Odense University Hospital
Odense, Region Syddanmark, 5000, Denmark
NCT Number: NCT04676984
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.
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Notify Me80 year and older
All sexes
Interventional
Not applicable
Odense, Region Syddanmark, 5000, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Time frame: 3 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Time frame: 6 months
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
Time frame: Baseline
Health-related quality of life will be measured using the Danish version of the Depression List.
Time frame: 3 months
Health-related quality of life will be measured using the Danish version of the Depression List.
Time frame: 6 months
Health-related quality of life will be measured using the Danish version of the Depression List.
Time frame: 3 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
Time frame: 6 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
Time frame: 12 months
Mortality will be assessed through the nationwide Danish Central Person Registry.
Time frame: Baseline, 3 months and 6 months
Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
Time frame: Baseline, 3 months and 6 months
Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13).
Time frame: Baseline, 3 months and 6 months
Hand-grip strength will be measured using a hand-grip dynamometer.
Time frame: Baseline, 3 months and 6 months
Ability to sit and stand will be measured via the 30-second stand-sit-test.
Time frame: 3 months, 6 months and 12 months
Number of medications dicontinued will be assessed through the medication lists.
Time frame: 3 months, 6 months and 12 months
Number of medication changes will be assessed through the medication lists.
Time frame: 3 months, 6 months and 12 months
Admissions will be assessed through the nationwide Danish National Patient Register.
Time frame: 3 months, 6 months and 12 months
Health care costs.
Time frame: 3 months, 6 months and 12 months
Succes rate of the intervention.
Odense University Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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