Clinical trial NCT02816086: A New Interdisciplinary Collaboration Structure to Improve Medication Safety in the Elderly
Official title: A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Services for the Aged
Medication Therapy Management
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
First posted: 2016-06-28
Enrollment: 516
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Emergency medical visits
timeFrame: 12 months after hospital discharge
Secondary outcomes:
measure: Self-reported quality of life
timeFrame: 1 months after hospital discharge
measure: Self-reported quality of life
timeFrame: 6 months after hospital discharge
measure: Self-reported quality of life
timeFrame: 12 months after hospital discharge
measure: length in days of index hospital stay
timeFrame: Days from hospitalization to discharge of index hospital stay, assessed up to 12 months
measure: Time to first rehospitalization
timeFrame: First rehospitalization after discharge from index hospital stay, up to 12 months after discharge.
measure: Visits to primary care physician
timeFrame: 12 months after discharge for index hospital stay
measure: Mortality rate
timeFrame: 12 months after randomization
measure: Total score of the Medication appropriateness index (MAI)
timeFrame: Baseline at randomization
measure: Change in total score of the Medication appropriateness index (MAI)
timeFrame: From baseline to date of discharge from hospital, assessed up to 12 months
measure: Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)
timeFrame: Baseline at randomization
measure: Change in Inappropriate medications identified through the Norwegian general practice criteria (NORGEP)
timeFrame: From baseline to date of discharge from hospital, assessed up to 12 months
measure: Change in inappropriate medications identified through the Norwegian general practice criteria (NORGEP)
timeFrame: From baseline to 3 months after discharge from index hospital stay, assessed up to 12 months
measure: Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)
timeFrame: Baseline at randomization
measure: Change in potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START)
timeFrame: From baseline to date of discharge from hospital, assessed up to 12 months
measure: Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)
timeFrame: Baseline at randomization
measure: Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)
timeFrame: From baseline to date of discharge from hospital, assessed up to 12 months
measure: Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP)
timeFrame: From baseline to 12 months after discharge from hospital
measure: Changes in medication, identified through screening of drug lists at their primary care physician.
timeFrame: 12 months after discharge from index hospital stay
measure: Changes in medication, identified through screening of drug lists at their primary care physician.
timeFrame: 3 months after discharge from index hospital stay
measure: Rehospitalizations where the reason for hospitalization is possibly, probably or certainly drug-related.
timeFrame: First rehospitalization after discharge from index hospital stay, up to 12 months after inclusion in study
measure: Hip fracture
timeFrame: 12 months after discharge from index hospital stay
measure: Stroke
timeFrame: 12 months after discharge from index hospital stay
measure: The proportion of patients readmitted acutely within 30 days
timeFrame: 30 days after discharge from index hospital stay
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University hospital of North Norway
Study officials:
affiliation: UiT The artic university of Norway
name: Beate H Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.