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      Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial

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          Abstract

          Background

          Over the last decade, health care delivery has shifted to partnering with patients and their families to improve health and quality of care, and to lower costs. Partnering with family members (FMs) of critically ill patients who lack capacity is particularly important for improving experiences and outcomes for both patients and FMs. How best to apply such partnering strategies, however, is yet unknown. The IMPACT trial will evaluate two interventions that enable partnerships with families of critically ill patients, each in a distinct content area, but similar in that they empower and support FMs.

          Methods

          This multi-center, open-label, randomized, phase II clinical trial aims to randomize 150 older, long-stay ICU patients and their families into one of three groups (50 in each group): (1) The OPTimal nutrition by Informing and Capacitating FMs of best practices (OPTICs) group, a multi-faceted intervention to engage and empower FMs to advocate for, and audit, best nutritional practices for their critically ill FMs, (2) A web-based decision-support intervention called the ICU Workbook (The Canadian Researchers at the End of Life Network (CARENET) ICU Workbook; https://www.myicuguide.ca/. Accessed 3 Feb 2017.) to support families in shared decision-making process regarding goals of medical treatments, and (3) Usual care. The main outcomes for this trial include nutritional adequacy in hospital and hand-grip strength prior to hospital discharge; satisfaction with decision-making; decision conflict; and degree of shared decision-making.

          Discussion

          With the goal of improving the functional recovery of nutritionally high-risk older patients and the quality of care at the end of life for these patients and their FMs in the ICU, we have proposed two novel family capacitation strategies. We hope that the nutrition and decision-support interventions implemented and evaluated in our study will contribute to the evidentiary basis for best family partnered care pathways focused on optimizing the quality of ICU care for patients with life-threatening illness and their families.

          Trial registration

          Clinical trials.gov, ID: NCT02920086. Registered on 30 September 2016. Protocol version dated 11 October 2016.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-017-2379-4) contains supplementary material, which is available to authorized users.

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          Most cited references26

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          Validation of a decisional conflict scale.

          The study objective was to evaluate the psychometric properties of a decisional conflict scale (DCS) that elicits: 1) health-care consumers' uncertainty in making a health-related decision; 2) the factors contributing to the uncertainty; and 3) health-care consumers' perceived effective decision making. The DCS was developed in response to the lack of instruments available to evaluate health-care-consumer decision aids and to tailor decision-supporting interventions to particular consumer needs. The scale was evaluated with 909 individuals deciding about influenza immunization or breast cancer screening. A subsample of respondents was retested two weeks later. The test-retest reliability coefficient was 0.81. Internal consistency coefficients ranged from 0.78 to 0.92. The DCS discriminated significantly (p < 0.0002) between those who had strong intentions either to accept or to decline invitations to receive influenza vaccine or breast cancer screening and those whose intentions were uncertain. The scale also discriminated significantly (p < 0.0002) between those who accepted or rejected immunization and those who delayed their decisions to be immunized. There was a weak inverse correlation (r = -0.16, p < 0.05) between the DCS and knowledge test scores. The psychometric properties of the scale are acceptable. It is feasible and easy to administer. Evaluations of responsiveness to change and validation with more difficult decisions are warranted.
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            The efficacy of psychological, educational, and behavioral treatment. Confirmation from meta-analysis.

            Conventional reviews of research on the efficacy of psychological, educational, and behavioral treatments often find considerable variation in outcome among studies and, as a consequence, fail to reach firm conclusions about the overall effectiveness of the interventions in question. In contrast meta-analytic reviews show a strong, dramatic pattern of positive overall effects that cannot readily be explained as artifacts of meta-analytic technique or generalized placebo effects. Moreover, the effects are not so small that they can be dismissed as lacking practical or clinical significance. Although meta-analysis has limitations, there are good reasons to believe that its results are more credible than those of conventional reviews and to conclude that well-developed psychological, educational, and behavioral treatment is generally efficacious.
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              The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks.

              To examine the psychometric properties of a revised scale, named 'observing patient involvement in decision making' (OPTION), by analysing its reapplication to a sample of routine primary care consultations. The OPTION instrument assesses to what degree clinicians involve patients in decision making. Cross-sectional assessment of medical interaction by two calibrated raters. Primary care. Twenty-one general practitioners provided 186 consultations for assessment. Observational score using the OPTION instrument. Compared with the first version of the OPTION scale, the revised scale that uses a magnitude instead of an attitude scale, when applied to the same data set, resulted in improvement in the scale's reliability and to lower scores for the levels of involvement achieved by the practitioners. Factor analysis confirms that it is acceptable to regard the scale as a single construct. Although there is moderate variability when raters are assessed on an item by item basis, the agreements between raters at the level of the overall OPTION score is high (the intraclass correlation coefficient scores for total OPTION score was 0.77), a level that is acceptable for the evaluation of a set of consultations per practitioner (e.g. between 5 and 10 consultations), where aggregate scores would be used for determining overall performance. We conclude that OPTION is sufficiently reliable to be used for formal assessment at the level of the whole instrument (all 12 items).
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                Author and article information

                Contributors
                dkh2@queensu.ca
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                4 January 2018
                4 January 2018
                2018
                : 19
                : 3
                Affiliations
                [1 ]ISNI 0000 0004 1936 8331, GRID grid.410356.5, Department of Critical Care Medicine, , Queen’s University, ; Kingston, ON Canada
                [2 ]ISNI 0000 0004 0633 727X, GRID grid.415354.2, Clinical Evaluation Research Unit, , Kingston General Hospital, ; Kingston, ON Canada
                [3 ]ISNI 0000 0001 2107 4242, GRID grid.266100.3, EBP/Research Nurse Liaison, , University of California, San Diego Health, ; San Diego, CA USA
                [4 ]ISNI 0000 0004 1936 8649, GRID grid.14709.3b, Department of Medicine, , McGill University, ; Montreal, QC Canada
                [5 ]ISNI 0000 0004 1936 7697, GRID grid.22072.35, Department of Critical Care Medicine and Division of Palliative Medicine, , University of Calgary, ; Calgary, AB Canada
                [6 ]ISNI 0000 0001 2097 4281, GRID grid.29857.31, Department of Medicine and Humanities, Division of Pulmonary, Allergy and Critical Care, , Pennsylvania State University, ; Hershey, PA USA
                [7 ]ISNI 0000 0001 0725 2874, GRID grid.36110.35, Faculty of Health Disciplines, , Athabasca University, ; Athabasca, AB Canada
                [8 ]GRID grid.17089.37, Faculty of Nursing, , University of Alberta, ; Edmonton, AB Canada
                [9 ]ISNI 0000 0004 0437 5432, GRID grid.1022.1, Menzies Health Institute Queensland, , Griffith University and Gold Coast Health, ; Southport, QLD Australia
                [10 ]ISNI 0000 0004 0633 727X, GRID grid.415354.2, Kingston General Hospital, ; Angada 4, Kingston, ON K7L 2 V7 Canada
                Article
                2379
                10.1186/s13063-017-2379-4
                5753514
                29301555
                247e7b5e-d996-4210-8d9a-b2dac0d6a587
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 March 2017
                : 24 November 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000024, Canadian Institutes of Health Research;
                Award ID: 361351
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                patient and family engagement,randomized trial,nutrition,end of life decision-making,supportive care,critical care

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