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.
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
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%)
- Conditions
- Inappropriate Prescribing
- 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 group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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. |
| Medication review | Experimental | 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. Receives: Procedure: Medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of potential difference in mean number of PIPs when applying nurses' observations
Measured: within the first 3 days after admission
The potential difference in patients receiving ≥ 1 PIP when applying nurses' observations
Measured: within the first 3 days after admission
Secondary outcomes (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.
- First posted3 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Center for Healthcare Improvement, Aalborg University Hospital, University College of North Jutland, The Nursing Department
- Responsible party
- Principal investigator, Ann Lykkegaard Sørensen, Aalborg University
- Investigators
- Ann L Sorensen, MHSc, Principal investigator, Aalborg University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inappropriate Prescribing for Psychiatric Patients Using Nurse-led Medication Reviews - an Interventional Study
- ClinicalTrials.gov ID
- NCT02052505
- Acronym / sponsor ID
- ALS01
- Conditions
- Inappropriate Prescribing
- Keywords
- inappropriate prescribing, psychiatry, medication quality, patient safety, medication errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish Center for Healthcare Improvement, Aalborg University Hospital, University College of North Jutland, The Nursing Department
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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. |
| Medication review | Experimental | Procedure: Medication reviewThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- admitted to one of the included psychiatric wards
- must be over 18 years
Key exclusion criteria (1 listed)
- concurrent admission to a somatic ward
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication reviewThe medication review will be based on the nurses experience, clinical knowledge and predefined categories of inappropriate prescribing | Procedure or surgery | Medication review |
Primary outcome
Estimation of potential difference in mean number of PIPs when applying nurses' observations
Time frame: 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann L Sorensen, MHSc principal investigator
Aalborg University
2 sites in 1 country: see every site and its status.
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.