- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052505
Reducing Inappropriate Prescribing for Psychiatric Patients Using Nurse-led Medication Reviews
Reducing Inappropriate Prescribing for Psychiatric Patients Using Nurse-led Medication Reviews - an Interventional Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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%)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark, 9000
- Aalborg University Hospital Psychiatry
-
Aalborg, Denmark, 9000
- Psychiatry, Aalborg University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- admitted to one of the included psychiatric wards
- must be over 18 years
Exclusion Criteria:
- concurrent admission to a somatic ward
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
The patients will receive the usual care when admitted.
This includes an examination by a physician, a medication review and the physician will prescribe medications for the patients as well as other necessary interventions.
|
|
Experimental: Medication review
The patients will receive the usual care when admitted.
This includes an examination by a physician, a medication review and the physician will prescribe medications for the patients as well as other necessary interventions.
Following this (usual care) a trained nurse will perform a medication review and discuss the observations with a physician.
|
The medication review will be based on the nurses experience, clinical knowledge and predefined categories of inappropriate prescribing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimation of potential difference in mean number of PIPs when applying nurses' observations
Time Frame: within the first 3 days after admission
|
within the first 3 days after admission
|
The potential difference in patients receiving ≥ 1 PIP when applying nurses' observations
Time Frame: within the first 3 days after admission
|
within the first 3 days after admission
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence and types of PIP where physicians responded to nurses' observations and changed medicationsintervention by a physician
Time Frame: within the first 3 days after admission
|
within the first 3 days after admission
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of type and severity of identified inappropriate prescriptions
Time Frame: up to 1 week after admission
|
up to 1 week after admission
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ann L Sorensen, MHSc, Aalborg University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ALS01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inappropriate Prescribing
-
Centre Hospitalier Universitaire VaudoisUnknownInappropriate PrescribingSwitzerland
-
Federal University of BahiaConselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de...CompletedInappropriate Prescribing
-
Anne NiquilleCompletedPolypharmacy | Inappropriate PrescribingSwitzerland
-
Monash UniversityHospital Raja Permaisuri BainunRecruitingAged | Polypharmacy | Inappropriate Prescribing | Deprescriptions | Potentially Inappropriate MedicationsMalaysia
-
Anne NiquilleCompletedPolypharmacy | Inappropriate PrescribingSwitzerland
-
Bruyere Research InstituteCanadian Institutes of Health Research (CIHR)UnknownPotentially Inappropriate Prescribing (PIP)
-
Bruyere Research InstituteOntario Ministry of Health and Long Term Care; Bruyere Centre for Learning,...UnknownPotentially Inappropriate Prescribing (PIP)Canada
-
Hospital AvicenneRoche Diagnostics; ProBayes; Biorance Laboratoires RéunisCompletedBiological Markers | Inappropriate PrescribingFrance
-
VA Office of Research and DevelopmentCompletedInappropriate Prescribing | Deprescriptions | Medical OveruseUnited States
-
Basque Health ServiceCarlos III Health Institute; European Union; Health Department of the Basque...Active, not recruitingImplementation Science | Inappropriate Prescribing | Behavioral SciencesSpain
Clinical Trials on Medication review
-
Joke WuytsAssociation of Belgian Pharmacies (APB)Completed
-
Anne Estrup OlesenFrederikshavn Kommune, Frederikshavn, Denmark; Lægeklinikken Frederikshavn,...Completed
-
Psychiatric Research Unit, Region Zealand, DenmarkRegion Zealand; Steno Diabetes Center SjaellandNot yet recruitingDiabetes | Schizophrenia | Metabolic Syndrome
-
Geriatric Education and Research InstituteTan Tock Seng Hospital; Changi General HospitalCompletedMultimorbidity | Polypharmacy | Potentially Inappropriate MedicationsSingapore
-
Monash University MalaysiaCompleted
-
University of AarhusAarhus University HospitalCompleted
-
Diakonhjemmet HospitalUniversity of Oslo; Diakonhjemmet Hospital Pharmacy; Diakonhjemmet FoundationCompletedDrug-Related Side Effects and Adverse Reactions | Drug Interaction Potentiation | Medication Compliance | Remission | Medicinal Substance; Adverse EffectNorway
-
University of East AngliaRecruiting
-
Umeå UniversityCompletedCognitive ImpairmentSweden
-
Memorial University of NewfoundlandEastern HealthCompleted