None listed
Conditions
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 study regions in three Australian states (NSW, VIC 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.
Interventions
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 in New South Wales (NSW; Northern Sydney and Hunter New England), Regional Victoria (VIC) and the Australian Capital Territory (ACT). For each study arm, six community pharmacy sites will be recruited in each trial region (n=48)
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 in New South Wales (NSW; Northern Sydney and Hunter New England), Regional Victoria (VIC) 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 be asked to 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.
Sponsors
The Pharmacy Guild of Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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. 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.
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.
Outcome results
None listed