Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02816086
Other study ID # 2016/41366
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2016
Est. completion date December 20, 2020

Study information

Verified date August 2020
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
Norway University hospital of North Norway Tromso

Sponsors (2)

Lead Sponsor Collaborator
University of Tromso University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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

Outcome

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
See also
  Status Clinical Trial Phase
Withdrawn NCT04893395 - Assessment of the Impact of Clinical Pharmacogenomics on Real and Potential Medication Use in Veterans N/A
Completed NCT02562352 - Team Approach to Polypharmacy Evaluation and Reduction N/A
Completed NCT02863341 - Nursing Home Team-Care Deprescribing Study N/A
Completed NCT01970774 - Medication Therapy Management With Pharmacogenetic Testing N/A
Completed NCT04151797 - Impact of a Mobile Geriatric Team With a Pharmacist on the Optimisation of Prescriptions in Elderly Inpatients N/A
Enrolling by invitation NCT06383364 - The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment N/A
Completed NCT03154489 - Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care N/A
Completed NCT03257605 - A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly N/A
Not yet recruiting NCT06310512 - Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients" N/A
Recruiting NCT02942927 - Team Approach to Polypharmacy Evaluation and Reduction N/A
Completed NCT03909035 - A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy N/A
Recruiting NCT03557944 - Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy) N/A
Completed NCT02820129 - Effectiveness of a Medication Wallet Card Phase 1
Terminated NCT03202264 - Team Approach to Polypharmacy Reduction to Improve Mobility Long-Term Care
Completed NCT03321058 - Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics N/A
Completed NCT02658604 - Home Medication Reviews by Pharmacists in Ontario, Canada N/A
Withdrawn NCT05711771 - Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes
Recruiting NCT05553015 - A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)
Active, not recruiting NCT05278650 - Senior PharmAssist: Co-Design and Evaluation of a Toolkit to Promote Scalable Implementation N/A
Recruiting NCT05351281 - Appropriate Medication Use in Dutch Terminal Care N/A