Medication Use and Quality of Life Among Older People (Pilot)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Region Of Southern Denmark
-
Odense, Region Of Southern Denmark, Danmark, 5000
- Odense University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HEALTH-RELATED QUALITY OF LIFE
Tidsram: Baseline
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
Baseline
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Tidsram: 3 months
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
3 months
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Tidsram: 6 months
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
6 months
|
|
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Tidsram: Baseline
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
Baseline
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Tidsram: 3 months
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
3 months
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Tidsram: 6 months
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
6 months
|
|
MORTALITY
Tidsram: 3 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
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3 months
|
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MORTALITY
Tidsram: 6 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
6 months
|
|
MORTALITY
Tidsram: 12 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
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12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
FUNKTIONSNIVÅ
Tidsram: Baslinje, 3 månader och 6 månader
|
Funktionsnivå kommer att mätas med den danska versionen av Vulnerable Elders Survey 13 (VES-13).
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Baslinje, 3 månader och 6 månader
|
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HANDGREP STYRKA
Tidsram: Baslinje, 3 månader och 6 månader
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Handgreppsstyrkan kommer att mätas med en handgreppsdynamometer.
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Baslinje, 3 månader och 6 månader
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|
ANTAL LÄKEMEDELSFÖRÄNDRINGAR
Tidsram: 3 månader, 6 månader och 12 månader
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Antalet läkemedelsbyten kommer att bedömas genom läkemedelslistorna.
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3 månader, 6 månader och 12 månader
|
|
COGNITIVE FUNCTION
Tidsram: Baseline, 3 months and 6 months
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Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
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Baseline, 3 months and 6 months
|
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ABILITY TO SIT AND STAND
Tidsram: Baseline, 3 months and 6 months
|
Ability to sit and stand will be measured via the 30-second stand-sit-test.
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Baseline, 3 months and 6 months
|
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NUMBER OF MEDICATIONS DISCONTINUED
Tidsram: 3 months, 6 months and 12 months
|
Number of medications dicontinued will be assessed through the medication lists.
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3 months, 6 months and 12 months
|
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HOSPITAL ADMISSIONS
Tidsram: 3 months, 6 months and 12 months
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Admissions will be assessed through the nationwide Danish National Patient Register.
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3 months, 6 months and 12 months
|
|
HEALTH CARE COSTS
Tidsram: 3 months, 6 months and 12 months
|
Health care costs.
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3 months, 6 months and 12 months
|
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SUCCESS RATE OF THE INTERVENTION
Tidsram: 3 months, 6 months and 12 months
|
Succes rate of the intervention.
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3 months, 6 months and 12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ODIN-1 Pilot
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