This project has results

Does Information on Benefits and Risks Help Patients Decide Between Stent Options?

Results Summary and Professional Abstract

Results Summary

Download Summary Español (pdf) Audio Recording (mp3)

What was the research about?

Narrow or blocked blood vessels in the heart can cause chest pain, shortness of breath, or a heart attack. Stents are small mesh tubes placed inside a narrow or blocked blood vessel to keep blood flow to the heart open. There are two types of stents. Bare-metal stents help keep blood vessels open. Drug-eluting stents also have a special drug coating to help reduce the chance of the blood vessel becoming blocked again. However, patients who use drug-eluting stents also need to take a pill that increases the risk of bleeding and bruising. Patients don’t often talk with their doctors about which stent to use.

The research team wanted to learn if patients who reviewed information about their personal benefits and risks would be more likely to discuss stent options with their doctors. The team compared different ways to encourage patients and doctors to make decisions about stents together:

Patients reviewed information about their personal benefits and risks of both types of stents and received coaching from a nurse, called a decision coach
Patients reviewed information about their personal benefits and risks of both types of stents without a decision coach
Patients received usual care, which was a personalized consent form without educational materials about stent trade-offs

What were the results?

Compared with patients who received usual care, patients who had a decision coach were more likely to

Discuss stent options with their doctor
Know more about stents
Say which stent they wanted

The team found no differences between patients who reviewed benefits and risk information without a decision coach and those who received usual care.

In all three groups, patients who said they wanted drug-eluting stents received them 98 percent of the time. Patients in all three groups who said they wanted bare-metal stents received these stents 53 percent of the time.

Who was in the study?

The study included 331 patients from two hospitals in Kansas City, Missouri. Of these patients, 80 percent were white and 20 percent were African American. The average age was 67, and 64 percent of patients were male.

What did the research team do?

While patients were getting ready for their stent procedure, the research team assigned them to one of three groups. Two groups received information about their personal benefits and risks with the two kinds of stents. Only one of these groups received coaching from a trained nurse. The third group received usual care.

The research team interviewed all patients before and after their procedures. The team asked patients about the benefits and risks of each stent, whether patients told their doctors which stent they wanted, and how the talk with the doctor or nurse went.

Patients, clinicians, and a health insurance representative gave the research team feedback throughout the study.

What were the limits of the study?

Patients who reviewed the benefit and risk information may not have had enough time before their procedures to reflect on the information and fully take part in deciding which stent they wanted. Giving the information to patients earlier may have changed the results. Hospital nurses often didn’t have enough time to provide coaching and nurses from the research team had to fill in at one of the hospitals.

Future research could explore ways to give the information to patients earlier or look into why patients who said they wanted bare-metal stents didn’t always receive these stents.

How can people use the results?

Hospitals that do stent procedures could consider offering patients information about their benefits and risks with decision coaching, to help patients participate in decisions about which type of stent to get.

Professional Abstract

Objective

To test the effectiveness of a shared decision making aid, with and without decision coaching, for patients undergoing percutaneous coronary intervention (PCI) who have the choice of receiving drug-eluting or bare-metal stents

Study Design

Design Elements	Description
Design	Pre versus post-intervention comparison
Population	331 patients undergoing PCI
Interventions/ Comparators	Shared decision making aid with decision coaching Shared decision making aid alone Personalized consent form without shared decision making aid (usual care)
Outcomes	Primary: participation in stent choice discussion Secondary: stent knowledge, patient preference for stent type, participation in decision making, concordance of patient stent preference with type of stent received
Timeframe	Immediate post-procedure follow-up for primary outcome

In shared decision making, patients are active partners in deciding their treatment with their clinicians. In this study, researchers developed a shared decision making aid for patients undergoing PCI using feedback from patient focus groups and clinician interviews. The aid used clinical information to create a personalized comparison of the benefits of avoiding a repeat procedure PCI procedure and drawbacks of drug-eluting stents and bare-metal stents.

Researchers compared outcomes in patients who received the decision aid with and without coaching with outcomes in patients who received usual care. The first group reviewed the shared decision making aid with coaching from a trained nurse, who talked about the displayed risks and benefits of the two types of stents and encouraged patients to discuss their preferences with their doctor before the procedure. The second group reviewed the decision aid without any coaching before choosing a stent type. The third group received usual care, which was a personalized consent form without the shared decision making aid. Researchers interviewed all patients on the study outcomes before and after the procedure.

