As defined by the World Health Organization, an adverse drug reaction (ADR) is an effect that is "noxious and unintended, and which occurs at doses used in man for prophylaxis, diagnosis, or therapy." The term has since been changed to an adverse drug event (ADE) which is more comprehensive and reflects any injury resulting from a pharmaceutical intervention.

Adverse drug events comprise a wide range of effects but in general can be designated as significant or non-significant. Significant effects again denote a range of effects, from temporary or permanent injury or death, to effects that, while not life-threatening, still require substantive intervention. The interventions may include further treatments (i.e. adding a drug) or may involve testing and procedures. Non-significant ADEs are minor effects that require, for instance, discontinuation of a medication. A non-significant effect would be mild dyspepsia that resolves spontaneously after stopping an NSAID. The purpose of the proposed study is to evaluate whether the methodology of patient-profiling and provider feedback truly improves quality. To test this hypothesis, we will conduct a randomized controlled trial. Over one year we will randomly assign approximately 50 patients every two weeks (for a total of approximately 900 eligible patients from 1300 risk profiles) to either at-risk profiling with provider feedback (intervention) or to the current standard of care of pharmacist and physician review (control). After one year (post-randomization), we will compare the number of actual ADEs, as measured by trained pharmacist reviewers blinded to patient assignment, and health utilization and economic outcomes between the intervention group (the patients whose doctors received alerts) and control groups (i.e., those receiving usual care). In addition, we will conduct a pre- and post-study physician survey to assess relevant attitudes (toward risk, cost-consciousness and utilization review) that might impact on acceptance of patient alerts.

Condition	Treatment or Intervention
Adverse drug reaction reporting systems	Behavior: Assessment of ADE profiling of patient's added to provider information prior to treatment

Genders Eligible for Study:  Both

Criteria

All veterans receiving treatment at VA study sites.

California
      VA Greater Los Angeles Healthcare System, West Los Angeles,  California,  90073,  United States; Recruiting

Study ID Numbers:  SAF 99-144
Record last reviewed:  December 2000
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00013143
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-10