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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Quality of Life; Hemorrhage; Platelet Aggregation Inhibitors
• Intervention / Treatment: Behavioral: good clinical practice; Behavioral: bundle group

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 Type: Interventional
• Enrollment (Actual): 448
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: standard of care
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: counseling regarding dual antiplatelet therapy management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	quality of life assessment in each patient by EQ-5D questionnaire	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergency room admission	number of access to emergency room service for bleeding	1 month
general practitioner visit	number of access to general practitioner for bleeding	1 month
dyspnea occurrence	number of patients suffering dyspnoea stratified according P2Y12 inhibitors	1 month
bleeding academic research consortium (BARC) 2-3	occurrence of BARC 2-3 complications	1 month
bleeding academic research consortium (BARC) 1	occurrence of BARC 1 complications	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ischemic adverse events	cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke	1 year
all-cause mortality	occurrence of all-cause death	1 year
BARC 1-3	occurrence of BARC1-3 complications	1 year

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Publications and helpful links

General Publications

• 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 patients on dual antiplatelet therapy: A randomized controlled trial. PLoS One. 2017 Aug 23;12(8):e0182124. doi: 10.1371/journal.pone.0182124. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia; Hemorrhage
• Other Study ID Numbers: 150595