An interventional study of Early detection and treatment of hyponatremia and No Intervention (SOC) in Hyponatremia and Accidental Falls, sponsored by Mª del Carmen Lobo Rodríguez. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Mª del Carmen Lobo Rodríguez · Not applicable, Interventional, and Prevention
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.
Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.
Aims:
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:
Exclusion Criteria:
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 · Other: No Intervention (SOC)
Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
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.
Usual pattern of work will be performed in all patients who enter in Hospital.
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
Time frame: 1 year
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
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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