A before and after, cross-sectional survey to evaluate the effectiveness of risk minimisation measures to minimise the risk of hospital-acquired hyponatraemia

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B05BA03) carbohydrates

  carbohydrates

  (B05BB02) electrolytes with carbohydrates

  electrolytes with carbohydrates

  (B05BB01) electrolytes

  electrolytes
• Medical condition to be studied:
  Hyponatraemia

Population studied

• Short description of the study population:
  The study population consisted of the target audience of the treatment guide, that is, all physicians working in Danish emergency departments. There are 38 emergency departments in Denmark distributed over 21 hospitals, and 348 physicians work in emergency departments in Denmark based on the estimated source population from 2014. We focused on emergency departments because IV fluid prescriptions are initiated in the emergency department, and previous research has shown that errors in the prescription of IV fluids are particularly likely in emergency departments.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The primary objective of this study was to evaluate the effectiveness of a treatment guide implemented as part of a risk minimisation measure to reduce the risk of hospital-acquired hyponatraemia by assessing prescribing practice before and after the introduction of the treatment guide.
• Outcomes:
  Prescribing practice measured as the selection of hypotonic fluids, • Knowledge about hyponatraemia and IV fluids • Process indicators • Usefulness of the treatment guide
• Data analysis plan:
  Statistical analyses were mainly descriptive. Each question was evaluated individually and described by frequency and percentage. Summary measures were calculated for all scenario questions (n=4), all knowledge questions (n=8) and all scenario and knowledge questions combined. Confidence intervals (95% CI) were calculated for all before and after comparisons. A priori we defined an absolute success criterion as a risk of being treated with hypotonic fluids of no more than 10% in each scenario. Relative risk reduction of being treated with hypotonic fluids was used as a measure of the effectiveness of the risk minimisation measure. Univariate logistic regression was used to explore the predictors of prescribing practice.