DeliriumNCT05172583
Nursing Intervention to Reduce Incidence and Duration of Delirium in Patients in Intensive Care
A study testing Interventions to reduce delirium based on DSM and scientific evidence in people with Delirium, run by Universidad Surcolombiana at 1 site in Colombia.
Trial summary
Introduction: Delirium is a cognitive alteration of acute onset and fluctuating course, characterized by the reduced capacity to pay attention to the environment, memory impairment, disorientation, language, and perception alteration. Its incidence varies between 20 and 90% in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Interventions to reduce delirium based on DSM and scientific evidence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteColombia
- Study dates
- 5 Jul 2021to 31 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People admitted to the adult intensive care unit
- People over 18 years of age.
- People who are agree to participate in the study by signing the informed consent.
- People who have no delirium at the time of recruitment (CAM - negative ICU).
Who cannot join
- People with any cognitive disorder or neurosurgical pathology.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario Hernando Moncaleano Perdomo
Neiva, Huila Department, 410010
Fabián H Olaya, RN, +57 320 4868285, somnius_2@hotmail.com
About this study
Introduction: Delirium is a cognitive alteration of acute onset and fluctuating course, characterized by the reduced capacity to pay attention to the environment, memory impairment, disorientation, language, and perception alteration. Its incidence varies between 20 and 90% in ICU patients. It shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.
General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptoms Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium in people hospitalized in the adult ICU.
Read more
Methodology: Study with a quantitative approach, experimental design of the type Randomized Controlled Clinical Trial of parallel groups, phase III in which the effectiveness and safety of the intervention designed in a particular population are evaluated, such as the ICU population, who are older risk of developing delirium. The sample will be 71 people for the intervention group and 142 for the control group, with a 2: 1 ratio.
Expected outcome: The primary results are: reduce the incidence and duration of delirium in ICU patients, and the secondary outcomes are: shorter ICU stay, mechanical ventilation, use of physical restraints, less pain intensity, and more days in RASS between -2 and + 1.
Risk: Greater than the minimum.
Read the detailed description
Framework Delirium epidemiology
Delirium is a cognitive alteration, with an acute onset and fluctuating course, characterized by a reduced ability to pay attention to the environment, memory impairment, disorientation, language and perception disturbances(1). Its occurrence varies between 20 and 90% in people hospitalized in the Intensive Care Unit (ICU) (2,3), with a duration between 1 and 5 days (2,3). Its hypoactive typology is frequent between 5 and 71.5% of the cases, hyperactive between 5.1 and 14%, and mixed between 5.1 and 89%. Its shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.
Various studies have found that the etiology of delirium is associated with predisposing and precipitating factors. Among the predisposing factors, there is age between 50 and 70 years (4). Also chronic kidney disease, cerebrovascular disorders and a previous history of delirium, cognitive dysfunction, depression, dementia, dependence on psychoactive substances and / or alcohol, postoperative states, arterial hypertension, disease severity, elevated blood urea nitrogen and creatinine, sodium and hyperthermia(4).
Among the precipitating factors of delirium are mechanical ventilation (5), benzodiazepines (2), low scores in the RASS scale (5), pain, stress, interruption of the sleep-wake cycle, physical immobilizations, and medical devices such as urinary catheter and central venous catheter. These factors are specific to the environment and ICU treatment and increase the risk of delirium, regardless of the presence or absence of predisposing factors. However, the precipitating factors are modifiable according to the diagnosis and evolution of the patient.
Its impact is highly negative since it increases the days of mechanical ventilation, of consciousness in deep sedation (5), stay and mortality in ICU and hospital (2), of the use of physical restraints accelerates the transition to dementia and reduces cognitive recovery, and physical functionality(3). For this reason, the American Guidelines of 2013 and 2018 and German of 2015 for the management of agitation, pain, and delirium, recommend monitoring and preventing it through mainly non-pharmacological measures, which is part of the strategy of humanization of care in the ICU.
The high incidence and consequences of delirium in people hospitalized in the ICU continues to be worrying; however, the detection of precipitating factors suggests alternative measures that make the environment and care modifiable, to reduce the incidence and duration of delirium. On the other hand, the predisposing factors of delirium suggest a baseline or possible confounding variables to detect and control in the present study.
