The Following Individuals and Institutions Participated in the Study
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1 E1 Online Supplement for: IMPACT OF A FAMILY INFORMATION LEAFLET ON EFFECTIVENESS OF INFORMATION PROVIDED TO FAMILY MEMBERS OF INTENSIVE CARE UNIT PATIENTS A MULTICENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL MEMBERS OF THE FRENCH FAMIREA GROUP The Following Individuals and Institutions Participated in the Study Djilali ANNANE, M.D., Garches; Doris BERDUGHO, R.N., Antoine PARROT, M.D., Fayçal SAIDI, M.D., Tenon, Paris; Pierre Edouard BOLLAERT, M.D., Nancy; Frederic BRUN, M.D., Auxerre; Isabelle CATTANEO, M.D., Bry sur Marne; Frederic CHAUSSOY, M.D, Berck; Thibaut DESMETTRE, M.D., Bethune; Didier DUBOIS, M.D., Arras; Pierre DUC, M.D., Boulogne; Fabienne FIEUX, M.D., Caroline BORNSTAIN, M.D., Saint-Louis, Paris; Veronique GADET, M.D., Douai; Hugues GEORGES, M.D., Tourcoing; Dany GOLDGRAN-TOLEDANO, M.D., Richard GALLIOT, M.D., Lariboisière, Paris; Merce JOURDAIN, M.D., Salengro, Lille; Christian LEMAIRE, M.D., Patrick HERBECQ, M.D., Roubaix; Bernadette LEPOULTRE, M.D., Lomme; Serge MOULRONT, M.D., Dunkerque; Étienne PIGNE, M.D., Arnaud De LASSENCE, M.D., Colombes; Catherine POISSON, M.D., Lens; Olivier SANCHEZ, M.D., Guy MEYER, M.D., Laënnec, Paris; Alain SERMENT, M.D., Luc Marie JOLY, M.D., Sainte Anne, Paris; Jerome TAYORO, M.D., Tours; Marie THUONG, M.D., Christophe ADRIE, M.D., Saint Denis; Anne WERNET, M.D., Frédéric POCHARD, M.D., Cochin, Paris; Jean-Ralph ZAHAR, M.D., Francois LEMAIRE, M.D., Créteil.
2 E2 Description of the Standardized Family Information Leaflet The family information leaflet (FIL) was designed specifically for this study. It was a simple, yellow sheet folded in two to yield four pages. The first page gave general information on the intensive care unit (ICU) and hospital. French Society for Critical Care was written at the top of the page, then the name and address of the hospital and the names of the head of the ICU, of all senior ICU physicians, of the social worker, and of the head nurse. The phone numbers of each ICU section were given, as well as the visiting hours and means of transportation to the hospital. The second page carried a blank space for writing the name of the ICU physician who cared for the patient immediately before the FIL was given to the family representative. The reasons for restricting the visiting hours and for isolating the patients were given, as well as information on the operation of the ICU, including the number of senior and junior ICU physicians present during the day and at night. The third page showed a diagram of a typical ICU room, with the names of all the devices in the room. The need for leaving the patient naked was explained in the same sentence as an assurance that the patient s privacy would be respected. Finally, an invitation to speak and to talk to the patient was extended on this page. The fourth page contained a glossary of 12 terms commonly used in ICUs: intubation, extubation, ventilation (and ventilator), sedation, cardiac monitor, inhospital transportation, catheter, gastric tube, iatrogenic event, nosocomial infection, clinical research, and information. Each page carried an invitation to ask the ICU caregivers for additional information or to ask for an appointment with the physician in charge of the patient or with the head of the ICU. Data Collection The following ICU characteristics were recorded: university or community hospital; structure of the unit (number of beds, number of senior physicians, number of junior physicians
3 E3 [fellows], patient-to-nurse ratio, existence of a waiting room, existence of a room used only for meeting with families); and habits regarding interactions with families (regular meetings of physicians and nurses to discuss family needs at least once a week, family information leaflet, total visiting hours allowed per day, whether a given family always received information from the same physician, and whether the ICU had a written protocol for interacting with families). For each patient, the following information was recorded: age, sex, geographic origin, marital status, occupation, reasons for ICU admission, and clinical status at admission including the Simplified Acute Physiology Score (SAPS II) score (E1). Length of ICU stay and vital status at ICU discharge were also recorded. Family member was defined as a relative or friend of the patient who was present at the first physician family meeting and was specifically designated by the patient (or by the family if the patient was unable to communicate) to speak for and represent the patient and family; thus, only one family member per patient was studied. All family representatives were told that a study of their needs was ongoing and that they could participate in the study by completing a questionnaire. Those who accepted were offered a seat in a quiet place and were asked to complete a questionnaire, the Critical Care Family Needs Inventory (CCFNI), anonymously (Appendix E1). A caregiver was available to answer any questions. CCFNI results were determined as follows: each item received a score between 1 (indicating extreme satisfaction, see APPENDIX E1) and 4 (indicating extreme dissatisfaction). The satisfaction score was calculated as the sum of the scores on all 14 items; thus, the smallest possible score was 14 (extreme satisfaction) and the highest possible score was 56 (extreme dissatisfaction). The family representative was then interviewed by the investigator, who did not know whether the representative had received an FIL. The interview served to evaluate comprehension of the diagnosis, prognosis, and treatment of the patient, as detailed below.
