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

Medication Therapy Management Clinical Trial

— IMMENSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816086
• Other study ID #: 2016/41366
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Health Services for the Aged
• Medication Therapy Management

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