Cooperation for Better Treatment of Polypharmacy in the Community

NCT ID: NCT06020391

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2024-10-22

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.

Conditions

Drug Usage

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Collaborative drug review.

Group Type: EXPERIMENTAL

Collaborative drug review

Intervention Type: OTHER

1. Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up 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 MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.

2. The MipAC physician will offer the patient's FP a telephone 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.

Control group

Usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collaborative drug review

1. Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up 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 MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.

2. The MipAC physician will offer the patient's FP a telephone 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

City of Oslo

UNKNOWN

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rita Romskaug

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rita Romskaug, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Geriatric Medicine, Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

Santervas LR, Wyller TB, Skovlund E, Jensen JL, Fjeld KG, Hove LH, Ringstad IB, Nordberg LB, Mellingen KM, Kristoffersen ES, Romskaug R. 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): study protocol for a randomized controlled trial. Trials. 2024 Sep 13;25(1):612. doi: 10.1186/s13063-024-08442-w.

Reference Type: DERIVED

PMID: 39272164 (View on PubMed)

Other Identifiers

2022066

Identifier Type: -

Identifier Source: org_study_id