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Inappropriate PrescribingNCT02052505

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

A study testing Medication review in people with Inappropriate Prescribing, run by Aalborg University at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inappropriate Prescribing
What is being tested?
Medication review
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
2 sitesDenmark
Study dates
Oct 2014to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • admitted to one of the included psychiatric wards
  • must be over 18 years

Who cannot join

  • concurrent admission to a somatic ward

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites
  • Aalborg University Hospital Psychiatry

    Aalborg, 9000

  • Psychiatry, Aalborg University Hospital

    Aalborg, 9000

Other trials in Denmark

About this study

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

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

Read the 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%)

Being tested
Medication review
Keywords
inappropriate prescribing, psychiatry, medication quality, patient safety, medication errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication reviewProcedure or surgery

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

Study groups in NCT02052505
Study groupRoleWhat they receive
Usual careNo interventionThe 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.
Medication reviewExperimentalThe 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.
Receives: Procedure: Medication review

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimation of potential difference in mean number of PIPs when applying nurses' observations

    Measured: within the first 3 days after admission

  2. The potential difference in patients receiving ≥ 1 PIP when applying nurses' observations

    Measured: within the first 3 days after admission

Secondary outcomes (1)
  1. Prevalence and types of PIP where physicians responded to nurses' observations and changed medicationsintervention by a physician

    Measured: within the first 3 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02052505
Sponsor's protocol ID
ALS01
Status last verified
Jan 2017
First submitted
29 Jan 2014
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Medication review in people with Inappropriate Prescribing, run by Aalborg University at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of potential difference in mean number of PIPs when applying nurses' observations (time frame: within the first 3 days after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.

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