NCT02272062

Brief Summary

Selection of a treatment strategy for patients with symptoms due to coronary artery disease requires consideration of patient preferences. In current clinical practice, patient preferences for treatment may not be known prior to diagnostic coronary angiography. The investigators will test an internet-based shared decision-making tool which will provide education and solicit preference information prior to angiography. The investigators seek to determine if this tool can accurately assess patient preferences, and if these preferences will lead to a change in clinical management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

October 20, 2014

Last Update Submit

August 2, 2016

Conditions

Coronary Artery DiseaseAngina Pectoris

Keywords

Coronary artery diseaseAnginaShared decision-makingPatient preferencesPercutaneous coronary interventionCoronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

  • Concordance of patient preference with delivered treatment

    Among patients with significant coronary artery disease on diagnostic angiography, the percentage of subjects with delivered therapy (medical management, percutaneous coronary intervention, coronary artery bypass graft) identical to preferences expressed prior to angiography.

    3 months

Secondary Outcomes (8)

  • Knowledge

    Within 2 hours of angiography

  • Knowledge

    3 months

  • Decisional conflict

    Within 2 hours of angiography

  • Patient satisfaction

    Within 2 hours of angiography

  • Patient satisfaction

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Preferences Not Provided

NO INTERVENTION

Subjects will complete a shared decision-making tool and express preferences regarding treatment for coronary artery disease, but these preferences will NOT be shared with the treating clinicians.

Preferences Provided

EXPERIMENTAL

Subjects will complete a shared decision-making tool and express preferences regarding treatment for coronary artery disease, and these preferences WILL be shared with the treating clinicians.

Other: Decision-making tool for coronary artery disease treatment

Interventions

Decision-making tool for coronary artery disease treatmentOTHER

A brief internet-based tool will provide education about coronary artery disease and assess patient preferences regarding treatment options (medical management, percutaneous coronary intervention, or coronary artery bypass graft). This information will be provided to the treating interventional cardiologist at the time of coronary angiography in the treatment group.

Preferences Provided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to the catheterization laboratory for diagnostic coronary angiography with a reasonable expectation of coronary artery disease, defined as chronic stable angina, chest pain with a positive functional study, unstable angina, or non-ST segment elevation myocardial infarction.

You may not qualify if:

  • Unable to provide informed consent
  • Unable to speak or read English
  • Critical illness
  • When a delay in angiography to administer the decision aid could lead to adverse clinical outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Doll JA, Jones WS, Lokhnygina Y, Culpepper S, Parks RL, Calhoun C, Au DH, Patel MR. PREPARED Study: A Study of Shared Decision-Making for Coronary Artery Disease. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005244. doi: 10.1161/CIRCOUTCOMES.118.005244.

    PMID: 30764651DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina PectorisPatient Preference

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Manesh Patel

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

US(1)