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Completed

NCT Number: NCT04676984

Medication Use and Quality of Life Among Older People (Pilot)

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. This registration concerns the initial pilot study.

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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. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).

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 seven 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. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her 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 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 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 consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

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 ≥15
  • Are able to provide informed consent

Exclusion criteria

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

Treatment and study plan

Consultations

Other

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.

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 SF-12v2 Health Survey.

  2. CHANGE FROM BASELINE 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 SF-12v2 Health Survey.

  3. CHANGE FROM BASELINE 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 SF-12v2 Health Survey.

  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.

  5. CHANGE FROM BASELINE 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.

  6. CHANGE FROM BASELINE 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.

  7. MORTALITY

    Time frame: 3 months

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

  8. MORTALITY

    Time frame: 6 months

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

  9. MORTALITY

    Time frame: 12 months

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

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-2 (MMSE-2) Standard Form.

  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. ABILITY TO SIT AND STAND

    Time frame: Baseline, 3 months and 6 months

    Ability to sit and stand will be measured via the 30-second stand-sit-test.

  5. NUMBER OF MEDICATIONS DISCONTINUED

    Time frame: 3 months, 6 months and 12 months

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

  6. NUMBER OF MEDICATION CHANGES

    Time frame: 3 months, 6 months and 12 months

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

  7. HOSPITAL ADMISSIONS

    Time frame: 3 months, 6 months and 12 months

    Admissions will be assessed through the nationwide Danish National Patient Register.

  8. HEALTH CARE COSTS

    Time frame: 3 months, 6 months and 12 months

    Health care costs.

  9. SUCCESS RATE OF THE INTERVENTION

    Time frame: 3 months, 6 months and 12 months

    Succes rate of the intervention.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Apr 26, 2022

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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