Lalita Subramanian1, Junhui Zhao1, Jarcy Zee2, Megan Knaus3, Angela Fagerlin4, Erica Perry3, June Swartz5, Margie McCall5, Nicole Bryant5, Francesca Tentori6. 1. Arbor Research Collaborative for Health, University of Michigan, Ann Arbor, MI. 2. Arbor Research Collaborative for Health, University of Michigan, Ann Arbor, MI. Electronic address: jarcy.zee@arborresearch.org. 3. Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI. 4. University of Utah, Salt Lake City, UT; Salt Lake City VA Center for Informatics Decision-Enhancement and Analytic Sciences (IDEAS) Center for Innovation, Salt Lake City, UT. 5. Advisory panel, Ann Arbor, MI. 6. Vanderbilt University, Nashville, TN; Davita Clinical Research, Minneapolis, MN.
Abstract
RATIONALE & OBJECTIVE: Annually, about 100,000 US patients face the difficult choice between the most common dialysis types, in-center hemodialysis and peritoneal dialysis. This study evaluated the value of a new decision aid to assist in the choice of dialysis modality. STUDY DESIGN: A parallel-group randomized controlled trial to test the efficacy of the decision aid on decision-making outcomes. SETTING & PARTICIPANTS: English-speaking US adults with advanced chronic kidney disease and internet access enrolled in 2015. INTERVENTION: Participants randomly assigned to the decision aid intervention received information about chronic kidney disease, peritoneal dialysis, and hemodialysis and a value clarification exercise through the study website using their own electronic devices. Participants in the control arm were only required to complete the control questionnaire. Questionnaire responses were used to assess differences across arms in decision-making outcomes. OUTCOMES: Treatment preference, decisional conflict, decision self-efficacy, knowledge, and preparation for decision making. RESULTS: Of 234 consented participants, 94 (40.2%) were lost to follow-up before starting the study. Among the 140 (70 in each arm) who started the study, 7 were subsequently lost to follow-up. Decision aid users had lower decisional conflict scores (42.5 vs 29.1; P<0.001) and higher average knowledge scores (90.3 vs 76.5; P<0.001). Both arms had high decisional self-efficacy scores independent of decision aid use. Uncertainty about choice of dialysis treatment declined from 46% to 16% after using the decision aid. Almost all (>90%) users of the decision aid reported that it helped in decision making. LIMITATIONS: Limited generalizability from the study of self-selected study participants who had to have internet access, speak English, and have computer literacy. High postrandomization loss to follow-up. Evaluation of only short-term outcomes. CONCLUSIONS: The decision aid improves decision-making outcomes immediately after use. Implementation of the decision aid in clinical practice may allow further assessment of its effects on patient engagement and empowerment in choosing a dialysis modality. FUNDING: This study was funded through a Patient Centered Outcomes Research Institute (PCORI) award (#1109). TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02488317.
RCT Entities:
RATIONALE & OBJECTIVE: Annually, about 100,000 US patients face the difficult choice between the most common dialysis types, in-center hemodialysis and peritoneal dialysis. This study evaluated the value of a new decision aid to assist in the choice of dialysis modality. STUDY DESIGN: A parallel-group randomized controlled trial to test the efficacy of the decision aid on decision-making outcomes. SETTING & PARTICIPANTS: English-speaking US adults with advanced chronic kidney disease and internet access enrolled in 2015. INTERVENTION: Participants randomly assigned to the decision aid intervention received information about chronic kidney disease, peritoneal dialysis, and hemodialysis and a value clarification exercise through the study website using their own electronic devices. Participants in the control arm were only required to complete the control questionnaire. Questionnaire responses were used to assess differences across arms in decision-making outcomes. OUTCOMES: Treatment preference, decisional conflict, decision self-efficacy, knowledge, and preparation for decision making. RESULTS: Of 234 consented participants, 94 (40.2%) were lost to follow-up before starting the study. Among the 140 (70 in each arm) who started the study, 7 were subsequently lost to follow-up. Decision aid users had lower decisional conflict scores (42.5 vs 29.1; P<0.001) and higher average knowledge scores (90.3 vs 76.5; P<0.001). Both arms had high decisional self-efficacy scores independent of decision aid use. Uncertainty about choice of dialysis treatment declined from 46% to 16% after using the decision aid. Almost all (>90%) users of the decision aid reported that it helped in decision making. LIMITATIONS: Limited generalizability from the study of self-selected study participants who had to have internet access, speak English, and have computer literacy. High postrandomization loss to follow-up. Evaluation of only short-term outcomes. CONCLUSIONS: The decision aid improves decision-making outcomes immediately after use. Implementation of the decision aid in clinical practice may allow further assessment of its effects on patient engagement and empowerment in choosing a dialysis modality. FUNDING: This study was funded through a Patient Centered Outcomes Research Institute (PCORI) award (#1109). TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02488317.
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