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Trial registered on ANZCTR


Registration number
ACTRN12618001105235p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2018
Date registered
3/07/2018
Date last updated
3/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhanced intervention to improve medication adherence in a community pharmacy setting
Scientific title
Three-arm comparison of an enhanced tailored adherence intervention to an educational adherence program and usual care in a community pharmacy setting: a cluster randomized controlled trial
Secondary ID [1] 295197 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 308290 0
Metabolic disorders 308291 0
Chronic obstructive pulmonary disease 308292 0
Depression 308293 0
Medication Adherence 308448 0
Condition category
Condition code
Cardiovascular 307296 307296 0 0
Hypertension
Metabolic and Endocrine 307297 307297 0 0
Metabolic disorders
Respiratory 307298 307298 0 0
Chronic obstructive pulmonary disease
Mental Health 307299 307299 0 0
Depression
Public Health 307427 307427 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Patient tailored brief complex interventions with monthly follow-up over 12 months to improve, reinforce and maintain adherence behaviour and their impact in clinical, economical and humanistic outcomes.
Arm 2: GuildLink software educational intervention as a guided counseling session to improve adherence behaviour and their impact in clinical, economical and humanistic outcomes.

Arm 1: The enhanced intervention is a brief complex intervention delivered once to eligible patients as identified through the GuildCare software by which aims to optimise medicines use on a systematic and regular basis.

Community pharmacists will be trained in two four-hour sessions on the study process, data collection, and behavioural change theoretical framework by study investigators trained in practice change facilitation. The training will be delivered via power point with printed materials and motivational interviewing practice sessions.

The face-to-face pharmacist-delivered adherence service (evidenced based intervention adapted from interventions for enhancing medication adherence a systematic review by Cochrane) has several interacting components based on a sequence of principles that imply over an estimated 10-minute session:
(1) the identification of non-adherent patients
(2) adherence assessment and the classification of the patient according to the type of non-adherence presented (intentional or non-intentional) based on the Morisky 4-item questionnaire
(3) the investigation of the specific barriers leading to the specific behaviour
(4) the provision of a pharmacist-intervention targeted to the barriers identified in the individual patient
(5) the assessment of the patient’s readiness to change, combined with
(6) communication and collaboration with the patient’s GP and
(7) a monthly follow-up process to assess progress over 12 months

Pharmacists will determine barriers based on asking the patient questions based on the Moresby 4-item questionnaire. These questions address patients' beliefs about their medication, knowledge of the medication, and if they stop or forget taking their medication ever. Additional questions based on pharmacist discretion (i.e. how often do you for forget to take your medication?) will be asked to further evaluate reasons for non-adherence.

Pharmacist delivered interventions will include one or all of the following based on what barriers were discovered for non-adherence:
- provide verbal information and medicine information pamphlet
- prepare or recommend: medication list, dose administration aid, alarm, cue-dose training
- explain benefits of medication as well as risks of non-adherence
- address misunderstandings or probability of side effects and ways to mange
- additional information or tools available under the pharmacist's discretion

Readiness to change will be based on the pharmacist's discretion, which we will address in the training sessions using the Transtheoretical Model.

The participant will only be involved in short, 10-minute monthly sessions when at the pharmacy to pick up their medications. If they so choose, they can opt into pharmacy repeat fill reminders to send an SMS or phone call monthly when their prescription is ready.

Arm 2: Two software programs: NTT and MedScreen Compliance guide an estimated one-time, 10-minute face-to-face pharmacist-patient interactions to enhance adherence. The NTT program is a pharmacist intervention provided to patients who are initiating on a medication for the first time. It provides information on how to take/use the medication to achieve ultimate health outcomes as well as medication adherence guidance with an optional monthly follow-up reminder to refill the medication. A software program guides a pharmacist and allows documentation of a patient’s response and understanding, made from readily available resources already used in pharmacies subscribed to the GuildCare software. In addition, a pharmacist can document a clinical intervention, including compliance or education issues, and recommendation made. Under the Community Pharmacy Agreement Pharmacy Practice Incentive Programme, pharmacies may be eligible to receive an incentive payment for conducting clinical interventions. This is already included in standard dispensing for pharmacies prescribed to the GuildCare software. Please find clinical interventions listed on the Pharmaceutical Society of Australia website here: https://www.psa.org.au/practice-standards/pharmacists-performing-clinical-interventions.

