DeliriumNCT03360474
Implementation of a Delirium Screening
A study testing Delirium Screen in people with Delirium and Cancer, run by University of Miami.
Trial summary
The purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the ICU setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Cancer, Bone Marrow Ablation
- What is being tested?
- Delirium Screen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included into the study who:
- Are over 18 years old
- Speak and read English
- Are admitted to the Sylvester Comprehensive Cancer Center intensive care unit in the first 60 days following implementation of the delirium protocol; approximately 10 patients per month.
- Patient data via electronic medical record (EMR) for all patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit up to 60 days prior to the implementation of the delirium protocol.
Who cannot join
- This study will exclude:
- Patients who are unable to speak and read English
- Patients who are unable to provide written consent to participate.
- Patient data via EMR for any patients who were admitted to the Sylvester Comprehensive Cancer Center intensive care unit prior to 60 days before to the implementation of the delirium protocol.
About this study
Official title: The Implementation of a Delirium Screening and Intervention Protocol for Critically Ill Patients
The purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the ICU setting. The hypothesis is that patients who receive an accurate and early diagnosis of delirium coupled with a standardized intervention protocol will demonstrate improved patient outcomes as evidenced by fewer days spent in the ICU, fewer days spent in the hospital (overall length of stay) and the need for less sedative medication throughout their ICU stay as compared to patient data prior to the implementation of a delirium protocol.
- Conditions
- Delirium, Cancer, Bone Marrow Ablation
- Being tested
- Delirium Screen
- Medical subject headings
- Delirium, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium ScreenBehavioural
Patients who screen positive for delirium will be assessed for pain, electrolyte imbalances,infection, the use of deliriogenic medications and any issues will be resolved. Those with persistent delirium following all other intervention will be treated with antipsychotic medication.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will be placed on the delirium screening intervention protocol arm. They will be screened for delirium twice per day. If positive, they will follow the treatment algorithm and assessed at 4 hour intervals until they reach 4 negative screens. Once 4 negative screens have been reached, they will be assessed twice daily. Receives: Behavioral: Delirium Screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay (LOS)
Patient's length of stay in the ICU
Measured: 60 days
Secondary outcomes (2)
Overall LOS in hospital
Patient's length of stay in hospital
Measured: 60 days
Sedation Medication
Total amount of sedating medication given to patient during their hospitalization.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study startJun 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Changed to a QI project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive analysis will be conducted on demographic (e.g., age, gender) variables to report characteristics of the sample. The data to be collected are reflected in the attached measures. Days spent in the ICU and total days spent in the hospital will be analyzed using standard t-tests to assess difference in length of stay in ICU and overall hospitalization for 60 days prior to initiation of the delirium protocol and 60 days following the initiation of the protocol.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Rueda-Lara, University of Miami
- Investigators
- Maria Rueda-Lara, MD, Principal investigator, SCCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360474
- Sponsor's protocol ID
- 20170784
- Status last verified
- Nov 2017
- First submitted
- 17 Nov 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 5th ED. Washington, DC: American Psychiatric Association; 2013.
Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
PubMed 17102966Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
PubMed 11797025McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.
PubMed 12752832Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
PubMed 18580517Breitbart W, Alici Y. Evidence-based treatment of delirium in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1206-14. doi: 10.1200/JCO.2011.39.8784. Epub 2012 Mar 12.
PubMed 22412123van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
PubMed 21926597Brummel, N., Jackson, J., Torres, R. et al: Does duration of ICU delirium predict long-term functional impairment? Am J. Respir Crit Care Med 2011; 183: A2653
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Spronk PE, Riekerk B, Hofhuis J, Rommes JH. Occurrence of delirium is severely underestimated in the ICU during daily care. Intensive Care Med. 2009 Jul;35(7):1276-80. doi: 10.1007/s00134-009-1466-8. Epub 2009 Apr 7.
PubMed 19350214Pandharipande P, Cotton BA, Shintani A, Thompson J, Costabile S, Truman Pun B, Dittus R, Ely EW. Motoric subtypes of delirium in mechanically ventilated surgical and trauma intensive care unit patients. Intensive Care Med. 2007 Oct;33(10):1726-31. doi: 10.1007/s00134-007-0687-y. Epub 2007 Jun 5.
