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Enhanced intervention to improve medication adherence in a community pharmacy setting

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001105235
Enrollment
686
Registered
2018-07-03
Start date
2018-09-03
Completion date
Unknown
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients are reported to be largely non-adherent to their medication, with medication non-adherence rates ranging from 30-70% among patients with chronic conditions. The Medication Adherence Service aims to develop, implement and evaluate a professional pharmacy service that is focused on increasing patient adherence whilst simultaneously examining the corresponding economic, clinical and humanistic implications the intervention poses. The research project proposes that a brief complex intervention tailored to the patient’s requirements performed on a regular basis during the dispensing process will improve patients’ adherence. The research project will be conducted in conjunction with GuildLink Pty. Ltd. a wholly owned subsidiary of the Pharmacy Guild of Australia, through use of their GuildCare software. A cluster randomised control trial will be conducted utilising a mixed method approach combining quantitative and qualitative data. The study aims to assess the impact that an enhanced intervention has on medication adherence when compared with usual care and the current adherence intervention provided through utilisation of GuildCare software.

Interventions

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 ident

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.

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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%

Exclusion criteria

Collecting someone else’s medication Communication limitations or any other impairment the recruiting pharmacist considers could preclude them from participating

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026