Protocol euroq2; European Quality Questionnaire. Families experiences of ICU quality of care. Development and validation of a European questionnaire
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1 Protocol euroq2; European Quality Questionnaire Hanne Irene Jensen Rik Gerritsen Matty Koopmans Families experiences of ICU quality of care. Development and validation of a European questionnaire Background Between 10% - 15% of patients admitted to intensive care units (ICUs) die at the unit (1;2). For the health care professionals the high tech therapies and environment becomes ordinary but for families this is a new and uncertain world (3). Knowledge about families experiences is a great help for health care professionals in regard to working with quality improvement of care (4), as studies have shown that family experiences correlate with patient experiences of quality of intensive care (5). Furthermore, studies have shown that being family members to seriously ill intensive care patients may subsequently lead to posttraumatic stress syndrome (PTSD) and depression (6;7). Care that also takes the needs of families into account is therefore very important, but to be able to offer family centred care it is necessary to obtain knowledge of families experiences (8). The Canadian questionnaire (FS-ICU) which examines families general satisfaction with intensive care (8;9) and the American questionnaire which examines families assessments with the quality of death and dying (QODD) (4;10) are some of the most well known and well validated questionnaires ICU family members. The QODD questionnaire has been used in a Dutch study (11), but the researchers found that many of the questions were targeted to American conditions, e.g. regarding decision-making and insurance issues. This means the questionnaire is not automatically transferable to European ICUs, and therefore there is a need to adapt it to European conditions. Aim To develop and validate a questionnaire to evaluate families experiences of ICU quality of care based on the FS-ICU and the QODD and adjusted to European conditions. The questionnaire is named euroq2. Method Pre studies Dutch study using the QODD among 100 Dutch family members (11). Danish prospective interview study with 8 family members (not yet published). 1
2 Main studies 1. Development and qualitative validation of the euroq2 A euroq2 for families is developed in English based on the FS-ICU, the QODD, interviews, experiences from the Dutch study, and inspiration from international ICU family literature. The final draft is discussed with the American QODD developer and is then translated into Danish and Dutch (two way translation, discussion in research group and consensus decision). The questionnaire is then tested qualitatively by interviewing participants after completion of the questionnaire regarding understanding, relevance, areas lacking etc. The test will be performed in both Denmark and The Netherlands among at least six family members connected to at least three different patients. The changes will be made in Danish and Dutch and translated into English as above mentioned and after consensus back to Danish and Dutch. 2. Quantitative validation of the questionnaire. Part one. The questionnaire will then be tested quantitatively in both Denmark and The Netherlands among 50 family members to patients who were discharged or died at the ICU with regard to floor/ceiling effect, missing data, construct validity and reliability. For each question participants are asked to assess relevance and understandability and to fill in the Hospital and Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R). Furthermore a test-retest is conducted among 20 family members from each country. While still at the ICU the families are asked by the patients nurse or physician whether they will take part in the study and are provided with written information about the study. Up to three family members pr. patient can participate. If they accept they fill in a form with name, address and phone number. Approximately three weeks after death or discharge the questionnaire is mailed to the participating family members. If the questionnaire has not been returned within two weeks the researcher contacts the participants by phone. The following patient data is obtained when families enter into the study: Gender, age, medical speciality, diagnosis, admission time at the ICU, any withholding or withdrawal decisions, APACHE II (Acute Physiology and Chronic Health Evaluation), SAPS (Simplified Acute Physiology Score) and SOFA (Sepsis-Related Organ Failure Score) scores. 3. Quantitative validation of the questionnaire. Part two. When an adjusted version of euroq2 is developed based on part 2 results, at least 1000 family members from at least 20 different ICU s, 10 in Denmark and 10 in the Netherlands are included in the study. Same procedure as above mentioned apart from mailing a reminder letter with a new questionnaire instead of contact by phone. 4. Pilot quantitative validation of the euroq2 questionnaire in Europe Four countries from different parts of Europe/Israel will participate. The questionnaire will go through a two-way translation into the different languages. Procedure is identical to quantitative validation part one except that the participants will not fill in the Hospital and Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R). 2
