Medication Use and Quality of Life Among Older People

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Reduction, Harm
• Intervention / Treatment: Behavioral: Deprescribing intervention

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. 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 eight 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. After retrieval of informed consent, patients are randomized. Patients randomized to the control group continue with usual care (consultations with their GP when needed). Patients in the intervention group receive the intervention, comprising a series of consultations between the patient and GP (at least three). During the first intervention consultation (3: Consultation 1), the patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepare (4: Preparation) by considering and verbalizing their 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 intervention 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 intervention 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 intervention consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal. A project nurse visits all patients (both patients randomized to the control and intervention group, respectively) at home 3 and 6 months after first home visit to retrieve follow-up measurements (8: Follow-ups). A project nurse retrieves medication lists at 3 months, 6 months, and 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina Lundby, PhD; Phone Number: 004523241245; Email: Carina.Lundby.Olesen@rsyd.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Odense, Region Of Southern Denmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Carina Lundby, Cand.pharm; Phone Number: 004523241245
      • Contact: Anton Pottegård, Prof; Phone Number: 004528913340; Email: apottegaard@health.sdu.dk

Participation Criteria

Eligibility Criteria

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

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 ≥18
• 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will not receive a series of consultations with their general practitioner. Controls will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.
Experimental: Intervention group; 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. Interventions will receive baseline measurements and follow-up measurements 3 months and 6 months following baseline measurements.	Behavioral: Deprescribing intervention; The intervention is comprised of a minimum of three consultations with a general practitioner (GP), where adjustment of the patient's medication is made according to the patient's preference, goals and needs Consultation 1: Patient and GP discuss how the patient feels about their medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. Consultation 2: A clinical pharmacist have beforehand examined the patient's medication list and provided suggestions to the GP on which drugs can be deprescribed. The patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. Consultation 3: Patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.

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 Short Form 12 Health Survey Version 2 (SF-12v2).	Baseline
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS	Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).	3 months
CHANGE FROM BASLINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS	Health-related quality of life will be measured using the Danish version of the Short Form 12 Health Survey Version 2 (SF-12v2).	6 months
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)	Health-related quality of life will be measured using the Danish version of the Depression List (DL).	Baseline
CHANGE FROM BASLINE 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 (DL).	3 months
CHANGE FROM BASLINE 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 (DL).	6 months
MORTALITY	Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).	3 months
MORTALITY	Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).	6 months
MORTALITY	Mortality will be assessed through the nationwide Danish Central Person Registry (CPR).	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 Version 2 Standard Form (MMSE-2).	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
NUMBER OF MEDICATION DISCONTINUED	Number of medications discontinued 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	Hospital admissions will be assessed through the nationwide Danish National Patient Registry.	3 months, 6 months and 12 months
HEALTH CARE COSTS	Health care costs will be assessed through nationwide Danish Health Care registries.	3 months, 6 months and 12 months
SUCCESS RATE OF THE INTERVENTION	Success rate will be assessed through persisting discontinuations and changes of medications via the medication lists.	3 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Anton Pottegård, Professor, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Polypharmacy; Guideline; Deprescribing; Shared decision-making
• Other Study ID Numbers: ODIN-1

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