Nursing has a dominant role in the approach to delirium. The assessment and Nurses' interventions are essential to prevent and treat delirium. Nurses are leaders in clinical decision-making; since they constantly evaluate people's conditions and their clinical results, they are the ones who have the most and timely communication with patients. von Rueden et al. (5) add that. Therefore, nursing interventions can reduce the risk of delirium, the length of stay in ICU, mortality, and long-term impairment of cognition.
Main propositions:
- Initial measures to address delirium include the identification and correction of precipitating cause. In addition, non-pharmacological interventions can prevent delirium.
- A variety of ICU care processes influence delirium, most of which are modifiable.
- Through the development and implementation of evidence-based interventions, it is possible to reduce the incidence and duration of delirium.
Main Gaps:
The incidence of delirium in the ICU remains high (20-90%) and its harmful consequences, although evidence-based packages prevent it.
- Health professionals, including nurses, have naturalized delirium in ICU patients, which has reduced the possibilities of prevention.
Justification
The onset of delirium in people in the ICU remains high in European, Asian, and American countries; it ranges between 20 and 90% (2). In Colombia, it ranges between 20.2 and 28% (6). It is associated with predisposing and precipitating factors. The latter is related to the care provided in the ICU, which is mostly modifiable. Its consequences are loss of factual memory, increased ICU and hospital stay, medical care costs, days of mechanical ventilation, and even mortality (2). Not only patients are affected, but also their families and the health system in general. Therefore, it is pertinent to develop strategies that mitigate their incidence and impact.
Although effective interventions are found in the scientific evidence to prevent and treat delirium, its incidence remains high, which justifies the need to develop and implement non-pharmacological interventions early. In this regard, in this study, in addition to implementing interventions based on scientific evidence, they will be designed from a theoretical perspective, such as the Dynamic Symptoms Model, which offers support to the approach method, since it provides a structure congruent with the phenomenon, in turn, giving, the novelty in the development of interventions, because it includes elements not addressed in other studies such as psychological, spiritual, social, environmental antecedents, previous and concomitant experiences and symptoms, as well as the broad participation of the family in all interventions.
It is feasible to carry out this research because there is access to the population and institution of study, with thematic and methodological advice and the academic and ethical support of the National University of Colombia. Furthermore, it is feasible because it is a phenomenon susceptible to measurement and intervention, there are validated tools, and the interventions will solve a problem in nursing practice.
Research question: What is the effectiveness of nursing interventions based on the Dynamic Symptom Model and scientific evidence, compared to daily care, to reduce the incidence and duration of delirium in people hospitalized in the adult ICU?
General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptom Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium, in people hospitalized in the adult ICU.
Specific objectives according to study phases:
Phases I. Design of the intervention
- Design the nursing intervention based on the conceptual structure of the Dynamic Symptoms Model and scientific evidence to reduce the incidence and duration of delirium in patients in intensive care.
- Analyze the feasibility, viability, and barriers of the designed intervention through validation by experts working in the institution.
Phase II. Evaluation of the intervention
- Characterize demographically and clinically the people participating in the study.
- Compare the intervention designed, versus daily care, in reducing the incidence and duration of delirium and other clinical outcomes (reduction in days of mechanical ventilation and stay in the ICU, the presence and intensity of pain, the use of physical restrictions, and the improvement of the state of consciousness).
Hypothesis
Study hypothesis: The nursing intervention based on the Dynamic Symptoms Model and scientific evidence reduce incidence and duration of delirium in people hospitalized in the ICU.
- Conditions
- Delirium
- Being tested
- Control, Interventions to reduce delirium based on DSM and scientific evidence
- Keywords
- Delirium, Intensive Care Units, Disease Prevention, Evaluation of the Efficacy-Effectiveness of Interventions, Non-pharmacological interventions
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
The control groups will receive the nursing interventions that are performed daily in the adult ICU. These are orientation in time, space, and place, accompaniment of the family for two hours in the morning and two hours in the afternoon, physical therapy once a day according to the patient's condition, medication with conscious sedation, and progressive reduction analgesics. opioids and benzodiazepines.
