TITLE: Feasibility of a connected interface implementation to foster the continuity of inpatient care: A pilot protocol for physicians handovers, in a tertiary maternity
AUTHORS: José Carlos Serufo Filho, Denise Utsch Gonçalves, Vitor Barbosa Abrantes, Bruna Barbosa Coimbra, Zilma Reis

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Background: </span><span>Handovers sessions are relevant medical activities in hospitals. Effective communication during the transfer of care is critical to foster the continuity of medical assistance and patient safety. In this opportunity, Electronic Health Records (EHR) has the potential to provide prompt and reliable information for authorized users of electronic systems, supporting decisions and offering alerts for critical conditions. </span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Objective: </span><span>To report a study protocol to evaluate the impact of an electronic handover implementation that supports the information transference of care, during doctors shifts sessions.</span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Methods:</span><span> Research protocol for connected interface implementation, single-group clinical trial to compare data-quality outcomes pre-post implementation of the intervention. A a random sample of handover sessions will be selected to assess the impact of the intervention. During the predeployment step, paper-based handover formularies will be recollected and analyzed. The priorities of health information transfer during handover, as well as its legal and security aspects will be used to add requirements to the novel system of communication. The handover system, integrated with the existent electronic medical record, will be developed according to the best clinical practice in care transference and obstetric protocols based on evidence. After EHR implementation, an after-before analysis will assess the impact of the invention. Primary outcomes are the quality of information registered in the medical handover record and data security, namely authenticity and traceability. As a secondary outcome, the duration of the transfer of care an external observer using a chronometer will evaluate sessions.</span></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"></div></div><div class = "text-block"><div class = "justify" style = "text-align:left"><span style = "font-weight:bold;">Results:</span><span> The study began in March 2018 with the training of the researchers to collect data during handover sessions. The first in loco evaluation of a handover session occurred: 2018-04-20. Planned date for the post-deployment evaluation is: 2019-08-31. Data analysis will be finalized and the final results are expected for December / 2019. This feasibility trial will confirm whether a connected interface implementation could impact in the quality of information transferred during doctors shifts sessions.
 </span></div></div><div class = "text-block"><span style = "font-weight:bold;">Ethics and disseminatio</span><span>n: Ethics review board approved the trial protocol. The authors intend to share the minimal anonymized data set necessary to replicate study findings. </span></div></div>

[STEPS]
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SettingThe scenario of this study is tertiary care university-affiliated maternity, with 2900 births-per-year and 31 beds. A staff of novice and senior physicians gathers five doctors working 12 hours on duty; one of them is the leader in charge. Verbal and written handovers occur twice a day, at 7 am and 7 pm.
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Research ethics approvalThe protocol of research was approved by the institutional review boards in Brazil, the Ethics Committees of the Universidade Federal de Minas Gerais, with a national register number in Plataforma Brasil: CAAE 82095517.3.0000.5149. A written informed consent was obtained from each participant of the monitored handovers.
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Dissemination policyThe authors intend to share the minimal deidentified data set necessary to replicate the study findings.
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Eligibility criteriaHandover sessions randomly selected to assess the quality of health information in the written documentation. Exclusion criterion is the handover briefings in which physicians do not agree with the voluntary participation in the study.
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InterventionThe intervention is an electronic handover interface, internally developed in the existent electronic medical record. The steps to choose the solution and implementation of the intervention are followed:a) Analysis of the initial scenario and challenges for the electronic handover implementationScientific background: to explore evidence and experience reports with a literature review concerning electronic handovers. Learning from previous experience.Challenges of the local situation: To access local practices of medical handovers with exploratory visits. A survey analysis of handover practices directed to clinical managers of the hospital.Legal electronic medical record (EMR) issues to attend: To explore standards for health data specification. To establish the needs for the system to ensure the persistence in the database, and to protect individual data.Stakeholders and end-users expectations: To confer with the chief information officer (CIO), as well as the Local Quality and Safety Committee, and with the Clinical Directory.b) Requirements analysis and specificationFunctional: to point needs to overcome the deficits of variable and unstructured forms of clinical handoverNon-functional: to specify constraints on the services or functions offered by the systemb) Requirements analysis and specificationFunctional: to point needs to overcome the deficits of variable and unstructured forms of clinical handoverNon-functional: to specify constraints on the services or functions offered by the systemc) A pilot test for validation: to evaluate the user impression and re-designed the template with the end-user in mind, if necessary. To provide an implement version control, to manage code development. When existent, to analyze valid reasons to do not implement a specified requirement.d) Full implementation: Promotion and installation with the training of end-users.e) Monitoring and analysis of the pre- post implementation scenario: A 3-month follow-up of the electronic handover implementation to evaluate system efficiency with primary and secondary endpoints.
A connected interface will able physicians to prompt access to individual clinical data and easily prepare an electronic written summary to support handover routine.
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Primary outcomes: Specific metrics will assess endpoints of interest to compare pre-post implementationOutcome 1: The quality of information registered in medical handover written reports.Outcome 2: Security of demographics and health information recorded in medical handover records.
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Secondary outcomeLenght of the transfer of care sessions between doctors shifts; evaluated by an external observer using a chronometer.
