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Medication Use and Quality of Life Among Older People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676984
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Carina Lundby, Odense University Hospital

Study Description
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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. This registration concerns the initial pilot study.

Condition or disease Intervention/treatment Phase
Quality of Life Reduction, Harm Other: Consultations Not Applicable

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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Medication Use and Quality of Life Among Older People
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Consultations
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.
 Other: Consultations
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.


Outcome Measures
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Primary Outcome Measures :
  1. QUALITY OF LIFE [ Time Frame: At 6 months. ]
    Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.

  2. MORTALITY [ Time Frame: At 12 months. ]
    Mortality will be assessed through the nationwide Danish Central Person Registry.

  3. QUALITY OF LIFE [ Time Frame: At 6 months. ]
    Health-related quality of life will be measured using the Danish version of the Depression List.


Secondary Outcome Measures :
  1. COGNITIVE FUNCTION [ Time Frame: At 3 months/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: At 3 months/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: At 3 months/6 months. ]
    Hand-grip strength will be measured using a hand-grip dynamometer.

  4. ABILITY TO SIT AND STAND [ Time Frame: At 3 months/6 months. ]
    Ability to sit and stand will be measured via the 30-second stand-sit-test.

  5. NUMBER OF MEDICATIONS DISCONTINUED [ Time Frame: At 3 months/6 months. ]
    Number of medications dicontinued will be assessed through the medication lists.

  6. NUMBER OF MEDICATION CHANGES [ Time Frame: At 3 months/6 months. ]
    Number of medication changes will be assessed through the medication lists.

  7. ADMISSIONS [ Time Frame: At 3 months/6 months. ]
    Admissions will be assessed through the nationwide Danish National Patient Register.

  8. HEALTH CARE COSTS [ Time Frame: At 3 months/6 months. ]
    Health care costs.

  9. SUCCESS RATE OF THE INTERVENTION [ Time Frame: At 3 months/6 months. ]
    Succes rate of the intervention.

  10. QUALITY OF LIFE [ Time Frame: At 3 months. ]
    Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.

  11. QUALITY OF LIFE [ Time Frame: At 3 months. ]
    Health-related quality of life will be measured using the Danish version of the Depression List.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥15
  • Are able to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676984


Contacts
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Contact: Carina Lundby 004523241245 carina.lundby.olesen@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Region Of Southern Denmark, Denmark, 5000
Contact: Carina Lundby, Cand.pharm    004523241245      
Contact: Anton Pottegård, Prof    004528913340    apottegaard@health.sdu.dk   
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
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Principal Investigator: Anton Pottegård, Prof apottegaard@health.sdu.dk
More Information
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Responsible Party: Carina Lundby, Postdoctoral Researcher, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04676984    
Other Study ID Numbers: ODIN-1 Pilot
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carina Lundby, Odense University Hospital:
Deprescribing
Polypharmacy
Guideline