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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life
Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry. Kalmar County Council, Sweden. (eHälsoinstitutet;eHealth Institute)ORCID iD: 0000-0001-7550-5706
Malmö University, Sweden;Norweigan University of Sciences and Technology, Norway.
Linnaeus University, Faculty of Health and Life Sciences, Department of Medicine and Optometry. (eHälsoinstitutet;eHealth Institute;DISA;DISA-IDP)ORCID iD: 0000-0002-4295-7201
Kalmar County Council, Sweden.ORCID iD: 0000-0001-5211-8818
2018 (English)In: JMIR Research Protocols, E-ISSN 1929-0748, Vol. 7, no 2, p. 1-15, article id e57Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients' adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes.

OBJECTIVE: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately.

METHODS: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient's medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use.

RESULTS: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019.

CONCLUSIONS: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy).

Place, publisher, year, edition, pages
JMIR Publications , 2018. Vol. 7, no 2, p. 1-15, article id e57
Keywords [en]
coronary artery disease, medication adherence, medication therapy management, pharmacist, randomized controlled trial
National Category
Social and Clinical Pharmacy
Research subject
Biomedical Sciences, Pharmacology
Identifiers
URN: urn:nbn:se:lnu:diva-71385DOI: 10.2196/resprot.8659ISI: 000432916000005PubMedID: 29463490Scopus ID: 2-s2.0-85083208653OAI: oai:DiVA.org:lnu-71385DiVA, id: diva2:1188029
Funder
The Kamprad Family FoundationAvailable from: 2018-03-06 Created: 2018-03-06 Last updated: 2024-01-17Bibliographically approved
In thesis
1. Pharmaceutical care in coronary heart disease
Open this publication in new window or tab >>Pharmaceutical care in coronary heart disease
2021 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Att stödja patienter med kranskärlssjukdom till bättre läkemedelsanvändning
Abstract [en]

Background: In coronary heart disease (CHD), pharmaceutical care implies that health care professionals cooperate with the patient to optimize drug therapy primarily for secondary prevention. Low adherence and discontinuation of drugs are common among patients with CHD, and this is associated with increased morbidity and mortality. The achievement of guidelines-recommended treatment goals for risk factors is disappointingly low in secondary prevention.

Aim: To study clinical and patient related aspects of pharmaceutical care for secondary prevention in patients with CHD.

Method: A pharmacist used medication review and motivational interviewing to impact patients’ beliefs about medicines and adherence in a pilot study. This intervention was further developed and tested in a randomized controlled trial (RCT) in 316 patients with verified CHD who were planned for follow-up at the cardiology clinic in Kalmar. The primary study outcome was the proportion ofpatients who reached the treatment goal for low-density lipoprotein (LDL)cholesterol. Patients’ adherence to cholesterol-lowering drugs according to a combination of refilled prescriptions and self-report was the key secondary outcome. In the RCT, pharmacists individualized both the dose and the content of thesupport based on the patient’s need. A process evaluation was planned alongside the trial to investigate implementation and mechanisms of impact such as pharmacists’ actions and effects on patients’ medication beliefs. In a separate qualitative study, we interviewed patients with CHD who had used their medicines for at least 12 months.

Results: At 15 months follow-up of the RCT, the primary outcome measure did not differ between groups. The intervention improved patient adherence to cholesterol-lowering medicines; 88% vs 77% of the patients were adherent, possibly because the intervention lowered patients’ concerns about medicines. In 84% of the intervention patients at least one actual drug-related problem (DRP) was identified, and for 90% of those DRPs actions were taken to resolve the problems. Analyses of the interviews with patients revealed that patients´ experiences with medicines varied greatly - from trivial to troublesome – and these were classified into one of seven categories: a sense of security, unproblematic, learning to live with it, taking responsibility for it, somewhat uncertain, troublesome, or distressing.

Conclusion: Pharmaceutical care improved the patients’ use of medicines in CHD but did not increase treatment goal achievement for LDL-cholesterol. Overall, the findings of this thesis emphasize that when support in managing medications is offered to patients, it should encompass various aspects of medicine-taking: safety, knowledge, beliefs, practical handling, impact on day-to-day life, and the patient’s medication experience.

Place, publisher, year, edition, pages
Växjö: Linnaeus University Press, 2021. p. 200
Series
Linnaeus University Dissertations ; 409/2021
Keywords
pharmaceutical care, patient experience, medication adherence, medicine management, medication review, motivational interviewing, coronary heart disease, secondary prevention, low-density lipoprotein cholesterol, cardiac rehabilitation, multi-professional collaboration, drug-related problems, pragmatic clinical trial, randomized controlled trial, qualitative analysis, process evaluation
National Category
Social and Clinical Pharmacy
Research subject
Natural Science, Biomedical Sciences; Health and Caring Sciences
Identifiers
urn:nbn:se:lnu:diva-101643 (URN)9789189283558 (ISBN)9789189283565 (ISBN)
Public defence
2021-04-16, Hjärnan, Länssjukhuset Kalmar, Kalmar, 09:00 (English)
Opponent
Supervisors
Available from: 2021-03-17 Created: 2021-03-17 Last updated: 2024-03-05Bibliographically approved

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Johansson Östbring, MalinPetersson, GöranHellström, Lina

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