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Electronic Transmission of Laboratory and Adherence Records of Heart Failure Patients to General Practitioners Screen (LabAdhDoc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04326101
Recruitment Status : Completed
First Posted : March 30, 2020
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. Laboratory measure the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) to support clinical decision and to guide treatment at every stage of HF. Many patients (including HF patients) do not follow therapeutic recommendations. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices.

We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is *not* to develop a telemonitoring system.


Condition or disease Intervention/treatment
Heart Failure Other: Transmission of adherence records

Detailed Description:

Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. To support clinical decision and to guide treatment at every stage of HF, the measurement of the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) has been recommended.

Many patients (including HF patients) do not follow therapeutic recommendations. Non-adherence to treatment can lead to acute decompensation that often requires urgent hospitalisation. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. We developed Time4MedTM, a small device that records date and time of medication intake. The recorded electronic data are visualized in a scatter diagram and several adherence estimates can be calculated such as days with missed doses, taking adherence or timing adherence. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices.

We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is *not* to develop a telemonitoring system.

This is a prospective, observational, feasibility study one medical practice in Basel-Stadt, one dedicated laboratory, and one community pharmacy as study centre.

Physicians will order NT-proBNP measurement and electronic adherence monitoring to patients with diagnosis New York Heart Association (NYHA) stage II-III, who are under guidelines-recommended multiple medications and whose clinical and/or biomedical targeted values are unmet (inadequate control). Laboratory and adherence reports will be generated in similar encrypted format and transferred via secured platform into physician's EHR.

We expect to show that electronic adherence reports can be gathered and electronically transferred by pharmacists into medical EHR in the same way as laboratory reports. The joint availability of medication adherence estimates and laboratory values in the EHR can guide physicians in the management and therapy of patients with HF.

Study Design
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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)
Actual Study Start Date : August 15, 2020
Actual Primary Completion Date : September 27, 2021
Actual Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Intervention Details:
  • Other: Transmission of adherence records
    Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)

Outcome Measures
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Primary Outcome Measures :
  1. Successful transmission [ Time Frame: one month ]
    The adherence records transmitted by the pharmacy are available in the health records system of GPs


Secondary Outcome Measures :
  1. Physician satisfaction [ Time Frame: through study completion, 1 year ]
    Satisfaction of physician with the availability of adherence records in his/her health records system


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
suffers from heart failure NYHA II-III
Criteria

Inclusion Criteria:

  • is ≥ 18 years old;
  • was diagnosed with HF NYHA II-III;
  • is under multiple regimen (ACE-Inhibitors and/or mineralocorticoid receptor antagonist (MRA) and/or betablocker (BB) and/or diuretic and/or other);
  • did not reach targeted clinical and/or biomedical objectives (HF is inadequately controlled);
  • self-administers medication (no help or supervision from a third person);
  • is suspected of inappropriate intake behaviour;
  • accepts to use the monitoring device for one month;
  • accepts a home-visit from the study pharmacist one month later;
  • signs the informed consent form.

Exclusion Criteria:

- Patients who are, in the opinion of the physician, unlikely to comply with the study schedule or are unsuitable for any other reason

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326101


Locations
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Switzerland
Praxis Hammer
Basel, Switzerland, 4057
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Kurt E Hersberger, Prof University of Basel
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04326101    
Other Study ID Numbers: 2019-01248
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases