Clinical trial NCT04023734: A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Diabetes Patients
Official title: A Targeted and Tailored Pharmacist Intervention to Improve Adherence to Antihypertensive Drugs Among Patients With Diabetes in Indonesia: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Medication Nonadherence
Keywords: Medication non-adherence
Type 2 diabetes
Antihypertensive agents
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: Universitas Padjadjaran
First posted: 2019-07-17
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to assess the effect of a targeted and tailored pharmacist intervention on medication adherence among diabetes patients non-adherent to antihypertensive drugs. The secondary objectives are to assess the effect of the intervention on blood pressure level and medication beliefs, and to evaluate the implementation and adoption of the intervention for pharmacists and patients.

Detailed description: Adherence to chronic medication is often suboptimal. However, existing interventions to improve adherence are either too complex or expensive for implementation and scale-up in low-middle income countries and/or not particularly effective.

A cluster randomized controlled trial with 3-months follow-up will be conducted in 10 Community Health Centers (CHCs) in Indonesia. Patients aged ≥18 years, diagnosed with type 2 diabetes and reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in the five CHCs randomized to the intervention group will receive a targeted and tailored pharmacist intervention at baseline (first session) and at 1-month follow-up (second session). The intervention will be low-cost, align with the current CHC workflow and will not require a substantial change to the current system. Before dispensing antihypertensive drugs during the first session, the pharmacist will discuss patient-specific barrier(s) for medication adherence based on their responses on MARS and three additional questions, which are derived from the Brief Medication Questionnaires. The intervention strategies will then be tailored to their identified adherence problems. Based on current literature, the investigators defined four non-adherence problems that can be addressed by the community pharmacist, i.e. (1) forgetfulness, (2) lack of knowledge, (3) lack of motivation or (4) other drug-related problems. Of note, patients might need a combined intervention strategy to address all experienced problems. The four non-adherence problems and recommended intervention strategies are specified below:

1. Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members.
2. The content of the counselling to cope with lack of knowledge will focus on educating patients about about the purpose of the medication, when and how to take the medication, the need for long-term use, the importance of medication adherence, and how to deal with possible side effects. To explore which education is needed, the patient will be asked whether they know why and how to take their medication. The teach-back method will be used, where the patient is asked to explain the pharmacist what he/she has understood after receiving the education.
3. The content of the counselling to cope with lack of motivation will focus on exploring and discussing the patients' concerns and necessity beliefs (motivational interviewing).
4. The content of the counselling to address other drug related problems will focus on exploring other problems underlying the non-adherence, for example experiencing side effects, costs, polypharmacy, difficulty to refill antihypertensive drugs in time, or medication intake problems, and offering solutions/alternatives when possible.

The follow-up session will be conducted in one month after the baseline session, when patients refill their medication at the next regular outpatient visit. The purpose of the follow-up session is (1) to evaluate the short-term effect of the intervention and discuss the patients' implementation of and experiences with the offered information and recommendations, and (2) to address non-adherence problems that were not yet addressed during the first session. Where needed, the pharmacist, together with patient, can make changes to the coping plan and discuss additional interventions. As the quality of the intervention will depend on the competences and skills of the pharmacist, treatment integrity will be enhanced by an obligatory communication training focusing on motivational interviewing and the teach-back method, and by providing supportive material as part of the intervention.

Patients in five CHCs randomized to the control group will receive pharmacist counselling based on the Indonesian guideline of pharmacy practice. At each visit, they can receive information about the quantity and dose of the dispensed drugs, when and how to use and store the drugs, side effects and how to deal with them, the importance of medication adherence, and confirming if the patient understands how to take medications correctly. Patients in the control group will complete all assessments at the same time points as those in the intervention group

The primary study outcome is the difference between intervention and control group in change in total adherence scores using the MARS between baseline and 3 months follow-up. Secondary outcomes are blood pressure (BP), medication beliefs using the Beliefs about Medicines Questionnaire (BMQ)-specific, and evaluate the intervention using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance).

Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* Diagnosed with type 2 diabetes for at least one year based on patient's medical record.
* Using at least one antihypertensive drug in the last three months.
* Provision of signed informed consent.
* Have sub-optimal medication adherence to antihypertensive drugs according to the MARS (\<20).

Exclusion Criteria:

* Patients with severe mental or physical constraints.
* Pregnancy or in the lactation period.
* Illiterate in Indonesian language.
* Enrollment in another intervention study.
* Those not responsible for taking their own medication

Primary outcomes:
measure: Medication adherence
timeFrame: Baseline, 1-month, and 3-month follow-up
Secondary outcomes:
measure: Blood pressure level
timeFrame: Baseline, 1-month, and 3-month follow-up
measure: Medication beliefs
timeFrame: Baseline and 3-month follow-up
measure: Reach
timeFrame: On completion of the final assessments at 3-month follow-up.
measure: Pharmacists' adoption of the intervention
timeFrame: On completion of the final assessments at 1-month follow-up.
measure: Patients' adoption of the intervention
timeFrame: On completion of the final assessments at 3-month follow-up.
measure: Pharmacists' suggestions for future implementation
timeFrame: On completion of the final assessments at 1-month follow-up.
measure: Patients' suggestions for future implementation
timeFrame: On completion of the final assessments at 3-month follow-up.
measure: Pharmacists' willingness to maintain the intervention
timeFrame: On completion of the final assessments at 1-month follow-up.
measure: Patients' willingness to maintain the intervention
timeFrame: On completion of the final assessments at 3-month follow-up.
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Community Health Centers
state: West Java
Study officials:
affiliation: University of Groningen
name: Sofa D Alfian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4.
citation: Kini V, Ho PM. Interventions to Improve Medication Adherence: A Review. JAMA. 2018 Dec 18;320(23):2461-2473. doi: 10.1001/jama.2018.19271.
citation: Cutrona SL, Choudhry NK, Fischer MA, Servi AD, Stedman M, Liberman JN, Brennan TA, Shrank WH. Targeting cardiovascular medication adherence interventions. J Am Pharm Assoc (2003). 2012 May-Jun;52(3):381-97. doi: 10.1331/JAPhA.2012.10211.
citation: van Boven JF, Stuurman-Bieze AG, Hiddink EG, Postma MJ, Vegter S. Medication monitoring and optimization: a targeted pharmacist program for effective and cost-effective improvement of chronic therapy adherence. J Manag Care Spec Pharm. 2014 Aug;20(8):786-92. doi: 10.18553/jmcp.2014.20.8.786.
citation: Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.
citation: Clifford S, Barber N, Horne R. Understanding different beliefs held by adherers, unintentional nonadherers, and intentional nonadherers: application of the Necessity-Concerns Framework. J Psychosom Res. 2008 Jan;64(1):41-6. doi: 10.1016/j.jpsychores.2007.05.004.
citation: Alfian SD, Abdulah R, Denig P, van Boven JFM, Hak E. Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial. BMJ Open. 2020 Jan 6;10(1):e034507. doi: 10.1136/bmjopen-2019-034507.