BATMAN: Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
Study Details
Study Description
Brief Summary
A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.
The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.
All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.
All patients randomized to the bundle group will receive:
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a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
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a 15-min visit by a member of the research team with a family member living near/with the patient. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
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brochure describing advantages, side effects and management of dual antiplatelet therapy. Contemporaneously, the investigators of the study will contact directly by phone and/or mail the general practionnaire of the patient to describe and explain the same topics and the clinical problem of her patient.
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availability of phone number to discuss potential side effects of DAPT. In addition, the study coordinator of the study will contact two times by month the patient by phone to assess DAPT compliance and potential BARC 1 bleedings.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: good clinical practice all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process |
Behavioral: good clinical practice
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
Other Names:
|
| Experimental: bundle group patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling) |
Behavioral: bundle group
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
Other Names:
|
Outcome Measures
Primary Outcome Measures
- quality of life [1 month]
quality of life assessment in each patient by EQ-5D questionnaire
Secondary Outcome Measures
- emergency room admission [1 month]
number of access to emergency room service for bleeding
- general practitioner visit [1 month]
number of access to general practitioner for bleeding
- dyspnea occurrence [1 month]
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
- bleeding academic research consortium (BARC) 2-3 [1 month]
occurrence of BARC 2-3 complications
- bleeding academic research consortium (BARC) 1 [1 month]
occurrence of BARC 1 complications
Other Outcome Measures
- ischemic adverse events [1 year]
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
- all-cause mortality [1 year]
occurrence of all-cause death
- BARC 1-3 [1 year]
occurrence of BARC1-3 complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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signed written informed consent
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hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
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percutaneous coronary intervention and drug eluting stent implantation
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indication to dual antiplatelet therapy for at least 6 months
Exclusion Criteria:
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oral anticoagulant therapy
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bleeding event in the 30 days before the enrolment
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planned surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Ferrara | Cona | Ferrara | Italy | 44124 |
Sponsors and Collaborators
- University Hospital of Ferrara
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 150595