PubMed 17549455Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PubMed 232691310-10 Numeric Pain Rating Scale: From McCaffery M, Pasero C. Pain: Clinical Manual, St. Louis, 1999, P. 16.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Delirium Screening and Intervention Protocol for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03360474
- Acronym / sponsor ID
- 20170784
- Conditions
- Delirium, Cancer, Bone Marrow Ablation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed to a QI project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to improve patient outcomes in individuals affected by cancer, through the implementation of a delirium screening and treatment protocol in the ICU setting. The hypothesis is that patients who receive an accurate and early diagnosis of delirium coupled with a standardized intervention protocol will demonstrate improved patient outcomes as evidenced by fewer days spent in the ICU, fewer days spent in the hospital (overall length of stay) and the need for less sedative medication throughout their ICU stay as compared to patient data prior to the implementation of a delirium protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive analysis will be conducted on demographic (e.g., age, gender) variables to report characteristics of the sample. The data to be collected are reflected in the attached measures. Days spent in the ICU and total days spent in the hospital will be analyzed using standard t-tests to assess difference in length of stay in ICU and overall hospitalization for 60 days prior to initiation of the delirium protocol and 60 days following the initiation of the protocol.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Delirium ScreenPatients will be placed on the delirium screening intervention protocol arm. They will be screened for delirium twice per day. If positive, they will follow the treatment algorithm and assessed at 4 hour intervals until they reach 4 negative screens. Once 4 negative screens have been reached, they will be assessed twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be included into the study who:
Key exclusion criteria (4 listed)
- This study will exclude:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delirium ScreenPatients who screen positive for delirium will be assessed for pain, electrolyte imbalances,infection, the use of deliriogenic medications and any issues will be resolved. Those with persistent delirium following all other intervention will be treated with antipsychotic medication. | Behavioural | Intervention |
Primary outcome
ICU Length of Stay (LOS)
Time frame: 60 days
Patient's length of stay in the ICU
2 secondary outcomes
Overall LOS in hospital
Time frame: 60 days
Sedation Medication
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- BackgroundDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition. 5th ED. Washington, DC: American Psychiatric Association; 2013.
- Background: PubMed 17102966Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
- Background: PubMed 11797025Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.
- Background: PubMed 12752832McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.
- Background: PubMed 18580517Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d.
- Background: PubMed 22412123Breitbart W, Alici Y. Evidence-based treatment of delirium in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1206-14. doi: 10.1200/JCO.2011.39.8784. Epub 2012 Mar 12.
- Background: PubMed 21926597van den Boogaard M, Schoonhoven L, Evers AW, van der Hoeven JG, van Achterberg T, Pickkers P. Delirium in critically ill patients: impact on long-term health-related quality of life and cognitive functioning. Crit Care Med. 2012 Jan;40(1):112-8. doi: 10.1097/CCM.0b013e31822e9fc9.
- BackgroundBrummel, N., Jackson, J., Torres, R. et al: Does duration of ICU delirium predict long-term functional impairment? Am J. Respir Crit Care Med 2011; 183: A2653
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 19350214Spronk PE, Riekerk B, Hofhuis J, Rommes JH. Occurrence of delirium is severely underestimated in the ICU during daily care. Intensive Care Med. 2009 Jul;35(7):1276-80. doi: 10.1007/s00134-009-1466-8. Epub 2009 Apr 7.
- Background: PubMed 17549455Pandharipande P, Cotton BA, Shintani A, Thompson J, Costabile S, Truman Pun B, Dittus R, Ely EW. Motoric subtypes of delirium in mechanically ventilated surgical and trauma intensive care unit patients. Intensive Care Med. 2007 Oct;33(10):1726-31. doi: 10.1007/s00134-007-0687-y. Epub 2007 Jun 5.
- Background: PubMed 23269131Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Rueda-Lara, MD principal investigator
SCCC
Questions about this trial
What is this clinical trial studying?
A study testing Delirium Screen in people with Delirium and Cancer, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (LOS) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360474, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.