key: cord-0766842-k5dra448 authors: González Aguña, Alexandra; Fernández Batalla, Marta; Díaz‐Tendero Rodríguez, Javier; Sarrión Bravo, Juan Antonio; Gonzalo de Diego, Blanca; Santamaría García, José María title: Validation of a manual of care plans for people hospitalized with COVID‐19 date: 2021-05-06 journal: Nurs Open DOI: 10.1002/nop2.900 sha: a43ef878a4f7e17b756cf556ef26c7cdc0e5e4b9 doc_id: 766842 cord_uid: k5dra448 AIM: Validate a manual of care plans for people hospitalized for coronavirus disease, COVID‐19. DESIGN: Validation study with a mixed‐method design. METHODS: Design and validation of a care plans manual for people hospitalized by COVID‐19. Care plans used standardized languages: NANDA‐I, Nursing Outcomes Classification (NOC) and Nursing Intervention Classification (NIC). The design included external and internal validation with quantitative and qualitative analysis. Data collection was between March and June 2020. The study methods were compliant with the Good Reporting of a Mixed Methods Study (GRAMMS) checklist. RESULTS: The manual integrated 24 NANDA‐I diagnoses, 34 NOC and 47 NIC different criteria. It was validated by experts of Scientific‐Technical Commission, who recommended linking the diagnoses to an assessment. The internal validation validated 17 of 24 diagnoses, 56 of 65 NOC and 86 of the 104 NIC. During the discussion group, 6 new diagnoses proposed were validated and the non‐validated diagnoses were linked to the baseline condition of the person. Some vaccines have already been approved, and the most vulnerable population or those facing the highest risk are being vaccinated (World Health Organization, 2020c) . However, care measures are the basis of intervention from the first outbreak and will prevail for healthy, at-risk and infected populations. Moreover, the common focus of attention for all nurses is the care needs of people, at any stage and vital circumstance, whether with or without disease. These needs are represented by nursing diagnosis. A nursing diagnosis is a clinical judgement concerning human responses (individual, family, group or community) to health conditions or life processes (Herdman & Kamitsuru, 2017) . The nursing diagnoses together with the outcome criteria and intervention criteria make up the care plans (Thoroddsen et al., 2011) . The care plans have a legal function that represents the care service that the patient receives (Østensen et al., 2020) . Nursing care plans and diagnoses are internationally recognized, there is legislation that regulates their professional use and university study plans and reference manuals include content on this topic (Alligood, 2018) . In Europe, Directive 2005/36/CE recognizes nursing professionals the ability to "competence to independently diagnose the nursing care required using current theoretical and clinical knowledge" (European Parliament, 2013) . This regulation is reflected in Spain in the Law 44/2003 on the Organisation of Health Professions when it is stated that nurses are in charge of "management, evaluation and provision of nursing care aimed at the promotion, maintenance and recovery of health, as well as the prevention of diseases and disabilities" (translated from the original in Spanish). In this sense, nurses are the leading professionals responsible for the care of people with conditions such as COVID-19 disease. The NANDA-I is the standard language for diagnostic labels, and NOC is the language for outcome criteria and NIC for intervention criteria (Butcher et al., 2018; Herdman & Kamitsuru, 2017; Moorhead et al., 2018) . The assessment does not have a recognized standardized language, although the regulations include specifying the reference model used to collect this information. In this sense, NOC taxonomy can be used to record the valuation phase. NOC outcomes are not designed for assessment, but their indicators can be used because they represent people's states, behaviours or perceptions. The indicators must correspond to the defining characteristics and, therefore, assessment and planning share a set of data collected at the beginning and that will be evaluated after the intervention (Moorhead et al., 2018) . The entire set of information recorded in standardized language in clinical records makes nursing work visible and allows for research studies in care (Østensen et al., 2020) . On 14 March 2020, Spain declared a state of alarm for the health crisis by COVID-19 (Ministerio de la Presidencia, Relaciones con las Cortes y Memoria Democrática, 2020). A week later, even without reaching the peak of the contagion curve, the COVID-19 IFEMA Hospital in the Community of Madrid was opened to provide health coverage to saturated hospitals (Gobierno de España, 2020; IFEMA Feria de Madrid, 2020). The COVID-19 IFEMA Hospital is a reference monographic hospital that opened on 21 March 2020 at the "IFEMA Fairground" and closed on 2 May 2020. The purpose of this centre was to serve adults (older than 18 years, age of majority in Spain) affected by COVID-19 of any severity and socio-sanitary field of origin. Among the admission criteria, people with a high level of dependency prior to admission, pregnant women and minors were excluded because the characteristics of the people required a more appropriate infrastructure, with services from other specialties or continuous accompaniment of parents or legal guardian. The sanitary complex used a total of more than 70,000 m 2 distributed in four pavilions (three for health care and one as a warehouse), changing rooms, offices and rest areas. The planned potential capacity was 5,500 beds, and more than 3,800 people were attended (Dirección de Enfermería, 2020; Gobierno de España, 2020) . The patients presented a mostly mild severity, although critically ill people were also treated in the Intensive Care Unit (ICU) (Dirección de Enfermería, 2020) . The health professionals came from Primary Care (first level of care that includes family and community care), the Community Medical Emergency Service of Madrid (SUMMA 112), the Municipal Emergency and Rescue