Hyponatremia in the Prevention of Hospitalized Patients Falls
- Conditions
- HyponatremiaAccidental Falls
- Interventions
- Other: Early detection and treatment of hyponatremiaOther: No Intervention (SOC)
- Registration Number
- NCT03265691
- Lead Sponsor
- Mª del Carmen Lobo Rodríguez
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Age >65 years
- Admitted to a participating study unit
- Wish to participate in the study and signature of informed consent.
- Transfer of the patient to a unit not included in the study
- Deterioration of the patient's condition to severe or extremely painful
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Early hyponatremia diagnosis and treatment Early detection and treatment of hyponatremia The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early. Early hyponatremia diagnosis and treatment No Intervention (SOC) The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls. 1 year The effectiveness will be measured in terms of less incidence of falls
- Secondary Outcome Measures
Name Time Method To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention. 1 year The cost-effectiveness will be indirectly measured using Average cost per inpatient day
Trial Locations
- Locations (1)
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain