Hyponatremia in the Prevention of Hospitalized Patients Falls (PRECAHI)

Mª del Carmen Lobo Rodríguez

Status: Completed

Conditions: Hyponatremia; Accidental Falls

Treatments: Other: Early detection and treatment of hyponatremia; Other: No Intervention (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03265691

V01_Enf

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Early hyponatremia diagnosis and treatment

Experimental group

Description:

The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.

Treatment:

Other: Early detection and treatment of hyponatremia

Other: No Intervention (SOC)

No intervention

No Intervention group

Description:

Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.