Assistance Service (SAMUR -Civil Protection) and other professionals from hospitals with ICU experience. In this sense, the COVID-19 IFEMA Hospital had to face a challenge for nursing. In addition to the pandemic emergency, the centre was made up of nurses of different healthcare levels and clinical experience. In addition, coronavirus disease mainly affects the respiratory system but also has a much broader impact on people's physical and social health. In this sense, the disciplinary and professional object of nursing is the holistic care of the person that includes the attention of all the care needs, both respiratory and any other that derives from this alteration. In order to unify the quality of care criteria as far as possible, the design of a care plan manual was proposed to serve as a guide for all the nursing professionals at the hospital. The aim of the study is to validate a manual of care plans for people hospitalized with COVID-19. What care problems do adults hospitalized for COVID-19 have? What standardized care plans can be applied to adults hospitalized for COVID-19? The design was based on a mixed-method study for the development and validation of a manual of care plans focussed on people hospitalized with COVID-19. The methods include text analysis and validation by a panel of experts with quantitative and qualitative techniques. The study methods were compliant with the Good Reporting of a Mixed Methods Study (GRAMMS) checklist. The object of research was the care plans for adults and elders, with COVID-19 and who are admitted to the hospital with mild-moderate severity. The study did not include care plans aimed at children or pregnant women. These care plans used the nursing taxonomies: NANDA for diagnoses, NOC for outcomes and NIC for nursing interventions. The study setting was the COVID-19 IFEMA Hospital, but the participation or use of data from a patient sample was not necessary. The study methodology used focus group techniques with text analysis and triangulation, external validation by experts and internal validation with quantitative and qualitative analysis. The study applied three phases that combine properties of different methods. This combination of methods, from the design of the manual to the validation on which the study focuses, sought to obtain the benefits of different techniques, while reducing the limitations that appear when using only one method. In this sense, the design of the manual applied text analysis and focus group of experts to cover the published knowledge with the clinical experience of experts who know the context of the study. The validation study used two groups and two techniques: an external group and an internal group to contrast two visions of the same manual; and a quantitative and a qualitative technique in the internal validation panel of experts to determine what content is approved and, in addition, to know the reasons that support each quantitative result and seek to improve the understanding of care plans. The design of the manual consisted of determining the diagnoses, outcomes and interventions that represent professional care for adults hospitalized by COVID-19. The technique used to prepare the manual was Taxonomic Triangulation. This technique acquires knowledge to determine the implicit care diagnoses in a data set that is analysed from three axes: the clinical information on the assessment of a person, the therapeutic goals to be achieved and the professional interventions to be carried out regarding a situation of health or problem (González Aguña, 2021a) . This technique allows to acquire the approved knowledge (by scientific societies and governmental entities) but it needs to be adapted to the specified characteristics of the field of study. This limitation is remedied by reviewing the proposed care plans and receiving an initial unanimous approval from the group of three experts. The proposal for a care plan manual was presented to the Director On 20 April 2020, the approval of the manual was received and, subsequently, it was implanted in the hospital. This validation was the first because it gave approval from nursing institution to a document designed for its implementation in a public hospital. If the document was not approved at this stage, the initial experts would have to thoroughly review the content and start the process again. Once the external validation was approved, the internal validation was carried out in two ordered phases. None of the panel participants had participated in the research in any of the previous phases. After two weeks of implementation of the manual of care plans in the hospital, internal validation was performed through an expert panel. All participants received a project presentation session. The panel consisted of twelve nurses in management positions at the health centre. The participants were selected by criteria of convenience, as responsible for professionals and care, and all fulfilled the eligibility criteria as experts established based on previous studies (Vega-Escaño et al., 2020) . The recruitment process considered two conditions. On the one hand, the country's regulations during confinement did not allow large group meetings to avoid contagion. On the other hand, the professionals came from different centres and the work shift days could not be managed, so their continuity could not be ensured. Faced with these conditions, the researchers looked for professionals who were continuously in the hospital and had access to a global vision of all the professionals. In this sense, the panel of experts was raised by nursing supervisors if they met eligibility criteria. The characteristics of the expert panel are summarized in Table 1 . All the participants had more than ten years of clinical experience, having a position of responsibility (director, supervisor or person in charge) for the care of the pandemic, teaching experience in undergraduate or graduate nursing, postgraduate studies and experience in the use of standardized languages. The study applied a first quantitative validation