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Contemp Clin Trials. 2018 Sep;72:26-34. doi: 10.1016/j.cct.2018.07.007. Epub 2018 Jul 20.

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

Author information

1
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
2
Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
3
North American Quitline Consortium, Phoenix, AZ, United States.
4
Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
5
Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
6
Houston Health Department, Houston, TX, United States.
7
Department of Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
8
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
9
Information & Quality Healthcare, Ridgeland, MS, United States.
10
Department of Radiology, Wake Forest School of Medicine, Winston-Salem, NC, United States.
11
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, United States. Electronic address: bvolk@mdanderson.org.

Abstract

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.

KEYWORDS:

Decision aids; Decision making; Early detection of cancer; Lung neoplasms; Patient participation; Patient reported outcome measures

PMID:
30010085
PMCID:
PMC6219628
[Available on 2019-09-01]
DOI:
10.1016/j.cct.2018.07.007

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