Clinical trial NCT05123313: Medication Use and Quality of Life Among Older People
Official title: Medication Use and Quality of Life Among Older People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Reduction, Harm
Keywords: Deprescribing
Polypharmacy
Shared decision-making
Guideline
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2021-11-17
Enrollment: 188
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: HEALTH-RELATED QUALITY OF LIFE
timeFrame: Baseline
measure: CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
timeFrame: 3 months
measure: CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
timeFrame: 6 months
measure: HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
timeFrame: Baseline
measure: CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
timeFrame: 3 months
measure: CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
timeFrame: 6 months
measure: MORTALITY
timeFrame: 3 months
measure: MORTALITY
timeFrame: 6 months
measure: MORTALITY
timeFrame: 12 months
Secondary outcomes:
measure: COGNITIVE FUNCTION
timeFrame: Baseline, 3 months and 6 months
measure: FUNCTIONAL LEVEL
timeFrame: Baseline, 3 months and 6 months
measure: HAND-GRIP STRENGTH
timeFrame: Baseline, 3 months and 6 months
measure: NUMBER OF MEDICATION DISCONTINUED
timeFrame: 3 months, 6 months and 12 months
measure: NUMBER OF MEDICATION CHANGES
timeFrame: 3 months, 6 months and 12 months
measure: HOSPITAL ADMISSIONS
timeFrame: 3 months, 6 months and 12 months
measure: HEALTH CARE COSTS
timeFrame: 3 months, 6 months and 12 months
measure: SUCCESS RATE OF THE INTERVENTION
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Anton Pottegård, Professor
role: PRINCIPAL_INVESTIGATOR
References: