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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Metabolic syndrome

Mental illness

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Mental Health

Psychosis and personality disorders

Mental Health

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]

Early detection / Screening

Intervention code [2]

Prevention

Comparator / control treatment

No control group for this study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the end of the 12 months implementation

Secondary outcome [1]

Determine the number of referrals to general practitioners assessed by audit of pharmacist records.

Timepoint [1]

At the end of the 12 months implementation

Secondary outcome [2]

Any change in weight assessed by digital weigh scales.

Timepoint [2]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [3]

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]

At the end of the 12 months implementation

Secondary outcome [4]

Determine the outcomes of patient referrals to GPs by auditing pharmacist records.

Timepoint [4]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [5]

Participant’s experience with the community pharmacist-led physical health monitoring, will be assessed by telephone interview

Timepoint [5]

At the end of the 12 months implementation

Secondary outcome [6]

Any change in waist circumference assessed by tape measure.

Timepoint [6]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [7]

Any change in body mass index (BMI = kg/m squared). Weight will be measured by digital scale and height measured using stadiometer.

Timepoint [7]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [8]

Any change in serum lipid levels assessed using a cholesterol measuring meter.

Timepoint [8]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [9]

Any change in serum glucose levels assessed using a glucose meter.

Timepoint [9]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [10]

Any change in blood pressure assessed using a blood pressure monitor.

Timepoint [10]

Baseline, 3 months, 6 months, 9 months and 12 months after intervention commencement.

Secondary outcome [11]

Assess the risk of sleep apnoea using a validated questionnaire (STOP-Bang Questionnaire).

Timepoint [11]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

SA,WA

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/12/2020

Ethics approval number [1]

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

Miss Tien Bui

Address

University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.

Country

Australia

Phone

+61 8 8302 1130

Fax

buitn001@mymail.unisa.edu.au

Contact person for public queries

Name

Tien Bui

Address

University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.

Country

Australia

Phone

+61 8 8302 0150

Fax

buitn001@mymail.unisa.edu.au

Contact person for scientific queries

Name

Tien Bui

Address

University of South Australia, Bradley Building, City West Campus, 61-68 North Terrace, Adelaide SA 5000.

Country

Australia

Phone

+61 8 8302 0150

Fax

buitn001@mymail.unisa.edu.au

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: buitn001@mymail.unisa.edu.au.

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

Source	Title	Year of Publication	DOI
Embase	Feasibility of a pharmacist-led physical health monitoring for patients on antipsychotic medications: Protocol for a longitudinal study.	2022	https://dx.doi.org/10.1136/bmjopen-2021-059573

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically