Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-09-26
2020-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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ICU Diary Group
Patients randomized to this group receive the ICU diary, along with PTSD education
Diary (blank journal) plus PTSD psycho-education
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
PTSD psycho-education alone
We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
PTSD Education-only Group
Control Group: patients randomized to this group only receive PTSD education
PTSD psycho-education alone
We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
Interventions
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Diary (blank journal) plus PTSD psycho-education
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
PTSD psycho-education alone
We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
Eligibility Criteria
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Inclusion Criteria
* sedated and mechanically ventilated for at least 24 hours.
* available over-the-phone, up to 6 months post-ICU discharge
Exclusion Criteria
* not fluent in the English language
* patients who have stayed in the ICU for less than 72 hours
* patients who have been sedated and mechanically ventilated for less than 24 hours
* patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
* patients with no phone number or reliable contact information for the sake of follow-up
* prisoners
* pregnant patients
18 Years
65 Years
ALL
No
Sponsors
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The Arnold P. Gold Foundation
OTHER
Tulane University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Rachel Hammer, MD, MFA
Role: PRINCIPAL_INVESTIGATOR
Tulane University School of Medicine
George Sayde, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Tulane University School of Medicine
Locations
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Tulane University School of Medicine
New Orleans, Louisiana, United States
Countries
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References
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Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.
Wintermann GB, Brunkhorst FM, Petrowski K, Strauss B, Oehmichen F, Pohl M, Rosendahl J. Stress disorders following prolonged critical illness in survivors of severe sepsis. Crit Care Med. 2015 Jun;43(6):1213-22. doi: 10.1097/CCM.0000000000000936.
Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
Myhren H, Ekeberg O, Toien K, Karlsson S, Stokland O. Posttraumatic stress, anxiety and depression symptoms in patients during the first year post intensive care unit discharge. Crit Care. 2010;14(1):R14. doi: 10.1186/cc8870. Epub 2010 Feb 8.
Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Erratum to: Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 Jul;41(7):1391. doi: 10.1007/s00134-015-3932-9. No abstract available.
Davydow DS, Kohen R, Hough CL, Tracy JH, Zatzick D, Katon WJ. A pilot investigation of the association of genetic polymorphisms regulating corticotrophin-releasing hormone with posttraumatic stress and depressive symptoms in medical-surgical intensive care unit survivors. J Crit Care. 2014 Feb;29(1):101-6. doi: 10.1016/j.jcrc.2013.08.016. Epub 2013 Sep 24.
Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.
Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan;37(1):184-91. doi: 10.1097/CCM.0b013e31819287f7.
Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80. doi: 10.1097/00003246-200103000-00019.
Karnatovskaia LV, Johnson MM, Benzo RP, Gajic O. The spectrum of psychocognitive morbidity in the critically ill: a review of the literature and call for improvement. J Crit Care. 2015 Feb;30(1):130-7. doi: 10.1016/j.jcrc.2014.09.024. Epub 2014 Oct 2.
Bergbom I, Svensson C, Berggren E, Kamsula M. Patients' and relatives' opinions and feelings about diaries kept by nurses in an intensive care unit: pilot study. Intensive Crit Care Nurs. 1999 Aug;15(4):185-91. doi: 10.1016/s0964-3397(99)80069-x.
Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Diaries for recovery from critical illness. Cochrane Database Syst Rev. 2014 Dec 9;2014(12):CD010468. doi: 10.1002/14651858.CD010468.pub2.
Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.
Sayde GE, Stefanescu A, Conrad E, Nielsen N, Hammer R. Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness. Gen Hosp Psychiatry. 2020 Sep-Oct;66:96-102. doi: 10.1016/j.genhosppsych.2020.06.017. Epub 2020 Jul 2.
Other Identifiers
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GH-17-022
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ICU Diary RCT NOLA
Identifier Type: -
Identifier Source: org_study_id
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