PolypharmacyAdAMNCT03430336
Application for an Electronic Medication Management Support System
A study testing CDSS provides drug-therapy relevant information, Modification of medication and Assessment of medication appropriateness in people with Polypharmacy, run by BARMER at 2 sites in Germany.
Trial summary
This study assesses whether an electronic medication management support system improves quality, safety, and cost-effectiveness of the drug therapy in adult patients with polypharmacy compared to usual care during the observation period of 15 months from baseline per practice (from 2017 4th quarter to 2020 3rd… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- CDSS provides drug-therapy relevant information, Modification of medication and Assessment of medication appropriateness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Feb 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age with polypharmacy (5 or more drugs taken for at least two quarters).
- Informed consent.
Who cannot join
- Incapacitated patients without legal representative
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Association of Statutory Health Insurance Physicians Westphalia/Lippe
Dortmund
BARMER Health Insurance
Wuppertal
About this study
Official title: Effectiveness and Cost-effectiveness of the Application of an Electronic Medication Management Support System in Patients With Polypharmacy in General Practice (AdAM).
This study assesses whether an electronic medication management support system improves quality, safety, and cost-effectiveness of the drug therapy in adult patients with polypharmacy compared to usual care during the observation period of 15 months from baseline per practice (from 2017 4th quarter to 2020 3rd quarter).
Read the detailed description
Title:
Application of an electronic medication management support system.
Objectives:
The aim of the study is to assess the effectiveness of an electronic medication management support system on hospitalization and death, its cost-effectiveness and its effects on the quality and safety of prescribing in patients with polypharmacy.
Methods:
A parallel, cluster-randomised controlled trial will be conducted in about 1,080 general practices located in the Westphalia-Region (Germany), which care for adult patients covered by BARMER health insurance. Per group, 17,200 clustered-randomized patients (about 32 patients per practice) will be included, if they take ≥ 5 long-term prescriptions (at least 2 consecutive quarters).
In the intervention group, family physicians will use an user-initiated clinical decision support system (CDSS) which provides drug-therapy relevant information (e.g. on diagnoses and treatments) and alerts in case of drug-drug, drug-disease and drug-age interactions. Based on that information, the family physician systematically assesses the appropriateness of patient's medication and optimizes it. Patients receive an updated medication plan in their mother's language, if needed.
In the control group, patients continue to receive usual care where there is no access to the CDSS.
The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions after the observation period of 12 quarters or 15 months per practice. The outcome measures will be based on secondary data (i.e. claims data). Primary and secondary outcomes will be measured at patient level. The primary analysis will be performed adhering to the intention-to-treat (ITT) principle.
Amendment (07/04/2020):
The parallel group comparison will be conducted, as planned. However, the design of the primary analysis will be changed into a cluster-randomised stepped wedge design with an open cohort, as the recruitment to the target of N=1,080 practices was not reached. The changes of the design will allow to safe the power of the trial of 80% to detect differences of the combined primary outcome between both groups. The primary outcome as well as the ITT-analysis were not changed. The changes of the design implied the following subsequent adaptations of the protocol:
- Arms and assigned interventions: The GP practices of the intervention group will continue to provide the experimental intervention as described in the experimental arm for the entire time in the trial. The GP practices of the control arm (usual care, no intervention) will switch to the experimental arm after five quarters control time and provide the experimental intervention for the remaining time in the trial.
- Case finding: The BARMER creates lists of potentially eligible patients ("Potenzialpatienten") in GP practices participating in the AdAM trial based on the fulfillment of inclusion/exclusion criteria in claims data at each quarter between the first quarter 2018 and the third quarter of 2020. Intervention practices receive the lists quarterly from the quarter after randomization and control practices quarterly starting on the date of switch.
- Informed consent:
The GPs in practices of the experimental arm (either they were randomized and assigned as intervention practices at the beginning of the trial or they switch after the end of five quarters control time) invite potentially eligible patients from the lists and ask for a written informed consent.