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Data collectiona)  Analysis of the initial scenario and challenges for the electronic handover implementationTool 1: Questionnaire about care transitions practices directed to clinical managers of the Hospital to explore local practices of medical handovers. b) Standard procedure to measure primary an secondary endpointsTool 2 : Quality of information registered in the medical handover written reports. The variables to assess quality are:Authenticity of data, and traceability of the report: patient identification as complete name and number of the hospital register, bed location, date and time of registration, the name of responsible professional, the existence of a secure copy of the handover report.Analysis of data quality in handovers content: clinical history, facts about the hospitalization, diagnosis, alerts for severe conditions, critical problems or values, adverse events, allergies, plan care. The existence of such data will evaluate the quality of central elements in the communication of the transfer of responsibility for care, based on SBAR handoff technique of communication: situation, background, assessment, recommendation [7].c) The length of handover session will be measured using a chronometer.
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Statistical methods for data analysisa) Sample size: To test the hypothesis of equivalence between the pre-post intervention on the quality of data, a sample of 349 clinical histories is necessary to detect an effect size of 15%. We assumed an alpha error of 0.05 and a power of test 0.80 to support a chi-square test with one degree of liberty. Sampling intends to arrange two groups randomly selected pre- and post-intervention with 175 clinical histories each one. For this, 18 handover sessions will be selected in each group, with the expectation of 10 individual clinical reports per handover. For the control-group, an electronic system chose for chance 18 date-time of handovers, in a list of 180 consecutive date-times between April and June/2018. After 3 months of the full implementation of the intervention, similar approach will select the case-group.b)  Data analysis: Demographics and baseline characteristics of the study group, as well the intervention measurements, will be summarized by the frequencies and the mean and standard deviation (SD), the whereas median and interquartile range will be preferred for non-normally distributed continuous variables. Regarding primary endpoints, category variables will be compared by means of association tests. Regarding the secondary endpoint, length of handover sessions, the modification of this numeric varible will be compared by independent t-test. The significance level for hypothesis tests will be 5%, together with 95% confidence intervals.
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AppendicesEthical approval
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Declaration of interestsThere are no financial and other competing interests for the investigators, for the overall trial.
?. [Background]
The hospital environment has a dynamic nature with potential for breakdowns in communication [1]. Handovers sessions periodically happen to transfer professional responsibility for some or all care for a patient between physicians and/or professional group [2]. The implementation of the electronic handover has the challenge to ensure this dynamism, enabling the safe updating of information on care and patient-related behaviors [3]. Electronic approaches have been described to overcome the deficits of variable and unstructured forms of clinical handover [4]. Electronic Health Record (EHR) is a longitudinal health record with entries by healthcare practitioners in multiple sites where care is provided [5]. Such essential properties of the registry are supposed to provide prompt and reliable information for authorized users of electronic systems, supporting decisions and offering alerts for critical conditions [6]. This report is a study protocol to evaluate the impact of a connected interface implementation with an existent EHR to support the information transference of care during doctors shifts sessions.
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Study design Research protocol for connected interface implementation, single-group clinical trial to compare data-quality outcomes pre-post implementation of the intervention.
?. [References]
1. Horwitz LI, Moin T, Krumholz HM et al. . Consequences of inadequate sign-out for patient care. Arch Intern Med 2008;168:1755–60.2. Australian Commission on Safety and Quality in Health Care. OSSIE guide to clinical hanodver improvement. Sydney: Australian Commission on Safety and Quality in Health Care. 2010. 3. Sharifah Munirah Alhamid, Desmond Xue-Yuan Lee, Hei Man Wong, Matthew Bingfeng Chuah, Yu Jun Wong, Kaavya Narasimhalu, Thuan Tong Tan, Su Ying Low; Implementing electronic handover: interventions to improve efficiency, safety and sustainability, International Journal for Quality in Health Care, Volume 28, Issue 5, 10 October 2016, Pages 608–614, https://doi.org/10.1093/intqhc/mzw0824.  Barnes SL, Campbell DA, Stockman KA et al. . From theory to practice of electronic handover. Aust Health Rev 2011;35:384–91.5. World Health Organization. Apps.WHO. 2006. Electronic health records: manual for developing countries   URL: http://apps.who.int/iris/handle/10665/207504 [accessed 2017-07-13] [WebCite Cache]6. ALBERGARIA, Elisa Tuler de et al. Identificando propriedades essenciais de registros eletrônicos de saúde. AtoZ: novas práticas em informação e conhecimento, [S.l.], v. 5, n. 1, p. 33-43, jul. 2016. ISSN 2237-826X. Disponível em: https://revistas.ufpr.br/atoz/article/view/44738>. Acesso em: 22 fev. 2019. doi:http://dx.doi.org/10.5380/atoz.v5i1.44738.7. Thomas, Cynthia M. EdD, RNC, CDONA; Bertram, Evelyn MS, RN; Johnson, Doreen MA, RN. The SBAR Communication Technique: Teaching Nursing Students Professional Communication Skills. Nurse Educator: July-August 2009 - Volume 34 - Issue 4 - p 176-180. doi: 10.1097/NNE.0b013e3181aaba54.
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Pre and post intervention evaluation timeline
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Trainig and certification of observersBefore monitoring handover sessions, four observers are trained and certificated by the main investigator at 04/14/2018. Data collection will be performed by health professionals and medical academics who have undergone training following the standard operational procedures. Tools for data recollection were pre-tested with real clinical histories obtained during the scenario exploring.