Interventions to reduce delirium based on DSM and scientific evidenceBehavioural
The interventions are designed from the structure of the Dynamic Symptoms Model (DSM), taking into account the antecedents of delirium, physiological such as the medical condition of mechanical ventilation and pain, and drug treatment with sedatives and analgesics; the psychological, social, and spiritual antecedents with stimulation in the values, life experience, personality and spirituality, and the environmental antecedents with an adaptation of the physical conditions of the ICU. In addition, previous experience with identification and care of concomitant symptoms such as fear, confusion, restlessness, loneliness, and discomfort, and with the measurement and classification of the trajectory of delirium when it occurs, will also be considered. The interventions follow the scientific evidence, mainly from the ABCDEF bundle. All interventions are non-pharmacological.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control groups will receive the nursing interventions that are performed daily in the adult ICU Receives: Behavioral: Control |
| Experimental | Experimental | Interventions for this group are based on the Dynamic Symptom Model and scientific evidence Receives: Behavioral: Interventions to reduce delirium based on DSM and scientific evidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale
The possible results are positive or negative for delirium
Measured: Through ICU length of stay, an average of 8 days.
Secondary outcomes (5)
Fluctuations in consciousness with Richmond Agitation-Sedation Scale (RASS).
The Richmond Agitation-Sedation Scale measures the sedation and agitation level in patient in Intensive care unit. Its possible results are: -5 unarousable, -4 deep sedation, -3 moderate sedation, -2 light sedation, -1 drowsy, 0 alert and calm, +1 restless, +2 agitated, +3 very agitated, and +4 combative.
Measured: Through ICU length of stay, an average of 8 days.
Changes in the Pain intensity. with Campbell scale in non-communicative critical patients, and Visual Analog Scale (VAS) in communicative critical patients.
Campbell scale measures the pain intensity. Its results are: 0 without pain, 1-3 between mild and moderated pain, 4-6 between moderate and severe pain, and >6 intensive pain. The possible results of Visual Analog Scale are 0 no pain, 1-3 mild pain, 4-6 between moderate and severe pain, 7-9 very severe pain, 10 worst pain possible.
Campbell scale measures the pain intensity. Its results are: 0 without pain, 1-3 between mild and moderated pain, 4-6 between moderate and severe pain, and >6 intensive pain. The possible results of Visual Analog Scale are 0 no pain, 1-3 mild pain, 4-6 between moderate and severe pain, 7-9 very severe pain, 10 worst pain possible.
Measured: Through ICU length of stay, an average of 8 days.
length of stay in ICU
length of stay in ICU
Measured: Through ICU length of stay, an average of 8 days.
Mechanical ventilation
Number of Mechanical ventilation days
Measured: Through ICU length of stay, an average of 8 days
Physical restrictions
Number with physical restrictions days
Measured: Through ICU length of stay, an average of 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 Jul 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruit upon admission to the ICU, patients and family members are asked to sign the informed consent and confidentiality agreement. The Assignment to the groups will be random. All interventions will be performed and will be adjusted according to the patient's condition. If the patient is recruited while under the effects of sedation, they will be asked to sign the informed consent when she is conscious; if she does not wish to participate, the withdrawal will be completed, and she will be excluded from the study. Follow-up will be done each shift, where the outcome variables will be measured and recorded in an established format.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Surcolombiana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Colombia
- Responsible party
- Sponsor
- Investigators
- Ángela M Henao Castaño, PhD, Study director, Universidad Nacional de ColombiaDolly O Arias Torres, PhD, Study chair, Universidad Surcolombiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172583
- Sponsor's protocol ID
- 53487
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.
PubMed 24082241Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.
PubMed 28254205Lee A, Mu JL, Chiu CH, Gin T, Underwood MJ, Joynt GM. Effect of motor subtypes of delirium in the intensive care unit on fast-track failure after cardiac surgery. J Thorac Cardiovasc Surg. 2018 Jan;155(1):268-275.e1. doi: 10.1016/j.jtcvs.2017.08.139. Epub 2017 Sep 30.
PubMed 29110954Park SA, Tomimaru Y, Shibata A, Miyagawa S, Noguchi K, Dono K. Incidence and Risk Factors for Postoperative Delirium in Patients After Hepatectomy. World J Surg. 2017 Nov;41(11):2847-2853. doi: 10.1007/s00268-017-4079-3.
PubMed 28608014Von Rueden KT, Wallizer B, Thurman P, McQuillan K, Andrews T, Merenda J, Son H. Delirium in Trauma Patients: Prevalence and Predictors. Crit Care Nurse. 2017 Feb;37(1):40-48. doi: 10.4037/ccn2017373.
