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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation
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;Norwegian 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 1, p. 1-12, article id e21Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation.

OBJECTIVE: This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective.

METHODS: The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease.

RESULTS: The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known.

CONCLUSIONS: This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

Place, publisher, year, edition, pages
JMIR Publications , 2018. Vol. 7, no 1, p. 1-12, article id e21
Keywords [en]
coronary artery disease, quality of health care, medication adherence, medication therapy management, pharmacist
National Category
Social and Clinical Pharmacy
Research subject
Biomedical Sciences, Pharmacology
Identifiers
URN: urn:nbn:se:lnu:diva-71384DOI: 10.2196/resprot.8660ISI: 000432915700019PubMedID: 29382630Scopus ID: 2-s2.0-85102335706OAI: oai:DiVA.org:lnu-71384DiVA, id: diva2:1188030
Available 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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