4 E4 Family representatives entered the following data on a standardized questionnaire: age, sex, relationship to the patient, occupation, and commuting time to the hospital; the time family representatives would have wanted to spend receiving information from the ICU physician and the time actually allowed them; how satisfied they were with the information provided by junior physicians; whether they received contradictory information; whether they were told of the specific role of each ICU caregiver; whether they were receiving support from their usual doctor (the family general practitioner or the physician who cared for the patient before ICU admission); whether they needed more information on the diagnosis, prognosis, or treatment of the patient; and whether they wanted help from a psychologist. Family representatives also completed the Hospital Anxiety and Depression Scale (HADS), a 14-item self-administered questionnaire developed by Zigmond and Snaith for detecting and classifying the severity of anxiety and depression (E2), with seven items on depression and seven on anxiety. A score of 10 on the anxiety or depression subscale has been found reliable for discriminating between patients with and without the corresponding disorder. The HADS is simple, requires little time to complete, has been validated in French, and has been proved sensitive as a screening tool (E2 E4). Instruments Used to Measure the Effectiveness of Information Provided to Family Representatives In each study ICU, comprehension by each family representative was assessed during an interview with the ICU s investigator, who was blinded to group assignment (FIL or no FIL). This interview used three prospectively defined components, as previously described (E5): comprehension of the diagnosis, defined as knowledge of which organ was primarily involved in the disease process; comprehension of the prognosis, defined as knowledge of whether the patient was expected to survive (not grave) or not (grave); and comprehension of the treatment, defined as knowledge of at least one of the major treatments used among the list of 10 given by
5 E5 the physicians. Poor comprehension was defined as failure to understand any of the three components, and good comprehension as understanding any combination of these components. I don t know answers were taken as indicating absence of comprehension. Satisfaction was measured using a modified version of the CCFNI (E6, E7). All CCFNI questionnaires were given to family representatives between the third and fifth days following admission and were recovered immediately after completion; none were taken home by family representatives. The study was approved by the Ethics Committee of the French Society for Critical Care. In accordance with French law, this approval was valid for all the participating ICUs, and the directors of the ICUs or the corresponding hospitals were not asked to give their consent, although they were informed of the study. The study design, conduct, and results were monitored by an independent oversight committee appointed by the Ethics Committee of the French Society for Critical Care. References E1. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SPAS II) based on a European/North American multicenter study. JAMA 1993;270: E2. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983;67: E3. Herrmann C. International experiences with the Hospital Anxiety and Depression Scale: a review of validation data and clinical results. J Psychosom Res 1997;42: E4. Lepine JP, Godchau M, Brun P. Anxiety and depression in inpatients. Lancet 1985;2: E5. Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med 2000;28:
6 E6 E6. Azoulay E, Pochard F, Chevret S, Lemaire F, Mokhtari M, Le Gall JR, Dhainaut JF, Schlemmer B, for the French FAMIREA group. Meeting the needs of ICU-patients families: a multicenter study. Am J Respir Crit Care Med 2001;163: E7. Johnson D, Wilson M, Cavanaugh B, Bryden C, Gudmundson D, Moodley O. Measuring the ability to meet family needs in an intensive care unit. Crit Care Med 1998;26; E8. Harvey MA, Ninos NP, Adler DC, Goodnough-Hanneman SK, Kaye WE, Nikas DL. Results of the consensus conference on fostering more humane critical care: creating a healing environment. Society of Critical Care Medicine. AACN Clin Issues Crit Care Nurs 1993;4: E9. Molter NC. Needs of relatives of critically ill patients: a descriptive study. Heart Lung 1979;8:
7 E7 APPENDIX E1. REPLIES TO THE ITEMS OF THE CRITICAL CARE FAMILY NEEDS INVENTORY * 1. Do you feel that the best possible care is being given to the patient? 77% 20.4% 2.6% 0% 2. Do you feel that the hospital personnel care about the patient? 77.7% 21% 1.3% 0% 3. Have the explanations given to you about the patient s condition been in terms you can understand? 55.5% 35% 9.5% 0 4. Do you feel that you have been given honest information about the patient s condition? 66.9% 27.4% 5.7% 0 5. Do you understand what is happening to the patient and why things are being done? 65.6% 26.7% 7.7% 0 6. Have the staff members been courteous to you? 85.4% 12.8% 1.8% 0 7. Have any of the staff members shown interest in how you are doing? 17.2% 14% 15.3% 53.5% 8. Do you believe that someone will call you at home with any major or significant change in the patient s condition? 77.5% 18.5% 3% 1% 9. Have the hospital personnel explained the equipment being used? 42% 16% 17.2% 24.8% 10. I am very satisfied with the medical care the patient receives 84% 13.4% 2.6% There are some things about the medical care the patient receives that could be better 1. None of the time 2. Only some of the time 3. Most of the time 4. Almost all the time 40.8% 38.2% 13.3% 7.7% 12. Do you feel comfortable visiting with the patient in the intensive care unit? 83.5% 14.6% 1.3% 0.6% 13. Is the waiting room comfortable? 44.6% 26.1% 13.4% 15.9% 14. Do you feel alone and isolated in the waiting room? 1. None of the time 2. Only some of the time 3. Most of the time 4. Almost all the time 44.6% 26.1% 13.4% 15.9% * References E6 E9; Items significantly improved by the family information leaflet are in bold characters.
METHODS. Keywords: family needs; satisfaction; comprehension; leaflet; information; intensive care
Impact of a Family Information on Effectiveness of Information Provided to Family Members of Intensive Care Unit Patients A Multicenter, Prospective, Randomized, Controlled Trial ELIE AZOULAY, FRÉDÉRIC
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