PubMed 28148613Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
PubMed 18495054Ely EW. The ABCDEF Bundle: Science and Philosophy of How ICU Liberation Serves Patients and Families. Crit Care Med. 2017 Feb;45(2):321-330. doi: 10.1097/CCM.0000000000002175.
PubMed 28098628Gomez Tovar LO, Henao Castano AM. Dynamic delirium - Nursing intervention to reduce delirium in patients critically Ill, a randomized control trial. Intensive Crit Care Nurs. 2024 Aug;83:103691. doi: 10.1016/j.iccn.2024.103691. Epub 2024 Mar 21.
PubMed 38518455
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention to Reduce Incidence and Duration of Delirium in Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT05172583
- Acronym / sponsor ID
- 53487
- Conditions
- Delirium
- Keywords
- Delirium, Intensive Care Units, Disease Prevention, Evaluation of the Efficacy-Effectiveness of Interventions, Non-pharmacological interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Universidad SurcolombianaUniversity, hospital or other
- Collaborators
- Universidad Nacional de Colombia
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 29 Dec 2021 (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.
Introduction: Delirium is a cognitive alteration of acute onset and fluctuating course, characterized by the reduced capacity to pay attention to the environment, memory impairment, disorientation, language, and perception alteration. Its incidence varies between 20 and 90% in ICU patients. It shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.
General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptoms Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium in people hospitalized in the adult ICU.
Methodology: Study with a quantitative approach, experimental design of the type Randomized Controlled Clinical Trial of parallel groups, phase III in which the effectiveness and safety of the intervention designed in a particular population are evaluated, such as the ICU population, who are older risk of developing delirium. The sample will be 71 people for the intervention group and 142 for the control group, with a 2: 1 ratio.
Expected outcome: The primary results are: reduce the incidence and duration of delirium in ICU patients, and the secondary outcomes are: shorter ICU stay, mechanical ventilation, use of physical restraints, less pain intensity, and more days in RASS between -2 and + 1.
Risk: Greater than the minimum.
Detailed description
Framework Delirium epidemiology
Delirium is a cognitive alteration, with an acute onset and fluctuating course, characterized by a reduced ability to pay attention to the environment, memory impairment, disorientation, language and perception disturbances(1). Its occurrence varies between 20 and 90% in people hospitalized in the Intensive Care Unit (ICU) (2,3), with a duration between 1 and 5 days (2,3). Its hypoactive typology is frequent between 5 and 71.5% of the cases, hyperactive between 5.1 and 14%, and mixed between 5.1 and 89%. Its shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.
Various studies have found that the etiology of delirium is associated with predisposing and precipitating factors. Among the predisposing factors, there is age between 50 and 70 years (4). Also chronic kidney disease, cerebrovascular disorders and a previous history of delirium, cognitive dysfunction, depression, dementia, dependence on psychoactive substances and / or alcohol, postoperative states, arterial hypertension, disease severity, elevated blood urea nitrogen and creatinine, sodium and hyperthermia(4).
Among the precipitating factors of delirium are mechanical ventilation (5), benzodiazepines (2), low scores in the RASS scale (5), pain, stress, interruption of the sleep-wake cycle, physical immobilizations, and medical devices such as urinary catheter and central venous catheter. These factors are specific to the environment and ICU treatment and increase the risk of delirium, regardless of the presence or absence of predisposing factors. However, the precipitating factors are modifiable according to the diagnosis and evolution of the patient.
Its impact is highly negative since it increases the days of mechanical ventilation, of consciousness in deep sedation (5), stay and mortality in ICU and hospital (2), of the use of physical restraints accelerates the transition to dementia and reduces cognitive recovery, and physical functionality(3). For this reason, the American Guidelines of 2013 and 2018 and German of 2015 for the management of agitation, pain, and delirium, recommend monitoring and preventing it through mainly non-pharmacological measures, which is part of the strategy of humanization of care in the ICU.
The high incidence and consequences of delirium in people hospitalized in the ICU continues to be worrying; however, the detection of precipitating factors suggests alternative measures that make the environment and care modifiable, to reduce the incidence and duration of delirium. On the other hand, the predisposing factors of delirium suggest a baseline or possible confounding variables to detect and control in the present study.
