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

NCT ID: NCT02554006

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

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.

Conditions

Myocardial Ischemia; Hemorrhage; Quality of Life; Platelet Aggregation Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

good clinical practice

all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process

Group Type: OTHER

good clinical practice

Intervention Type: BEHAVIORAL

education from physician regarding dual antiplatelet therapy as part of the routine discharge process

bundle group

patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)

Group Type: EXPERIMENTAL

bundle group

Intervention Type: BEHAVIORAL

visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Interventions

good clinical practice

education from physician regarding dual antiplatelet therapy as part of the routine discharge process

Intervention Type: BEHAVIORAL

bundle group

visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Intervention Type: BEHAVIORAL

Other Intervention Names

standard of care; counseling regarding dual antiplatelet therapy management

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

interventional cardiologist and assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Ferrara

Cona, Ferrara, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 28832589 (View on PubMed)

Other Identifiers

150595

Identifier Type: -

Identifier Source: org_study_id