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

Study Overview
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Brief Summary
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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.

Official Title
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A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly

Conditions
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Health Services for the Aged, Medication Therapy Management

Intervention / Treatment
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* Other: Interdisciplinary collaboration structure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>The study participants receives standard care in the ward, this does not include a pharmacist. | |
| Experimental: Intervention<br>Interdisciplinary collaboration structure | Other: Interdisciplinary collaboration structure<br>* 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.<br>|

What is the study measuring?
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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 |