Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000268842
Ethics application status
Approved
Date submitted
13/01/2021
Date registered
11/03/2021
Date last updated
22/10/2021
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The acceptability of a pharmacist-led intervention on polypharmacy in older adults.
Scientific title
Feasibility and acceptability of a novel pharmacist-led intervention to manage inappropriate polypharmacy in older adults presenting to general practice.
Secondary ID [1] 302002 0
None
Universal Trial Number (UTN)
U1111-1256-5807
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 318658 0
Condition category
Condition code
Public Health 316676 316676 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feasibility/acceptability trial.

Physical or informational materials that will be used in the intervention:
Patient reported outcome measure - Living with Medicine version 3 (LMQ3) questionnaire
Practitioner reported questionnaire - Attitudes Towards Collaboration Instruments for General Practitioners (ATCI-GP) questionnaire

Each of the procedures, activities, and/or processes used, including any enabling or support activities:
1. Polypharmacy information technology tool
The study will utilize the MidCentral District Health Board based computerized polypharmacy information technology tool which searches New Zealand Ministry of Health provided national pharmaceutical claims data, to identify and triage polypharmacy adults aged 65 years and over who were dispensed 11 or more unique long-term medications enrolled at the participating general practice clinic.

2. Presentation to participating general practice team
The general practice GPs, Nurse Practitioners and managers will be offered a researcher and clinical pharmacist-led training session to:
• Discuss the clinic’s polypharmacy trends.
• Provide polypharmacy education and rational medication use guidelines.
• Formulate a consensus for a clinic action plan to reduce inappropriate polypharmacy for their patients.

3. Medication Therapy Assessment
Intervention patient participants will be provided a 30-minute clinical pharmacist-led Medication Therapy Assessment (MTA) in partnership with their GP/Nurse Practitioner, at their general practice.
A MTA is a core medication management service provided by clinically experienced, MTA accredited pharmacists as part of their working roles within multidisciplinary healthcare teams. MTAs are “a systematic, patient-centered clinical assessment of all medicines currently taken by a patient” (1). The clinical pharmacist will meet with the patient to discuss their medications and individual therapy goals. Then, utilizing their knowledge of medications, develop a patient centered medication treatment plan. In this study, the goals of the MTA will be to:
- Rationalize and reduce inappropriate polypharmacy.
- Identify, resolve and avoid medication related problems.
- Improve the effectiveness of the patient’s medication therapy.
The protocol to conduct MTAs was based on guidelines from Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model (2) and involves:
1. Meeting with the patient and reviewing their clinical information.
2. Evaluating patient characteristics such as literacy level which may affect their health or medication outcomes.
3. Evaluating whether any patient symptoms could be attributed to the adverse effects or interactions from their medications.
4. Interpreting, assessing and monitoring patient laboratory results.
5. Assessing, detecting, and prioritizing patient medication concerns including inappropriate polypharmacy, inappropriate medications, dosage or regimens, adverse effects, contraindications, or interactions.
6. Working with the patient to develop a mutually agreed plan to resolve identified medication issues.
7. Providing patient medication education and training.
8. Monitoring, follow-up, and evaluating patient medication response.
9. Communicating recommendations to the GP/Nurse Practitioner and other healthcare professionals.

Pharmacist recommendations following the MTA will be discussed with the participant’s GP/Nurse Practitioner in person and through electronic task messages within the practice management system. The GP/Nurse Practitioner will be free to accept or decline the pharmacist’s recommendations.
After the MTA, 30-minutes will be allocated for patient participants to be interviewed and complete the Living with Medicines Questionnaire version 3 (LMQ3), a 41 item Patient Reported Outcome Measure questionnaire (3) to evaluate their health and medicine use.

4. Follow-up
After 8-weeks, patient participants will meet with the researcher again at the clinic for a follow up 30-minute interview and LMQ-3 questionnaire. Changes to LMQ-3 scores will be used to evaluate health/medicine use.

5. Study Conclusion
At study conclusion, clinic GPs and Nurse Practitioners will be posted an anonymous 5-minute, 13 item Attitudes Towards Collaboration Instruments for General Practitioners (ATCI-GP) questionnaire (4) to complete which evaluate GP/Nurse Practitioner experience of the pharmacist’s integration and impact on polypharmacy/health outcomes. Completed questionnaires will be returned to the researcher by paid return post.

References
1. Pharmaceutical Society of New Zealand. Medicines Therapy Assessment [Internet]. New Zealand: Pharmaceutical Society of New Zealand; 2021. Available from: https://www.psnz.org.nz/college/accreditation/mta
2. American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model [Internet]. United States of America: American Pharmacists Association and the National Association of Chain Drug Stores Foundation; 2008. Available from: https://www.pharmacist.com/sites/default/files/files/core_elements_of_an_mtm_practice.pdf
3. Katusiime B, Corlett S, Krska J. Development and Validation of a Revised Instrument to Measure Burden of Long-term Medicines Use: the Living with Medicines Questionnaire version 3. Patient Relat Outcome Meas. 2018; 9: 155-168
4. Van C, Costa D, Mitchell B, Abbott P, Krass I. Development and Validation of a Measure and a Model of General Practitioner Attitudes Toward Collaboration with Pharmacists. Res Social Adm Pharm. 2019; 6(6): 688-699

Who will deliver the intervention and their expertise:
Clinical pharmacist with:
- Greater than 2 years' experience working in general practice providing patient centered Medication Therapy Assessments.
- Postgraduate qualification in clinical pharmacy.

The mode of delivery:
Face to face provided individually between participant and clinical pharmacist.

The number of times the intervention will be delivered and over what period of time:
Patient participants will be offered one 30-minute Medication Therapy Assessment session with the clinical pharmacist.

Location where the intervention occurs: urban general practice clinic
Intervention code [1] 318360 0
Prevention
Intervention code [2] 319683 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324841 0
Primary outcome: Patient participant recruitment rate.
Method of assessment:
Patient participant recruitment will be tracked by the researcher. The recruitment rate is calculated using number of eligible patients who consented to participate versus the total number of eligible patients (over the age of 65 years who were dispensed 11 or more medications) enrolled in the clinic, measured using the MidCentral District Health Board based polypharmacy IT tool.
Timepoint [1] 324841 0
1-month after intervention commencement
Primary outcome [2] 326452 0
Primary Outcome: Inclusion/exclusion rates.
Method of assessment:
Number for referrals from general practice, assessed using general practice records
Versus number of referred patients eligible after screening using study inclusion criteria.
Versus number of referred patient excluded after screening using study inclusion criteria.
Reasons for referred patients to be excluded after screening assessed using general practice records.
Timepoint [2] 326452 0
1-month after intervention commencement
Primary outcome [3] 326454 0
Primary outcome: Success/refusal rates.
Method of assessment:
As tracked by the researcher:
Number for referrals from general practice assessed using general practice records.
Versus number of patients that agree to participate after being referred.
Versus number of patients that do not participate after being referred.
Reasons for patients not to participate/barriers to participation assessed through researcher field notes.
Timepoint [3] 326454 0
1-month after intervention commencement
Secondary outcome [1] 385898 0
Primary outcome: Adherence of participants to study protocol.
Method of assessment:
Researcher field notes: Number of participants that did not complete the Medication Therapy Assessment and Living with Medicines Questionnaire version 3 to its entirety.
Reasons for patient non-adherence to study protocol assessed through patient interview analyzed using thematic analysis.
Timepoint [1] 385898 0
8-weeks after intervention commencement
Secondary outcome [2] 391535 0
Primary outcome: Length of time to complete study intervention.
Method of assessment:
Researcher field notes:
Minimum and maximum time taken for participants to complete the Medication Therapy Assessment.
Minimum and maximum time taken for participants to complete the Living with Medicines Questionnaire version 3.
Timepoint [2] 391535 0
8-weeks after intervention commencement
Secondary outcome [3] 391536 0
Primary outcome: Retention rate of participants.
Method of assessment:
Researcher field notes:
The number of signed Consent Forms versus the number of participants contacting the researcher requesting to be removed from the study.
Reasons for participant withdrawal analysed through researcher field notes.
Timepoint [3] 391536 0
8-weeks after intervention commencement
Secondary outcome [4] 391537 0
Primary outcome: Can the information technology used effectively collect and manage data.
Method of assessment:
Polypharmacy patients identified using the MidCentral District Health Board polypharmacy IT tool compared to general practice patient records.
Timepoint [4] 391537 0
At intervention commencement
Secondary outcome [5] 391538 0
Primary Outcome: Participant understanding of the intervention and questionnaire.
Method of assessment:
Clarification questions asked by participants regarding the Medication Therapy Assessment and the Living with Medicines Questionnaire version 3, through patient interview analyzed using thematic analysis.
Timepoint [5] 391538 0
At intervention commencement and 8-weeks after intervention commencement (primary timepoint)
Secondary outcome [6] 391539 0
Primary outcome: Participant ability to complete the intervention and questionnaire.
Method of assessment:
Participant challenges observed or stated when completing the Medication Therapy Assessment and the Living with Medicines Questionnaire version 3 through patient interview analyzed using thematic analysis.
Timepoint [6] 391539 0
At intervention commencement and 8-weeks after intervention commencement (primary timepoint)
Secondary outcome [7] 391540 0
Primary outcome: Appropriateness of the location to deliver the intervention.
Method of assessment:
Any participant issues with the space allocated for delivering the intervention (such as availability, space, privacy, accessibility) through patient interview analyzed using thematic analysis.
Timepoint [7] 391540 0
At intervention commencement and 8-weeks after intervention commencement (primary timepoint)
Secondary outcome [8] 391541 0
Primary outcome: Acceptability of the intervention for clinicians.
Method of assessment:
Attitudes Toward Collaboration Instrument for GPs questionnaire response/scores by general practice GPs and Nurse Practitioners.
Timepoint [8] 391541 0
8-weeks after intervention commencement
Secondary outcome [9] 391542 0
Composite primary outcome: Participant response to the intervention.
Method of assessment:
Changes in participant Living with Medicines Questionnaire version 3 scores at 8-week follow up.
The number of pharmacist recommendations actioned by GP at 8-week follow up as measured using general practice patient records.
Participant satisfaction with the intervention at 8-week follow up through patient interview analyzed using thematic analysis.
Timepoint [9] 391542 0
At intervention commencement and at 8-weeks after intervention commencement (primary timepoint)
Secondary outcome [10] 391543 0
Primary outcome: Any relevant outcome measures that were not assessed.
Method of assessment: Researcher documentation/field notes of any issues or limitations with outcome measures.
Timepoint [10] 391543 0
8-weeks after study commencement

