Hyponatremia in the Prevention of Hospitalized Patients Falls

Study Overview
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Brief Summary
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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.

Detailed Description
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Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls. Aims: To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence. 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.

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

Conditions
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Hyponatremia, Accidental Falls

Intervention / Treatment
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* Other: Early detection and treatment of hyponatremia
* Other: No Intervention (SOC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early hyponatremia diagnosis and treatment<br>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<br>* 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.<br>Other: No Intervention (SOC)<br>* Usual pattern of work will be performed in all patients who enter in Hospital.<br>|
| No Intervention: No intervention<br>Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse