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      Use of a patient-centred educational exchange (PCEE) to improve patient’s self-management of medicines after a stroke: a randomised controlled trial study protocol

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          Abstract

          Introduction

          National and international guidelines make recommendations for secondary prevention of stroke including the use of medications. A strategy which engages patients in a conversation to personalise evidence-based educational material (patient-centred educational exchange; PCEE) may empower patients to better manage their medications.

          Methods and analysis

          This protocol outlines a non-blinded randomised controlled trial. Consenting patients admitted with a diagnosis of stroke or transient ischaemic attack will be randomised 1:1 to receive either a PCEE composed of two sessions, one at the bedside before discharge and one by telephone at least 10 days after discharge from hospital in addition to usual care (intervention) or usual care alone (control). The primary aim of this study is to determine whether a PCEE improves adherence to antithrombotic, antihypertensive and lipid-lowering medications prescribed for secondary prevention of stroke over the 3 months after discharge, measured using prescription-refill data. Secondary aims include investigation of the impact of the PCEE on adherence over 12 months using prescription-refill data, self-reported medication taking behaviour, self-reported clinical outcomes (blood pressure, cholesterol, adverse medication events and readmission), quality of life, the cost utility of the intervention and changes in beliefs towards medicines and illness.

          Ethics and dissemination

          Communication of the trial results will provide evidence to aid clinicians in conversations with patients about medication taking behaviour related to stroke prevention. The targeted audiences will be health practitioners and consumers interested in medication taking behaviour in chronic diseases and in particular those interested in secondary prevention of stroke.

          The trial has ethics approval from Metro South Human Research Ethics Committee (HREC/15/QPAH/531) and The University of Queensland Institutional Human Research Ethics (2015001612).

          Trial registration number

          ACTRN12615000888561; Pre-results.

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          Most cited references34

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          Where is the evidence? A systematic review of shared decision making and patient outcomes.

          L. Shay, Jennifer Elston Lafata (2014)
          Despite widespread advocacy for shared decision making (SDM), the empirical evidence regarding its effectiveness to improve patient outcomes has not been systematically reviewed. The purpose of this study was to systematically review the empirical evidence linking patient outcomes and SDM, when the decision-making process has been explicitly measured, and to identify under what measurement perspectives SDM is associated with which types of patient outcomes (affective-cognitive, behavioral, and health). PubMed (through December 2012) and hand search of article bibliographies. Studies were included if they empirically 1) measured SDM in the context of a patient-clinician interaction and 2) evaluated the relationship between SDM and at least 1 patient outcome. Study results were categorized by SDM measurement perspective (patient-reported, clinician-reported, or observer-rated) and outcome type (affective-cognitive, behavioral, or health). Thirty-nine studies met inclusion criteria. Thirty-three used patient-reported measures of SDM, 6 used observer-rated measures, and 2 used clinician-reported measures. Ninety-seven unique patient outcomes were assessed; 51% affective-cognitive, 28% behavioral, and 21% health. Only 43% of assessments (n = 42) found a significant and positive relationship between SDM and the patient outcome. This proportion varied by SDM measurement perspective and outcome category. It was found that 52% of outcomes assessed with patient-reported SDM were significant and positive, compared with 21% with observer-rated and 0% with clinician-reported SDM. Regardless of measurement perspective, SDM was most likely to be associated with affective-cognitive patient outcomes (54%), compared with 37% of behavioral and 25% of health outcomes. The relatively small number of studies precludes meta-analysis. Because the study inclusion and exclusion criteria required both an empirical measure of SDM and an assessment of the association between that measure and a patient outcome, most included studies were observational in design. SDM, when perceived by patients as occurring, tends to result in improved affective-cognitive outcomes. Evidence is lacking for the association between empirical measures of SDM and patient behavioral and health outcomes. © The Author(s) 2014.
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            Educational outreach visits: effects on professional practice and health care outcomes.

