Depression Clinical Trial
— FCROfficial title:
PROSPECTIVE EVALUATION OF FAMILY CARE RITUALS IN THE ICU AND VALIDATION OF THE END-of-Life ScorING-System (ENDING-S), a Multicenter, Multinational Trial
Verified date | July 2017 |
Source | Brown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate whether or not engaging family members of patients admitted to the ICU in "Family Care Rituals" will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are defined as several domains in which family participation may be of benefit, focusing on the 5 physical senses as well as the personal care of the patient and spirituality of the patient
Status | Completed |
Enrollment | 452 |
Est. completion date | June 12, 2017 |
Est. primary completion date | March 12, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Families of patients admitted to the intensive care unit (ICU) with attending physician predicted ICU mortality of greater than 30%. - Patients with ICU length of stay greater than 4 days, regardless of mortality, are considered for ENDING-S score Exclusion Criteria: - Families of patients with an anticipated ICU length of stay less than 24 hours - Families of patients admitted to the ICU for palliative/comfort care only - Families of patients with age less than 18 - Families of patients who are pregnant - Families of patients who are incarcerated - Family members who are less than 18 - Family members who are pregnant - Family members who are incarcerated |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria Careggi | Florence | |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Brown University | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Brown University | James M. Cox Foundation |
United States, Italy,
Abbott KH, Sago JG, Breen CM, Abernethy AP, Tulsky JA. Families looking back: one year after discussion of withdrawal or withholding of life-sustaining support. Crit Care Med. 2001 Jan;29(1):197-201. — View Citation
Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. — View Citation
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 Aug;28(8):3044-9. — View Citation
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review. — View Citation
Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474. Erratum in: JAMA. 2017 May 23;317(20):2134. — View Citation
Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum in: JAMA. 2014 Apr 2;311(13):1360. — View Citation
Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, Khandelwal N, Young JP, Engelberg RA. Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care. Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. doi: 10.1164/rccm.201505-0900OC. — View Citation
Engström A, Söderberg S. The experiences of partners of critically ill persons in an intensive care unit. Intensive Crit Care Nurs. 2004 Oct;20(5):299-308; quiz 309-10. — View Citation
Fumis RR, Ranzani OT, Martins PS, Schettino G. Emotional disorders in pairs of patients and their family members during and after ICU stay. PLoS One. 2015 Jan 23;10(1):e0115332. doi: 10.1371/journal.pone.0115332. eCollection 2015. — View Citation
Hanson LC, Danis M, Garrett J. What is wrong with end-of-life care? Opinions of bereaved family members. J Am Geriatr Soc. 1997 Nov;45(11):1339-44. — View Citation
Hartog CS, Schwarzkopf D, Riedemann NC, Pfeifer R, Guenther A, Egerland K, Sprung CL, Hoyer H, Gensichen J, Reinhart K. End-of-life care in the intensive care unit: a patient-based questionnaire of intensive care unit staff perception and relatives' psychological response. Palliat Med. 2015 Apr;29(4):336-45. doi: 10.1177/0269216314560007. Epub 2015 Jan 29. — View Citation
Harvey MA. Evolving toward--but not to--meeting family needs. Crit Care Med. 1998 Feb;26(2):206-7. — View Citation
Heyland DK, Rocker GM, O'Callaghan CJ, Dodek PM, Cook DJ. Dying in the ICU: perspectives of family members. Chest. 2003 Jul;124(1):392-7. — View Citation
Jones C, Skirrow P, Griffiths RD, Humphris G, Ingleby S, Eddleston J, Waldmann C, Gager M. Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med. 2004 Mar;30(3):456-60. Epub 2004 Feb 4. — View Citation
Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203. — View Citation
Lilly CM, De Meo DL, Sonna LA, Haley KJ, Massaro AF, Wallace RF, Cody S. An intensive communication intervention for the critically ill. Am J Med. 2000 Oct 15;109(6):469-75. — View Citation
Lynn J, Teno JM, Phillips RS, Wu AW, Desbiens N, Harrold J, Claessens MT, Wenger N, Kreling B, Connors AF Jr. Perceptions by family members of the dying experience of older and seriously ill patients. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Ann Intern Med. 1997 Jan 15;126(2):97-106. — View Citation
McAdam JL, Arai S, Puntillo KA. Unrecognized contributions of families in the intensive care unit. Intensive Care Med. 2008 Jun;34(6):1097-101. doi: 10.1007/s00134-008-1066-z. Epub 2008 Mar 28. — View Citation
Piers RD, Azoulay E, Ricou B, Dekeyser Ganz F, Decruyenaere J, Max A, Michalsen A, Maia PA, Owczuk R, Rubulotta F, Depuydt P, Meert AP, Reyners AK, Aquilina A, Bekaert M, Van den Noortgate NJ, Schrauwen WJ, Benoit DD; APPROPRICUS Study Group of the Ethics Section of the ESICM. Perceptions of appropriateness of care among European and Israeli intensive care unit nurses and physicians. JAMA. 2011 Dec 28;306(24):2694-703. doi: 10.1001/jama.2011.1888. — View Citation
Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. — View Citation
Reyniers T, Deliens L, Pasman HR, Morin L, Addington-Hall J, Frova L, Cardenas-Turanzas M, Onwuteaka-Philipsen B, Naylor W, Ruiz-Ramos M, Wilson DM, Loucka M, Csikos A, Rhee YJ, Teno J, Cohen J, Houttekier D. International variation in place of death of older people who died from dementia in 14 European and non-European countries. J Am Med Dir Assoc. 2015 Feb;16(2):165-71. doi: 10.1016/j.jamda.2014.11.003. Epub 2014 Dec 18. — View Citation
Seferian EG, Afessa B. Adult intensive care unit use at the end of life: a population-based study. Mayo Clin Proc. 2006 Jul;81(7):896-901. — View Citation
Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901. — View Citation
Sprung CL, Woodcock T, Sjokvist P, Ricou B, Bulow HH, Lippert A, Maia P, Cohen S, Baras M, Hovilehto S, Ledoux D, Phelan D, Wennberg E, Schobersberger W. Reasons, considerations, difficulties and documentation of end-of-life decisions in European intensive care units: the ETHICUS Study. Intensive Care Med. 2008 Feb;34(2):271-7. Epub 2007 Nov 9. Erratum in: Intensive Care Med. 2008 Feb;34(2):392-3. — View Citation
Teno JM, Clarridge BR, Casey V, Welch LC, Wetle T, Shield R, Mor V. Family perspectives on end-of-life care at the last place of care. JAMA. 2004 Jan 7;291(1):88-93. — View Citation
Villa G, De Gaudio AR, Falsini S, Lanini I, Curtis JR. Development of END-of-Life ScorING-System to identify critically ill patients after initial critical care who are highly likely to die: a pilot study. Minerva Anestesiol. 2015 Dec;81(12):1318-28. Epub 2015 Jan 23. — View Citation
White DB. Strategies to Support Surrogate Decision Makers of Patients With Chronic Critical Illness: The Search Continues. JAMA. 2016 Jul 5;316(1):35-7. doi: 10.1001/jama.2016.8691. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms of Post-Traumatic Stress Disorder in family members of intensive care patients | Symptoms of PTSD are measured by the Impact of Events Scale revised (IES-r). This survey is conducted via phone 90 days after patient discharge. | 90 days post patient discharge from ICU | |
Secondary | Symptoms of depression in family members of intensive care patients | Symptoms of Depression are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are conducted via phone 90 days after patient discharge | 90 days post patient discharge from ICU | |
Secondary | Symptoms of anxiety in family members of intensive care patients | Symptoms of Anxiety are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are via phone 90 days after patient discharge | 90 days post patient discharge from the ICU | |
Secondary | Family satisfaction with ICU care | Measured by the Family Satisfaction in the ICU- 24 (FS-ICU-24) questionnaire via phone communication at 90 days | 90 days post discharge from ICU | |
Secondary | Congruency of goals of care | Enrolled family members, day time nurse and attending physician are surveyed on enrollment day (day 0) and day 5 with a questionnaire designed to evaluate comfort with the care plan and identify why, if uncomfortable, they are uncomfortable with the care plan | Evaluated at enrollment and if patient is still in the ICU on hospital day 5 during active enrollment | |
Secondary | Validation of the End of Life Scoring System (ENDING-S) | Multicenter prospective validation of ENDING-S. This score produces a number based on the following calculation: [ENDING-S = (7.25 · Days of Mechanical ventilation/ICU Length of stay) + (10.45 · Days of Vasoactive drugs/ICU length of stay) + (3 · Sepsis) + (0.3 · ICU Length of stay)] where "sepsis" is binary yes/no as to whether or not the patient is septic. Will also include evaluation of the addition of multi-parametric variables (such as functional status, spiritual and communicative variables) to the ENDING-S to generate a final score based on in hospital morbidity combined with prehospital comorbidities | Through study completion, anticipated to be 18 months | |
Secondary | ICU length of stay | In an effort to evaluate resources used during study period, ICU length of stay will be collected to ascertain whether or not the intervention reduces length of stay | Through study completion, anticipated to be 18 months | |
Secondary | Use of palliative/spiritual care during ICU stay | In an effort to evaluate resources used during study period, data on whether or not a palliative/spiritual care order was placed will be collected to ascertain whether or not the intervention impacts use of these resources | Through study completion, anticipated to be 18 months | |
Secondary | Location of discharge from ICU | In an effort to understand type of discharge (death, another hospital floor, nursing home, hospice, etc), charts will be reviewed for location of discharge from the ICU to ascertain whether or not the intervention impacted discharge | Through study completion, anticipated to be 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |