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Clinical Trials/NCT02816086
NCT02816086
Completed
N/A

A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly

University of Tromso1 site in 1 country516 target enrollmentSeptember 21, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Services for the Aged
Sponsor
University of Tromso
Enrollment
516
Locations
1
Primary Endpoint
Emergency medical visits
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.

Registry
clinicaltrials.gov
Start Date
September 21, 2016
End Date
December 20, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged ≥70 years
  • Admitted to the geriatric internal medicine ward in the University Hospital of North Norway (UNN) Tromsø or the general internal medicine ward in UNN Harstad.
  • Willing to provide written informed consent during hospital stay (patient or next of kin)

Exclusion Criteria

  • Unable to communicate in Norwegian (patient or next of kind)
  • Terminally ill, e.g cancer in end-life stage
  • Control group patients where the physician request an assessment from a pharmacist
  • Time from admittance to the ward to inclusion is more than 72 hours
  • Occupying a bed in the study wards but under the care of physicians from a non-study ward.
  • Planned discharged on the inclusion day

Outcomes

Primary Outcomes

Emergency medical visits

Time Frame: 12 months after hospital discharge

Rate of emergency Medical visits at 12 months. Emergency Medical visits is a composite endpoint including emergency department visits and unscheduled hospitalization

Secondary Outcomes

  • Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)(Baseline at randomization)
  • Change in potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)(From baseline to date of discharge from hospital, assessed up to 12 months)
  • Change in Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(From baseline to date of discharge from hospital, assessed up to 12 months)
  • Time to first rehospitalization(First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.)
  • Total score of the Medication appropriateness index (MAI)(Baseline at randomization)
  • Mortality rate(12 months after randomization)
  • Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)(Baseline at randomization)
  • Changes in medication, identified through screening of drug lists at their primary care physician.(3 months after discharge from index hospital stay)
  • Rehospitalizations where the reason for hospitalization is possibly, probably or certainly drug-related.(First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study)
  • Self-reported quality of life(12 months after hospital discharge)
  • length in days of index hospital stay(Days from hospitalization to discharge of index hospital stay, assessed up to 12 months)
  • Change in total score of the Medication appropriateness index (MAI)(From baseline to date of discharge from hospital, assessed up to 12 months)
  • Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(Baseline at randomization)
  • Visits to primary care physician(12 months after discharge for index hospital stay)
  • Change in inappropriate medications identified through the Norwegian general practice criteria (NORGEP)(From baseline to 3 months after discharge from index hospital stay, assessed up to 12 months)
  • Hip fracture(12 months after discharge from index hospital stay)
  • Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)(From baseline to 12 months after discharge from hospital)
  • Stroke(12 months after discharge from index hospital stay)
  • The proportion of patients readmitted acutely within 30 days(30 days after discharge from index hospital stay)

Study Sites (1)

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