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  • A Personalized Decision Aid to Help W...

This project has results

A Personalized Decision Aid to Help Women with Lupus Nephritis from Racially and Ethnically Diverse Backgrounds Make Decisions about Taking Immune-Blocking Medicines

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Results Summary and Professional Abstract

Results Summary
Download Summary Español (pdf) Audio Recording (mp3)

Results Summary

What was the research about?

Lupus is an illness in which the immune system attacks parts of the body. Lupus can cause a kidney disease called lupus nephritis, a swelling of the kidneys. Lupus nephritis is more common and more severe in minority groups than in other people. Medicines that weaken the immune system’s action, called immune-blocking medicines, are used to treat lupus nephritis. There are many types of immune-blocking medicines. The medicines differ in how well they work, their side effects, and their costs. It can be hard for people with lupus nephritis to choose which medicine to use.

In this study, the research team made an online decision aid for women with lupus nephritis. Decision aids help people use what is most important to them when choosing between two or more treatments. The decision aid shared information about the benefits and side effects of immune-blocking medicines. The research team tailored the information in the decision aid to women’s personal situations, such as their ethnic group and current treatments. The decision aid was available in English and Spanish.

The research team compared use of the decision aid with use of a pamphlet on lupus nephritis. The team wanted to see which was more helpful to patients in making treatment decisions. The team looked at how well the decision aid worked for women of different races and ethnic groups.

What were the results?

Compared with women who read the pamphlet, women who used the decision aid felt less doubt about their medicine choices. This was true for African-American and white women who used the decision aid, but not for Hispanic women.

Women in most races and ethnic groups who used the decision aid didn’t feel more informed than women in those groups who read the pamphlet. The only group of women who felt more informed when they used the decision aid was non-Hispanic white women.

Whether women read the pamphlet or used the decision aid didn’t change how they talked with their doctors. Women who used the decision aid and women who read the pamphlet also had similar feelings of control over making decisions.

Compared with women who used the pamphlet, more women who used the decision aid said that the information source was easy to use. They also rated the information about lupus nephritis and medicines as excellent.

Who was in the study?

The study included 301 women with lupus nephritis. All women in the study were thinking about starting or changing an immune-blocking medicine.

The women were patients at four hospitals across the United States. Of the women, 47 percent were African American, 26 percent were Hispanic, 15 percent were white, 7 percent were Asian, and 5 percent were other races or ethnicities.

What did the research team do?

The research team assigned women to one of two groups by chance. One group received the decision aid. The other group received the pamphlet. Before reading the pamphlet or using the decision aid, the women took a survey. The survey asked the women about feeling doubt and feeling informed when choosing a medicine. The women then took the same survey after they had read the pamphlet or used the decision aid. The second survey also asked how they felt talking with their doctor.

The research team worked with patients with lupus nephritis to design the study and the decision aid.

What were the limits of the study?

There were not enough Asian women in the study to see how the decision aid worked for them. Because lupus is more common in women, the research team didn’t include male patients in the study. The research team surveyed patients shortly after they read the pamphlet or used the decision aid. Patients might feel differently at a later time.

How can people use the results?

Doctors’ offices may want to use the decision aid for women with lupus nephritis who are making a decision about immune-blocking medicines. The decision aid may help patients feel more confident in their treatment choices.

Professional Abstract

Professional Abstract

Objective

To determine the comparative effectiveness of a computerized decision aid versus a usual-care information pamphlet in helping women from racially and ethnically diverse backgrounds reduce decisional conflict and make informed choices about immunosuppressive medications for lupus nephritis

Study Design

Design Elements Description
Design Randomized controlled trial
Population 301 women with lupus nephritis
Interventions/
Comparators
  • Individualized, computerized decision aid tailored to patient literacy and numeracy level, ethnicity, health status, and treatment choice
  • Information pamphlet from the American College of Rheumatology
Outcomes

Primary: decisional conflict, informed choice

Secondary: patient-physician communication, patient control over decision making, acceptability and feasibility of the decision aid, patient-centered communication

Timeframe Immediate follow-up for primary outcomes

This multicenter, two-arm, randomized controlled trial assessed a culturally tailored, individualized, computerized decision aid that was available in both English and Spanish. The study tested whether the decision aid improved decision making about taking immunosuppressive drugs among women with lupus nephritis when compared with a lupus information pamphlet from the American College of Rheumatology.

The research team used information from focus groups with patients to tailor the decision aid to ethnicity, health status, and treatment choice. The team worked with patients, advocates, and clinicians to design the study, develop and pilot test the decision aid, refine enrollment criteria, and help recruit study participants.

Patients completed baseline assessments of decisional conflict and informed choice. Questionnaires that patients completed immediately after receiving their assigned interventions measured all primary and secondary outcomes.

Study participants included 301 adult women with lupus nephritis who were considering a change in, or initiation of, immunosuppressive medication. The women were patients at four teaching hospitals across the United States. Of the participants, 47% were African American, 26% were Hispanic, 15% were white, 7% were Asian, and 5% were from other races or ethnicities.

