Medication Therapy Management Clinical Trial
— IMMENSEOfficial title:
A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
Verified date | August 2020 |
Source | University of Tromso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 516 |
Est. completion date | December 20, 2020 |
Est. primary completion date | December 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | University hospital of North Norway | Tromso |
Lead Sponsor | Collaborator |
---|---|
University of Tromso | University Hospital of North Norway |
Norway,
Johansen JS, Havnes K, Halvorsen KH, Haustreis S, Skaue LW, Kamycheva E, Mathiesen L, Viktil KK, Granås 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Self-reported quality of life | Change in self-reported quality of life using the validated EQ-5D | 1 months after hospital discharge | |
Secondary | Self-reported quality of life | Change in self-reported quality of life using the validated EQ-5D | 6 months after hospital discharge | |
Secondary | Self-reported quality of life | Change in self-reported quality of life using the validated EQ-5D | 12 months after hospital discharge | |
Secondary | 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 | |
Secondary | Time to first rehospitalization | Days to first hospitalization | First rehospitalization after discharge from index hospital stay, up to 12 months after discharge. | |
Secondary | Visits to primary care physician | Visitation rate at 12 months | 12 months after discharge for index hospital stay | |
Secondary | Mortality rate | 12 months after randomization | ||
Secondary | Total score of the Medication appropriateness index (MAI) | Baseline at randomization | ||
Secondary | Change in total score of the Medication appropriateness index (MAI) | From baseline to date of discharge from hospital, assessed up to 12 months | ||
Secondary | Inappropriate medications identified through the Norwegian general practice criteria (NORGEP) | Baseline at randomization | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Potentially inappropriate prescribing identified through the Screening Tool to Alert doctors to Right treatment (START) | Baseline at randomization | ||
Secondary | 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 | ||
Secondary | Potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP) | Baseline at randomization | ||
Secondary | 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 | ||
Secondary | Change in potentially inappropriate prescribing identified through the Screening Tool of Older Persons' Prescriptions (STOPP) | From baseline to 12 months after discharge from hospital | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Hip fracture | Rate of hip fractures | 12 months after discharge from index hospital stay | |
Secondary | Stroke | Stroke rate during 12 months follow-up | 12 months after discharge from index hospital stay | |
Secondary | The proportion of patients readmitted acutely within 30 days | 30 days after discharge from index hospital stay |
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