
At the conclusion of the intervention
Secondary outcome [28] 382629 0
PharMIbridge service acceptability from the perspective of other health care professionals involved in the intervention (e.g. prescribers, nominated GPs and mental health workers) as assessed by a questionnaire developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT
Timepoint [28] 382629 0
At the conclusion of the intervention
Secondary outcome [29] 382630 0
Experiences with the PharMIbridge service from the perspective of IG consumer participants as assessed by a consumer-reported experience measure (questionnaire) developed specifically for the PharMIbridge RCT based on published literature and the findings of the RCT
Timepoint [29] 382630 0
At the conclusion of the intervention
Secondary outcome [30] 382631 0
Cost effectiveness of the PharMIbridge intervention from the health-care sector perspective, as assessed by cost per additional adherer
Timepoint [30] 382631 0
At the conclusion of the intervention
Secondary outcome [31] 382632 0
Cost effectiveness of the PharMIbridge intervention from the health-care sector perspective, as assessed by cost per additional quality adjusted life year
Timepoint [31] 382632 0
At the conclusion of the intervention

Eligibility
Key inclusion criteria
Pharmacy eligibility
Community pharmacies will be included if they:
• are located within the selected RCT regions;
• be approved to dispense pharmaceutical benefits as part of the Pharmaceutical Benefits Scheme (PBS) defined in Section 90 of the National Health Act 1953 (Cth) (Section 90 Pharmacy);
• are accredited against Quality Care Community Pharmacy Standard (AS85000);
• have a demographic of clientele that includes consumers living with SPMI;
• routinely provide MedsCheck as an established professional service (i.e. MedsCheck is not a new service in the pharmacy);
• can guarantee that the PharMIbridge intervention is carried out by a Registered Pharmacist that has successfully completed the training and any consultations are undertaken with the consumer and/or the consumer’s carer with consideration of the consumer’s comfort and right to privacy
• have a private consultation room or area for confidential conversations and assessments;
• consent (by the pharmacy owner/manager) to participate; and,
• have an established working relationship with local GP practices or centres, mental health care teams, and/or are already engaged with mental health promotion.
Similar to professional practice guidelines for MedsCheck, it is a requirement that trained pharmacists involved in the RCT are not responsible for dispensing or other professional duties whilst interacting with consumer participants (e.g. when providing a MedsCheck service or undertaking the Initial Health Review as part of the PharMIbridge intervention). As some pharmacies in the selected RCT regions may only have one pharmacist on-duty at a particular time, these consultations must be conducted outside the standard pharmacy operating hours or whilst another pharmacist is on duty.
Pharmacies from WA that participated in the 5CPA project and located within the selected study regions would be eligible to participate. Community pharmacies that are involved in the 6CPA Community Pharmacy in Health Care Homes Trial, or any other trials, would be assessed for suitability in terms of workload.

Consumer Eligibility
Consumers will be eligible to participate in the RCT if they meet all of the following criteria:
• have the capacity to provide consent (as determined by a trained pharmacist and/or member of the consumer participant’s treating team);
• aged 16 years and over and residing in the community;
• be using at least one antipsychotic or mood stabiliser for at least six-months, continuously, for the treatment of SPMI such as schizophrenia or bipolar disorder (consumers who change medication during this time would still be eligible to participate, and can be using other medication for their mental and physical health);
• have a complex medication need (e.g. adherence concerns) or unmanaged physical health problems;
• provide consent for pharmacists to contact at least one of their treating healthcare professionals (GP, case manager, psychiatrist) regarding RCT participation; and,
• provide consent for researchers to access their medication dispensing data from the pharmacy, MBS, PBS, hospitalisation and emergency department visit data for 12-months pre- and 6-months post- RCT period.


Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pharmacies will be excluded from the RCT if they:
• are not located within the selected RCT regions;
• would find it particularly difficult to recruit the required number of consumer participants living with a SPMI (i.e. do not see many of these consumers);
• do not currently provide or a regular provider of a MedsCheck service;
• do not have a private consultation area where conversations and assessments can be kept confidential;
• do not actively engage with other healthcare professionals (e.g. local GP) or mental health care teams; and,
• do not have approval to participate from the pharmacy owner or manager.
Consumers will be excluded from participating in the RCT if they:
• are aged under 16 years;
• have unstable mental health symptoms as recognised by the pharmacist or deemed unsuitable for participation by their treating healthcare professional or carer;
• use antipsychotic or mood stabiliser medications inconsistently or ‘when required’, or have not used these medications on a regular basis for the last six months;
• are prescribed an antipsychotic or mood stabiliser medication for the treatment of another illness other than those defined in inclusion criteria (for example, off-label use for alternative condition such as quetiapine for sleep or anxiety); or
• do not give consent to contact their treating healthcare professionals, or to access PBS, MBS, hospitalisation and/or emergency department data.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods
Pharmacies will be randomised into the IG or CG after stratification by region and geographic location (urban/rural/remote). Location will be categorised according to Pharmacy Access/Remoteness Index of Australia. Within each stratum, pharmacies will be randomly allocated in a ratio of 1:1 to the IG or CG. Randomisation will occur after all pharmacies for that RCT region have been recruited. The number of full-time equivalent employees will be ranked within each stratum, and pharmacies will be formed into pairs. A list of computer-generated random numbers will be used to allocate either the PharMIbridge intervention (IG) or MedsCheck service (CG) to the first of each pair; the second in each pair will be allocated the alternative service.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation
Based on a recent study conducted in a similar population we assume the baseline rate of non-adherence assessed using pharmacy dispensing data will be 56%. Note this outcome will be available for all participants who have not actively withdrawn, regardless of treatment compliance. As this is a cluster RCT we need to account for the non-independence of observations from within the same cluster. We assume a median number of consumer participants at each pharmacy of 10, and conservatively assume the ICC = 0.03, giving a design effect of 1.27. We assume the percentage of non-adherent participants in the active comparator arm will drop to 51% (based on the results of previous studies exploring adherence as an outcome of a MedsCheck service) and the educational training intervention will drop to 35%. With alpha = 0.05, we will have 80% power to find a statistically significant difference between study arms if we recruit 190 individuals to each arm (after accounting for clustering). In total this equates to collecting data from 38 pharmacies. Assuming that 20% of pharmacies will withdraw from the study without enrolling any participants, we will need to recruit a total of 48 pharmacies. Given that each of the 48 pharmacies will be asked to recruit 10 consumers, this will result in 480 consumer participants recruited in total. This number (n=480) will result in oversampling, thereby allowing for the potential drop out of consumer participants or pharmacies from the RCT.

Statistical analysis for outcome measures
Descriptive statistics will be described using mean (standard deviation) or median (25th-75th percentile) for continuous data and as frequency (percentage) for categorical data. We will compare the primary outcome of percentage adherence between arms using a mixed-effects logistic regression model, with treatment arm entered as the fixed effect and pharmacy entered as a random effect, to account for possible non-independence of observations from participants who attend the same pharmacy. Results will be reported as odds ratios and 95% Wald-based confidence intervals. For secondary analyses, interval data will be analysed using mixed-effects linear regression, binary data using mixed-effects logistic regression, and count data using mixed-effect Poisson regression models. In all cases the likely non-independence of data from individuals enrolled through the same pharmacy will be accounted for as random effects in the regression models. Analyses will be based on the intention-to-treat principle, with participants analysed according to the treatment they were allocated to receive.

No interim analyses will be conducted.

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)
ACT,NSW,WA

Funding & Sponsors
Funding source category [1] 302611 0
Government body
Name [1] 302611 0
Australian Government, Department of Health
Address [1] 302611 0
Department of Health
GPO Box 9848
Canberra ACT 2601, Australia
Country [1] 302611 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Pharmacy Guild of Australia
Address
Level 2, 15 National Circuit, Barton, ACT 2600 Australia
PO Box 310, Fyshwick, ACT 2609 Australia

