Medication Use and Quality of Life Among Older People

NCT ID: NCT05123313

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2025-12-31

Brief Summary

This project will provide new evidence on how to optimize medication use among older people with limited life expectancy. This will be done by testing whether a patient-centered deprescribing intervention, focused on aligning medical treatment with patients' preferences, can improve quality of life among older people with limited life expectancy.

Detailed Description

In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process.

The process can be summarized in eight steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. After retrieval of informed consent, patients are randomized. Patients randomized to the control group continue with usual care (consultations with their GP when needed). Patients in the intervention group receive the intervention, comprising a series of consultations between the patient and GP (at least three). During the first intervention consultation (3: Consultation 1), the patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepare (4: Preparation) by considering and verbalizing their goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next intervention consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new intervention consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent intervention consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal. A project nurse visits all patients (both patients randomized to the control and intervention group, respectively) at home 3 and 6 months after first home visit to retrieve follow-up measurements (8: Follow-ups). A project nurse retrieves medication lists at 3 months, 6 months, and 12 months.

Conditions

Quality of Life; Reduction, Harm

Study Design

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

Study Groups

Control group

The control group will not receive a series of consultations with their general practitioner. Controls will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences. Interventions will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.

Group Type: EXPERIMENTAL

Deprescribing intervention

Intervention Type: BEHAVIORAL

The intervention is comprised of a minimum of three consultations with a general practitioner (GP), where adjustment of the patient's medication is made according to the patient's preference, goals and needs

Consultation 1: Patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation.

Consultation 2: A clinical pharmacist have beforehand examined the patient's medication list and provided suggestions to the GP on which drugs can be deprescribed. The patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities.

Consultation 3: Patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

Interventions

Deprescribing intervention

The intervention is comprised of a minimum of three consultations with a general practitioner (GP), where adjustment of the patient's medication is made according to the patient's preference, goals and needs

Consultation 1: Patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation.

Consultation 2: A clinical pharmacist have beforehand examined the patient's medication list and provided suggestions to the GP on which drugs can be deprescribed. The patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities.

Consultation 3: Patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 80 years
• Take ≥ 8 different medications
• Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
• have a Mini-Mental State Exam (MMSE) score of ≥18
• Are able to provide informed consent

Exclusion Criteria

• Not able to communicate
• Does not speak and understand Danish

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carina Lundby

Postdoctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anton Pottegård, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Odense University Hospital

Odense, Region Syddanmark, Denmark

Countries

Denmark

Other Identifiers

ODIN-1

Identifier Type: -

Identifier Source: org_study_id