Reduction of Polypharmacy in Elderly People With Multiple Diseases

Polypharmacy Clinical Trial

— RED  

Official title:

Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526963
• Other study ID #: RaPHaeL_001_RED
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: May 2024

Study information

• Verified date: September 2022
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Alexander Bauer, Dr.
• Phone: +493455575338
• Email: raphael[@]uk-halle.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.

Description:

Introduction: Many elderly people are multimorbid and are treated with five or more medications (polypharmacy) at the same time. Due to age related physiological changes they are especially vulnerable to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Up to 16% of unplanned hospitalizations of elderly people with polypharmacy are caused by ADRs. The primary aim of this study is the evaluation of the effectivity of a multi-component-intervention to reduce the frequency of ADRs in multimorbid patients aged 70 years and older.

Methods: We are planning a multi-center stepped wedge cluster randomized controlled trial at 40 primary care practices affiliated to the RaPHaeL-network (Research Practices Halle-Leipzig) in Saxony-Anhalt and Saxony, Germany. The planned intervention follows the recommendations of the New Medical Research Council and comprises a pharmacological medication plan review according to the STOPP/START-criteria and an adherence support measure employing motivational interviewing. Control group will receive usual care. Eligible patients are ≥ 70 years old, are diagnosed with three or more chronic medical conditions and are prescribed five or more medications. The primary outcome is the rate of ADRs six months post intervention. The secondary outcomes are number of ADRs, hospitalization rate due to ADRs, medication adherence (Morisky Adherence Score MMAS-8), the health-related quality of life (Euro-QOL EQ-5D-5L), the number of PIPs (according to STOPP/START), number of primary care physician per quarter, the medication appropriateness index and the mean number of de-prescriptions per patient. The planned sample size is 1,146 patients.

Discussion: Multimorbid patients with polypharmacy show an increased risk for PIPs, since prescriptions can be based on evidence for pharmacological therapy of a single condition without taking into account the complex drug interactions. Based on the existing evidence we are aiming to reduce ADRs in this patient population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1146
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• = 5 longterm medications (> 6 months) (polypharmacy)

• = 3 chronic diseases (multimorbidity)

• = 1 family doctor consultation within the last 6 months

Exclusion Criteria:

• Patients with a critically reduced life expectancy

• Patients who cannot autonomously visit the family practice

• Patients who cannot participate in the informed consent process

• Patients who are residing in a nursing home

• Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99

• Patients who are participating in another medical study with a focus on polypharmacy or multimorbidity

Related Conditions & MeSH terms

• Multimorbidity
• Polypharmacy

Intervention

Other:
• Medication plan review
Intervention group patients will receive a revised medication plan by external pharmacologist based on the the STOPP/START criteria. The revised medication plan will be provided to the family physician who then will provide it to the patient. The revision comes along with evidence based information for the physician to prevent possible uncertainties by the physicians.

Behavioral:
• Adherence support
Intervention group patients will receive a study nurse administered adherence support measure based on telephone-based motivational interviewing. The measure includes information on possible consequences of inadherence and signs of adverse drug reactions that is comprehensible for lay persons.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	Hannover Medical School, University of Leipzig

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse drug reactions	Rate of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care.	6 months
Secondary	Potentially inappropriate prescriptions	The number of potentially inappropriate prescriptions based on the STOPP(Screening Tool of Older Persons' potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria.	6 months
Secondary	Hospitalizations	The frequency of hospitalizations due to adverse drug reactions.	6 months
Secondary	Adherence	The patient's adherence to the medication plan based on the Morisky medication adherence score 8 (MMAS-8). Response categories are yes/no for each item with a dichotomous response and a 5-point Likert response for the last item. The summed total score ranges from 0 to 8 otal MMAS-8 scores can range from 0 to 8 and will be been categorized into three levels of adherence: high adherence (score = 8), medium adherence (score of 6 to < 8), and low adherence (score< 6).	6 months
Secondary	Health-related quality of life	The health-related quality of life will be measured using the six-item European Quality of Life 5 Dimensions 3 Level Version (Euro-QOL EQ-5D-5L) tool, ranging from 0 to 100 on a visual analoge scale with higher values indicating a higher quality of life.	6 months
Secondary	Family doctor consultations	The number of family doctor consultations within the time frame between recruitment and follow-up.	6 months
Secondary	Medication appropriateness	The medication appropriateness will be measured using the medication appropriateness index (MAI)	6 months
Secondary	Deprescription	The number of medication de-prescriptions per patient	6 months
Secondary	Types of adverse drug reactions	Number and types of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care. Each symptom's severity will be quantified by use of an analogue scale from 0 (no severity) to 10 (maximum imaginable severity)	6 months