Nursing has a dominant role in the approach to delirium. The assessment and Nurses' interventions are essential to prevent and treat delirium. Nurses are leaders in clinical decision-making; since they constantly evaluate people's conditions and their clinical results, they are the ones who have the most and timely communication with patients. von Rueden et al. (5) add that. Therefore, nursing interventions can reduce the risk of delirium, the length of stay in ICU, mortality, and long-term impairment of cognition.
Main propositions:
- Initial measures to address delirium include the identification and correction of precipitating cause. In addition, non-pharmacological interventions can prevent delirium.
- A variety of ICU care processes influence delirium, most of which are modifiable.
- Through the development and implementation of evidence-based interventions, it is possible to reduce the incidence and duration of delirium.
Main Gaps:
The incidence of delirium in the ICU remains high (20-90%) and its harmful consequences, although evidence-based packages prevent it.
- Health professionals, including nurses, have naturalized delirium in ICU patients, which has reduced the possibilities of prevention.
Justification
The onset of delirium in people in the ICU remains high in European, Asian, and American countries; it ranges between 20 and 90% (2). In Colombia, it ranges between 20.2 and 28% (6). It is associated with predisposing and precipitating factors. The latter is related to the care provided in the ICU, which is mostly modifiable. Its consequences are loss of factual memory, increased ICU and hospital stay, medical care costs, days of mechanical ventilation, and even mortality (2). Not only patients are affected, but also their families and the health system in general. Therefore, it is pertinent to develop strategies that mitigate their incidence and impact.
Although effective interventions are found in the scientific evidence to prevent and treat delirium, its incidence remains high, which justifies the need to develop and implement non-pharmacological interventions early. In this regard, in this study, in addition to implementing interventions based on scientific evidence, they will be designed from a theoretical perspective, such as the Dynamic Symptoms Model, which offers support to the approach method, since it provides a structure congruent with the phenomenon, in turn, giving, the novelty in the development of interventions, because it includes elements not addressed in other studies such as psychological, spiritual, social, environmental antecedents, previous and concomitant experiences and symptoms, as well as the broad participation of the family in all interventions.
It is feasible to carry out this research because there is access to the population and institution of study, with thematic and methodological advice and the academic and ethical support of the National University of Colombia. Furthermore, it is feasible because it is a phenomenon susceptible to measurement and intervention, there are validated tools, and the interventions will solve a problem in nursing practice.
Research question: What is the effectiveness of nursing interventions based on the Dynamic Symptom Model and scientific evidence, compared to daily care, to reduce the incidence and duration of delirium in people hospitalized in the adult ICU?
General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptom Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium, in people hospitalized in the adult ICU.
Specific objectives according to study phases:
Phases I. Design of the intervention
- Design the nursing intervention based on the conceptual structure of the Dynamic Symptoms Model and scientific evidence to reduce the incidence and duration of delirium in patients in intensive care.
- Analyze the feasibility, viability, and barriers of the designed intervention through validation by experts working in the institution.
Phase II. Evaluation of the intervention
- Characterize demographically and clinically the people participating in the study.
- Compare the intervention designed, versus daily care, in reducing the incidence and duration of delirium and other clinical outcomes (reduction in days of mechanical ventilation and stay in the ICU, the presence and intensity of pain, the use of physical restrictions, and the improvement of the state of consciousness).
Hypothesis
Study hypothesis: The nursing intervention based on the Dynamic Symptoms Model and scientific evidence reduce incidence and duration of delirium in people hospitalized in the ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be recruit upon admission to the ICU, patients and family members are asked to sign the informed consent and confidentiality agreement. The Assignment to the groups will be random. All interventions will be performed and will be adjusted according to the patient's condition. If the patient is recruited while under the effects of sedation, they will be asked to sign the informed consent when she is conscious; if she does not wish to participate, the withdrawal will be completed, and she will be excluded from the study. Follow-up will be done each shift, where the outcome variables will be measured and recorded in an established format.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlThe control groups will receive the nursing interventions that are performed daily in the adult ICU |
| Experimental | Experimental | Behavioral: Interventions to reduce delirium based on DSM and scientific evidenceInterventions for this group are based on the Dynamic Symptom Model and scientific evidence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People admitted to the adult intensive care unit
- People over 18 years of age.
- People who are agree to participate in the study by signing the informed consent.
- People who have no delirium at the time of recruitment (CAM - negative ICU).
Key exclusion criteria (1 listed)
- People with any cognitive disorder or neurosurgical pathology.
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 |
|---|---|---|
| ControlThe control groups will receive the nursing interventions that are performed daily in the adult ICU. These are orientation in time, space, and place, accompaniment of the family for two hours in the morning and two hours in the afternoon, physical therapy once a day according to the patient's condition, medication with conscious sedation, and progressive reduction analgesics. opioids and benzodiazepines. | Behavioural | Control |
| Interventions to reduce delirium based on DSM and scientific evidenceThe interventions are designed from the structure of the Dynamic Symptoms Model (DSM), taking into account the antecedents of delirium, physiological such as the medical condition of mechanical ventilation and pain, and drug treatment with sedatives and analgesics; the psychological, social, and spiritual antecedents with stimulation in the values, life experience, personality and spirituality, and the environmental antecedents with an adaptation of the physical conditions of the ICU. In addition, previous experience with identification and care of concomitant symptoms such as fear, confusion, restlessness, loneliness, and discomfort, and with the measurement and classification of the trajectory of delirium when it occurs, will also be considered. The interventions follow the scientific evidence, mainly from the ABCDEF bundle. All interventions are non-pharmacological. | Behavioural | Experimental |
Primary outcome
Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale
Time frame: Through ICU length of stay, an average of 8 days.
The possible results are positive or negative for delirium
5 secondary outcomes
Fluctuations in consciousness with Richmond Agitation-Sedation Scale (RASS).
Time frame: Through ICU length of stay, an average of 8 days.
Changes in the Pain intensity. with Campbell scale in non-communicative critical patients, and Visual Analog Scale (VAS) in communicative critical patients.
Time frame: Through ICU length of stay, an average of 8 days.
length of stay in ICU
Time frame: Through ICU length of stay, an average of 8 days.
Mechanical ventilation
Time frame: Through ICU length of stay, an average of 8 days
Physical restrictions
Time frame: Through ICU length of stay, an average of 8 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Results publication: PubMed 24082241Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.
- Results publication: PubMed 28254205Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.
- Results publication: PubMed 29110954Lee A, Mu JL, Chiu CH, Gin T, Underwood MJ, Joynt GM. Effect of motor subtypes of delirium in the intensive care unit on fast-track failure after cardiac surgery. J Thorac Cardiovasc Surg. 2018 Jan;155(1):268-275.e1. doi: 10.1016/j.jtcvs.2017.08.139. Epub 2017 Sep 30.
- Results publication: PubMed 28608014Park SA, Tomimaru Y, Shibata A, Miyagawa S, Noguchi K, Dono K. Incidence and Risk Factors for Postoperative Delirium in Patients After Hepatectomy. World J Surg. 2017 Nov;41(11):2847-2853. doi: 10.1007/s00268-017-4079-3.
- Results publication: PubMed 28148613Von Rueden KT, Wallizer B, Thurman P, McQuillan K, Andrews T, Merenda J, Son H. Delirium in Trauma Patients: Prevalence and Predictors. Crit Care Nurse. 2017 Feb;37(1):40-48. doi: 10.4037/ccn2017373.
- Results publication: PubMed 18495054Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
- Results publication: PubMed 28098628Ely EW. The ABCDEF Bundle: Science and Philosophy of How ICU Liberation Serves Patients and Families. Crit Care Med. 2017 Feb;45(2):321-330. doi: 10.1097/CCM.0000000000002175.
- Derived from this study: PubMed 38518455Gomez Tovar LO, Henao Castano AM. Dynamic delirium - Nursing intervention to reduce delirium in patients critically Ill, a randomized control trial. Intensive Crit Care Nurs. 2024 Aug;83:103691. doi: 10.1016/j.iccn.2024.103691. Epub 2024 Mar 21.
- 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.
Ángela M Henao Castaño, PhD study director
Universidad Nacional de Colombia
Dolly O Arias Torres, PhD study chair
Universidad Surcolombiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions to reduce delirium based on DSM and scientific evidence in people with Delirium, run by Universidad Surcolombiana at 1 site in Colombia.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luz O Gómez Tovar, MSN (+57 3134747420, omaira.gomez@usco.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale (time frame: Through ICU length of stay, an average of 8 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 NCT05172583, which also lists 8 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 29 Dec 2021.