The study included 331 patients scheduled to receive PCI at two hospitals in Kansas City, Missouri. Of these patients, 80% were white and 20% were African American. The average patient age was 67, and 64% of patients were male. The three groups did not differ significantly in demographics.

Patients, clinicians, and a payer were part of the study’s steering committee and provided feedback throughout all phases of the research.

Results

Compared with patients who received usual care, those who reviewed the shared decision making aid with coaching from a nurse

Were more likely to discuss stent options with nurses (p<0.001) or doctors (p<0.001)
Had higher stent knowledge scores (p<0.001)
Were more likely to state a stent preference (p<0.001)
Were more likely to participate in shared decision making (p<0.001)

The study found no differences between patients who reviewed the shared decision making aid without coaching and those who received usual care.

In this study, patients who preferred to receive drug-eluting stents received them 98% of the time, while patients who preferred bare-metal stents received these stents 53% of the time. Use of the shared decision making aid with or without coaching did not affect this finding.

Limitations

Because patients reviewed the shared decision making aid right before their stent procedure, they may not have had enough time to reflect on the information and fully engage in shared decision making. Hospital nursing staff were often unavailable to provide decision coaching, and nurses from the research team had to fill in, suggesting that decision coaching may not be sustainable without hospitals investing in decision coaches.

Conclusions and Relevance

Findings suggest that the shared decision making aid was only effective at encouraging discussions and increasing patient knowledge of stent options when paired with decision coaching. The inconsistency of concordance between patients’ stent preference and the type of stent they received suggests that clinicians may not always place a high priority on patients’ preferences in stents.

Future Research Needs

Future research could explore strategies to deliver the shared decision making aid to patients earlier and investigate why patients who preferred bare-metal stents did not always receive these stents.

Final Research Report

View this project's final research report.

Journal Articles

Circulation: Cardiovascular Quality and Outcomes

Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design

Catheterization and Cardiovascular Interventions

Beyond restenosis: Patients' preference for drug eluting or bare metal stents

Catheterization and Cardiovascular Interventions

Predicting long-term bleeding after percutaneous coronary intervention

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

Explaining that the study was conducted in three phases, so time was the variable that determined which patients were exposed to the shared decision-making tool and coaching interventions.
Clarifying that the primary outcome of the study was the impact of the studied tool on patient-physician shared decision making about stent selection in percutaneous coronary intervention. The researchers explained that the analysis of stent choice concordance with the patient’s stent preference was a secondary outcome, and therefore the results of these analyses were described in less detail.
Revising the results to explain that clinician interviews were conducted after implementation of the shared decision-making tool, and why these interviews were only conducted at one site. The researchers also acknowledged in their Limitations section that more physician follow-up interviews about stent selection and use of the shared decision-making tool would have been useful to help understand the study results.
Discussing in the Limitations section the lack of available nurse decision coaches and physician engagement, and how these may have affected the study outcomes. Although better physician engagement might have led to positive larger effect of the decision aids, the researchers noted in their response to reviewers that better engagement would not be a realistic expectation in most cardiology practices.
Responding to reviewer concerns about problems with intervention implementation and uptake at the clinical sites by noting that these problems were part of the real-world experience of working in these clinical settings and would need to be overcome for improved implementation of a shared decision-making tool.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

John Spertus, MD, MPH

Project Status

Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted

Project Title

Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in PCI

Board Approval Date

September 2013

Project End Date

May 2018

Organization

University of Missouri Kansas City

Year Awarded

2013

State

Missouri

Year Completed

2018

Project Type

Research Project

Health Conditions

Cardiovascular Diseases

Coronary or Ischemic Heart Disease

Intervention Strategies

Behavioral Interventions
Other Clinical Interventions
Other Health Services Interventions
Shared Decision Making
Technology Interventions
Training and Education Interventions

Populations

Racial/Ethnic Minorities
Low Income
Women

Funding Announcement

Assessment of Prevention, Diagnosis, and Treatment Options

Project Budget

$1,732,240

DOI - Digital Object Identifier

10.25302/5.2019.CE.13046448

Study Registration Information

HSRP20143512

NCT02046902

Page Last Updated:

February 20, 2020