Quality of Life, Reduction, Harm
Conditions
Keywords
Deprescribing, Polypharmacy, Guideline
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. This registration concerns the initial pilot study.
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. 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.
Interventions
OTHERConsultations
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.
Sponsors
University of Southern Denmark
Odense University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEALTH-RELATED QUALITY OF LIFE | Baseline | Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey. |
| CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS | 3 months | Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey. |
| CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS | 6 months | Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey. |
| HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) | Baseline | Health-related quality of life will be measured using the Danish version of the Depression List. |
| CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS | 3 months | Health-related quality of life will be measured using the Danish version of the Depression List. |
| CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS | 6 months | Health-related quality of life will be measured using the Danish version of the Depression List. |
| MORTALITY | 3 months | Mortality will be assessed through the nationwide Danish Central Person Registry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HEALTH CARE COSTS | 3 months, 6 months and 12 months | Health care costs. |
| COGNITIVE FUNCTION | 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. |
| SUCCESS RATE OF THE INTERVENTION | 3 months, 6 months and 12 months | Succes rate of the intervention. |
| FUNCTIONAL LEVEL | Baseline, 3 months and 6 months | Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13). |
| HAND-GRIP STRENGTH | Baseline, 3 months and 6 months | Hand-grip strength will be measured using a hand-grip dynamometer. |
| ABILITY TO SIT AND STAND | Baseline, 3 months and 6 months | Ability to sit and stand will be measured via the 30-second stand-sit-test. |
| NUMBER OF MEDICATIONS DISCONTINUED | 3 months, 6 months and 12 months | Number of medications dicontinued will be assessed through the medication lists. |
| NUMBER OF MEDICATION CHANGES | 3 months, 6 months and 12 months | Number of medication changes will be assessed through the medication lists. |
| HOSPITAL ADMISSIONS | 3 months, 6 months and 12 months | Admissions will be assessed through the nationwide Danish National Patient Register. |
Countries
Denmark
Outcome results
None listed