- Conditions
- Polypharmacy
- Being tested
- CDSS provides drug-therapy relevant information, Modification of medication, Assessment of medication appropriateness, Medication plan, Guidance in medication process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS provides drug-therapy relevant informationOther
External computerized decision support system (CDSS: RpDoc® eMMa Software, RpDoc® Solutions GmbH, Saarbruecken) provides drug-therapy relevant information about participating patients with polypharmacy on demand to the general practitioners (GPs) such as data about diagnoses and treatments. The information is based on claims data gathered from all health care professionals involved in the care of the patient (e.g. specialized physicians, other GPs, psychotherapists as well as data about hospital stays and prescription data from pharmacies).
Modification of medicationOther
GPs can add and modify patient's data within the CDSS (e.g. remove drugs which are not taken by the patient anymore, add most recent laboratory findings about kidney function etc.) to enrich and update claims data based information.
Assessment of medication appropriatenessOther
GPs systematically assess the appropriateness of the medication supported by the CDSS, which will alert in case of drug-drug, drug-disease, and drug-age interactions as well as other inappropriateness, such as prescriptions with regard to incorrect dosage or Dear Doctor letters.
Medication planOther
GPs print out the updated medication plan including also recommendations for medication use and reasons for prescription in lay language (also available in foreign languages for patients with migration background) as well as recommendations on drugs to use / to avoid including over-the-counter drugs (OTC) (optional) and hand it out to the patient.
Guidance in medication processOther
GPs receive guidance via the CDSS (e.g. recommendations addressing certain types of medication errors and high risk prescribing, developed by the German Society for Internal Medicine in collaboration with other scientific medical societies).
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted medication management | Experimental | Family physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication:
* CDSS provides drug-therapy relevant information
* modification of medication
* assessment of medication appropriateness
* medication plan
* Guidance in medication process Receives: Other: CDSS provides drug-therapy relevant information; Other: Modification of medication; Other: Assessment of medication appropriateness; Other: Medication plan; Other: Guidance in medication process |
| Control arm | No intervention | Patients will receive the usual clinical care based on current clinical practice guidelines during intervention period. After completion of trial, the patients in the control group will be invited to participate after written informed consent to receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of all-cause mortality and all-cause hospital admissions
The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions (including night- and day-only admissions) in patients with polypharmacy.
Measured: Observation period of 15 months per practice
Secondary outcomes (3)
Number of potential inappropriate prescriptions
Number of potential inappropriate prescriptions: to ascertain whether the complex intervention improves the appropriateness of prescriptions (high-risk prescriptions) in patients with polypharmacy.
Measured: Observation period of 15 months per practice
All-cause hospital admissions
All-cause hospital admissions: to evaluate whether the complex intervention reduces all-cause hospital admissions (including day- or night-only admissions) (number and duration) in patients with polypharmacy.
Measured: Observation period of 15 months per practice (quarterly)
All-cause mortality
All-cause mortality: to assess whether the complex intervention reduces all-cause mortality in patients with polypharmacy.
Measured: Observation period of 15 months per practice (quarterly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start9 Feb 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- BARMER
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Statutory Health Insurance Physicians Westphalia/Lippe, Germany, Goethe University, University of Cologne, Ruhr University of Bochum, Bielefeld University, University of Wuppertal
- Responsible party
- Principal investigator, Christiane Muth, MD, MPH, Goethe University
- Investigators
- Petra Kellermann-Mühlhoff, Study director, BARMER Health Insurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430336
- Sponsor's protocol ID
- IfA
- Acronym
- AdAM
- Status last verified
- Jul 2021
- First submitted
- 6 Feb 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basten J, Koberlein-Neu J, Ihle P, Meyer I, Timmesfeld N; eHealth COMPATH Study Group. Patterns of CDSS adoption in primary care: a cluster analysis and predictive modelling study from a stepped wedge trial. Implement Sci. 2026 Jun 18;21(1):38. doi: 10.1186/s13012-026-01516-0.
PubMed 42316212Piotrowski A, Coenen J, Rupietta C, Basten J, Muth C, Soling S, Zimmer V, Karbach U, Kellermann-Muhlhoff P, Koberlein-Neu J; AdAM study group. Factors facilitating the implementation of a clinical decision support system in primary care practices: a fuzzy set qualitative comparative analysis. BMC Health Serv Res. 2023 Oct 26;23(1):1161. doi: 10.1186/s12913-023-10156-9.
