Heart Diseases
Conditions
Keywords
coronary artery disease, cardiac stent, PCI procedure, Patient preference
Brief summary
The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.
Detailed description
Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups. Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making. Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted. Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
University of Missouri, Kansas City
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* \>18 years old * English or Spanish speaking * Presence of coronary disease, or a caregiver/relative of one with coronary disease
Exclusion criteria
* non-English or non-Spanish speaking * dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | 30 months | The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than doctor alone in response to the question Who chose the type of stent? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | 30 months | Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than I don't care or I don't know in response to the question After reviewing the risks and benefits of both types of stents, which type of stent did you want? |
Countries
United States
Participant flow
Recruitment details
Between May 2014 and December 2016, patients were recruited from 2 percutaneous coronary intervention (PCI) centers, Saint Luke's Mid America Heart Institute (MAHI) and Truman Medical Center (TMC), following institutional review board (IRB) approval at each site.
Participants by arm
| Arm | Count |
|---|---|
| Pre-Implementation Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching. | 336 |
| Post-implementation With Decision Coaching Patients received the consent form, the SDM tool for stent selection, and decision coaching | 113 |
| Post-implementation Without Decision Coaching patients received the consent form and the SDM tool, but no decision coaching | 137 |
| Total | 586 |
Baseline characteristics
| Characteristic | Pre-Implementation | Total | Post-implementation Without Decision Coaching | Post-implementation With Decision Coaching |
|---|---|---|---|---|
| Admission Status Emergent | 21 Participants | 22 Participants | 1 Participants | 0 Participants |
| Admission Status Inpatient | 116 Participants | 217 Participants | 57 Participants | 44 Participants |
| Admission Status Outpatient | 189 Participants | 327 Participants | 71 Participants | 67 Participants |
| Age, Continuous | 66.1 years STANDARD_DEVIATION 11.8 | 67.43 years STANDARD_DEVIATION 12.1 | 68.6 years STANDARD_DEVIATION 11.6 | 67.6 years STANDARD_DEVIATION 12.9 |
| Diabetes | 152 Participants | 270 Participants | 69 Participants | 49 Participants |
| Hypertension | 266 Participants | 464 Participants | 106 Participants | 92 Participants |
| Peripheral arterial disease | 29 Participants | 71 Participants | 20 Participants | 22 Participants |
| Prior Coronary Artery Bypass Graft | 53 Participants | 101 Participants | 28 Participants | 20 Participants |
| Prior Percutaneous Coronary Intervention | 137 Participants | 253 Participants | 66 Participants | 50 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity | 5 Participants | 10 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 116 Participants | 18 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 250 Participants | 457 Participants | 116 Participants | 91 Participants |
| Sex: Female, Male Female | 93 Participants | 181 Participants | 49 Participants | 39 Participants |
| Sex: Female, Male Male | 166 Participants | 325 Participants | 88 Participants | 71 Participants |
| Site Mid America Heart Insitute | 191 Participants | 409 Participants | 132 Participants | 86 Participants |
| Site Truman Medical Center/Univ. of Missouri KC | 145 Participants | 177 Participants | 5 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching
The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than doctor alone in response to the question Who chose the type of stent?
Time frame: 30 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-Implementation | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly you | 2 Participants |
| Pre-Implementation | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor and you equally | 40 Participants |
| Pre-Implementation | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor Alone | 235 Participants |
| Pre-Implementation | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly Doctor | 51 Participants |
| Pre-Implementation | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | You alone | 8 Participants |
| Post-implementation With Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor and you equally | 32 Participants |
| Post-implementation With Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor Alone | 45 Participants |
| Post-implementation With Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly Doctor | 19 Participants |
| Post-implementation With Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly you | 11 Participants |
| Post-implementation With Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | You alone | 6 Participants |
| Post-implementation Without Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | You alone | 1 Participants |
| Post-implementation Without Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly you | 6 Participants |
| Post-implementation Without Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor Alone | 106 Participants |
| Post-implementation Without Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Doctor and you equally | 4 Participants |
| Post-implementation Without Decision Coaching | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | Mostly Doctor | 20 Participants |
Secondary
Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.
Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than I don't care or I don't know in response to the question After reviewing the risks and benefits of both types of stents, which type of stent did you want?
Time frame: 30 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pre-Implementation | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Drug eluting stent | 83 Participants |
| Pre-Implementation | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Bare metal stent | 36 Participants |
| Pre-Implementation | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't care | 119 Participants |
| Pre-Implementation | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't know | 98 Participants |
| Post-implementation With Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't know | 6 Participants |
| Post-implementation With Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Drug eluting stent | 49 Participants |
| Post-implementation With Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't care | 29 Participants |
| Post-implementation With Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Bare metal stent | 29 Participants |
| Post-implementation Without Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't know | 43 Participants |
| Post-implementation Without Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Bare metal stent | 2 Participants |
| Post-implementation Without Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | I don't care | 69 Participants |
| Post-implementation Without Decision Coaching | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Drug eluting stent | 23 Participants |