The MedScreen Compliance and Compliance program creates a guided face-to-face pharmacist and patient interaction to target non-adherent patients and increase medication adherence. The software calculates the patient's MedsIndex score, an already readily available resource from the dispensing data collected in the GuildCare software, which represents how much medicine the doctor intended the patient to take compared to the actual interval between the patients dispense dates. A score out of 100 is calculated to indicate the patient's level of compliance with their prescribed regimen. The software program guides a pharmacist through the following steps and allows documentation of a patient’s response and understanding. In addition, a pharmacist can document a clinical intervention and recommendation made. No follow-up is initiated.
• Simple support session with the patient where the pharmacist discusses any real or perceived barriers to adherence
• Relevant patient handouts such as Consumer Medicines Information (CMI), sets goals for their treatment targets
• Patient one off follow-up options such as SMS, email, phone calls by GuildLink Pty Ltd. pharmacists to remind the patient their next medication dispense is due so they do not run out of medication at home.

Phamacists in the GuildLink programs will be trained in the study process and data collection only.

Fidelity of both intervention arms will be assessed by audio recording, signed by a patient and pharmacist consent form. At least 10 intervention sessions of each intervention arm will be monitored and assessed by a member of the research team. The patient name will not be mentioned in the recording or if so, the pharmacist will erase the mention of the name. A poster will also be displayed in the pharmacy in a prominent location providing information of the project for quick viewing.
Intervention code [1] 301503 0
Behaviour
Comparator / control treatment
Patients in the control group will follow the same 12 monthly interviews with the pharmacist but only sociodemographic and clinical control data will be collected and usual care will be provided. By usual care it means the safe supply of medicines and medication-taking advice to the patient without involving theoretical framework.

Pharmacists in the control group will be trained on the study process and data collection only.
Control group
Active

Outcomes
Primary outcome [1] 306252 0
Medication Adherence: medication possession ratio (MPR) in all arms. This data will be collected from the GuildCare software dispensing records (prescription dispense dates).
Timepoint [1] 306252 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Primary outcome [2] 306253 0
Calculation of percentage of Proportion of Days Covered (PDC) in all arms. This data will be collected from the GuildCare software dispensing records (prescription dispense dates). 'Days Covered' are determined by the formula in PDC, adding total days dispensed over a period of time. This accounts for gaps in the dispense records if patients pick up their dispensed medication early.
Timepoint [2] 306253 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Primary outcome [3] 306301 0
Self-report of adherence by Morisky 4-item questionnaire
Timepoint [3] 306301 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [1] 347993 0
For hyperlipidemia, total cholesterol will be measured using blood test with a cholesterol meter (total cholesterol levels).
Timepoint [1] 347993 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [2] 348110 0
For COPD, a Clinical COPD Questionnaire (CCQ) will be asked to patients
Timepoint [2] 348110 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [3] 348111 0
For Hypertension (HBP), control of the disease will be done by the measurement of Blood pressure levels using a digital blood pressure monitor.
Timepoint [3] 348111 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [4] 348112 0
For Humanistic Outcomes: Quality of Life will be measured by the EuroQol-5D-5L
Timepoint [4] 348112 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [5] 348113 0
Number of medications and their cost based on Australian Medicare data will be used to assess costs associated with non-adherence and the intervention effects.
Timepoint [5] 348113 0
Every 3 months over 12 months from baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [6] 348114 0
For depression: Psychological Health Questionnaire (PHQ-9) catgorizes severity.
Timepoint [6] 348114 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [7] 348349 0
Number of hospital admissions will be measure with Australian Medicare data to determine the intervention effects on cost to the healthcare system.
Timepoint [7] 348349 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.
Secondary outcome [8] 348350 0
Time of training and average time spent for the pharmacist on the interview and average time PCF supporting interventional pharmacists will be measured by pharmacy and researcher records to measure the cost associated with the intervention.
Timepoint [8] 348350 0
Every 3 months over 12 months starting at baseline, with primary timepoint being 12 months post baseline.

