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

September 29, 2021 updated by: University of Tromso

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months after hospital discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported quality of life
Time Frame: 1 months after hospital discharge
Change in self-reported quality of life using the validated EQ-5D
1 months after hospital discharge
Self-reported quality of life
Time Frame: 6 months after hospital discharge
Change in self-reported quality of life using the validated EQ-5D
6 months after hospital discharge
Self-reported quality of life
Time Frame: 12 months after hospital discharge
Change in self-reported quality of life using the validated EQ-5D
12 months after hospital discharge
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
Days from hospitalization to discharge of index hospital stay, assessed up to 12 months
Time to first rehospitalization
Time Frame: First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.
Days to first hospitalization
First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.
Visits to primary care physician
Time Frame: 12 months after discharge for index hospital stay
Visitation rate at 12 months
12 months after discharge for index hospital stay
Mortality rate
Time Frame: 12 months after randomization
12 months after randomization
Total score of the Medication appropriateness index (MAI)
Time Frame: Baseline at randomization
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
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
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
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
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
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
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
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
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
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.
12 months after discharge from index hospital stay
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.
3 months after discharge from index hospital stay
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
First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study
Hip fracture
Time Frame: 12 months after discharge from index hospital stay
Rate of hip fractures
12 months after discharge from index hospital stay
Stroke
Time Frame: 12 months after discharge from index hospital stay
Stroke rate during 12 months follow-up
12 months after discharge from index hospital stay
The proportion of patients readmitted acutely within 30 days
Time Frame: 30 days after discharge from index hospital stay
30 days after discharge from index hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tromso

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of North Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beate H Garcia, PhD, UiT The artic university of Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/41366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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