Medication Use and Quality of Life Among Older People

Not Applicable

Recruiting

• Conditions: Quality of Life; Reduction, Harm
• Interventions: Behavioral: Deprescribing intervention

• Registration Number: NCT05123313
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2021-10-26
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Deprescribing intervention	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.

Primary Outcome Measures

Name	Time	Method
HEALTH-RELATED QUALITY OF LIFE	Baseline	Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)	Baseline	Health-related quality of life will be measured using the Danish version of the Depression List (DL).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS	3 months	Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS	6 months	Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS	3 months	Health-related quality of life will be measured using the Danish version of the Depression List (DL).
MORTALITY	12 months	Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS	6 months	Health-related quality of life will be measured using the Danish version of the Depression List (DL).

Secondary Outcome Measures

Name	Time	Method
NUMBER OF MEDICATION DISCONTINUED	3 months, 6 months and 12 months	Number of medications discontinued will be assessed through the medication lists.
COGNITIVE FUNCTION	Baseline, 3 months and 6 months	Cognitive function will be measured using the Danish version of the Mini-Mental State Examination Version 2 Standard Form (MMSE-2).
FUNCTIONAL LEVEL	Baseline, 3 months and 6 months	Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13).
HAND-GRIP STRENGTH	Baseline, 3 months and 6 months	Hand-grip strength will be measured using a hand-grip dynamometer.
NUMBER OF MEDICATION CHANGES	3 months, 6 months and 12 months	Number of medication changes will be assessed through the medication lists.
HOSPITAL ADMISSIONS	3 months, 6 months and 12 months	Hospital admissions will be assessed through the nationwide Danish National Patient Registry.
HEALTH CARE COSTS	3 months, 6 months and 12 months	Health care costs will be assessed through nationwide Danish Health Care registries.
SUCCESS RATE OF THE INTERVENTION	3 months, 6 months and 12 months	Success rate will be assessed through persisting discontinuations and changes of medications via the medication lists.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Region Of Southern Denmark, Denmark