            Mary Ann Thomson O'Brien, Stephen Rogers, Gro Jamtvedt … (2007)
            Educational outreach visits (EOVs) have been identified as an intervention that may improve the practice of healthcare professionals. This type of face-to-face visit has been referred to as university-based educational detailing, academic detailing, and educational visiting. To assess the effects of EOVs on health professional practice or patient outcomes. For this update, we searched the Cochrane EPOC register to March 2007. In the original review, we searched multiple bibliographic databases including MEDLINE and CINAHL. Randomised trials of EOVs that reported an objective measure of professional performance or healthcare outcomes. An EOV was defined as a personal visit by a trained person to healthcare professionals in their own settings. Two reviewers independently extracted data and assessed study quality. We used bubble plots and box plots to visually inspect the data. We conducted both quantitative and qualitative analyses. We used meta-regression to examine potential sources of heterogeneity determined a priori. We hypothesised eight factors to explain variation across effect estimates. In our primary visual and statistical analyses, we included only studies with dichotomous outcomes, with baseline data and with low or moderate risk of bias, in which the intervention included an EOV and was compared to no intervention. We included 69 studies involving more than 15,000 health professionals. Twenty-eight studies (34 comparisons) contributed to the calculation of the median and interquartile range for the main comparison. The median adjusted risk difference (RD) in compliance with desired practice was 5.6% (interquartile range 3.0% to 9.0%). The adjusted RDs were highly consistent for prescribing (median 4.8%, interquartile range 3.0% to 6.5% for 17 comparisons), but varied for other types of professional performance (median 6.0%, interquartile range 3.6% to 16.0% for 17 comparisons). Meta-regression was limited by the large number of potential explanatory factors (eight) with only 31 comparisons, and did not provide any compelling explanations for the observed variation in adjusted RDs. There were 18 comparisons with continuous outcomes, with a median adjusted relative improvement of 21% (interquartile range 11% to 41%). There were eight trials (12 comparisons) in which the intervention included an EOV and was compared to another type of intervention, usually audit and feedback. Interventions that included EOVs appeared to be slightly superior to audit and feedback. Only six studies evaluated different types of visits in head-to-head comparisons. When individual visits were compared to group visits (three trials), the results were mixed. EOVs alone or when combined with other interventions have effects on prescribing that are relatively consistent and small, but potentially important. Their effects on other types of professional performance vary from small to modest improvements, and it is not possible from this review to explain that variation.
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              What are validated self-report adherence scales really measuring?: a systematic review.

              Thi-My-Uyen Nguyen, Adam La Caze, W Cottrell (2014)
              Medication non-adherence is a significant health problem. There are numerous methods for measuring adherence, but no single method performs well on all criteria. The purpose of this systematic review is to (i) identify self-report medication adherence scales that have been correlated with comparison measures of medication-taking behaviour, (ii) assess how these scales measure adherence and (iii) explore how these adherence scales have been validated.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2018
                Publication date (Electronic): 30 August 2018
                Volume: 8
                Issue: 8
                Electronic Location Identifier: e022225
                Affiliations
                [1 ] departmentSchool of Pharmacy , University of Queensland , Brisbane, Queensland, Australia
                [2 ] departmentPharmacy Department , Princess Alexandra Hospital , Brisbane, Queensland, Australia
                [3 ] departmentSchool of Pharmacy and Medical Sciences , University of South Australia , Adelaide, South Australia, Australia
                [4 ] departmentDATIS, Southern Adelaide Local Health Network , Flinders Medical Centre , Adelaide, South Australia, Australia
                [5 ] departmentNorwich Medical School , University of East Anglia , Norwich, UK
                Author notes
                [Correspondence to ] Judith Ann Coombes; judith@ 123456pharmacy.uq.edu.au
                Author information
                http://orcid.org/0000-0003-4871-7783
                Article
                Publisher ID: bmjopen-2018-022225
                DOI: 10.1136/bmjopen-2018-022225
                PMC ID: 6119418
                PubMed ID: 30166304
                SO-VID: 4954e7e1-4bd0-4640-88a5-72132084348f
                Copyright © © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 25 April 2018
                Date accepted : 13 July 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100008407, School of Pharmacy, University of Queensland;
                Categories
                Subject: Patient-Centred Medicine
                Subject: Protocol
                Subject: 1506
                Subject: 1722
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: adherence,stroke,secondary prevention,medication,academic detailing,stroke medicine
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: adherence, stroke, secondary prevention, medication, academic detailing, stroke medicine

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