using the Delphi technique with a self-administered questionnaire to assess with a Likert scale of 1-5 points (1 = not representative and 5 = fully representative) each diagnosis, outcomes and intervention proposed. Each expert assessed the diagnoses under the question "Do you consider each diagnosis appropriate for the care situation of a person hospitalized by COVID-19?" For their part, the outcome criteria were assessed according to "Do you consider each proposed NOC outcome adequate for each of the diagnoses?" That is, the NOC in relation to the care problem proposed for people hospitalized by COVID-19. Likewise, the NIC intervention criteria were assessed according to "Do you consider each proposed NIC intervention adequate for each of the diagnoses?" That is, its suitability as an intervention to solve the care problem proposed for people hospitalized by COVID-19. In addition, the experts were offered the opportunity of adding other diagnostic labels that they considered for the analysed situation. The analysis of the responses of each of the three parts was performed using a content validation index (VCI) criterion. Each item (diagnosis, outcome or intervention) included the number of positive responses on the Likert scale. A positive evaluation was a score of 4 or 5. The number of responses obtained was a score divided by the total number of participants. An item obtained "approved" when its index was greater than 0.78 and "revised" when its index was equal to or <0.78. The diagnoses, outcomes and interventions with a score >0.78 were considered with good validation and did not go to the second round, while the rest were analysed qualitatively to be approved or to know the reasons The first group of experts developed a Manual of care plans for people hospitalized with COVID-19. The manual contains 24 NANDA-I diagnoses, 34 NOC outcome criteria and 47 different NIC intervention criteria, after duplicates have been removed. The approach considered that patients at COVID-19 IFEMA Hospital were adults or elders and were mostly of mild or medium severity. A minority of COVID-19 cases require admission to intensive care units. The care plan manual is shown in Table 2 . The Scientific-Technical Commission of CODEM reviewed the manual, considered the use of the NANDA-I, NOC and NIC taxonomies a success and approved the identified diagnoses, along with their corresponding criteria for outcomes and intervention. The Commission indicated that in the introduction "it would be interesting to explain that, in addition to these diagnoses, patients may present others. We understand that those proposed are the most prevalent (and priority to detect and solve) in the proposed environment." Other diagnoses they raised are from the psychosocial or social sphere. The Commission considered it interesting to reflect on this type of care problem and clarify that these needs may exist, although the manual does not include them because the problems set out in the manual are a priority and prevalent. Likewise, the experts indicated that these social problems could be dealt with at other levels of care or moments of the process. As future improvements, the Commission proposed linking the diagnoses "to functional patterns or another option for nurse evaluation." The results obtained for the validation index of the diagnoses are shown in Table 3 . 17 of the 24 diagnoses were validated with a CVI between 0.83-1.00. The CVI for the NOC outcome criteria are shown in Table 4 . In total, 65 NOC relationships to NANDA-I were assessed. The 34 outcome criteria were linked to each diagnosis and may appear one or more times. In total, 56 of the 65 NOC to NANDA-I relationships established were validated. The CVI for the NIC intervention criteria appear in The experts reviewed the non-validated diagnoses in the first round, and the proposals made by at least two group members in the discussion group. Non-validated diagnoses obtained the same qualitative consideration. Participants explained that these diagnoses of self-care deficit and urinary incontinence were care problems typical of the person's baseline situation: "Incontinence is not caused by COVID-19 or by being hospitalized. They had this problem before and will continue to do so when they are discharged." Bowel incontinence (00014) was modified by the group for Diarrhea (00013). The panel of experts unanimously approved this diagnosis. The panel explained that Anxiety (00146) and Fear (00148) appeared in the first days of hospitalization and in relation to the uncertainty of the evolution of the disease. The problem of low situational self-esteem was validated because "many people felt that they were not worth it and worried that they would not be able to be The study designs and validates a manual of care plans for people hospitalized with COVID-19. This manual offers a common guide for all nurses in the world because they share a common professional model and language. Other nursing research on COVID-19 focuses on the life experiences of nurses and changes made in health centres. However, stud- presents the experience of the design, implementation and practical evaluation of nursing care plans specifically designed for a context of hospitalization of adults with mild-moderate severity. (González Aguña et al., 2021a , 2021b Moorhead et al., 2020) . Similar research is on care plans focussed on other problems (cardiology, oncology) or qualitative studies on the opinion of nurses in the use of care plans and clinical history records. Standardized nursing languages are not used in any of these studies (Kuusisto et al., 2020; Lee, 2005; Pöder et al., 2015) . The mixed methodology with text analysis and quantitative and qualitative validation by experts is novel compared with similar studies. Previous studies on the design of care plans used retrospective analysis methodologies in medical records. This type of methodology could not be used for several reasons: there were no previous historical records because the health problem was new, the available records had different formats, and