PubMed 37884934Freund J, Piotrowski A, Buhrmann L, Oehler C, Titzler I, Netter AL, Potthoff S, Ebert DD, Finch T, Koberlein-Neu J, Etzelmuller A. Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing. Implement Sci Commun. 2023 Oct 16;4(1):126. doi: 10.1186/s43058-023-00505-4.
PubMed 37845776Soling S, Demirer I, Koberlein-Neu J, Hower KI, Muller BS, Pfaff H, Karbach U; AdAM Study Group. Complex implementation mechanisms in primary care: do physicians' beliefs about the effectiveness of innovation play a mediating role? Applying a realist inquiry and structural equation modeling approach in a formative evaluation study. BMC Prim Care. 2023 Jun 27;24(1):131. doi: 10.1186/s12875-023-02081-x.
PubMed 37369994Muller BS, Klaassen-Mielke R, Gonzalez-Gonzalez AI, Grandt D, Hammerschmidt R, Koberlein-Neu J, Kellermann-Muhlhoff P, Trampisch HJ, Beckmann T, Duvel L, Surmann B, Flaig B, Ihle P, Soling S, Grandt S, Dinh TS, Piotrowski A, Meyer I, Karbach U, Harder S, Perera R, Glasziou P, Pfaff H, Greiner W, Gerlach FM, Timmesfeld N, Muth C; AdAM study group. Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM). BMJ Open. 2021 Sep 28;11(9):e048191. doi: 10.1136/bmjopen-2020-048191.
PubMed 34588245Brunn R, Muller BS, Flaig B, Kellermann-Muhlhoff P, Karbach U, Soling S, Muth C, van den Akker M; AdAM Study consortium. "I must, and I can live with that": a thematic analysis of patients' perspectives on polypharmacy and a digital decision support system for GPs. BMC Fam Pract. 2021 Aug 21;22(1):168. doi: 10.1186/s12875-021-01517-6.
PubMed 34418964Soling S, Koberlein-Neu J, Muller BS, Dinh TS, Muth C, Pfaff H, Karbach U; AdAM Study Group. From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy. Implement Sci. 2020 Sep 21;15(1):82. doi: 10.1186/s13012-020-01043-6.
PubMed 32958010
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of the Application of an Electronic Medication Management Support System in Patients With Polypharmacy in General Practice (AdAM).
- ClinicalTrials.gov ID
- NCT03430336
- Acronym / sponsor ID
- AdAM / IfA
- Conditions
- Polypharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- BARMERUniversity, hospital or other
- Collaborators
- Association of Statutory Health Insurance Physicians Westphalia/Lippe, Germany, Goethe University, University of Cologne, Ruhr University of Bochum, Bielefeld University, University of Wuppertal
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses whether an electronic medication management support system improves quality, safety, and cost-effectiveness of the drug therapy in adult patients with polypharmacy compared to usual care during the observation period of 15 months from baseline per practice (from 2017 4th quarter to 2020 3rd quarter).
Detailed description
Title:
Application of an electronic medication management support system.
Objectives:
The aim of the study is to assess the effectiveness of an electronic medication management support system on hospitalization and death, its cost-effectiveness and its effects on the quality and safety of prescribing in patients with polypharmacy.
Methods:
A parallel, cluster-randomised controlled trial will be conducted in about 1,080 general practices located in the Westphalia-Region (Germany), which care for adult patients covered by BARMER health insurance. Per group, 17,200 clustered-randomized patients (about 32 patients per practice) will be included, if they take ≥ 5 long-term prescriptions (at least 2 consecutive quarters).
In the intervention group, family physicians will use an user-initiated clinical decision support system (CDSS) which provides drug-therapy relevant information (e.g. on diagnoses and treatments) and alerts in case of drug-drug, drug-disease and drug-age interactions. Based on that information, the family physician systematically assesses the appropriateness of patient's medication and optimizes it. Patients receive an updated medication plan in their mother's language, if needed.
In the control group, patients continue to receive usual care where there is no access to the CDSS.
