Pilot Study of a Multicomponent Nurse Intervention to Reduce the Incidence and Severity of Delirium in Hospitalized Older Adults: MID-Nurse-P
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Delirium incidence (% participants)
研究概览
简要总结
Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU.
Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU "Complejo Hospitalario Universitario from Albacete" (Albacete, Spain).
Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29 control group).
Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care.
Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.
详细描述
Parallel-group, double blind (evaluation and analysis), randomized clinical trial (pilot study). The design was based on recommendations for conducting pilot studies (Thabane 2010).
The main objective of the MID-Nurse (Randomized Clinical Trial) was to analyze if a multicomponent nurse-led intervention reduces the incidence, duration, and severity of delirium in hospitalized older adults in an Acute Geriatric Unit (AGU).
Specific objectives and evaluating criteria of the MID-Nurse-P (Pilot Study) were:
- Process: To determine the recruitment rate (criteria: at least 70% of the eligible patients can be recruited), the complete follow-up rate (criteria: at least 85% of the included participants complete the follow-up), and the adherence to intervention (criteria: at least 80% of the included participants receive every scheduled intervention).
- Resources: To assess capacity of the team and process time to conduct the trial. Criteria: Less than 10% of the participants can´t complete the intervention program due to study team problems, and daily time employed per participant is not longer than 30 minutes.
- Management: To analyze potential study personnel and data managing problems.
- Scientific: To estimate the intervention effect and the variance.
In the first 24 hours from admission, all the following data were collected by the evaluation nurses, once the informed consent was signed, and randomization performed by the principal investigator, who did not take part in the rest of the data collection and clinical intervention: Demographic data, Charlson comorbidity index, mean clinical diagnosis for admission, usually consumed drugs before admission, Barthel index, Holden´s FAC instrument, Pfeiffer´s Short Portable Mental Status Questionnaire, Reisberg´s Global Deterioration Scale, Dowton scale, pain with the visual analogical scale, and pressure ulcers risk with the Braden scale. Vital signs were determined on admission, including blood pressure, heart rate, temperature, hydration level, and oxygen saturation. Medical or nurse procedures were recorded, including bladder catheterization, nasogastric tube placement, venous or arterial access, blood sample acquisition, and other invasive procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an age equal or older than 65 years
- •Hospitalized at the Acute Geriatric Unit of the "Complejo Hospitalario Universitario of Albacete"
- •Valid signed informed consent by the patient or legal representative.
排除标准
- •Agonic situation
- •Non-Spanish speaking
- •Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7)
- •Patients sharing the same room with a previously included participant
结局指标
主要结局
Delirium incidence (% participants)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Delirium incidence during hospitalization (% participants)
次要结局
- Mean daily delirium severity (mean score Delirium Rating Scale-Revised-98)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Process time (time in minutes)(Up to five months)
- Length of stay (days)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Restraint measures (number of participants with these measures)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Delirium severity (sum of total Delirium Rating Scale-Revised-98 socres during hospitalization)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Mortality (% of participants)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Delirium prevalence (% of participants)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Adherence to intervention (% of participants)(Up to five months)
- Capacity of the team (% of participants)(Up to five months)
- Recruitment rate (% of patients)(Up to five months)
- Drugs for delirium (% of participants using neuroleptics or benzodiazepines)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Complete follow-up rate (% of participants)(Up to five months)
研究者
Pedro Abizanda
MD,PhD
Complejo Hospitalario Universitario de Albacete