"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design

ConditionsBreathlessness Cardiovascular Pulmonary Mental Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorGeneral Practitioners Research Institute

About this trial

This prospective stepped-wedge study evaluates whether use of the Breathlessness diagnostics in a Box (BiaB) tool shortens the time to diagnosis in patients presenting with breathlessness, compared with usual care. The study is conducted in general practice settings in the Netherlands, Spain, and Portugal. Participating sites start with a usual care period and transition sequentially to the BiaB intervention period. Data are collected during routine clinical visits, from electronic medical records, and through questionnaires completed by patients and healthcare professionals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patient must be at least 18 years old at the time of signing the informed consent.

Patients that present with undiagnosed dyspnea (breathlessness); or Patients who have existing diseases that could cause breathlessness, but have residual or increasing breathlessness that could be caused by other not yet detected diseases. Or HCP has doubts or requires additional tests to confirm diagnosis or to suspect new, parallel, diagnoses. For example, breathlessness in patients assessed within the framework of Cardiovascular Risk Management or for COPD monitoring

Acute worsening of previous diagnosed chronic disease where there is no suspicion of comorbidities (for example when a patient with clear COPD diagnosis has an exacerbation where typically the HCP will not perform additional tests).

Inability to understand and sign the written consent form.

Trial design

Design model

Sequential

Treatments tested in this trial

Breathlessness diagnostics in a Box (BiaB)
Diagnostic test
The Breathlessness diagnostics in a Box (BiaB) is a diagnostic support tool used in general practice to assist healthcare professionals in the assessment of patients presenting with breathlessness as part of routine clinical care.

Treatment groups

900 Participants

are divided into 2 treatment groups

Group A: Usual careNo intervention 0 interventions

Group B: BiaB InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Time to diagnosis of the cause of breathlessness

Number of days between the first presentation or consultation for breathlessness and the date of diagnosis of the underlying cause of breathlessness, comparing periods of usual care and periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.

Time frame

From first presentation or consultation for breathlessness up to the date of diagnosis, assessed during the study period (up to 40 weeks per site).

Secondary outcomes

Number of new diagnoses of COPD and cardiovascular disease

Number of newly diagnosed cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) identified during periods of usual care compared with periods with use of the Breathlessness diagnostics in a Box (BiaB) intervention.

Time frame

Assessed during the study period (up to 40 weeks per site).

Usability and efficiency of the BiaB tool

Usability and efficiency of the Breathlessness diagnostics in a Box (BiaB) tool as assessed by questionnaires completed by healthcare professionals and patients during the intervention period.

Time frame

During the intervention period, with follow-up questionnaires completed up to 12 months after the index visit.