Reduction of Polypharmacy in Elderly People With Multiple Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorMartin-Luther-Universität Halle-Wittenberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 5 longterm medications (> 6 months) (polypharmacy)
≥ 3 chronic diseases (multimorbidity)
≥ 1 family doctor consultation within the last 6 months
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Medication plan review
Other interventionIntervention 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
BehavioralIntervention 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.
Treatment groups
1,146 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
Hospitalizations
The frequency of hospitalizations due to adverse drug reactions.
Time frame
6 months3
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).
Time frame
6 months4
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.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin-Luther-Universität Halle-Wittenberg
Lead sponsor
University of Leipzig
Collaborator
Hannover Medical School
Collaborator
Source ClinicalTrials.gov