Medication Use and Quality of Life Among Older People (Pilot)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medication Use and Quality of Life Among Older People (Pilot)

Conditions
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Quality of Life, Reduction, Harm

Intervention / Treatment
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* Other: Consultations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Consultations<br>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. | Other: Consultations<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEALTH-RELATED QUALITY OF LIFE | 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 | 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 | 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) | 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 | 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 | Health-related quality of life will be measured using the Danish version of the Depression List. | 6 months | 
| MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 3 months | 
| MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 6 months | 
| MORTALITY | Mortality will be assessed through the nationwide Danish Central Person Registry. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COGNITIVE FUNCTION | Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form. | Baseline, 3 months and 6 months | 
| FUNCTIONAL LEVEL | Functional level will be measured using the Danish version of the Vulnerable Elders Survey 13 (VES-13). | Baseline, 3 months and 6 months | 
| HAND-GRIP STRENGTH | Hand-grip strength will be measured using a hand-grip dynamometer. | Baseline, 3 months and 6 months | 
| ABILITY TO SIT AND STAND | Ability to sit and stand will be measured via the 30-second stand-sit-test. | Baseline, 3 months and 6 months | 
| NUMBER OF MEDICATIONS DISCONTINUED | Number of medications dicontinued will be assessed through the medication lists. | 3 months, 6 months and 12 months | 
| NUMBER OF MEDICATION CHANGES | Number of medication changes will be assessed through the medication lists. | 3 months, 6 months and 12 months | 
| HOSPITAL ADMISSIONS | Admissions will be assessed through the nationwide Danish National Patient Register. | 3 months, 6 months and 12 months | 
| HEALTH CARE COSTS | Health care costs. | 3 months, 6 months and 12 months | 
| SUCCESS RATE OF THE INTERVENTION | Succes rate of the intervention. | 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing, Polypharmacy, Guideline