Country
Australia
Secondary sponsor category [1] 302957 0
University
Name [1] 302957 0
The University of Sydney
Address [1] 302957 0
THE UNIVERSITY OF SYDNEY
Camperdown
NSW 2006
Country [1] 302957 0
Australia
Secondary sponsor category [2] 302958 0
University
Name [2] 302958 0
Griffith University
Address [2] 302958 0
170 Kessels Road
Nathan, Qld
4111
Country [2] 302958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303245 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 303245 0
Office for Research, Nathan campus, Griffith University, 170 Kessels Road, Nathan QLD, 4111, Australia
Ethics committee country [1] 303245 0
Australia
Date submitted for ethics approval [1] 303245 0
Approval date [1] 303245 0
26/06/2019
Ethics approval number [1] 303245 0
2019/493
Ethics committee name [2] 303874 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 303874 0
Office for Research, Nathan campus, Griffith University, 170 Kessels Road, Nathan, QLD, 4111, Australia
Ethics committee country [2] 303874 0
Australia
Date submitted for ethics approval [2] 303874 0
Approval date [2] 303874 0
13/06/2019
Ethics approval number [2] 303874 0
2019/473

Summary
Brief summary
The Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) Cluster Randomised Controlled Trial (C-RCT) aims to evaluate the effectiveness of an individualised, pharmacist-led support service for people living with severe and persistent mental illness (SPMI). The PharMIbridge service focuses on improving medication adherence, and mental and physical wellbeing of consumers living with SPMI. Pharmacists within four Australian regions in NSW, WA and the ACT, will be randomly allocated to deliver either the PharMIbridge intervention or standard care involving a medication management service (MedsCheck). Pharmacists and pharmacy support staff (e.g. assistants) involved in the trial will receive Blended-Mental Health First Aid training. Pharmacists delivering the PharMIbridge service will also receive further training on medication adherence, goal setting, motivational interviewing, managing physical health concerns and complex issues relating to medications used to treat SPMI. It is expected that the PharMIbridge service will lead to improvements in medication adherence. Secondary outcomes will be changes in factors associated with cardiometabolic risk and quality of life, with an emphasis on physical health and psychological wellbeing; medication-related problems; community pharmacists’ knowledge, confidence and ability to support consumers living with SPMI; and any effects on health care service acceptability, utilisation and cost-effectiveness.
Trial website
griffith.edu.au/pharmibridge
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92990 0
Dr Claire O'Reilly
Address 92990 0
Room 516, Pharmacy and Bank Building A15
The University of Sydney, Camperdown, NSW 2006
Country 92990 0
Australia
Phone 92990 0
+61293512729
Fax 92990 0
Email 92990 0
claire.oreilly@sydney.edu.au
Contact person for public queries
Name 92991 0
Ms Anni Bohn
Address 92991 0
Room 1.10, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, Nathan, QLD 4111
Country 92991 0
Australia
Phone 92991 0
+61737358056
Fax 92991 0
Email 92991 0
pharmibridge@griffith.edu.au
Contact person for scientific queries
Name 92992 0
Prof Amanda Wheeler
Address 92992 0
Room 1.05, Building N70
Menzies Health Institute Queensland
Nathan Campus, Griffith University
170 Kessels Road, Nathan, QLD 4111
Country 92992 0
Australia
Phone 92992 0
+61 733821068
Fax 92992 0
Email 92992 0
a.wheeler@griffith.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
Consent for publication of raw data has not been sought
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7535 0
Study protocol
Citation [1] 7535 0
The study protocol will be submitted to a journal for peer-review, and will be made available once published as a journal article.
Link [1] 7535 0
Email [1] 7535 0
Other [1] 7535 0
Attachment [1] 7535 0
Type [2] 7536 0
Statistical analysis plan
Citation [2] 7536 0
Link [2] 7536 0
Email [2] 7536 0
pharmibridge@griffith.edu.au
Other [2] 7536 0
Attachment [2] 7536 0
Type [3] 7537 0
Informed consent form
Citation [3] 7537 0
Link [3] 7537 0
Email [3] 7537 0
pharmibridge@griffith.edu.au
Other [3] 7537 0
Attachment [3] 7537 0
Type [4] 7538 0
Ethical approval
Citation [4] 7538 0
Link [4] 7538 0
Email [4] 7538 0
pharmibridge@griffith.edu.au
Other [4] 7538 0
Attachment [4] 7538 0
Summary results
No Results