None listed
Conditions
Brief summary
This study seeks to trial a community pharmacist-led physical health monitoring program for mental health consumers taking at least one second generation antipsychotic medication on a regular basis. Participants will be required to attend a total of five consultations with the pharmacist (initial session and then every 3 months thereafter for 12 months). The sessions will involve assessment of medical history, lifestyle factors and measurement of blood glucose and cholesterol level involving finger prick tests. Blood pressure, height, weight, waist circumference and calculated body mass index will also be measured. Screening for obstructive sleep apnoea using a questionnaire will be conducted at the first appointment only. Each consultation may take approximately 45 to 60 minutes. The length of the consultation will depend on the findings from the assessment. Only one cohort will be recruited. Although community pharmacists have previously provided programs in-store to help support mental health consumers, there are insufficient published data on pharmacists providing metabolic monitoring for mental health consumers on medications with high risk of metabolic syndrome. This study is expected to explore the feasibility of community pharmacists in conducting physical health monitoring (that includes metabolic monitoring) in store and explore whether intervention was able to result in any detectable change. We expect our data to at least reveal that the program is feasible in a community pharmacy environment and that consumers find the service accessible and convenient. We also expect that responses will indicate that mental health consumers feel supported in the management of known side effects of second generation anti-psychotic use (e.g. weight gain) and any trend towards differences in metabolic responses to the initial baseline findings. Findings from each session will be discussed with the consumer by the pharmacist and advice (including diet or lifestyle) will be provided where necessary. Should it be required, referrals will be made to participant's regular doctor will be made and the pharmacist will communicate the findings with participant's regular doctor and arrange for a follow-up appointment.
Interventions
Stage 1: Pharmacist Training The study will be conducted at community pharmacies in Australia, these pharmacies will vary in demographic population and physical location and will include both metropolitan and rural sites. Prior to the commencement of the study, site pharmacists will be required to complete an online training. The training will be facilitated by researcher TB and content will be delivered by multiple personnel who are professionals within the area (dietician, psychologist, diabetes educator and peer practitioner). Contents will be pre-recorded (4 x 1 hour sessions) short videos. Site pharmacists will be required to complete an assessment upon the completion of the training program. Pharmacist will have access to the pre-recorded online training materials for the entire duration of the project and can complete the training at their own pace. They can also re-visit the content if required even after they have successfully completed the training. Training content was designed by the research team specifically for this study. This was done through the review of existing literature and collaboration with trainers. Content includes: 1. Understanding of study procedures and aims - How to use the electronic templates provided (i.e data collection sheet and referral letter) - Familiarisation with the physical health monitoring procedure guidelines - Familiarisation with the STOP-Bang Questionnaire for sleep apnoea risk assessment - When referral is required and need for documentation 2. Effective communication with mental health consumers - Understanding of consumer’s experiences - What to do in case of a mental health crisis - Identifying online resources and support hotlines - Counselling and strategic goal planning in lifestyle and behavioural factors for consumers with mental health - Motivational interviewing skills including open-ended questions, affirmations, reflection and summaries 3. Monitoring of metabolic parameters - Antipsychotics and their effect on metabolism and glycaemic management. - Confidence in collection of plasma glucose and serum lipid levels - Safe disposal of sharps - Interpretation of results 4. Provision of basic nutritional advice - Identifying available online nutrition resources for patient information? - Identifying challenges in behavioural changes and strategies to support patients - Introduction to Australian guidelines to healthy eating Overall duration of Stage 1 is two months, pharmacists must notify principal researcher (TB) of their completion, TB will then grant approval for stage 2 to commence. Pharmacists are expected to complete Stage 1 at least 24 hours prior to start of Stage 2. Stage 2: Implementation of the program Consumers (age 18 years or older) with a diagnosis of a mental health condition and taking at least one second generation antipsychotic medication long term can participate in this program. Participants will be required to attend a total of five consultations with the pharmacist (baseline review then every 3 months thereafter for a total duration of 12 months). The sessions will involve an assessment of medical history, lifestyle factors and measurement of blood glucose and cholesterol level involving finger prick tests. Blood pressure, height, weight, waist circumference and measure body mass index. As obstructive sleep apnoea (OSA) is a manifestation of the metabolic syndrome, participants will also be screened for OSA during their physical health monitoring (at the first appointment only). All of these parameters will be measured by a pharmacist who has completed the training (mentioned above). Findings from each session will be discussed with the consumer by the pharmacist and tailored verbal and written health information consistent with the patient’s needs (including lifestyle) will be offered where necessary. Tailored verbal and written information will be provided by the pharmacists and will be based on the pharmacist's professional judgement and practice expertise. Community pharmacists are already involved in providing health information to customers on a day to day basis. Should it be required, referral to participant’s regular doctor will be made and the pharmacist will communicate the findings with participant’s nominated doctor and arrange for a follow-up appointment. Anticipated duration of each session may vary depending on whether it's a baseline review or a follow-up review. It is anticipated that the first session (baseline review) may take longer (approx 40 minutes) and subsequent follow ups may be shorter in duration (20 mins). Participant's adherence to the intervention (e.g following set lifestyle goals) will be assessed at each follow-up session by the pharmacists. This will be achieved through discussion with the participants and monitoring of metabolic parameters. Pharmacist's recruitment progress will be assessed by researcher TB monthly via face to face and/or email correspondence. Pharmacists will have a session attendance checklists that they can mark off once participants have attended the session. Reminder emails will be sent to the pharmacists 2 weeks prior to when the participant is due for their follow up sessions (at 3,6,9 and 12 months) by researcher TB.
Sponsors
Study design
Eligibility
Inclusion criteria
Community pharmacies that meet the following criteria will be eligible to participate as a study site: 1. Have a private counselling area in the pharmacy that is separate to the common pharmacy area 2. Capacity to perform regular follow ups Consumers who meet the following criteria are eligible to participate in this study as participants: 1. Age above or equal to 18 years old 2. Able to give written informed consent 3. Diagnosed with a mental illness and currently taking at least one second generation antipsychotic (SGA) on a regular basis
Exclusion criteria
People who are pregnant and/or unable to give informed consent will be excluded from the study.