Clinical trial NCT06020391: Cooperation for Better Treatment of Polypharmacy in the Community
Official title: Cooperation Across Healthcare Service Levels for Medication Reviews in Older People with Polypharmacy Admitted to a Municipal In-patient Acute Care Unit (The COOP II Study): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Usage
Keywords: Polypharmacy
Geriatrics
Drug review
Medication review
Elderly
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: South-Eastern Norway Regional Health Authority
name: City of Oslo
First posted: 2023-08-31
Enrollment: 139
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.

Detailed description: The aim of this study is to evaluate the effect of collaborative drug reviews by MipAC physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in the MipAC patient population aged 70+. The investigators will also assess the environmental impact of the study intervention and compare it to usual care.

The study is a randomized, single-blind, controlled trial with 16 weeks follow-up. In addition, we plan to acquire registry data on MipAC readmissions, hospital admissions, and mortality after one year.

The investigators will recruit 1-4 MipAC physicians to take part in the study. The project physicians will be responsible for the patient's general medical treatment, but will also perform a structured, clinical drug review that goes beyond what is considered usual care. The project physicians will provide necessary information on the patient's medical history and drug use from the medical records, carry out a medical history from the patient, and a physical examination. Relevant blood analyses and other supplementary tests will be ordered if not already available. The clinical drug review will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The investigators will develop a structured framework for the drug reviews, and the MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.

After performing the clinical drug review, the MipAC physician will offer the patient's FP a telephone based or digital meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.

Eligibility criteria: Inclusion Criteria:

* Age 70+
* Admitted to the MipAC unit
* Use of at least six different systemic medications taken regularly
* Informed consent by the patient

Exclusion Criteria:

* Previously included in the study
* Not speaking or understanding Norwegian
* Residing outside of the municipality of Oslo
* Planned discharge within 24 hours
* Isolated for infection control reasons
* Considered too ill to approach or life expectancy judged to be less than six months
* Personnel at the MipAC unit discourage participation (in case of important reasons not covered by the other exclusion criteria)

Primary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: 16 weeks
Secondary outcomes:
measure: Handgrip strength
timeFrame: 16 weeks
measure: Digit span forward
timeFrame: 16 weeks
measure: Digit span backwards
timeFrame: 16 weeks
measure: Unstimulated whole saliva flow
timeFrame: 16 weeks
measure: The Shortened Xerostomia Inventory (SXI)
timeFrame: 16 weeks
measure: The eight-item Visual Analog Scale xerostomia questionnaire
timeFrame: 16 weeks
measure: Oral pain/discomfort
timeFrame: 16 weeks
measure: Orthostatic blood pressure
timeFrame: 16 weeks
measure: Falls
timeFrame: 16 weeks
measure: Admissions to health institutions
timeFrame: 16 weeks and 1 year
measure: Mortality
timeFrame: 16 weeks and 1 year
Other outcomes:
measure: Environmental impact measures
timeFrame: 16 weeks
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Dept. of Geriatric Medicine, Oslo University Hospital
name: Rita Romskaug, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: