NCT02052505

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 29, 2014

Last Update Submit

January 4, 2017

Conditions

Keywords

inappropriate prescribingpsychiatrymedication qualitypatient safetymedication errors

Outcome Measures

Primary Outcomes (2)

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

    within the first 3 days after admission

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

    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

    within the first 3 days after admission

Other Outcomes (1)

  • Assessment of type and severity of identified inappropriate prescriptions

    up to 1 week after admission

Study Arms (2)

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.

Procedure: Medication review

Interventions

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

Medication review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- concurrent admission to a somatic ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg University Hospital Psychiatry

Aalborg, 9000, Denmark

Location

Psychiatry, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Ann L Sorensen, MHSc

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MHSc

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 3, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations