NCT06809894 | NOT YET RECRUITING | Delirium Treatment

Detailed Description:

1. Generalities Delirium, also known as acute confusional syndrome (ACS), is one of the most common complications in hospitalized patients because its underdiagnosed, increased dependence on basic activities of daily living (ADLs), morbidity and mortality, with nearly 23 deaths per 100 patients diagnosed with delirium. It affects up to 40% of patients over 65 years of age. Its occurrence is more frequent in specific hospital settings, such as intensive care units (ICU), emergency departments, or units treating respiratory conditions. Several risk factors contribute to the development of delirium, including age (patients over 65 are at higher risk), gender (it is more common in men), polypharmacy, and invasive procedures like bladder catheterization. Patients with urinary tract infections (UTIs) or strictures also face an increased risk. In addition, comorbidities like diabetes, stroke, heart failure, or COPD increases the risk of tdeveloping delirium. The duration of delirium symptoms can be hours to days, in the 80% of cases, and 20% lasting weeks or even months (4). To minimize its impact, it's crucial to focus on proper prevention, early detection, and effective management. A non-pharmacological approach to treatment is key, as reducing medication use can help prevent adverse effects that may worsen the patient's condition. Provide adequate training and education for healthcare professionals is essential. To reduce the incidence of delirium in hospitalized patients, a protocol has been developed for its prevention, detection, and treatment through non-pharmacological interventions. 2. Aims General aim To reduce episodes of delirium through the management of non-pharmacological therapy in the internal medicine unit of professionals at the University Hospital of Igualada in the prevention, diagnosis and treatment of hospitalized elderly patients. 2.1. Specific aims To determine whether there are differences in the incidence of delirium before and after the intervention. * To evaluate the effectiveness, for one year, of the implementation of a delirium protocol in hospitalized patients. * To improve the knowledge of healthcare staff about delirium and its treatment. * To reduce unnecessary pharmacology in patients with delirium by promoting the use of non-invasive therapies. * To reduce the incidence of delirium in the hospital in the internal medicine hospitalization unit. * To imporve the well-being of the patient and their environment after the onset of delirium. * To reduce the length of stay of adult patients over 65 years of age admitted to the internal medicine units of the University Hospital of Igualada with a diagnosis of delirium. * To guarantee an early diagnosis of delirium in hospitalized patients over 65 years of age, with risk criteria, using the CAM scale. 3. Scope of application The application of the protocol is aimed at the University Hospital of Igualada, at the internal medicine units, with the possibility of extrapolating to other units or health centers. The protocol is aimed at nurses and nurses' assistants in the aforementioned units and may receive help from other professionals such as rehabilitation, cleaning, or medical staff in collaborating in the development of the activities. 4. Population and sample The population will include the total number of patients admitted to medical units 1 and 2, as well as the nursing staff from these units. The patient sample will consist of those who have at least one risk factor for developing delirium, such as age (over 65 years old), gender (male), or polypharmacy. The total sample size will be 65 patients, calculated using the QuestionPro website, based on a population of 77 diagnosed delirium cases in the study units over a 6-month period in 2024 (information provided by the HUI research team). This tool has a margin of error of 5% and a confidence level of 95%. As for the nursing professionals, the total population is 36 nurses from the different units, and this will be the sample of professionals assigned to this phase of the study. 4.1. Inclusion/exclusion criteria Inclusion criteria: Age over 65 years. Exclusion criteria: Age under 65 years, foreseeable death on admission not caused by delirium. 