Delirium Clinical Trial
— MID-Nurse-POfficial title:
Pilot Study of a Multicomponent Nurse Intervention to Reduce the Incidence and Severity of Delirium in Hospitalized Older Adults: MID-Nurse-P
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Agonic situation - Non-Spanish speaking - Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7) - Patients sharing the same room with a previously included participant |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de Albacete | Albacete |
Lead Sponsor | Collaborator |
---|---|
Complejo Hospitalario Universitario de Albacete |
Spain,
Hshieh TT, Yue J, Oh E, Puelle M, Dowal S, Travison T, Inouye SK. Effectiveness of multicomponent nonpharmacological delirium interventions: a meta-analysis. JAMA Intern Med. 2015 Apr;175(4):512-20. doi: 10.1001/jamainternmed.2014.7779. Erratum in: JAMA Intern Med. 2015 Apr;175(4):659. — View Citation
Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. Review. — View Citation
Siddiqi N, Stockdale R, Britton AM, Holmes J. Interventions for preventing delirium in hospitalised patients. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005563. Review. — View Citation
Vidán MT, Sánchez E, Alonso M, Montero B, Ortiz J, Serra JA. An intervention integrated into daily clinical practice reduces the incidence of delirium during hospitalization in elderly patients. J Am Geriatr Soc. 2009 Nov;57(11):2029-36. doi: 10.1111/j.1532-5415.2009.02485.x. Epub 2009 Sep 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delirium incidence (% participants) | Delirium incidence during hospitalization (% participants) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Mean daily delirium severity (mean score Delirium Rating Scale-Revised-98) | Mean delirium severity per day with delirium (mean score Delirium Rating Scale-Revised-98) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Mortality (% of participants) | Mortality (% of participants) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Length of stay (days) | Length of hospitalization time (days) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Restraint measures (number of participants with these measures) | Use of restraint measures for delirium control (number of participants with these measures) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Drugs for delirium (% of participants using neuroleptics or benzodiazepines) | Use of drugs (neuroleptics or benzodiazepines) for delirium control (% of participants) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Delirium prevalence (% of participants) | Delirium prevalence during hospitalization (% of participants) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | No |
Secondary | Delirium severity (sum of total Delirium Rating Scale-Revised-98 socres during hospitalization) | Delirium severity during hospitalization (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 | No |
Secondary | Recruitment rate (% of patients) | % of the eligible patients recruited | Up to five months | No |
Secondary | Complete follow-up rate (% of participants) | % of the included participants completing the follow-up | Up to five months | No |
Secondary | Adherence to intervention (% of participants) | % of included participants receiving every scheduled intervention | Up to five months | No |
Secondary | Capacity of the team (% of participants) | % of participants that can´t complete the intervention program due to study team problems | Up to five months | No |
Secondary | Process time (time in minutes) | Daily time employed per participant for delivering the intervention | Up to five months | No |
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