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

A New Interdisciplinary Collaboration Structure in Secondary and Primary Care 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.

Study Overview

• Status: Completed
• Conditions: Health Services for the Aged; Medication Therapy Management
• Intervention / Treatment: Other: Interdisciplinary collaboration structure

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromso, Norway, 9030
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; The study participants receives standard care in the ward, this does not include a pharmacist.
Experimental: Intervention; Interdisciplinary collaboration structure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported quality of life	Change in self-reported quality of life using the validated EQ-5D	1 months after hospital discharge
Self-reported quality of life	Change in self-reported quality of life using the validated EQ-5D	6 months after hospital discharge
Self-reported quality of life	Change in self-reported quality of life using the validated EQ-5D	12 months after hospital discharge
length in days of index hospital stay	Days from hospital admission to discharge of index hospital stay	Days from hospitalization to discharge of index hospital stay, assessed up to 12 months
Time to first rehospitalization	Days to first hospitalization	First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.
Visits to primary care physician	Visitation rate at 12 months	12 months after discharge for index hospital stay
Mortality rate		12 months after randomization
Total score of the Medication appropriateness index (MAI)		Baseline at randomization
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
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
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
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
Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)		Baseline at randomization
Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)		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)		From baseline to 12 months after discharge from hospital
Changes in medication, identified through screening of drug lists at their primary care physician.	Drug changes made during hospitalization implemented by the primary care physician.	12 months after discharge from index hospital stay
Changes in medication, identified through screening of drug lists at their primary care physician.	Drug changes made during hospitalization implemented by the primary care physician.	3 months after discharge from index hospital stay
Rehospitalizations where the reason for hospitalization is possibly, probably or certainly drug-related.	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	First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study
Hip fracture	Rate of hip fractures	12 months after discharge from index hospital stay
Stroke	Stroke rate during 12 months follow-up	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

Collaborators and Investigators

• Sponsor: University of Tromso
• Collaborators: University Hospital of North Norway
• Investigators: Principal Investigator: Beate H Garcia, PhD, UiT The artic university of Norway

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016/41366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO