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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Reduction, Harm
• Intervention / Treatment: Other: Consultations

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.

What is the study measuring?

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
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
NUMBER OF MEDICATION CHANGES	Number of medication changes will be assessed through the medication lists.	3 months, 6 months and 12 months
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
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
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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Anton Pottegård, Prof, apottegaard@health.sdu.dk

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Polypharmacy; Guideline; Deprescribing
• Other Study ID Numbers: ODIN-1 Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No