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OpenTrials
Active, Not Recruiting

NCT Number: NCT05123313

Medication Use and Quality of Life Among Older People

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deprescribing Intervention

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.

Primary outcomes

  1. HEALTH-RELATED QUALITY OF LIFE

    Time frame: Baseline

    Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).

  2. CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS

    Time frame: 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).

  3. CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS

    Time frame: 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).

  4. HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)

    Time frame: Baseline

    Health-related quality of life will be measured using the Danish version of the Depression List (DL).

  5. CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS

    Time frame: 3 months

    Health-related quality of life will be measured using the Danish version of the Depression List (DL).

  6. CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS

    Time frame: 6 months

    Health-related quality of life will be measured using the Danish version of the Depression List (DL).

  7. MORTALITY

    Time frame: 3 months

    Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).

  8. MORTALITY

    Time frame: 6 months

    Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).

  9. MORTALITY

    Time frame: 12 months

    Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).

Secondary outcomes

  1. COGNITIVE FUNCTION

    Time frame: 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).

  2. FUNCTIONAL LEVEL

    Time frame: Baseline, 3 months and 6 months

    Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13).

  3. HAND-GRIP STRENGTH

    Time frame: Baseline, 3 months and 6 months

    Hand-grip strength will be measured using a hand-grip dynamometer.

  4. NUMBER OF MEDICATION DISCONTINUED

    Time frame: 3 months, 6 months and 12 months

    Number of medications discontinued will be assessed through the medication lists.

  5. NUMBER OF MEDICATION CHANGES

    Time frame: 3 months, 6 months and 12 months

    Number of medication changes will be assessed through the medication lists.

  6. HOSPITAL ADMISSIONS

    Time frame: 3 months, 6 months and 12 months

    Hospital admissions will be assessed through the nationwide Danish National Patient Registry.

  7. HEALTH CARE COSTS

    Time frame: 3 months, 6 months and 12 months

    Health care costs will be assessed through nationwide Danish Health Care registries.

  8. SUCCESS RATE OF THE INTERVENTION

    Time frame: 3 months, 6 months and 12 months

    Success rate will be assessed through persisting discontinuations and changes of medications via the medication lists.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2021
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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