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Implementation of Decision Aid for Lupus in practice settings for shared decision making (SDM): IDEAL Study
Investigator (PI): Singh, Jasvinder
Performing Organization (PO): (Current): University of Alabama at Birmingham, School of Medicine, Department of Medicine, Division of Clinical Immunology and Rheumatology / (205) 934-0897
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/SDM-2017C2-8224
Funding: Total Award Amount: $2,739,953
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: What research finding is this project disseminating? The project team is proposing to put into practice a shared decision making (SDM) strategy (a decision making process jointly shared by patients and their health care providers) using an individualized, culturally appropriate, computerized decision aid (DA, a tool to help each person make individual treatment decisions) for systemic lupus erythematosus (SLE). In a Patient-Centered Outcomes Research Institute (PCORI)-funded and recently completed multicenter randomized trial, 301 high-risk adult women with lupus kidney disease, including racial/ethnic minorities with low socioeconomic status, either received the lupus DA or the American College of Rheumatology (ACR) lupus paper pamphlet with information on treatments. Compared to the ACR paper pamphlet group, people who used the lupus DA had a much greater decrease in decisional conflict (uncertainty in choosing options) for immunosuppressive drugs and were much more likely to choose the treatment option most consistent with their values, having viewed information that mattered the most for the treatment decision (two primary patient-centered outcomes). Compared to the pamphlet group, more patients rated the information in the lupus DA to be excellent for understanding the impact of lupus (49 percent versus 33 percent), risk factors (43 percent versus 27 percent), medication options (50 percent versus 33 percent), evidence about medications (47 percent versus 24 percent); and they rated the ease of use of materials higher (51 percent versus 38 percent). Why is this research finding important? Lupus is a chronic rare disease (a PCORI focus), primarily affecting young women in their reproductive years of life. It is an autoimmune disease, in which one's own immune system attacks one's body. About 50 percent or more of lupus patients develop kidney disease within 10 years of lupus onset, and a large percentage develop involvement of other vital organs, including the brain, blood vessels, skin, heart, lung, or gastrointestinal tract. The death rate in lupus is 2.5 times that of individuals without lupus of similar age. People with lupus are frequently hospitalized for severe disease flares, which lead to high health care costs. Lupus is rare, occurring in 0.1 percent in the general population, but it accounts for 2 percent of all end-stage renal disease in the United States, which shows the devastating nature of this disease. Long-term immunosuppressive drug and glucocorticoid (called "steroid," "medrol," or "prednisone") therapy, often lifesaving and kidney-saving, can be complex and has significant risks, including serious infections, shingles, and infertility, significantly affecting young women of child-bearing potential. Treatment decisions are complex, and the lack of knowledge regarding lupus and its treatment options may interfere with health care choices. Clear patient-provider communication is needed. To address these issues, the project team developed a computerized lupus DA based on discussions with lupus patients and systematic review of all published data on treatments. This lupus DA is culturally and linguistically appropriate for lupus patients from a variety of backgrounds, including minorities and those with limited health literacy, and use can be individualized to one's knowledge needs and treatment choices. Although the initial testing was limited to women with lupus kidney disease, the most common disease manifestation, the DA is relevant to all lupus patients for several reasons: it includes general information about lupus; treatments for other serious manifestations of lupus are similar to those of kidney disease; 50 percent or more of lupus patients get kidney disease; and in the team's recent pilot study, >80 percent of lupus patients without kidney disease found the lupus DA to be relevant. The researchers will make slight modifications as needed, including adding information on serious features of lupus other than kidney disease. The team will identify facilitators and barriers to DA implementation during a regular clinic visit and evaluate the effectiveness of interventions designed to improve sustained adoption of the DA. The DA will be implemented across a number of different practice types to ensure the widespread implementation and improve outcomes of patients with lupus. What is the goal of the dissemination project? Specific aim 1 is to