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  • 1.
    Johansson Östbring, Malin
    et al.
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO). Kalmar County Council.
    Eriksson, Tommy
    Malmö University;Norwegian University of Sciences and Technology, Norway.
    Petersson, Göran
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO).
    Hellström, Lina
    Kalmar County Council.
    Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.2018Ingår i: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 7, nr 1, s. 1-12, artikel-id e21Artikel i tidskrift (Refereegranskat)
    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.

  • 2.
    Johansson Östbring, Malin
    et al.
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO). Kalmar County Council.
    Eriksson, Tommy
    Malmö University;Norweigan University of Sciences and Technology, Norway.
    Petersson, Göran
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO).
    Hellström, Lina
    Kalmar County Council.
    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.2018Ingår i: JMIR Research Protocols, ISSN 1929-0748, E-ISSN 1929-0748, Vol. 7, nr 2, s. 1-15, artikel-id e57Artikel i tidskrift (Refereegranskat)
    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).

  • 3.
    Stevenson-Ågren, Jean
    et al.
    Linnéuniversitetet, Fakulteten för konst och humaniora (FKH), Institutionen för språk (SPR). Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för hälso- och vårdvetenskap (HV). University of Sheffield, UK.
    Israelsson, Johan
    Kalmar County Hospital.
    Nilsson, Gunilla
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för hälso- och vårdvetenskap (HV).
    Petersson, Göran
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO).
    Bath, Peter A.
    University of Sheffield, UK.
    Vital sign documentation in electronic records: the development of workarounds2018Ingår i: Health Informatics Journal, ISSN 1460-4582, E-ISSN 1741-2811, Vol. 24, nr 2, s. 2061-215Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Workarounds are commonplace in health care settings. An increase in the use of electronic health records (EHR) has led to an escalation of workarounds as health care professionals cope with systems which are inadequate for their needs. Closely related to this, the documentation of vital signs in EHR has been problematic. The accuracy and completeness of vital sign documentation has a direct impact on the recognition of deterioration in a patient’s condition. We examined work flow processes to identify workarounds related to vital signs in a 372-bed hospital in Sweden. In three clinical areas a qualitative study was performed with data collected during observations and interviews and analysed through thematic content analysis. We identified paper workarounds in the form of hand-written notes and a total of eight pre-printed paper observation charts. Our results suggested that nurses created workarounds to allow a smooth workflow and to ensure patients safety.

  • 4.
    Stevenson-Ågren, Jean
    et al.
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO). University of Sheffield, UK.
    Israelsson, Johan
    Linnéuniversitetet, Fakulteten för teknik (FTK), Sjöfartshögskolan (SJÖ). Kalmar County Hospital, Sweden;Linköping University.
    Petersson, Göran
    Linnéuniversitetet, Fakulteten för Hälso- och livsvetenskap (FHL), Institutionen för medicin och optometri (MEO).
    Bath, Peter
    University of Sheffield, UK.
    Factors influencing the quality of vital signs data in electronic health records: a qualitative study2018Ingår i: Journal of Clinical Nursing, ISSN 0962-1067, E-ISSN 1365-2702, Vol. 27, nr 5-6, s. 1276-1286Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Aims and objectives

    To investigate reasons for inadequate documentation of vital signs in an electronic health record.

    Background

    Monitoring vital signs is crucial to detecting and responding to patient deterioration. The ways in which vital signs are documented in electronic health records have received limited attention in the research literature. A previous study revealed that vital signs in an electronic health record were incomplete and inconsistent.

    Design

    Qualitative study.

    Methods

    Qualitative study. Data were collected by observing (68 hr) and interviewing nurses (n = 11) and doctors (n = 3), and analysed by thematic analysis to examine processes for measuring, documenting and retrieving vital signs in four clinical settings in a 353-bed hospital.

    Results

    We identified two central reasons for inadequate vital sign documentation. First, there was an absence of firm guidelines for observing patients’ vital signs, resulting in inconsistencies in the ways vital signs were recorded. Second, there was a lack of adequate facilities in the electronic health record for recording vital signs. This led to poor presentation of vital signs in the electronic health record and to staff creating paper “workarounds.”

    Conclusions

    This study demonstrated inadequate routines and poor facilities for vital sign documentation in an electronic health record, and makes an important contribution to knowledge by identifying problems and barriers that may occur. Further, it has demonstrated the need for improved facilities for electronic documentation of vital signs.

    Relevance to clinical practice

    Patient safety may have been compromised because of poor presentation of vital signs. Thus, our results emphasised the need for standardised routines for monitoring patients. In addition, designers should consult the clinical end-users to optimise facilities for electronic documentation of vital signs. This could have a positive impact on clinical practice and thus improve patient safety.

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