The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions after the observation period of 12 quarters or 15 months per practice. The outcome measures will be based on secondary data (i.e. claims data). Primary and secondary outcomes will be measured at patient level. The primary analysis will be performed adhering to the intention-to-treat (ITT) principle.
Amendment (07/04/2020):
The parallel group comparison will be conducted, as planned. However, the design of the primary analysis will be changed into a cluster-randomised stepped wedge design with an open cohort, as the recruitment to the target of N=1,080 practices was not reached. The changes of the design will allow to safe the power of the trial of 80% to detect differences of the combined primary outcome between both groups. The primary outcome as well as the ITT-analysis were not changed. The changes of the design implied the following subsequent adaptations of the protocol:
- Arms and assigned interventions: The GP practices of the intervention group will continue to provide the experimental intervention as described in the experimental arm for the entire time in the trial. The GP practices of the control arm (usual care, no intervention) will switch to the experimental arm after five quarters control time and provide the experimental intervention for the remaining time in the trial.
- Case finding: The BARMER creates lists of potentially eligible patients ("Potenzialpatienten") in GP practices participating in the AdAM trial based on the fulfillment of inclusion/exclusion criteria in claims data at each quarter between the first quarter 2018 and the third quarter of 2020. Intervention practices receive the lists quarterly from the quarter after randomization and control practices quarterly starting on the date of switch.
- Informed consent:
The GPs in practices of the experimental arm (either they were randomized and assigned as intervention practices at the beginning of the trial or they switch after the end of five quarters control time) invite potentially eligible patients from the lists and ask for a written informed consent.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted medication management | Experimental | Other: CDSS provides drug-therapy relevant information, Other: Modification of medication, Other: Assessment of medication appropriateness, Other: Medication plan, Other: Guidance in medication processFamily physician adds, modifies and optimizes medication in patient's with polypharmacy assisted by an user-initiated computerized decision support system (CDSS) which provides drug-therapy relevant information about patients (e.g. diagnoses and treatments) and alerts in case of drug-drug, drug-disease, drug-age interactions to systematically assess the appropriateness of medication: * CDSS provides drug-therapy relevant information * modification of medication * assessment of medication appropriateness * medication plan * Guidance in medication process |
| Control arm | No intervention | –Patients will receive the usual clinical care based on current clinical practice guidelines during intervention period. After completion of trial, the patients in the control group will be invited to participate after written informed consent to receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age with polypharmacy (5 or more drugs taken for at least two quarters).
- Informed consent.
Key exclusion criteria (1 listed)
- Incapacitated patients without legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSS provides drug-therapy relevant informationExternal computerized decision support system (CDSS: RpDoc® eMMa Software, RpDoc® Solutions GmbH, Saarbruecken) provides drug-therapy relevant information about participating patients with polypharmacy on demand to the general practitioners (GPs) such as data about diagnoses and treatments. The information is based on claims data gathered from all health care professionals involved in the care of the patient (e.g. specialized physicians, other GPs, psychotherapists as well as data about hospital stays and prescription data from pharmacies). | Other | Computer-assisted medication management |
| Modification of medicationGPs can add and modify patient's data within the CDSS (e.g. remove drugs which are not taken by the patient anymore, add most recent laboratory findings about kidney function etc.) to enrich and update claims data based information. | Other | Computer-assisted medication management |
| Assessment of medication appropriatenessGPs systematically assess the appropriateness of the medication supported by the CDSS, which will alert in case of drug-drug, drug-disease, and drug-age interactions as well as other inappropriateness, such as prescriptions with regard to incorrect dosage or Dear Doctor letters. | Other | Computer-assisted medication management |
| Medication planGPs print out the updated medication plan including also recommendations for medication use and reasons for prescription in lay language (also available in foreign languages for patients with migration background) as well as recommendations on drugs to use / to avoid including over-the-counter drugs (OTC) (optional) and hand it out to the patient. | Other | Computer-assisted medication management |
| Guidance in medication processGPs receive guidance via the CDSS (e.g. recommendations addressing certain types of medication errors and high risk prescribing, developed by the German Society for Internal Medicine in collaboration with other scientific medical societies). | Other | Computer-assisted medication management |
Primary outcome
Combined endpoint of all-cause mortality and all-cause hospital admissions
Time frame: Observation period of 15 months per practice
The primary outcome is the combined endpoint of all-cause mortality and all-cause hospital admissions (including night- and day-only admissions) in patients with polypharmacy.
