Hyponatremia in the Prevention of Hospitalized Patients Falls (PRECAHI)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyponatremia; Accidental Falls
• Intervention / Treatment: Other: Early detection and treatment of hyponatremia; Other: No Intervention (SOC)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early hyponatremia diagnosis and treatment; The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.	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.; Other: No Intervention (SOC); Usual pattern of work will be performed in all patients who enter in Hospital.
No Intervention: No intervention; Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mª del Carmen Lobo Rodríguez
• Collaborators: Fundación Mutua Madrileña
• Investigators: Principal Investigator: Carmen Lobo-Rodriguez, pHd, carmen.lobo@salud.madrid.org

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Nurse; Elderly; Hyponatremia; Risk factors; Accidental Falls
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: V01_Enf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No