Quality of Life Clinical Trial
Official title:
Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
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.
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:
i) 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.
ii) 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.
iii) 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.
iv) 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.
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