3 secondary outcomes
Number of potential inappropriate prescriptions
Time frame: Observation period of 15 months per practice
All-cause hospital admissions
Time frame: Observation period of 15 months per practice (quarterly)
All-cause mortality
Time frame: Observation period of 15 months per practice (quarterly)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 42316212Basten J, Koberlein-Neu J, Ihle P, Meyer I, Timmesfeld N; eHealth COMPATH Study Group. Patterns of CDSS adoption in primary care: a cluster analysis and predictive modelling study from a stepped wedge trial. Implement Sci. 2026 Jun 18;21(1):38. doi: 10.1186/s13012-026-01516-0.
- Derived from this study: PubMed 37884934Piotrowski A, Coenen J, Rupietta C, Basten J, Muth C, Soling S, Zimmer V, Karbach U, Kellermann-Muhlhoff P, Koberlein-Neu J; AdAM study group. Factors facilitating the implementation of a clinical decision support system in primary care practices: a fuzzy set qualitative comparative analysis. BMC Health Serv Res. 2023 Oct 26;23(1):1161. doi: 10.1186/s12913-023-10156-9.
- Derived from this study: PubMed 37845776Freund J, Piotrowski A, Buhrmann L, Oehler C, Titzler I, Netter AL, Potthoff S, Ebert DD, Finch T, Koberlein-Neu J, Etzelmuller A. Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing. Implement Sci Commun. 2023 Oct 16;4(1):126. doi: 10.1186/s43058-023-00505-4.
- Derived from this study: PubMed 37369994Soling S, Demirer I, Koberlein-Neu J, Hower KI, Muller BS, Pfaff H, Karbach U; AdAM Study Group. Complex implementation mechanisms in primary care: do physicians' beliefs about the effectiveness of innovation play a mediating role? Applying a realist inquiry and structural equation modeling approach in a formative evaluation study. BMC Prim Care. 2023 Jun 27;24(1):131. doi: 10.1186/s12875-023-02081-x.
- Derived from this study: PubMed 34588245Muller BS, Klaassen-Mielke R, Gonzalez-Gonzalez AI, Grandt D, Hammerschmidt R, Koberlein-Neu J, Kellermann-Muhlhoff P, Trampisch HJ, Beckmann T, Duvel L, Surmann B, Flaig B, Ihle P, Soling S, Grandt S, Dinh TS, Piotrowski A, Meyer I, Karbach U, Harder S, Perera R, Glasziou P, Pfaff H, Greiner W, Gerlach FM, Timmesfeld N, Muth C; AdAM study group. Effectiveness of the application of an electronic medication management support system in patients with polypharmacy in general practice: a study protocol of cluster-randomised controlled trial (AdAM). BMJ Open. 2021 Sep 28;11(9):e048191. doi: 10.1136/bmjopen-2020-048191.
- Derived from this study: PubMed 34418964Brunn R, Muller BS, Flaig B, Kellermann-Muhlhoff P, Karbach U, Soling S, Muth C, van den Akker M; AdAM Study consortium. "I must, and I can live with that": a thematic analysis of patients' perspectives on polypharmacy and a digital decision support system for GPs. BMC Fam Pract. 2021 Aug 21;22(1):168. doi: 10.1186/s12875-021-01517-6.
- Derived from this study: PubMed 32958010Soling S, Koberlein-Neu J, Muller BS, Dinh TS, Muth C, Pfaff H, Karbach U; AdAM Study Group. From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy. Implement Sci. 2020 Sep 21;15(1):82. doi: 10.1186/s13012-020-01043-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Kellermann-Mühlhoff study director
BARMER Health Insurance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS provides drug-therapy relevant information, Modification of medication and Assessment of medication appropriateness in people with Polypharmacy, run by BARMER at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of all-cause mortality and all-cause hospital admissions (time frame: Observation period of 15 months per practice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430336, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.