TY - JOUR
T1 - Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening
T2 - Implementation of a PCORI study protocol and lessons learned
AU - Lowenstein, Lisa M.
AU - Escoto, Kamisha H.
AU - Leal, Viola B.
AU - Bailey, Linda
AU - Bevers, Therese B.
AU - Cantor, Scott B.
AU - Cinciripini, Paul M.
AU - E. Jacobs, Lianne
AU - Esparza, Angelina
AU - Godoy, Myrna C.
AU - Housten, Ashley J.
AU - Lin, Heather
AU - Luckett, Pamela
AU - Munden, Reginald F.
AU - Rabius, Vance
AU - Volk, Robert J.
N1 - Funding Information:
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award ( CER-1306-03385 ), the NIH/NCI under award number P30CA016672 and used the Biostatistics Resource Group and Clinical Protocal and Data Management, and The University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment . All statements in this article, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
Funding Information:
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1306-03385), the NIH/NCI under award number P30CA016672 and used the Biostatistics Resource Group and Clinical Protocal and Data Management, and The University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment. All statements in this article, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
Publisher Copyright:
© 2018
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/9
Y1 - 2018/9
N2 - Purpose: We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions. Methods: The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening. Results: We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement. Conclusions: Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning. PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID: NCT02286713
AB - Purpose: We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions. Methods: The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening. Results: We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement. Conclusions: Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning. PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID: NCT02286713
KW - Decision aids
KW - Decision making
KW - Early detection of cancer
KW - Lung neoplasms
KW - Patient participation
KW - Patient reported outcome measures
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U2 - 10.1016/j.cct.2018.07.007
DO - 10.1016/j.cct.2018.07.007
M3 - Article
C2 - 30010085
AN - SCOPUS:85050076924
VL - 72
SP - 26
EP - 34
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
ER -