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Health Services for the AgedIMMENSENCT02816086

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

A study testing Interdisciplinary collaboration structure in people with Health Services for the Aged and Medication Therapy Management, run by University of Tromso at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Interdisciplinary collaboration structure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteNorway
Study dates
21 Sep 2016to 20 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University hospital of North Norway

    Tromsø, 9030

Other trials in Norway

About this study

Official title: 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.

Being tested
Interdisciplinary collaboration structure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interdisciplinary collaboration structureOther

    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.

Study groups in NCT02816086
Study groupRoleWhat they receive
Standard careNo interventionThe study participants receives standard care in the ward, this does not include a pharmacist.
InterventionExperimentalInterdisciplinary collaboration structure
Receives: Other: Interdisciplinary collaboration structure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after hospital discharge

Secondary outcomes (23)

  1. Self-reported quality of life

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

    Measured: 1 months after hospital discharge

  2. Self-reported quality of life

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

    Measured: 6 months after hospital discharge

  3. Self-reported quality of life

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

    Measured: 12 months after hospital discharge

  4. length in days of index hospital stay

    Days from hospital admission to discharge of index hospital stay

    Measured: Days from hospitalization to discharge of index hospital stay, assessed up to 12 months

  5. Time to first rehospitalization

    Days to first hospitalization

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

  6. Visits to primary care physician

    Visitation rate at 12 months

    Measured: 12 months after discharge for index hospital stay

  7. Mortality rate

    Measured: 12 months after randomization

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

    Measured: Baseline at randomization

  9. Change in total score of the Medication appropriateness index (MAI)

    Measured: From baseline to date of discharge from hospital, assessed up to 12 months

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

    Measured: Baseline at randomization

  11. Change in Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)

    Measured: 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)

    Measured: 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)

    Measured: Baseline at randomization

  14. Change in potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)

    Measured: 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)

    Measured: Baseline at randomization

  16. Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)

    Measured: 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)

    Measured: From baseline to 12 months after discharge from hospital

  18. 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.

    Measured: 12 months after discharge from index hospital stay

  19. 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.

    Measured: 3 months after discharge from index hospital stay

  20. 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

    Measured: First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study

  21. Hip fracture

    Rate of hip fractures

    Measured: 12 months after discharge from index hospital stay

  22. Stroke

    Stroke rate during 12 months follow-up

    Measured: 12 months after discharge from index hospital stay

  23. The proportion of patients readmitted acutely within 30 days

    Measured: 30 days after discharge from index hospital stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2016 (estimated)
  2. Study start21 Sep 2016
  3. Primary completion20 Dec 2020
  4. Study completion20 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02816086
Sponsor's protocol ID
2016/41366
Other IDs
2016
Acronym
IMMENSE
Status last verified
Aug 2020
First submitted
30 May 2016
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 29362276

  • 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.

    PubMed 38884880

  • 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.

    PubMed 37991657

  • 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.

    PubMed 36289541

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary collaboration structure in people with Health Services for the Aged and Medication Therapy Management, run by University of Tromso at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergency medical visits (time frame: 12 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02816086, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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