ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000567426

Ethics application status

Approved

Date submitted

7/05/2025

Date registered

3/06/2025

Date last updated

3/06/2025

Date data sharing statement initially provided

3/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of a pharmacist-led intervention on medication adherence and the quality use of medicines in people using clozapine attending the Colombo south teaching hospital, Sri Lanka

Scientific title

The effect of a pharmacist-led intervention on medication adherence and the quality use of medicines in people using clozapine attending the Colombo south teaching hospital, Sri Lanka

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Patients with Schizophrenia

Condition category

Condition code

Mental Health

Schizophrenia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention
Medication history and reconciliation
For each outpatient included in the study, the PhD candidate will obtain the most accurate best possible medication history, beginning with the most recent medication list available on the clinic’s medication card. This card, which the patient takes to the pharmacy to obtain their medications, includes a medication list covering the previous 5–6 months. The list was initially compiled by the treating doctor in accordance with standard hospital procedures, the clinical knowledge, skills and experience and was supplemented with additional sources, including: (i) handwritten medical records kept by the patient, (ii) handwritten medical records maintained at the hospital for individual patients who regularly attend the clinic, and (iii) information gathered through patient conversations or interviews conducted during clinic visits or upon admission. This whole appointment will take approximately 30 minutes including history taking, assessing their level of understanding of medications and delivering patient education. One meeting will be conducted with each patient every four weeks for four months.

A structured conversation with the patient or carer will be conducted to clarify current medication use. For each medicine included in the medication list, the current use, dosage, and time of administration will be checked. The PhD candidate will conduct a comprehensive medication reconciliation based on the obtained medication history, patient records, hospital records, and the clinic’s medication card and record any discrepancies identified. Following the medication reconciliation, the physical health check prompt will be used as a conversation starter and their physical health, mental wellbeing and quality of life will be assessed.

Any discrepancies identified during the reconciliation process, as well as any physical health or mental well-being, quality of life issues, will be documented in a adapted medication action plan (MAP) (1). The MAP is a validated tool used in Australia to record a patient’s medication regimen prior to hospital presentation and to document any issues with the regimen following hospital admission or at each clinic visit. It prioritises issues identified by the pharmacist, focusing on urgent clinical concerns, such as cases where a patient has stopped taking clozapine. For each identified issue, the pharmacist includes proposed actions such as medication dose adjustments, omission of any medication if it’s unnecessary or addition of medication if any untreated condition identified, for example if the patient is really struggling out of constipation, the pharmacist can suggest to the treating team that patient’s dose of medication for constipation can be increased or can be change another group of medication which is available at the hospital and the MAP provides space for the treating doctor to document responses to these recommendations, creating a collaborative, trackable plan. This MAP will be shared with their treating doctor, ensuring that any discrepancies between the clinic’s medication card and the best possible medication list from the medication history, along with any additional physical health concerns, are communicated to the treating doctor.

Based on the presentation of the patient, the treating doctor will be adjusted the prescription in order to provide optimal therapy. The detected discrepancies will be classified according to Pharmaceutical Care Network Europe classification (PCNE) V 9.1 (2).

In Sri Lanka, clozapine treatment in state hospitals follows the Ceylon Hospital Formulary, which is adapted from UK guidelines based on the availability of medications in the country. Therefore, the PhD candidate will follow the Ceylon Hospital Formulary, the British National Formulary (BNF), and the hospital’s clozapine treatment guideline. Furthermore, the PhD candidate will also observe whether the hospital guideline is being followed at the study site and document both the content of the guideline and the actual practices being implemented.

Medication review
Upon consent the PhD candidate will collect the patient’s clinical measures, including weight, body mass index, abdominal girth, and blood pressure, and document these measures in the hospital’s metabolic monitoring chart of the individual patient. Additionally, laboratory investigation results such as blood glucose, lipids (if available with the patient) will be reviewed and compared with the patient’s medical and medication records to monitor metabolic status and to address any other physical health or mental well-being and quality of life issues. Medication charts of the hospital medical records (if needed) and laboratory investigation results will be used from the medical record to conduct the medication review. Any identified issues and recommendations made by the PhD candidate will also be documented in the MAP.

Patient education
All patients will receive both verbal and written education on clozapine, using reputable sources to enhance their knowledge and understanding of the medication (3). The translated information leaflets will be obtained with the necessary approvals and professionally translated through accredited language agencies. The translations and appropriateness or suitability of the content such as available dosage forms in the state sector will be validated by the psychiatrist (one of the supervisors of the PhD candidate) at the study hospital. These leaflets will be used as a guide to educate patients, following the same format observed on the original website (4). Initially patient’s knowledge on clozapine and other medications or their level of understanding of the medications will be assessed by asking simple questions such as “what they are? what are the benefits of taking them? or what will happen if you don’t take them on a regular basis?. Then according to their level of understanding there will be an incremental teaching or education about their medications, such as what are they, why they should take them or the benefits of taking them, what are the possible side effects or what are the side effects commonly reported and how can they manage their side effects if they identify or what they should do if they identify any side effects. Additional tailored education such as non-pharmacological measures to manage side effects, lifestyle modifications will be provided to certain patients based on specific issues identified during their assessment.
This whole appointment will take approximately 30 minutes including history taking, assessing their level of understanding of medications and delivering patient education. One meeting will be conducted with each patient every four weeks for four months.

For each inpatient included in the study, the PhD candidate will visit the patient after their recovery, will try and take best possible medication history, review the medication chart and reconcile the discharge medication list with the hospital records. PhD candidate will also explain the importance of medication persistence, managing side effects, and attending regular follow-ups. The candidate will work to build a strong therapeutic relationship, provide education on clozapine use, and ensure ongoing follow-up with the patient.
References
1. National Medication Management Plan. Accessed at: https://www.safetyandquality.gov.au/our-work/medication-safety/medication-reconciliation/national-medication-management-plan [Internet]. [cited 14.11.2024].
2. PCNE Classification for Drug-Related Problems V9.1. Accessed at: https://www.pcne.org/upload/files/417_PCNE_classification_V9-1_final.pdf [Internet]. [cited 11.11.24].
3. Choice and Medication Patient-Information-Leaflets Queensland Health. Accessed at: https://www.choiceandmedication.org/queenslandhealth/printable-leaflets/patient-information-leaflets/37/ALL/. [cited 21.05.2025].
4. Choice and Medication Patient-Information-Leaflets Queensland Health. Accessed at: https://www.choiceandmedication.org/queenslandhealth/generate/billclozapinearabicau.pdf. [cited 21.05.2025].

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Medication-related problems

Timepoint [1]

Any problems identified for 3 months after the first interview

Secondary outcome [1]

Clozapine knowledge

Timepoint [1]