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Completed

NCT Number: NCT02816086

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

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.

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Key information

Conditions

Health Services for the Aged Medication Therapy Management

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of North Norway

Tromsø, 9030, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interdisciplinary collaboration structure

Other

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.

Primary outcomes

  1. 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

  1. Self-reported quality of life

    Time frame: 1 months after hospital discharge

    Change in self-reported quality of life using the validated EQ-5D

  2. Self-reported quality of life

    Time frame: 6 months after hospital discharge

    Change in self-reported quality of life using the validated EQ-5D

  3. Self-reported quality of life

    Time frame: 12 months after hospital discharge

    Change in self-reported quality of life using the validated EQ-5D

  4. 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

  5. Time to first rehospitalization

    Time frame: First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.

    Days to first hospitalization

  6. Visits to primary care physician

    Time frame: 12 months after discharge for index hospital stay

    Visitation rate at 12 months

  7. Mortality rate

    Time frame: 12 months after randomization

  8. Total score of the Medication appropriateness index (MAI)

    Time frame: Baseline at randomization

  9. 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

  10. Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)

    Time frame: Baseline at randomization

  11. 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

  12. 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

  13. Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)

    Time frame: Baseline at randomization

  14. 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

  15. Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)

    Time frame: Baseline at randomization

  16. 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

  17. 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

  18. 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.

  19. 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.

  20. 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

  21. Hip fracture

    Time frame: 12 months after discharge from index hospital stay

    Rate of hip fractures

  22. Stroke

    Time frame: 12 months after discharge from index hospital stay

    Stroke rate during 12 months follow-up

  23. The proportion of patients readmitted acutely within 30 days

    Time frame: 30 days after discharge from index hospital stay

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: IMMENSE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2016
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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