Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings

Not Applicable

Completed

• Conditions: Quality of Life; Myocardial Ischemia; Hemorrhage; Platelet Aggregation Inhibitors
• Interventions: Behavioral: bundle group; Behavioral: good clinical practice

• Registration Number: NCT02554006
• Lead Sponsor: University Hospital of Ferrara

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.

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:

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2016-03
• Study Completion: 2017-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

• signed written informed consent
• hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
• percutaneous coronary intervention and drug eluting stent implantation
• indication to dual antiplatelet therapy for at least 6 months

Exclusion Criteria

• oral anticoagulant therapy
• bleeding event in the 30 days before the enrolment
• planned surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bundle group	bundle group	patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
good clinical practice	good clinical practice	all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process

Primary Outcome Measures

Name	Time	Method
quality of life	1 month	quality of life assessment in each patient by EQ-5D questionnaire

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy