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Clinical Trials/NCT04676984
NCT04676984
Completed
Not Applicable

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

Odense University Hospital1 site in 1 country3 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Odense University Hospital
Enrollment
3
Locations
1
Primary Endpoint
HEALTH-RELATED QUALITY OF LIFE
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 8, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carina Lundby

Postdoctoral Researcher

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not able to communicate
  • Does not speak and understand Danish

Outcomes

Primary Outcomes

HEALTH-RELATED QUALITY OF LIFE

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 6 months

Health-related quality of life will be measured using the Danish version of the Depression List.

MORTALITY

Time Frame: 12 months

Mortality will be assessed through the nationwide Danish Central Person Registry.

Secondary Outcomes

  • COGNITIVE FUNCTION(Baseline, 3 months and 6 months)
  • FUNCTIONAL LEVEL(Baseline, 3 months and 6 months)
  • HAND-GRIP STRENGTH(Baseline, 3 months and 6 months)
  • ABILITY TO SIT AND STAND(Baseline, 3 months and 6 months)
  • NUMBER OF MEDICATIONS DISCONTINUED(3 months, 6 months and 12 months)
  • NUMBER OF MEDICATION CHANGES(3 months, 6 months and 12 months)
  • HOSPITAL ADMISSIONS(3 months, 6 months and 12 months)
  • HEALTH CARE COSTS(3 months, 6 months and 12 months)
  • SUCCESS RATE OF THE INTERVENTION(3 months, 6 months and 12 months)

Study Sites (1)

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