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Clinical Trials/NCT05123313
NCT05123313
Active, not recruiting
Not Applicable

Medication Use and Quality of Life Among Older People

Odense University Hospital1 site in 1 country188 target enrollmentOctober 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Odense University Hospital
Enrollment
188
Locations
1
Primary Endpoint
HEALTH-RELATED QUALITY OF LIFE
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2021
End Date
December 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carina Lundby

Postdoctoral Researcher

Odense University Hospital

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

Outcomes

Primary Outcomes

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).

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).

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).

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).

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).

MORTALITY

Time Frame: 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

Time Frame: 6 months

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

Secondary Outcomes

  • NUMBER OF MEDICATION DISCONTINUED(3 months, 6 months and 12 months)
  • COGNITIVE FUNCTION(Baseline, 3 months and 6 months)
  • FUNCTIONAL LEVEL(Baseline, 3 months and 6 months)
  • HAND-GRIP STRENGTH(Baseline, 3 months and 6 months)
  • NUMBER OF MEDICATION CHANGES(3 months, 6 months and 12 months)
  • HOSPITAL ADMISSIONS(3 months, 6 months and 12 months)
  • HEALTH CARE COSTS(3 months, 6 months and 12 months)
  • SUCCESS RATE OF THE INTERVENTION(3 months, 6 months and 12 months)

Study Sites (1)

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