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

Quality of Life Clinical Trial

— BATMAN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554006
• Other study ID #: 150595
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2018
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hemorrhage
• Ischemia
• Myocardial Ischemia
• Platelet Aggregation Inhibitors
• Quality of Life

Intervention

Behavioral:
• good clinical practice
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
• bundle group
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Biscaglia S, Tonet E, Pavasini R, Serenelli M, Bugani G, Cimaglia P, Gallo F, Spitaleri G, Del Franco A, Aquila G, Vieceli Dalla Sega F, Tebaldi M, Tumscitz C, Ferrari R, Campo G. A counseling program on nuisance bleeding improves quality of life in patie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ischemic adverse events	cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke	1 year
Other	all-cause mortality	occurrence of all-cause death	1 year
Other	BARC 1-3	occurrence of BARC1-3 complications	1 year
Primary	quality of life	quality of life assessment in each patient by EQ-5D questionnaire	1 month
Secondary	emergency room admission	number of access to emergency room service for bleeding	1 month
Secondary	general practitioner visit	number of access to general practitioner for bleeding	1 month
Secondary	dyspnea occurrence	number of patients suffering dyspnoea stratified according P2Y12 inhibitors	1 month
Secondary	bleeding academic research consortium (BARC) 2-3	occurrence of BARC 2-3 complications	1 month
Secondary	bleeding academic research consortium (BARC) 1	occurrence of BARC 1 complications	1 month