Reduction of Polypharmacy in Elderly People With Multiple Diseases

NCT ID: NCT05526963

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Polypharmacy; Multimorbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Medication review (STOPP/START-criteria) + telephone-based adherence support measure (motivational interviewing)

Group Type: EXPERIMENTAL

Medication plan review

Intervention Type: OTHER

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.

Adherence support

Intervention Type: BEHAVIORAL

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.

Control Group

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Alexander Bauer

Reserach Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Frese, Prof.

Role: STUDY_CHAIR

MLU Halle-Wittenberg

Locations

HAP ANZ

Halle, Saxony-Anhalt, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Alexander Bauer, Dr.

Role: CONTACT

raphael@uk-halle.de

+493455575338

Facility Contacts

Hildegard Anz, MD

Role: primary

+49 345 6783847

Other Identifiers

RaPHaeL_001_RED

Identifier Type: -

Identifier Source: org_study_id