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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

ABSTRACT: 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.

SUBMITTER: Ostbring MJ

PROVIDER: S-EPMC5811650 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

Östbring Malin Johansson MJ Eriksson Tommy T Petersson Göran G Hellström Lina L

JMIR research protocols 20180130 1

<h4>Background</h4>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 an ...[more]

PMID: 29382630

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Project description:Background and objectiveVaccine uptake during pregnancy remains low. Our objectives were to describe 1) development and adaptation of a clinician communication training intervention for maternal immunizations and 2) obstetrics and gynecology (ob-gyn) clinician and staff perspectives on the intervention and fit for the prenatal care context.MethodsDesign of the Motivational Interviewing for Maternal Immunizations (MI4MI) intervention was based on similar communication training interventions for pediatric settings and included presumptive initiation of vaccine recommendations ("You're due for two vaccines today") combined with motivational interviewing (MI) for hesitant patients. Interviews and focus group discussions were conducted with ob-gyn clinicians and staff in five Colorado clinics including settings with obstetric physicians, certified nurse midwives (CNMs), and clinician-trainees. Participants were asked about adapting training to the ob-gyn setting and their implementation experiences. Feedback was incorporated through iterative changes to training components.ResultsInterview and focus group discussion results from participants before (n = 3), during (n = 11) and after (n = 25) implementation guided intervention development and adaptation. Three virtual, asynchronous training components were created: a video and two interactive modules. This virtual format was favored due to challenges attending group meetings; however, participants noted opportunities to practice skills through role-play were lacking. Training modules were adapted to include common challenging vaccine conversations and live-action videos. Participants liked interactive training components and use of adult learning strategies. Some participants initially resisted the presumptive approach but later found it useful after applying it in their practices. Overall, participants reported that MI4MI training fit well with the prenatal context and recommended more inclusion of non-clinician staff.ConclusionsMI4MI training was viewed as relevant and useful for ob-gyn clinicians and staff. Suggestions included making training more interactive, and including more complex scenarios and non-clinician staff.

Project description: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).

Project description:Background and purposeAdherence to medication is often suboptimal after stroke and transient ischemic attack (TIA), which increases the risk of recurrent stroke and death. Complex interventions and motivational interviewing (MI) have been proven effective in other areas of medicine. The objective of this study was to investigate the effectiveness of a multifaceted intervention including MI in improving medication adherence for secondary stroke prevention.MethodsIn this randomized controlled trial, TIA and stroke patients receiving a pharmacist intervention in a hospital setting were compared with patients receiving usual care. The intervention consisted of a focused medication review, an MI-approached consultation and 3 follow-up telephone calls and lasted for 6 months. The primary outcome was a composite medication possession ratio (MPR) for antiplatelets, anticoagulants and statins in the year after hospitalization, assessed by analyzing pharmacy records and reported as both a continuous rate and a binary outcome. Secondary outcomes included composite MPRs at 3, 6 and 9 months as well as adherence and persistence to specific thrombopreventive medications at 12 months. Clinical outcomes included a combined end point of cardiovascular death, stroke or acute myocardial infarction. Patient satisfaction with the service was assessed for the intervention patients.ResultsThe analyses included 102 intervention patients and 101 controls. At 12 months, the median MPRs (IQR) were 0.95 (0.77-1) in the intervention group and 0.91 (0.83-0.99) in the control group, and 28 and 21% of the patients, respectively, were nonadherent (MPR <0.80; risk difference: 7%; 95% CI: -5 to 19%). In both groups, the median MPR decreased over time. From 3 to 12 months, the MPR fell by 5% (p < 0.05) in the intervention group and by 9% (p < 0.05) in the control group, but between the groups, comparisons showed no statistically significant difference. No significant differences were found for adherence and persistence to specific thrombopreventive agents or for the clinical outcome. The intervention patients were satisfied with the service; about half of them reported increased knowledge about medication, and one third reported increased confidence with medication use. Pharmacists identified drug-related problems in one third of the patients.ConclusionsA multifaceted pharmacist intervention including MI did not improve adherence or persistence to secondary stroke prevention therapy and had no impact on clinical outcomes. However, due to the high adherence rates, only little room for improvement existed. Future studies should focus on patients at high risk of nonadherence and include outcomes more sensitive to the impact of behavioral interventions.