5. Data collection and analysis Data collection will be carried out through the completion of nursing tasks related to the center's SAVAC program. A dedicated section will be added specifically for assessing delirium, which will be filled out upon admission and then every 24 hours until the patient is discharged. These tasks will be carried out in the SAVAC, with support from the center's Research Supervisor. The data entered into these forms will be automatically transferred into an Excel document generated by the program. This document will be downloaded by the center's IT team at 3 months and 6 months after the protocol is implemented, for further analysis. Each time the document is downloaded, the data will be cleared, as it will be continuously updated. The Excel document will display the results from each scale, categorized into the following items for further evaluation of the indicators: * Number of patients at risk of delirium (including those who are subsequently diagnosed and those who are not): This is the number of patients who have risk criteria, without the realization of the CAM scale. * Number of patients diagnosed with delirium: This is the number of patients with risk criteria, and a positive CAM scale. * Number of patients with a score of less than 16 on the DRS-R-98 scale: This is the number of patients diagnosed with delirium but with remission of the severity of this clinic, assessed by DRS-R-98. * Number of days diagnosed with delirium: Of the total number of days hospitalized, how many with delirium. * Total number of days hospitalized: Total number of days hospitalized. * Number of patients receiving treatment for delirium: Total number of patients receiving non-pharmacological and pharmacological treatment for delirium. * Number of patients with drug use for treatment: Of the patients receiving non-pharmacological treatment for delirium, how many need drugs. * Number of patients who died with a diagnosis of delirium: Of the total number of patients diagnosed with delirium, how many die. Below are the indicators that will be used for the analysis of the data: INDICATOR 1 Indicator: Rate of patients at risk of developing delirium Zone: Internal medicine unit Quality criteria Any patient presenting symptomatology equivalent to delirium must be assigned this diagnosis. Definitions: The CAM scale is the reference scale for making the diagnosis of delirium in patients, assessing affirmative answers in 3 or 4 of its items. Justifications: The diagnosis is made using the CAM scale, assessed once there is a suspicion of the diagnosis, which serves as an element in the diagnosis of the disease. It is recorded using the center's computer program. Target population: Hospitalized patients over 65 years of age with 3 or more risk factors for the development of delirium. Formula: Numerator: No. of patients with delirium\* 100 / Denominator: Total number of assessed risk patients Type of indicator: Result Data source: Registered in SAVAC program. Responsible: Nursing Periodicity: * On the appearance of symptoms * Every 24 hours in the SAVAC computer program, individually for each patient who requires it. * Quarterly INDICATOR 2 Indicator: Rate of patients diagnosed with delirium who improve their clinical severity Zone: Internal medicine unit Quality criteria: All patients diagnosed with delirium must be treated and their symptomatology reduced, assessing the severity of the symptoms. Definitions: The DRS-R-98 scale assesses the severity of clinical delirium with the evaluation of 7 items, rated from 0 to 4. A higher score indicates more severity, up to 48 points. Justification: Through DRS-R-98, the severity of the clinical condition is assessed and whether it improves with the application of non-pharmacological therapy. Recorded in the center's computer program, every 24 hours. Any score equal to or less than 16 will be considered a favorable score, and therefore, a seriousness of the clinic. On the contrary, scores equal to or higher than 17 points, up to a maximum of 48, will indicate a serious severity. Target population: Hospitalized patients over 65 years old diagnosed with delirium. Formula: Numerator: No. of patients with a score of less than 16 on the DRS-R-98 scale \* 100 / Denominator: No. of patients diagnosed with delirium Type of indicator: Process Data source: Registered on SAVAC program. Responsible: Nursing Periodicity: * Every 24 hours in the SAVAC computer program, individually for each patient who requires it. * Quarterly INDICATOR 3 Indicator: Average length of hospital stays in patients diagnosed with delirium. Zone: Internal medicine unit Quality: All patients diagnosed with delirium and treated must be able to reduce their hospital stay. Definitions: Patients diagnosed with delirium tend to have longer hospital stays due to this diagnosis if they are not treated. Justification: It is assessed on the basis of the number of days spent in hospital, recorded in the patient's clinical history. Target population: Hospitalized patients over 65 years old diagnosed with delirium. Formula: Numerator: No. of days with a diagnosis of delirium\* 10 / Denominator: Total number of hospitalized days Type of indicator: Result Data source. Clinical history Responsible: Nursing supervision