Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001435875
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
25/10/2021
Date last updated
20/04/2022
Date data sharing statement initially provided
25/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of a pharmacist-led physical health monitoring program for mental health consumers on a regular second generation antipsychotic.
Scientific title
Feasibility of a pharmacist-led physical health monitoring for patients on a second generation antipsychotic: a longitudinal study.
Secondary ID [1] 305052 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome
 323252 0
Mental illness
 323253 0
Condition category
Condition code
Metabolic and Endocrine 320822 320822 0 0
Metabolic disorders
Mental Health 320823 320823 0 0
Psychosis and personality disorders
Mental Health 320824 320824 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321448 0
Early detection / Screening
Intervention code [2] 321654 0
Prevention
Comparator / control treatment
No control group for this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328625 0
The primary outcome is to determine the feasibility of the pharmacist-led intervention. To assess the feasibility of the physical health monitoring, all participating pharmacists will be asked to a telephone interview conducted by the main researchers. Data collected in the interview will include: (i) Likert-scale and, (ii) open-ended questions.
Timepoint [1] 328625 0
At the end of the 12 months implementation
Secondary outcome [1] 399735 0
Determine the number of referrals to general practitioners assessed by audit of pharmacist records.

Timepoint [1] 399735 0
At the end of the 12 months implementation
Secondary outcome [2] 399736 0
Any change in weight assessed by digital weigh scales.
Timepoint [2] 399736 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [3] 399737 0
Determine if the pharmacist-led intervention led to any change in the consumer’s attitudes towards their mental illness assessed by telephone interview.
Timepoint [3] 399737 0
At the end of the 12 months implementation
Secondary outcome [4] 400754 0
Determine the outcomes of patient referrals to GPs by auditing pharmacist records.
Timepoint [4] 400754 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [5] 400820 0
Participant’s experience with the community pharmacist-led physical health monitoring, will be assessed by telephone interview
Timepoint [5] 400820 0
At the end of the 12 months implementation
Secondary outcome [6] 401666 0
Any change in waist circumference assessed by tape measure.
Timepoint [6] 401666 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [7] 401667 0
Any change in body mass index (BMI = kg/m squared). Weight will be measured by digital scale and height measured using stadiometer.

Timepoint [7] 401667 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [8] 401668 0
Any change in serum lipid levels assessed using a cholesterol measuring meter.
Timepoint [8] 401668 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [9] 401669 0
Any change in serum glucose levels assessed using a glucose meter.
Timepoint [9] 401669 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [10] 401670 0
Any change in blood pressure assessed using a blood pressure monitor.
Timepoint [10] 401670 0
Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.
Secondary outcome [11] 401671 0
Assess the risk of sleep apnoea using a validated questionnaire (STOP-Bang Questionnaire).
Timepoint [11] 401671 0
Baseline only.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are pregnant and/or unable to give informed consent will be excluded from the study.


Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative outcomes will be analysed using IBM Statistics SPSS software. To test for changes overtime, physical and serum parameters will be compared between each visit (from baseline up until last follow up session) using regression analysis. Additional statistical tests may be employed as appropriate depending on the nature of the data. Statistical significance will be at a 0.05. Qualitative outcomes will be analysed via thematic analysis. As this is a feasibility study, there will be no set sample size.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA,WA

Funding & Sponsors
Funding source category [1] 309448 0
University
Name [1] 309448 0
University of South Australia
Country [1] 309448 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 310415 0
None
Name [1] 310415 0
Address [1] 310415 0
Country [1] 310415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309241 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 309241 0
University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.
Ethics committee country [1] 309241 0
Australia
Date submitted for ethics approval [1] 309241 0
Approval date [1] 309241 0
10/12/2020
Ethics approval number [1] 309241 0
203433

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113462 0
Miss Tien Bui
Address 113462 0
University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.
Country 113462 0
Australia
Phone 113462 0
+61 8 8302 1130
Fax 113462 0
Email 113462 0
[email protected]
Contact person for public queries
Name 113463 0
Miss Tien Bui
Address 113463 0
University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.
Country 113463 0
Australia
Phone 113463 0
+61 8 8302 0150
Fax 113463 0
Email 113463 0
[email protected]
Contact person for scientific queries
Name 113464 0
Miss Tien Bui
Address 113464 0
University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.
Country 113464 0
Australia
Phone 113464 0
+61 8 8302 0150
Fax 113464 0
Email 113464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All shared data will be de-identified and will not contain names of participants.

Feedback from telephone interviews with participants and pharmacists will be shared. Other shared findings from consultations includes - changes in metabolic parameters mentioned previously over time, number of GP referrals made and outcome of GP referrals.
When will data be available (start and end dates)?
Beginning and end dates for when the data is expected to be available immediately following publication and ending 5 years following main results publication.
Available to whom?
Data will be available only to researchers who provide a methodologically sound proposal at the discretion of the authors.
Available for what types of analyses?
Available for any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Email: [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a pharmacist-led physical health monitoring for patients on antipsychotic medications: Protocol for a longitudinal study.2022https://dx.doi.org/10.1136/bmjopen-2021-059573
N.B. These documents automatically identified may not have been verified by the study sponsor.