Individualized decision aid for diverse women with lupus nephritis (IDEA-WON)

A randomized controlled trial

Jasvinder A. Singh, Liana Fraenkel, Candace Green, Graciela S. Alarcón, Jennifer Barton, Kenneth G. Saag, Leslie M. Hanrahan, Sandra C. Raymond, Robert P. Kimberly, Amye L. Leong, Elyse Reyes, Richard L. Street, Maria E. Suarez-Almazor, Guy S. Eakin, Laura Marrow, Charity J. Morgan, Brennda Caro, Jeffrey A. Sloan, Bochra Jandali, Salvador R. Garcia & 8 others Jennifer Grossman, Kevin Winthrop, Laura Trupin, Maria Dall’era, Alexa Meara, Tara Rizvi, W. Winn Chatham, Jinoos Yazdany

Research output: Contribution to journalArticle

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Abstract

Background Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. Methods and findings In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in-or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of < $40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (stan-dard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. Conclusions An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. Trial registration Clinicaltrials.gov, NCT02319525.

Original languageEnglish (US)
Article numbere1002800
JournalPLoS medicine
Volume16
Issue number5
DOIs
StatePublished - May 1 2019

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Lupus Nephritis
Decision Support Techniques
Randomized Controlled Trials
Pamphlets
Immunosuppressive Agents
Medication Adherence
Rheumatology
Random Allocation
Hispanic Americans
Social Class
African Americans
Decision Making
Outpatients
Therapeutics
Education
Conflict (Psychology)

ASJC Scopus subject areas

  • Medicine(all)

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Individualized decision aid for diverse women with lupus nephritis (IDEA-WON) : A randomized controlled trial. / Singh, Jasvinder A.; Fraenkel, Liana; Green, Candace; Alarcón, Graciela S.; Barton, Jennifer; Saag, Kenneth G.; Hanrahan, Leslie M.; Raymond, Sandra C.; Kimberly, Robert P.; Leong, Amye L.; Reyes, Elyse; Street, Richard L.; Suarez-Almazor, Maria E.; Eakin, Guy S.; Marrow, Laura; Morgan, Charity J.; Caro, Brennda; Sloan, Jeffrey A.; Jandali, Bochra; Garcia, Salvador R.; Grossman, Jennifer; Winthrop, Kevin; Trupin, Laura; Dall’era, Maria; Meara, Alexa; Rizvi, Tara; Chatham, W. Winn; Yazdany, Jinoos.

In: PLoS medicine, Vol. 16, No. 5, e1002800, 01.05.2019.

Research output: Contribution to journalArticle

Singh, JA, Fraenkel, L, Green, C, Alarcón, GS, Barton, J, Saag, KG, Hanrahan, LM, Raymond, SC, Kimberly, RP, Leong, AL, Reyes, E, Street, RL, Suarez-Almazor, ME, Eakin, GS, Marrow, L, Morgan, CJ, Caro, B, Sloan, JA, Jandali, B, Garcia, SR, Grossman, J, Winthrop, K, Trupin, L, Dall’era, M, Meara, A, Rizvi, T, Chatham, WW & Yazdany, J 2019, 'Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial', PLoS medicine, vol. 16, no. 5, e1002800. https://doi.org/10.1371/journal.pmed.1002800
Singh, Jasvinder A. ; Fraenkel, Liana ; Green, Candace ; Alarcón, Graciela S. ; Barton, Jennifer ; Saag, Kenneth G. ; Hanrahan, Leslie M. ; Raymond, Sandra C. ; Kimberly, Robert P. ; Leong, Amye L. ; Reyes, Elyse ; Street, Richard L. ; Suarez-Almazor, Maria E. ; Eakin, Guy S. ; Marrow, Laura ; Morgan, Charity J. ; Caro, Brennda ; Sloan, Jeffrey A. ; Jandali, Bochra ; Garcia, Salvador R. ; Grossman, Jennifer ; Winthrop, Kevin ; Trupin, Laura ; Dall’era, Maria ; Meara, Alexa ; Rizvi, Tara ; Chatham, W. Winn ; Yazdany, Jinoos. / Individualized decision aid for diverse women with lupus nephritis (IDEA-WON) : A randomized controlled trial. In: PLoS medicine. 2019 ; Vol. 16, No. 5.
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abstract = "Background Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. Methods and findings In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in-or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47{\%} were African-American, 26{\%} Hispanic, and 15{\%} white. Mean age (standard deviation [SD]) was 37 (12) years, 57{\%} had annual income of < $40,000, and 36{\%} had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (stan-dard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41{\%} versus 31{\%} (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50{\%} versus 35{\%} (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22{\%} versus 44{\%} (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49{\%} versus 33{\%}), risk factors (43{\%} versus 27{\%}), medication options (50{\%} versus 33{\%}; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51{\%} versus 38{\%}; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. Conclusions An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. Trial registration Clinicaltrials.gov, NCT02319525.",
author = "Singh, {Jasvinder A.} and Liana Fraenkel and Candace Green and Alarc{\'o}n, {Graciela S.} and Jennifer Barton and Saag, {Kenneth G.} and Hanrahan, {Leslie M.} and Raymond, {Sandra C.} and Kimberly, {Robert P.} and Leong, {Amye L.} and Elyse Reyes and Street, {Richard L.} and Suarez-Almazor, {Maria E.} and Eakin, {Guy S.} and Laura Marrow and Morgan, {Charity J.} and Brennda Caro and Sloan, {Jeffrey A.} and Bochra Jandali and Garcia, {Salvador R.} and Jennifer Grossman and Kevin Winthrop and Laura Trupin and Maria Dall’era and Alexa Meara and Tara Rizvi and Chatham, {W. Winn} and Jinoos Yazdany",
year = "2019",
month = "5",
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TY - JOUR

T1 - Individualized decision aid for diverse women with lupus nephritis (IDEA-WON)

T2 - A randomized controlled trial

AU - Singh, Jasvinder A.

AU - Fraenkel, Liana

AU - Green, Candace

AU - Alarcón, Graciela S.

AU - Barton, Jennifer

AU - Saag, Kenneth G.

AU - Hanrahan, Leslie M.

AU - Raymond, Sandra C.

AU - Kimberly, Robert P.

AU - Leong, Amye L.

AU - Reyes, Elyse

AU - Street, Richard L.

AU - Suarez-Almazor, Maria E.

AU - Eakin, Guy S.

AU - Marrow, Laura

AU - Morgan, Charity J.

AU - Caro, Brennda

AU - Sloan, Jeffrey A.

AU - Jandali, Bochra

AU - Garcia, Salvador R.

AU - Grossman, Jennifer

AU - Winthrop, Kevin

AU - Trupin, Laura

AU - Dall’era, Maria

AU - Meara, Alexa

AU - Rizvi, Tara

AU - Chatham, W. Winn

AU - Yazdany, Jinoos

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Background Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. Methods and findings In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in-or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of < $40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (stan-dard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. Conclusions An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. Trial registration Clinicaltrials.gov, NCT02319525.

AB - Background Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. Methods and findings In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in-or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of < $40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (stan-dard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. Conclusions An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. Trial registration Clinicaltrials.gov, NCT02319525.

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