3 5. Quantitative validation of the questionnaire in Europe When an adjusted version of euroq2 is developed based on the further parts of the study, further international validation and testing will take place. At least 50 family members from at least 10 different European countries are included in the study (same procedure as above). Data analyses Data is entered in EpiData v and data will be analysed using Stata 13 and SPSS 18. For European studies data will be entered via a webpage. For normally distributed continuous data the student s t-test will be used. For not normally distributed continuous data and ordinal data the Mann-Whitney U test will be used for unpaired analyses and the weighted kappa and the Wilcoxon signed-ranked test for paired analyses. The chi-square test or Fishers exact test will be used to compare categorical data. Furthermore correlation analyses will be conducted. P < 0.05 is considered significant. Data will be presented by mean, percentages, median and inter quartile ranges as appropriate. Time-frame Part 1 December 2012 November 2013 Part 2 November 2013 July 2014 Part 3 September 2014 September 2015 Part 4 January 2015 December 2015 Part 5 January 2016 December 2016 Organisation Project manager for part 1-3. Postdoc Hanne Irene Jensen, Department of Anaesthesiology and Intensive Care, Vejle Hospital, Denmark Helpers connected to the different phases will be included based on needs. The Heads of the Anaesthesiology Department, Vejle Hospital will be overall responsible for the study. Project manager for part 4-5: R.Th.Gerritsen, MD, FCCM, Intensivist. Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands Additional participating countries will be found through the ESICM s (European Society of Intensive Care Medicine) network. Ethics In Denmark, the project is registered with the Danish Data Protection Agency and permission to register patient data without consent from the patients is obtained from the Danish Health and Medicine Authority. According to Danish law the project does not need approval from the Regional Scientific Ethical Committees. 3
4 In The Netherlands the IRB approved the study and granted a waiver of informed consent. Family members are approached by the patient s nurse or physician and provided with written information about the project. If they agree to participate, they fill in a form with contact information. Publications The project will be presented on national and international conferences and a number of papers will be published in international, peer-reviewed journals. The first paper will include the development and validation process of the questionnaire, part 1-2 (joint Danish/Dutch authorship, Danish first authorship), the second and third paper will consist of validation work based on part 3 (joint Danish/Dutch authorship, Danish first authorship on second paper and Dutch first authorship on third paper ), the fourth paper will present results from part 4 (joint Danish/Dutch authorship, Dutch first authorship), and the fifth paper will consist of results from the part 5 (joint Danish/Dutch authorship, Dutch first authorship). Perspective Firstly, the project will provide knowledge regarding families experiences of the quality of death and dying in the ICU; a knowledge that is of great value when working with quality improvements. Secondly, the project will provide a tool that can be used prospectively to ensure high quality in death and dying. Thirdly, a validated questionnaire adjusted to European conditions will be a valuable tool to assess the effect of different intervention studies aimed at improving ICU care for patients and their families. 4
5 Reference List (1) Jensen HI, Ammentorp J, Ording H. Withholding or withdrawing therapy in Danish regional ICUs: frequency, patient characteristics and decision process. Acta Anaesthesiol Scand 2011 Mar;55(3): (2) Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, et al. End-of-life practices in European intensive care units: the Ethicus Study. JAMA 2003 Aug 13;290(6): (3) Agard AS, Harder I. Relatives' experiences in intensive care--finding a place in a world of uncertainty. Intensive Crit Care Nurs 2007 Jun;23(3): (4) Curtis JR, Patrick DL, Engelberg RA, Norris K, Asp C, Byock I. A measure of the quality of dying and death. Initial validation using after-death interviews with family members. J Pain Symptom Manage 2002 Jul;24(1): (5) Stricker KH, Kimberger O, Brunner L, Rothen HU. Patient satisfaction with care in the intensive care unit: can we rely on proxies? Acta Anaesthesiol Scand 2011 Feb;55(2): (6) Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, et al. Risk of posttraumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med 2005 May 1;171(9): (7) Gries CJ, Engelberg RA, Kross EK, Zatzick D, Nielsen EL, Downey L, et al. Predictors of symptoms of posttraumatic stress and depression in family members after patient death in the ICU. Chest 2010 Feb;137(2): (8) Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med 2007 Jan;35(1): (9) Heyland DK, Tranmer JE. Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care 2001 Dec;16(4): (10) Downey L, Curtis JR, Lafferty WE, Herting JR, Engelberg RA. The Quality of Dying and Death Questionnaire (QODD): empirical domains and theoretical perspectives. J Pain Symptom Manage 2010 Jan;39(1):9-22. (11) Gerritsen RT, Hofhuis JG, Koopmans M, van der Woude M, Bormans L, Hovingh A, et al. Perception by family members and ICU staff of the quality of dying and death in the ICU: a prospective multicenter study in The Netherlands. Chest 2013 Feb 1;143(2):
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