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

NCT02816086 | Completed

• 1 other identifier: 2016/41366
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Services for the Aged; Medication Therapy Management

Outcome Measures

Primary Outcomes (1)

• Emergency medical visits

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

  12 months after hospital discharge

Secondary Outcomes (23)

• Self-reported quality of life

  1 months after hospital discharge

• Self-reported quality of life

  6 months after hospital discharge

• 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

• Time to first rehospitalization

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

Study Arms (2)

Standard care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

Interdisciplinary collaboration structure

Other: Interdisciplinary collaboration structure

Interventions

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.

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Occupying a bed in the study wards but under the care of physicians from a non-study ward.

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator

Study Sites (1)

University hospital of North Norway

Tromsø, 9030, Norway

Location

Related Publications (4)

• 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.

  PMID: 29362276 BACKGROUND

• 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.

  PMID: 38884880 DERIVED

• 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.

  PMID: 37991657 DERIVED

• 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.

  PMID: 36289541 DERIVED

Study Officials

• Beate H Garcia, PhD

  UiT The artic university of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 28, 2016
• Study Start: September 21, 2016
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: September 30, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)