Periodicity: Quarterly INDICATOR 4 Indicator: Mortality rate in patients diagnosed with delirium Zone: Internal medicine unit Quality criteria: The application of the protocol should reduce the number of deaths of patients with delirium. Definitions: The incidence of mortality is the number of deaths at the center. It can be evaluated on a quarterly, half-yearly or annual basis. Justification: Assessment through the review of the clinical history of patients with delirium admitted to the units where the protocol is implemented. Target population: Hospitalized patients over 65 years old diagnosed with delirium Formula: Numerator: Nº patients with delirium deaths\* 100 / Denominator: Total no. of patients diagnosed with delirium Type of indicator: Result Data source: Clinical history Responsible: Nursing supervision Periodicity: Quarterly 5. Activities that protocol includes 5.1. Prevention Prevention will be applied to all patients who are admitted to the units where the protocol is applied and present at least 1 risk factor for the development of delirium. As risk factors, they will be considered (2): * Advanced age (over 65 years old). * Sex: more common in men. * Sensory deficits. * Dehydration and malnutrition. * Cognitive impairment. * Comorbidities: hypertension, alcohol abuse, chronic pain, terminal illness, etc. * Functional disorders. An other precipitant factors: * Hypoxia. * Immobilization. * Conducting invasive processes. * Drug abuse. * Environmental and psychosocial management. * Fractures or trauma. * Cardiac surgery. * Recurrent clinical processes: UTI. The activities classified with the level of evidence (number) and the degreee of evidence (letter) are: 1. Cognitive Stimulation * (1, A) Encourage the patient to say their name, the day of the week, and where they are during daily hygiene, meals, or medication, with the help of nursing staff. * (1, A) Ask the patient if they know the reason for their admission to the hospital and explain it to them if they do not understand clearly, but do so without making them feel worried or nervous. * (1, A) Ask the patient to share facts about their life, such as whether they have children, siblings, what they enjoy doing, etc., during mealtimes when they are comfortable. This can be done by auxiliary nursing staff. 2. Early Mobilization * (1, A) Postural changes by nursing and auxiliary nursing staff. * (1, A) Encourage the patient to move around as soon as possible, always considering their capabilities. * (1, A) Encourage physiotherapy. 3. Optimal Hydration and Nutrition * (1, A) Ensure proper water intake during the patient's breaks to prevent dehydration, and encourage drinking water throughout the day. * (1, A) Monitor the amount of food the patient consumes by having the nursing staff check the food trays when they collect them and provide food to those patients who are unable to do so themselves. 4. Maintenance of the Sleep-Wake Cycle * (1, A) Illuminate the room by opening the windows during the day, between 8 am and 6 pm in the winter, and between 8 am and 7 pm in the spring and summer, to support the circadian rhythm. This task should be carried out by auxiliary and nursing staff when performing the first vital signs and hygiene routines. * (1, A) Close the windows and dim the lights at night, from 6 pm in the winter and 7 pm in the spring/summer. * (1, A) Maintain silence during the patient's rest, especially after midnight. * (1, A) Minimize invasive techniques and entry into the patient's room at night. * Minimize the number of visits to the patient's room by nurses to administer medication and try to administer it at scheduled times. 5. Promotion of Spatial and Temporal Orientation * (1, A) Use wall panels in front of the patients' beds, one per room. Ensure they are regularly updated and on time, both by nursing staff and assistants. * (1, A) Use up-to-date calendars with large, easy-to-read numbers that show the current date, placed beneath the wall or TV in the rooms. * (1, A) Keep the room doors open. * (1, A) Offer a radio or television to the patient to stay updated with daily news, which they can use during the day until night, after which it should be turned off for rest time. If a radio is used, it should be provided by the patient's family 5.2. Diagnosis The diagnostic phase is intended to be carried out by nurses, when a patient starts some kind of symptomatology that may trigger delirium. The nurses cannot assign any type of diagnosis to a patient, but they do have at our disposal tools that facilitate this detection and, together with the medical staff, can determine whether the patient has a diagnosis of delirium. To make the diagnosis, the Confusional Assessment Method (CAM) and Delirium Rating Scale-Revision-98 (DRS-R-98) will be used