Cooperation for Better Treatment of Polypharmacy in the Community

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Drug Usage

Clinical Trial Details

NCT number	NCT06020391
Study type	Interventional
Source	Oslo University Hospital
Contact	Rita Romskaug, MD, PhD
Phone	98094324
Email	ritulf@gmail.com
Status	Recruiting
Phase	N/A
Start date	September 6, 2023
Completion date	June 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.