the emergency required agile methodologies. (Park, 2014) . Clinical nurses (in direct contact with patients) were not included because there was a high turnover rate and they came from other health centres to provide specific days, which did not allow continuity throughout the study or ensure that the criteria to be considered experts were met. In addition, face-to-face meetings of large groups of professionals were not legally allowed during the study time due to the declaration of the state of alarm in Spain and it limited the number of participants in the subsequent discussion group. This meeting was held once the health activity of the hospital was closed and with strict compliance with preventive measures (Ministerio de la Presidencia & Relaciones con las Cortes y Memoria Democrática, 2020; Ministerio de Sanidad, 2020b). The union of the results issued by the three groups seeks to ensure the quality of the findings by triangulating with a mixed method that unites three different perspectives on the same object of interest. In addition, the techniques include quantitative and qualitative assessments, which allows us to better understand the evaluation of the experts (Carter et al., 2014; Raphiphatthana et al., 2020; Shapiro et al., 2020) . Standardized language care plans are necessary to retrieve and use the information contained in clinical records. These plans are legal documents and serve to investigate (Østensen et al., 2020) . However, although the importance of these care plans and standardized language is recognized, even today there are difficulties for their generalized implementation by nurses. Some alleged reasons are that the elaboration of care plans is not part of the routines in daily care, records in free text are easier to note changes in patients, lack of time, the complexity of patients makes individualization difficult or the lack of support from those responsible in the organization (Castellà-Creus et al., 2019; Conrad et al., 2012) . In this sense, when the importance of developing care plans is identified, the nursing diagnosis is not made explicit (Glasper, 2020) . did not include care plans, nursing diagnoses or a framework of care (Ministerio de Sanidad, 2020a , 2020c . The studies published on nursing management in the face of this pandemic focus the interest on human and material resources, but do not allude to the identification of care problems in the population Legido-Quigley et al., 2020; Martínez-Estalella et al., 2020) . A global analysis shows that the proposed diagnoses focus on domains 11. Safety/protection with eight diagnoses (a distinction is made between the potential problems of respiratory and skin infection), 3. Elimination and exchange with six diagnoses and 4. Other diagnoses that could be considered in the social area were not introduced in this manual because, since the opening of the hospital, measures of contact with the family were introduced through electronic devices such as tablets. All patients were able to keep in touch with the family. In addition, the social impact of the pandemic caused many people to donate materials, such as books, and volunteered for entertainment activities to those admitted. All this following the contagion prevention measures. The NOC outcomes and NIC interventions were mostly approved, but their analysis requires more detailed studies that include the aetiology of the problem and the main interventions that can be performed in the professional context. Furthermore, the inclusion of experts from different professional fields can be associated with the variability of possible NOC and NIC for the same care problem in The COVID-19 Hospitalized Care Plans Manual provides a set of validated diagnoses, outcomes and interventions with a high degree of expert agreement. Care plans approved are shown in Table 6 . This manual provides a knowledge base that can be used in other studies to understand the impact of COVID-19 on care around the world. In addition, the electronic implementation in the medical record would allow research on validation, effectiveness of interventions and improvement of the evidence in care. Research with care plans would show the impact of nursing in obtaining health results and patient satisfaction. However, additional studies are necessary to continue expanding knowledge about the COVID-19 pandemic from a careful approach and with standardized language. The authors would like to thank Official College of Nursing of Madrid (CODEM) for its concern in professional development, the University of Alcalá for its commitment to Nursing Informatics, and, finally, acknowledge the Madrid Scientific Society of Care (SoCMaC) for supporting the study of vulnerability and languages. On the other hand, the authors would like to extend their thanks to all the nurses who provided care at the COVID-19 IFEMA Hospital during the health crisis. No conflict of interest has been declared by the author(s). All authors have approved the manuscript and declare that this manuscript has not been published before and have not received funding source. Alexandra González and José María Santamaría: Study conception, data analysis and manuscript drafting. Marta Fernández: Data analysis and critical review with substantial contributions. Javier Díaz-Tendero and Juan Antonio Sarrión: Research process and critical review with substantial contributions. Blanca Gonzalo: Supporting the study and manuscript reviewing, including the latest contributions from the reviewers. The study was presented and approved by the COVID-19 IFEMA Hospital with internal code 20/03-AB-VAL_MAN. In addition, the project was approved by the Epistemology and Bioethics Committee of the Madrid Scientific Care Society All participants were informed of the study and gave their written consent. The Nursing Directorate granted consent for the study and the voluntary participation of professionals. Data sharing is not applicable to this article as no data sets were generated or analysed during the current study. 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