Project description:BackgroundHeart failure (HF) is characterized by an increasing prevalence, representing a public health problem and a significant cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF. Patients play a crucial role in managing their condition, given that several adverse health outcomes might be avoided with adequate self-care. In this regard, the literature describes motivational interviewing (MI) as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.ObjectiveThe primary study aim is to test the efficacy of a structured program, including scheduled MI interventions, in improving self-care maintenance in the 3-month follow-up from the enrollment. Secondary aims comprehend the assessment of the effectiveness of the above intervention on secondary outcomes (eg, self-care monitoring, quality of life, sleep disturbance) and the corroboration of the superiority of caregivers' participation to the intervention over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes at 3, 6, 9, and 12 months from the enrollment.MethodsThis study protocol designed a prospective, parallel-arm, open-label, 3-arm, controlled trial. The MI intervention will be administered by nurses trained in HF self-care and MI; the education program will be provided to nurses by an expert psychologist. Analyses will be performed within the framework of intention-to-treat analysis. Comparisons between groups will be based on an alpha of 5% and 2-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.ResultsThe data collection was started in May 2017. We completed the data collection with the last follow-up in May 2021. We plan to perform data analysis by December 2022. We plan to publish the study results within March 2023.ConclusionsMI enhances potential self-care practices in patients with HF and their caregivers. Although MI is effectively largely employed either alone or combined with other treatments and is administered in different settings and ways, face-to-face interventions seem to be more effective. Dyads with higher shared HF knowledge are more efficient in promoting self-care adherence behaviors. Moreover, patients and caregivers may perceive proximity with health care professionals, resulting in a better ability to follow the received health professionals' directions. The scheduled in-person meetings with patients and caregivers will be exploited to administer MI, respecting all the safety regulations for infection containment. The conduction of this study may support changes in clinical practice to include MI to improve self-care for patients with HF.Trial registrationClinicalTrials.gov NCT05595655; https://clinicaltrials.gov/ct2/show/NCT05595655.International registered report identifier (irrid)DERR1-10.2196/44629.

Project description:BackgroundAfrican American or Black young men who have sex with men (BYMSM) are at a disproportionate risk for contracting HIV and have high rates of undiagnosed, and therefore untreated, HIV infection. In the southern United States, BYMSM face region-specific hurdles to HIV prevention, such as limited access to care and high levels of racism and intersectional stigma, necessitating HIV testing and pre-exposure prophylaxis interventions that address sociocultural and structural barriers while motivating BYMSM to engage in prevention. Brothers Saving Brothers (BSB) is a motivational interviewing behavioral intervention that successfully and simultaneously increased community-based HIV testing and prevention counseling and education among BYMSM in the midwestern United States.ObjectiveThe aim of this protocol is to detail the process for the adaption of the BSB intervention for midwestern BYMSM to the Kings intervention for southern BYMSM. During the adaptation process, the intervention will be modernized to include rapid HIV testing, as opposed to HIV testing that requires BYMSM to return for test results, pre-exposure prophylaxis, and the provision of structural supports, and for relevance in the southern United States.MethodsAim 1 is to gather qualitative data through focus groups and in-depth interviews with BYMSM aged 18 to 29 years in Alabama and in-depth interviews with prevention and outreach workers who routinely work with BYMSM in Alabama. NVivo qualitative software (QSR International) will be used for the coding and analysis of the transcripts via a thematic analysis approach. For aim 2, intervention mapping will guide the adaptation process, intervention content, components, and design. Both aims 1 and 2 will leverage the Exploration, Preparation, Implementation, Sustainment implementation science framework, with emphasis on the exploration and preparation phases of this model. By applying these frameworks, the original midwestern BSB intervention will be scientifically adapted to the southern BYMSM Kings intervention.ResultsThis study is ongoing as of 2022 and is expected to conclude in 2024, with aims 1 and 2 being completed in 2023. Qualitative data will offer insight into the current real-world experiences and preferences of BYMSM in Alabama. Feedback will be collected through the adaptation process to inform intervention refinement. Institutional review board approvals have been received.ConclusionsThe findings will inform next steps, that is, testing the Kings intervention for feasibility, acceptability, and preliminary effectiveness in a pilot hybrid type 1 effective-implementation randomized controlled trial. The study results will provide insights about important considerations for HIV prevention among BYMSM in the southern United States.Trial registrationClinicalTrials.gov NCT03680729; https://clinicaltrials.gov/ct2/show/NCT03680729.International registered report identifier (irrid)PRR1-10.2196/36655.

Project description:Background Implementation of clinical medication reviews in daily practice is scarcely evaluated. The Opti-Med intervention applied a structured approach with external expert teams (pharmacist and physician) to conduct medication reviews. The intervention was effective with respect to resolving drug related problems, but did not improve quality of life. Objective The objective of this process evaluation was to gain more insight into the implementation fidelity of the intervention. Setting Process evaluation alongside a cluster randomized trial in 22 general practices and 518 patients of 65 years and over. Method A mixed methods design using quantitative and qualitative data and the conceptual framework for implementation fidelity was used. Implementation fidelity is defined as the degree to which the various components of an intervention are delivered as intended. Main outcome measure Implementation fidelity for key components of the Opti-Med intervention. Results Patient selection and preparation of the medication analyses were carried out as planned, although mostly by the Opti-Med researchers instead of practice nurses. Medication analyses by expert teams were performed as planned, as well as patient consultations and patient involvement. 48% of the proposed changes in the medication regime were implemented. Cooperation between expert teams members and the use of an online decision-support medication evaluation facilitated implementation. Barriers for implementation were time constraints in daily practice, software difficulties with patient selection and incompleteness of medical files. The degree of embedding of the intervention was found to influence implementation fidelity. The total time investment for healthcare professionals was 94 min per patient. Conclusion Overall, the implementation fidelity was moderate to high for all key components of the Opti-Med intervention. The absence of its effectiveness with respect to quality of life could not be explained by insufficient implementation fidelity.

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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

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Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

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