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

Heart Failure Clinical Trial

— LabAdhDoc  

Official title:

Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326101
• Other study ID #: 2019-01248
• Status: Completed
• Start date: August 15, 2020
• Est. completion date: September 27, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Transmission of adherence records
Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)

Locations

Country	Name	City	State
Switzerland	Praxis Hammer	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful transmission	The adherence records transmitted by the pharmacy are available in the health records system of GPs	one month
Secondary	Physician satisfaction	Satisfaction of physician with the availability of adherence records in his/her health records system	through study completion, 1 year