A New Interdisciplinary Collaboration Structure to Improve Medication Safety in the Elderly

Overview

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.

Full Title of Study: “A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2021

Interventions

  • Other: Interdisciplinary collaboration structure
    • A pharmacist is integrated in the team surrounding the patient, working by the Integrated Medicines Management (IMM) model. The IMM-model consist of medication reconciliation, medication review, standardized medication reports and counseling patients about their medication at discharge. In addition a phone meeting between the primary care physician and the study pharmacist is added after discharge.

Arms, Groups and Cohorts

  • No Intervention: Standard care
    • The study participants receives standard care in the ward, this does not include a pharmacist.
  • Experimental: Intervention
    • Interdisciplinary collaboration structure

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Self-reported quality of life
    • Time Frame: 1 months after hospital discharge
    • Change in self-reported quality of life using the validated EQ-5D
  • Self-reported quality of life
    • Time Frame: 6 months after hospital discharge
    • Change in self-reported quality of life using the validated EQ-5D
  • Self-reported quality of life
    • Time Frame: 12 months after hospital discharge
    • Change in self-reported quality of life using the validated EQ-5D
  • length in days of index hospital stay
    • Time Frame: Days from hospitalization to discharge of index hospital stay, assessed up to 12 months
    • Days from hospital admission to discharge of index hospital stay
  • Time to first rehospitalization
    • Time Frame: First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.
    • Days to first hospitalization
  • Visits to primary care physician
    • Time Frame: 12 months after discharge for index hospital stay
    • Visitation rate at 12 months
  • Mortality rate
    • Time Frame: 12 months after randomization
  • Total score of the Medication appropriateness index (MAI)
    • Time Frame: Baseline at randomization
  • Change in total score of the Medication appropriateness index (MAI)
    • Time Frame: From baseline to date of discharge from hospital, assessed up to 12 months
  • Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)
    • Time Frame: Baseline at randomization
  • Change in Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)
    • Time Frame: 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)
    • Time Frame: From baseline to 3 months after discharge from index hospital stay, assessed up to 12 months
  • Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)
    • Time Frame: Baseline at randomization
  • Change in potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)
    • Time Frame: From baseline to date of discharge from hospital, assessed up to 12 months
  • Potentially inappropriate prescribing identified through the Screening Tool of Older Persons’ Prescriptions (STOPP)
    • Time Frame: Baseline at randomization
  • Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons’ Prescriptions (STOPP)
    • Time Frame: From baseline to date of discharge from hospital, assessed up to 12 months
  • Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons’ Prescriptions (STOPP)
    • Time Frame: From baseline to 12 months after discharge from hospital
  • Changes in medication, identified through screening of drug lists at their primary care physician.
    • Time Frame: 12 months after discharge from index hospital stay
    • Drug changes made during hospitalization implemented by the primary care physician.
  • Changes in medication, identified through screening of drug lists at their primary care physician.
    • Time Frame: 3 months after discharge from index hospital stay
    • Drug changes made during hospitalization implemented by the primary care physician.
  • Rehospitalizations where the reason for hospitalization is possibly, probably or certainly drug-related.
    • Time Frame: First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study
    • A chart review will be done retrospectively to evaluate if the patients first rehospitalization was drug related or not. Classified by a multiprofessional team of experts
  • Hip fracture
    • Time Frame: 12 months after discharge from index hospital stay
    • Rate of hip fractures
  • Stroke
    • Time Frame: 12 months after discharge from index hospital stay
    • Stroke rate during 12 months follow-up
  • The proportion of patients readmitted acutely within 30 days
    • Time Frame: 30 days after discharge from index hospital stay

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Tromso
  • Collaborator
    • University Hospital of North Norway
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beate H Garcia, PhD, Principal Investigator, UiT The artic university of Norway

References

Johansen JS, Havnes K, Halvorsen KH, Haustreis S, Skaue LW, Kamycheva E, Mathiesen L, Viktil KK, Granås AG, Garcia BH. Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (IMMENSE study): study protocol for a randomised controlled trial. BMJ Open. 2018 Jan 23;8(1):e020106. doi: 10.1136/bmjopen-2017-020106.

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