Hyponatremia in the Prevention of Hospitalized Patients Falls

Accidental Falls Clinical Trial

— PRECAHI  

Official title:

Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265691
• Other study ID #: V01_Enf
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: August 28, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Description:

Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Aims:

1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence.

2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention.

Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B).

The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance ** and 124 patients receiving the experimental intervention *, if necessary, by participant Unit).

Data collection: In each of the study participants Units both interventions will be held. First the participants Units have been randomized in two groups (Group A: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will be potentially included. First of all, collaborators will give them an informed consent to ask for their participation.

The interventions are:

• Experimental intervention: early diagnosis, treatment of hyponatremia until resolution and valuation according to the Dynamic Gait Index test. Duration: 6 months

• Habitual action: the usual pattern of work will be performed in all patients who enter. Duration: 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age >65 years

• Admitted to a participating study unit

• Wish to participate in the study and signature of informed consent.

Exclusion Criteria:

• Transfer of the patient to a unit not included in the study

• Deterioration of the patient's condition to severe or extremely painful

Related Conditions & MeSH terms

• Accidental Falls
• Hyponatremia

Intervention

Other:
• Early detection and treatment of hyponatremia
In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
• No Intervention (SOC)
Usual pattern of work will be performed in all patients who enter in Hospital.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Mª del Carmen Lobo Rodríguez	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.	The effectiveness will be measured in terms of less incidence of falls	1 year
Secondary	To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.	The cost-effectiveness will be indirectly measured using Average cost per inpatient day	1 year