Eligibility
Key inclusion criteria
Inclusion criteria
- Age 65 or over
- Taking 11 or more unique long term medications each day
- Able to give informed consent
- Currently enrolled as a patient at participating general practice
- GP/Nurse Practitioner clinicians practicing at the participating general practice
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Efficacy
Statistical methods / analysis
Qualitative data including participant interviews will be used to provide insights into experiences of using the intervention. Data can be analyzed using inductive Thematic Analysis with NVIVO 10. Quantitative data such as participant recruitment rate, inclusion/exclusion rates, length of time to complete the intervention will be analyzed as percentages

The study was designed to test the feasibility of the intervention to guide the planning of a full-scale evaluation. Furthermore, it will not be used to estimate parameters with accuracy. Therefore, the study did not require a sample size calculation, and the number of participants was pragmatically determined based on the study’s timeline, resources available, and a sample size for sufficient data on feasibility outcomes to be collected. Based upon comparable study protocols that evaluate the feasibility of interventions to improve polypharmacy for older adults in primary care (1), a target of ten participants was deemed satisfactory to meet the objectives of the study.

Reference
1. Rankin A, Cadogan C, Barry H, Gardner E, Agus A, Molloy G, Goman A, Ryan C, Leathem C, Maxwell M, Gormley G, Ferrett A, McCarthy P, Fahey T, Hughes C. An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (Polyprime): study protocol [Internet]. ResearchSquare; 2020. Available from: https://www.researchgate.net/publication/344717716_An_External_Pilot_Cluster_Randomised_Controlled_Trial_of_a_Theory-based_Intervention_to_Improve_Appropriate_Polypharmacy_in_Older_People_in_Primary_Care_Polyprime_Study_Protocol

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2021
Actual
12/05/2021
Date of last participant enrolment
Anticipated
30/04/2021
Actual
31/05/2021
Date of last data collection
Anticipated
15/07/2021
Actual
17/08/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 22858 0
New Zealand
State/province [1] 22858 0
Manawatu/Mid-Central

Funding & Sponsors
Funding source category [1] 306422 0
Self funded/Unfunded
Name [1] 306422 0
Lisheng Liu
Country [1] 306422 0
New Zealand
Primary sponsor type
Individual
Name
Lisheng Liu
Address
MidCentral District Health Board
Heretaunga Street, Palmerston North 4414
Country
New Zealand
Secondary sponsor category [1] 306933 0
None
Name [1] 306933 0
Address [1] 306933 0
Country [1] 306933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306619 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 306619 0
Ethics committee country [1] 306619 0
New Zealand
Date submitted for ethics approval [1] 306619 0
01/12/2020
Approval date [1] 306619 0
12/01/2021
Ethics approval number [1] 306619 0
20/STH/238

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104490 0
Mr Lisheng Liu
Address 104490 0
MidCentral District Health Board
Heretaunga Street, Palmerston North 4414
Country 104490 0
New Zealand
Phone 104490 0
+64 7 270 1871
Fax 104490 0
Email 104490 0
[email protected]
Contact person for public queries
Name 104491 0
Lisheng Liu
Address 104491 0
MidCentral District Health Board
Heretaunga Street, Palmerston North 4414
Country 104491 0
New Zealand
Phone 104491 0
+64 6 359 4264
Fax 104491 0
Email 104491 0
[email protected]
Contact person for scientific queries
Name 104492 0
Lisheng Liu
Address 104492 0
MidCentral District Health Board
Heretaunga Street, Palmerston North 4414
Country 104492 0
New Zealand
Phone 104492 0
+64 6 359 4264
Fax 104492 0
Email 104492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.