Medication Use and Quality of Life Among Older People (Pilot)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Region Of Southern Denmark
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Odense, Region Of Southern Denmark, Denemarken, 5000
- Odense University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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HEALTH-RELATED QUALITY OF LIFE
Tijdsspanne: Baseline
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Tijdsspanne: 3 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Tijdsspanne: 6 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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6 months
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HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Tijdsspanne: Baseline
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Health-related quality of life will be measured using the Danish version of the Depression List.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Tijdsspanne: 3 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Tijdsspanne: 6 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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6 months
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MORTALITY
Tijdsspanne: 3 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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3 months
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MORTALITY
Tijdsspanne: 6 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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6 months
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MORTALITY
Tijdsspanne: 12 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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FUNCTIONEEL NIVEAU
Tijdsspanne: Basislijn, 3 maanden en 6 maanden
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Het functionele niveau wordt gemeten met behulp van de Deense versie van de Vulnerable Elders Survey 13 (VES-13).
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Basislijn, 3 maanden en 6 maanden
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HANDGREEPSTERKTE
Tijdsspanne: Basislijn, 3 maanden en 6 maanden
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Handgreepkracht wordt gemeten met behulp van een handgreepdynamometer.
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Basislijn, 3 maanden en 6 maanden
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AANTAL MEDICATIEVERANDERINGEN
Tijdsspanne: 3 maanden, 6 maanden en 12 maanden
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Het aantal medicatiewisselingen wordt beoordeeld aan de hand van de medicatielijsten.
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3 maanden, 6 maanden en 12 maanden
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COGNITIVE FUNCTION
Tijdsspanne: 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
Tijdsspanne: Baseline, 3 months and 6 months
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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
Tijdsspanne: 3 months, 6 months and 12 months
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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
Tijdsspanne: 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
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HEALTH CARE COSTS
Tijdsspanne: 3 months, 6 months and 12 months
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Health care costs.
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3 months, 6 months and 12 months
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SUCCESS RATE OF THE INTERVENTION
Tijdsspanne: 3 months, 6 months and 12 months
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Succes rate of the intervention.
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3 months, 6 months and 12 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- ODIN-1 Pilot
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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