Results

Decisional conflict. Compared with women who read the pamphlet, women who used the decision aid had lower decisional conflict (p=0.005). Reduction in decisional conflict was greater in African-American and white women, but not in Hispanic women (p<0.001, p=0.002, and p=0.07, respectively). The proportion of women whose decisional conflict remained unresolved postintervention was significantly lower among patients who used the decision aid compared with patients who read the pamphlet (p<0.001).

Informed choice. There was no significant difference in informed choice between women who used the decision aid and women who read the pamphlet (p=0.08).

Acceptability and feasibility. Compared with women who read the pamphlet, more women who used the decision aid said the intervention was easy to use (p=0.006). Women who used the decision aid rated its information about the condition, risk factors, medication options, evidence about medications, and studies about other patients as excellent (p≤0.006).

Other secondary outcomes. There were no significant differences between the two groups in patient-physician communication, patient-centered communication, or patient control over decision making, with high rates in both groups.

Limitations

The sample size for Asian women was too small to determine statistical differences in outcomes. Because lupus occurs predominantly in women, this study excluded male patients. The research team assessed outcomes immediately after patients received the intervention. Changes in decisional conflict and informed choice may not persist over weeks or months.

Conclusions and Relevance

The decision aid reduced decisional conflict about immunosuppressive drug decision making among women with lupus nephritis, particularly among African-American and white women. Compared with the pamphlet, the decision aid was easier to use.

Future Research Needs

Future research could look at the effect of the decision aid on outcomes following treatment decisions, such as medication adherence, quality of life, and satisfaction with medication choice.

Final Research Report

View this project's final research report.

Related PCORI Dissemination and Implementation Project

Implementing an Individualized Lupus Nephritis Patient Decision-Aid for Immunosuppressive Drugs

Journal Articles

Article Highlight: Lupus, an illness in which the immune system attacks parts of the body, can cause a kidney disease called lupus nephritis, a swelling of the kidneys. Treatment with immune system-blocking medicines can be effective, but patients must weigh potential benefits and risks with their personal preferences. Researchers in this study developed and tested a decision aid to help these patients. As they report in PLOS Medicine, compared with those who received a standard informational pamphlet, women who used the decision aid felt more confident about their treatment choices.

Results of This Project

PLOS Medicine

Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial

The Journal of Rheumatology

Treatments for Lupus Nephritis: A Systematic Review and Network Metaanalysis

Systematic Reviews

Comparative effectiveness of immunosuppressive drugs and corticosteroids for lupus nephritis: a systematic review and network meta-analysis

BMC Medicine

Risk of serious infections with immunosuppressive drugs and glucocorticoids for lupus nephritis: a systematic review and network meta-analysis

Related Articles

BMC Musculoskeletal Disorders

Individualized patient decision-aid for immunosuppressive drugs in women with lupus nephritis: study protocol of a randomized, controlled trial

Arthritis Care & Research

Mapping Perceptions of Lupus Medication Decision-Making Facilitators: The Importance of Patient Context

Arthritis Research & Therapy

Minorities with lupus nephritis and medications: a study of facilitators to medication decision-making

The Journal of Rheumatology

Barriers to Medication Decision Making in Women with Lupus Nephritis: A Formative Study using Nominal Group Technique

More on this Project  

Blogs

Informing Patients with a Rare Disease About Their Treatment Options
Around half of all patients with the autoimmune disease lupus develop kidney disease. Because lupus is more common and more severe in minority patients, this PCORI-funded study developed a decision aid to help African-American and Hispanic patients with lupus kidney disease make informed decisions about treatments.

Videos

Improving Discussions on Treatment Options for Lupus Nephritis
Study Principal Investigator Jasvinder Singh, MD, MPH, speaks about the decision aid that he developed to help African-American and Hispanic patients have quality discussions with their clinicians regarding treatment options for lupus nephritis, a rare disease that affects young women. His team is now working to expand the decision aid’s use in clinical practice with a PCORI dissemination and implementation award.

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, Singh made changes including

  • Adding more description of the laptop-based intervention tool
  • Providing support for the statement that the tool was culturally sensitive
  • Revising statements so that the results that were not statistically significant were interpreted accurately
  • Providing more detail on why men were excluded, whether incident cases were included, and on the network meta-analysis, in order to better adhere to the PCORI Methodology Standards

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator
Jasvinder Singh, MBBS, MPH
Project Status
Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted
Project Title
Individualized Patient Decision Making for Treatment Choices among Minorities with Lupus
Board Approval Date
September 2013
Project End Date
April 2018
Organization
University of Alabama at Birmingham
Year Awarded
2013
State
Alabama
Year Completed
2018
Project Type
Research Project
Health Conditions  
Allergies and Immune Disorders
Lupus
Rare Diseases
Intervention Strategies
Drug Interventions
Other Health Services Interventions
Technology Interventions
Populations
Individuals with Multiple Chronic/co-morbid Conditions
Individuals with Rare Disease
Low Health Literacy/Numeracy
Low Income
Racial/Ethnic Minorities
Women
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Project Budget
$1,513,089
DOI - Digital Object Identifier
10.25302/10.2019.CE.13046631
Study Registration Information
HSRP20143522
NCT02319525
Page Last Updated: 
May 14, 2020

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