Eligibility
Key inclusion criteria
Age > 18 years
Signed consent form
Signed data linkage consent form
Able to complete questionnaires
Prescribed either/or a blood pressure, cholesterol, depression, anxiety or COPD medication
Eligibility identified via GuildCare software
MPR < 70%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Collecting someone else’s medication
Communication limitations or any other impairment the recruiting pharmacist considers could preclude them from participating

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent researcher will assign pharmacies after they agree to participate in the study to either intervention group or control group using a computer-generated list of random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher will assign pharmacies after they agree to participate in the study to either intervention group or control group using a computer-generated list of random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculation of the sample size is based on the assumed effect of the enhanced intervention with an increased adherence rate of 10% for each of the disease type (as identified via specific program numbers). The calculation is further based on the following assumptions:
• the power of the study to detect a true effect: 80%
• type I error rate: 5%
• ratio between intervention and control arms: 1:1:1
• one-tailed significance test for hypothesis.

For the calculation of the design effect (DE), the following are assumed:
• average cluster size: 10 (patients per pharmacy)
• intraclass correlation coefficient: 0.05
• each type of disease and condition is independent in terms of their mediating behaviour as well as each sub-population of patients is also independent from others.
We are assuming an additional 20% for lost to follow up.

Total patients: 686
Total pharmacies: 69

The selected pharmacies will be distributed in control or intervention groups using a 1:1:1 ratio from a list of random numbers. Each pharmacy will include a minimum of 10 patients with at least 2 patients on each molecule. The inclusion of more patients will be possible by pharmacist judement.

The quantitative data from interviews and databases will be coded and entered into the statistical data package SPSS. Mean and standard variables will be used to summarise quantitative variables. To compare quantitative variables, tests for independent samples will be used. T-test analysis will be performed for comparisons of proportions between independent groups. The qualitative data from interviews and participant observation will be analysed using SPSS statistics software. Qualitative variables will be described using frequencies and percentages.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
686
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299754 0
University
Name [1] 299754 0
University of Technology Sydney
Country [1] 299754 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 299137 0
Other
Name [1] 299137 0
GuildLink Pty Ltd
Address [1] 299137 0
301/151 Castlereagh St, Sydney NSW 2000
Country [1] 299137 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300644 0
UTS Human Research Ethics Committee (HREC)
Ethics committee address [1] 300644 0
Ethics committee country [1] 300644 0
Australia
Date submitted for ethics approval [1] 300644 0
18/03/2018
Approval date [1] 300644 0
Ethics approval number [1] 300644 0

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

Contacts
Principal investigator
Name 84322 0
Dr Victora Garcia-Cardenas
Address 84322 0
University of Technology Sydney
Graduate School of Health
PO Box 123 Broadway NSW 2007 Australia
Country 84322 0
Australia
Phone 84322 0
+61 (02) 9514 9297
Fax 84322 0
Email 84322 0
victoria.garciacardenas@uts.edu.au
Contact person for public queries
Name 84323 0
Elyssa Wiecek
Address 84323 0
University of Technology Sydney
Graduate School of Health
PO Box 123 Broadway NSW 2007 Australia
Country 84323 0
Australia
Phone 84323 0
+61 (02) 9514 9223
Fax 84323 0
Email 84323 0
elyssa.wiecek@uts.edu.au
Contact person for scientific queries
Name 84324 0
Elyssa Wiecek
Address 84324 0
University of Technology Sydney
Graduate School of Health
PO Box 123 Broadway NSW 2007 Australia
Country 84324 0
Australia
Phone 84324 0
+61 (02) 9514 9223
Fax 84324 0
Email 84324 0
elyssa.wiecek@uts.edu.au

No information has been provided regarding IPD availability


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
No additional documents have been identified.