NCT03430336

Brief 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 quarter).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

February 6, 2018

Last Update Submit

July 20, 2021

Conditions

Polypharmacy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Observation period of 15 months per practice

Secondary Outcomes (3)

  • Number of potential inappropriate prescriptions

    Observation period of 15 months per practice

  • All-cause hospital admissions

    Observation period of 15 months per practice (quarterly)

  • All-cause mortality

    Observation period of 15 months per practice (quarterly)

Other Outcomes (1)

  • Cost Effectiveness

    Observation period of 15 months per practice

Study Arms (2)

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

Other: CDSS provides drug-therapy relevant informationOther: Modification of medicationOther: Assessment of medication appropriatenessOther: Medication planOther: 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.

Interventions

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).

Computer-assisted medication management
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.

Computer-assisted medication management
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.

Computer-assisted medication management
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.

Computer-assisted medication management
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).

Computer-assisted medication management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years of age with polypharmacy (5 or more drugs taken for at least two quarters).
  • Informed consent.

You may not qualify if:

  • Incapacitated patients without legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Association of Statutory Health Insurance Physicians Westphalia/Lippe

Dortmund, Germany

Location

BARMER Health Insurance

Wuppertal, Germany

Location

Related Publications (6)

  • Piotrowski 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.

    PMID: 37884934DERIVED

  • Freund 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.

    PMID: 37845776DERIVED

  • Soling 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.

    PMID: 37369994DERIVED

  • Muller 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.

    PMID: 34588245DERIVED

  • Brunn 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.

    PMID: 34418964DERIVED

  • Soling 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.

    PMID: 32958010DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Petra Kellermann-Mühlhoff

    BARMER Health Insurance

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the character of the intervention, blinding is not possible.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 12, 2018

Study Start

February 9, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)