Reducing Inappropriate Prescribing for Psychiatric Patients Using Nurse-led Medication Reviews

Inappropriate Prescribing Clinical Trial

Official title:

Reducing Inappropriate Prescribing for Psychiatric Patients Using Nurse-led Medication Reviews - an Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052505
• Other study ID #: ALS01
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: January 4, 2017
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of nurse-led medication reviews on the frequency, type and potential severity of PIP in psychiatric patients

Description:

Studies indicate that potential inappropriate prescribing (PIP) is associated with a higher number of admissions, increased morbidity and mortality and that medication reviews might decrease the prevalence of PIP. PIP has only been investigated in elderly populations and, to our knowledge, never in a psychiatric, general population. There is a growing body of evidence on the effect of medication reviews but very little research on the effect of medication reviews in psychiatric populations. Medication reviews are a time consuming task which requires an extensive clinical knowledge about the individual patient as well as pharmacology. Healthcare systems across the world are looking to improve quality and safety for the same or fewer economic resources and medication reviews are introduced as obligatory in more and more hospitals and other institutions. This calls for alternative use of existing resources.

Nurses have most of the direct patient contact but very few studies investigate the potential role of nurses in improving medication quality and medication safety. Administration af drugs and observation for effect and sideeffects of drugs are already important aspects in nursing. Therefore the purpose of this study is to evaluate the effect of nurse-led medication reviews in a controlled interventional study. Outcome measures include prevalence, type and severity of the identified PIP as well as the proportion of identified PIP which leads to a change in prescription by a physician.

Definitions

In this study PIP is defined as

• The use of drugs with a known risk of en adverse drug event or where evidence for a less risky, equally or more effective drug treating the same condition exists.

• PIP includes the use of drugs with a higher frequency or longer duration than indicated, concurrent use of drugs with known drug-drug interactions or interaction between drug and the underlying disease.

• PIP also includes the omission of drugs which are clinically indicated and where no contraindications are known.

Design

Prospective, controlled before- and after study where 2 acute psychiatric wards have been selected for intervention and control. Ahead of the intervention the nurses have received pharmacological training and instructions on performing medication reviews. The patients are included consecutively.

Data

The nurses in the interventional ward will perform medication reviews after the patients have been seen by the attending physician and thus have received usual care. This procedure was chosen because most of the patients are admitted through one ward. With each medication review the nurses fill out a structured paper form with their observations. The nurses also register whether interventions by the physician were based - or in parts based - on the nurses observations

Data analysis

Primary outcome is the difference in the proportion of patients receiving PIPs in the two wards. Two senior clinical pharmacologists will also perform medication reviews on the included patients. These medication reviews will serve as golden standard when the quality of the nurse-led medication reviews is evaluated.

Secondary outcomes will be an analysis of the proportion of PIPs identified by nurses and the proportion of PIPs ending in an intervention prescribed by a physician.

Power calculations

The investigators anticipate a prevalence of PIP on 30% among psychiatric patients and an expectation of a reduction to 15% PIP due to nurse-led medication reviews. Based on these assumptions there will be a need for 120 patients in each group in order to sufficiently identify a difference (risk of type 1 error - 5% and a power of 80%)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admitted to one of the included psychiatric wards

• must be over 18 years

Exclusion Criteria:

• concurrent admission to a somatic ward

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Inappropriate Prescribing

Intervention

Procedure:
• Medication review
The medication review will be based on the nurses experience, clinical knowledge and predefined categories of inappropriate prescribing

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital Psychiatry	Aalborg
Denmark	Psychiatry, Aalborg University Hospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University	Aalborg Universitetshospital, Danish Center for Healthcare Improvement, University College of North Jutland, The Nursing Department

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of type and severity of identified inappropriate prescriptions		up to 1 week after admission	Yes
Primary	Estimation of potential difference in mean number of PIPs when applying nurses' observations		within the first 3 days after admission	Yes
Primary	The potential difference in patients receiving = 1 PIP when applying nurses' observations		within the first 3 days after admission	Yes
Secondary	Prevalence and types of PIP where physicians responded to nurses' observations and changed medicationsintervention by a physician		within the first 3 days after admission	Yes