NCT02558777

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

July 28, 2015

Last Update Submit

September 23, 2015

Conditions

Delirium

Keywords

DeliriumPilot StudyNurse interventionHospitalization

Outcome Measures

Primary Outcomes (1)

  • Delirium incidence (% participants)

    Delirium incidence during hospitalization (% participants)

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (12)

  • 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

  • Mortality (% of participants)

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • 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

  • 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

  • +7 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Multicomponent nurse-led intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain)

Other: Multicomponent nurse-led intervention

Control Group

NO INTERVENTION

Usual care

Interventions

Multicomponent nurse-led interventionOTHER

Participants in the intervention group received the first intervention in the first 24 hours from admission, and thereafter daily until hospital discharge. The intervention was carried out exclusively by the "intervention nurses", and was composed of two main parts, being the first one a risk factor analysis, and the second one the intervention on the risk factors detected (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain). Furthermore, the intervention nurses identified the principal caregiver in the first 24 hours from admission, and provided an informative booklet about strategies and recommendations to prevent delirium incidence, including ambient strategies, orientation abilities, and identification of alert signs.

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Agonic situation
  • Non-Spanish speaking
  • Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7)
  • Patients sharing the same room with a previously included participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

Related Publications (5)

  • 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.

    PMID: 23992774BACKGROUND

  • 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.

    PMID: 25643002BACKGROUND

  • Siddiqi N, Stockdale R, Britton AM, Holmes J. Interventions for preventing delirium in hospitalised patients. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD005563. doi: 10.1002/14651858.CD005563.pub2.

    PMID: 17443600BACKGROUND

  • Vidan MT, Sanchez 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.

    PMID: 19754498BACKGROUND

  • Avendano-Cespedes A, Garcia-Cantos N, Gonzalez-Teruel Mdel M, Martinez-Garcia M, Villarreal-Bocanegra E, Oliver-Carbonell JL, Abizanda P. Pilot study of a preventive multicomponent nurse intervention to reduce the incidence and severity of delirium in hospitalized older adults: MID-Nurse-P. Maturitas. 2016 Apr;86:86-94. doi: 10.1016/j.maturitas.2016.02.002. Epub 2016 Feb 8.

    PMID: 26921934DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Pedro Abizanda, MD,PhD

    Complejo Hospitalario Universitario de Albacete (SESCAM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

July 28, 2015

First Posted

September 24, 2015

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

ES(1)