conduct a formative evaluation in 16 diverse clinics to assess stakeholder needs and identify clinic and contextual characteristics (e.g., readiness for change, physician attitudes, patient barriers) to inform strategy component selection and influence implementation effectiveness of lupus DA (aim 2). Specific aim 2 is to assess the effectiveness of a multicomponent (standardized and tailored) strategy for the implementation of the DA in 16 lupus clinics (minimum 35 patients/clinic) by examining changes in subjective and objective measures of implementation effectiveness over 27 months. Specific aim 3 is to identify opportunities for sustaining and disseminating the DA via semi-structured debriefing interviews with key clinic informants of aims 1 and 2 and patients and develop a manual that provides a step-by-step implementation guide for incorporating the DA into regular lupus clinic visits and care pathways. What is the project team doing? The project team's approach to implementing lupus DA in clinics includes two components. All participating clinics will receive the capacity building activities to help them to overcome commonly identified clinic and patient barriers to utilizing the lupus DA. In addition, based on their unique needs and capabilities, each clinic will choose among a set of clinic-targeted activities that further help transform existing work processes with additional steps/actions to integrate the DA and/or the patient-targeted activities that raise awareness and educate patients about the DA to help overcome additional patient barriers. The team chose these activities to address key facilitators and barriers to DA implementation found in pilot work with patients, providers, and staff from the participating clinics. How will the project team evaluate their dissemination activities? The team's implementation approach will be evaluated using an observational study design in which each clinic serves as a case. The researchers will utilize a longitudinal design involving validated surveys, semi-structured interviews, clinic administrative data, and research team field notes to evaluate effects on patient-centered outcomes (decision conflict, decision making role, satisfaction), clinical/health care outcomes (emergency room and inpatient visits), patient-physician communication, implementation success (percentage of patients receiving lupus DA), practice-level outcomes (number and type of implementation activities used), and implications for sustenance of DA. The team will focus on context and strategy as facilitators and barriers to effective implementation of the lupus DA in busy, clinical practices of various types--for example, private versus academic, urban versus suburban, large versus small group practice. How is the project team involving patients and others in this dissemination project? The project team continues to have strong collaborations from patient and patient stakeholder partners from its recently completed PCORI lupus DA study. The team's patient research partners, Leong and Reyes, and patient advocacy organization representatives, Guy Eakin, PhD (Arthritis Foundation) and Trish Davidson (Lupus Foundation of America), who were extremely active and engaged on the original study, have been critical in planning this dissemination and implementation (D&I) study with regular conference calls over the last three months. They will serve in consulting roles throughout the project period and will participate in monthly stakeholder conference calls. In addition, the team has engaged other key stakeholders including two expert lupus clinicians (Chatham, Yazdany), one DA expert (Fraenkel), one language expert (Caro), and two researchers (PI, Eisen) in project planning, and they will be key stakeholders for the proposed project. Each person will bring a unique stakeholder perspective to the table. How will this project help ensure future uptake and use of PCORI results? Through better understanding of facilitators and barriers to DA implementation in busy clinics and strategies that are successful (or not) at overcoming these barriers, the project team will adjust/modify the DA implementation protocol to improve its effectiveness. These lessons will be documented in detailed steps in a manual for future use. Dissemination of project results will be provided by the key stakeholders at scientific, clinical, and patient educational online meetings, and in peer-reviewed publications.
MeSH Terms:
  • Computer Programs
  • Cultural Characteristics
  • Decision Making
  • Female
  • Humans
  • Immunosuppressants /therapeutic use
  • * Lupus Erythematosus, Systemic /*therapy
  • Multicenter Studies as Topic
  • Observational Studies as Topic
  • Patient-Centered Outcomes Research
  • Poverty
  • Randomized Controlled Trials as Topic
  • Rheumatology /*methods
Country: United States
State: Alabama
Zip Code: 35294
UI: 20192433
Project Status: Ongoing
Record History: ('2021: Project extended to 2022. ',)