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

NCT ID: NCT02816086

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-21

Study Completion Date

2020-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Health Services for the Aged Medication Therapy Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard care

The study participants receives standard care in the ward, this does not include a pharmacist.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Interdisciplinary collaboration structure

Group Type EXPERIMENTAL

Interdisciplinary collaboration structure

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role collaborator

University of Tromso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beate H Garcia, PhD

Role: PRINCIPAL_INVESTIGATOR

UiT The artic university of Norway

Locations

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University hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

References

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Johansen JS, Havnes K, Halvorsen KH, Haustreis S, Skaue LW, Kamycheva E, Mathiesen L, Viktil KK, Granas 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.

Reference Type BACKGROUND
PMID: 29362276 (View on PubMed)

Robinson EG, Gyllensten H, Granas AG, Halvorsen KH, Garcia BH. Health-related quality of life among older adults following acute hospitalization: longitudinal analysis of a randomized controlled trial. Qual Life Res. 2024 Aug;33(8):2219-2233. doi: 10.1007/s11136-024-03689-x. Epub 2024 Jun 17.

Reference Type DERIVED
PMID: 38884880 (View on PubMed)

Robinson EG, Gyllensten H, Johansen JS, Havnes K, Granas AG, Bergmo TS, Smabrekke L, Garcia BH, Halvorsen KH. A Trial-Based Cost-Utility Analysis of a Medication Optimization Intervention Versus Standard Care in Older Adults. Drugs Aging. 2023 Dec;40(12):1143-1155. doi: 10.1007/s40266-023-01077-7. Epub 2023 Nov 22.

Reference Type DERIVED
PMID: 37991657 (View on PubMed)

Johansen JS, Halvorsen KH, Svendsen K, Havnes K, Robinson EG, Wetting HL, Haustreis S, Smabrekke L, Kamycheva E, Garcia BH. Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (The IMMENSE study) - a randomized controlled trial. BMC Health Serv Res. 2022 Oct 26;22(1):1290. doi: 10.1186/s12913-022-08648-1.

Reference Type DERIVED
PMID: 36289541 (View on PubMed)

Other Identifiers

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2016/41366

Identifier Type: -

Identifier Source: org_study_id

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