to assess the symptomatology and severity of the symptoms. The following is a summary of what characterizes each scale: * Confusional Assessment Method (CAM): This is characterized by 5 items that define the assessment at the onset of symptomatology, inattention, disorganized thinking and altered level of consciousness. To confirm the diagnosis of delirium, the patient must have a positive response in domains 1 and 2, as well as a positive response in domains 3 or 4 or both. * Delirium Rating Scale - Revision -98: This is based on quantifying the severity of delirium by assessing the following domains: cognitive, higher order thinking, circadian cycle, accessory symptoms, and clinical characteristics. These domains have different items included in each of them for their assessment. The score for each item can range from 0 to 3, with a total score of 48. A higher score indicates greater severity of delirium, while a score of 0 indicates that the patient does not suffer from delirium. These will be completed in the SAVAC program for each nurse in the nursery tasks, where these scales will be included in the patient's registration form. Once completed, and depending on the results obtained, it will be decided whether the patient is a candidate for a diagnosis of delirium, the respective doctor will be notified, and therefore, specific activities for the treatment of symptomatology will be implemented in the patient's care. 5.3. Treatment's intervention Action on the symptoms will be carried out once the patient has been diagnosed with delirium. The activities to be carried out are similar to those developed in the prevention phase, but more focused on improving the patient's cognitive status. They will be conducted, once again, by nursing staff and auxiliary nursing technicians, without leaving aside other professionals such as rehabilitation, physiotherapy or doctors who may collaborate in their development. The activities classified with the level of evidence (number) and the degreee of evidence (letter) are: 1. Cognitive Stimulation • (1, A) Enable relatives to visit the patient to keep their social circle close, at specific times. In the case of Covid-19, daily video calls at a set time. Talk to the nursing team and the family to arrange visiting hours or video calls, preferably before bedtime, as this is when the patient is most alert, especially after dinner, to ensure the patient gets a good night's rest. • (1, A) Ask the patient to tell us their full name, the day of the week, and where they are. This should be done during hygiene routines or when food is served, both by nurses and nursing assistants. * (1, A) Management of the sleep-wake cycle. Maintain quiet during the night to support the patient's rest. * (1, A) Avoid entering the room during the night as much as possible. * (1, A) Open the shutters and let daylight into the room during the day, from 8 am to 6 pm in the late afternoon and winter, and from 8 am to 7 pm during spring and summer. 2. Physical Exercises • (1, A) Whenever possible, allow the patient to walk around the room before each treatment to prevent hunger or tiredness. Encourage physiotherapy. • (1, A) Enhance exercise routines. Physical exercises in bed or at the bedside, if standing is not tolerated, such as pulling up the bed, moving the arms, etc. Encourage physiotherapy. 3. Orientation Management * (1, A) Constantly remind the patient where they are and why. * Talk to the patient about where they are and why they are in the hospital during moments of intimacy and trust, such as during hygiene procedures or dressing times, especially by nursing assistants. Take advantage of moments when injuries are being treated or medication is being administered, especially by nurses. * (1, A) Always introduce yourself when entering the room and identify yourself as the relevant healthcare staff (nurse, nursing assistant, etc.). * (1, A) Let the patient know the time and day whenever possible when entering the room. d. Music Therapy * (1, A) Play music that the patient enjoys. Ask about their musical preferences and talk to the family so they can listen to a radio station 5.4. Assessment of symptoms The assessment of symptoms will be carried out by the nursing staff every 48 hours after the diagnosis of delirium until the patient is discharged from the unit. This will be the last phase of the application of the protocol, assessing the fluctuation of symptomatology and the effectiveness of the activities conducted. This phase will be completed with the new completion of the DRS-R-98 scale in the program, as soon as the tasks in the infirmary are completed. The results of the data, as well as the indicators and subsequent evaluation of the impact of the protocol, will be carried out by the hospital supervisor.