Abstract
Objective
To determine at which phase in the recruitment process for participation in clinical
research studies do health literacy and other patient characteristics influence recruitment
outcomes.
Patients and Methods
Using a sample of 5872 patients hospitalized with cardiovascular disease approached
for participation in the Vanderbilt Inpatient Cohort Study from October 2011 through
December 2015, we examined the independent association of patients’ health literacy
with two steps in their research participation decision-making process: (1) research
interest — willingness to hear more about a research study; and (2) research participation
— the decision to enroll after an informed consent discussion. Best practices for
effective health communication were implemented in recruitment approaches and informed
consent processes. Using logistic regression models, we determined patient characteristics
independently associated with patients’ willingness to hear about and participate
in the study.
Results
In unadjusted analyses, participants with higher health literacy, and those who were
younger, female, or had more education had higher levels of both research interest
and research participation. Health literacy remained independently associated with
both outcomes in multivariable models, after adjustment for sociodemographic factors.
Conclusion
Because identical variables predicted both research interest and eventual consent,
efforts to recruit broad populations must include acceptable methods of approaching
potential participants as well as explaining study materials.
Abbreviations and Acronyms:
ACS (acute coronary syndrome), ADHF (acute decompensated heart failure), BHLS (Brief Health Literacy Screen), VICS (Vanderbilt Inpatient Cohort Study)To read this article in full you will need to make a payment
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References
- Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups.BMC Med Res Methodol. 2014; 14: 42
- Factors associated with participation in research conducted in a pediatric emergency department.Pediatr Emerg Care. 2015; 31: 348-352
- Recruiting hospitalized patients for research: how do participants differ from eligible nonparticipants?.J Hosp Med. 2013; 8: 208-214
- A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders.Am J Public Health. 2014; 104: e16-e31
- More than Tuskegee: understanding mistrust about research participation.J Health Care Poor Underserved. 2010; 21: 879-897
- Participation in surgical oncology clinical trials: gender-, race/ethnicity-, and age-based disparities.Ann Surg Oncol. 2007; 14: 3328-3334
- Health Literacy. A Prescription to End Confusion.National Academies Press, Washington, DC2004
- The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy (NCES 2006-483).U.S. Department of Education, National Center for Education Statistics, Washington, DC2006
- Association of health literacy and numeracy with interest in research participation.J Gen Intern Med. 2019; 34: 544-551
- Clinical research in low-literacy populations: using teach-back to assess comprehension of informed consent and privacy information.IRB. 2008; 30: 13-19
- Effect of health literacy on research follow-up.J Health Commun. 2015; 20: 83-91
- Determinants of health after hospital discharge: rationale and design of the Vanderbilt Inpatient Cohort Study (VICS).BMC Health Serv Res. 2014; 14: 10
- Teaching about health literacy and clear communication.J Gen Intern Med. 2006; 21: 888-890
- Inclusion of special populations in clinical research: important considerations and guidelines.J Clin Transl Res. 2018; 4: 56-69
- Development and implementation of a health literacy training program for medical residents.Med Educ Online. 2006; 11: 4612
- Implementing routine health literacy assessment in hospital and primary care patients.Jt Comm J Qual Patient Saf. 2014; 40: 68-76
- Brief questions to identify patients with inadequate health literacy.Fam Med. 2004; 36: 588-594
- Psychometric properties of the brief health literacy screen in clinical practice.J Gen Intern Med. 2014; 29: 119-126
- IBM SPSS Statistics for Windows, Version 24.0. [computer program]. IBM Corp., Armonk, NY2016 (Released)
- Health literacy predicts participant understanding of orally-presented informed consent information.Clin Res Trials. 2015; 1: 15-19
- Interventions to improve research participants' understanding in informed consent for research: a systematic review.JAMA. 2004; 292: 1593-1601
- A cross-sectional survey examining motivation and beliefs to participating in a web-based prospective cohort study on nutrition and health among individuals with a low socioeconomic status.BMC Public Health. 2020; 20: 348
- How one small text change in a study document can impact recruitment rates and follow-up completions.Internet Interv. 2019; 18: 100284
- Using qualitative research perspectives to inform patient engagement in research.Res Involv Engagem. 2018; 4: 20
- Are racial and ethnic minorities less willing to participate in health research?.PLoS Med. 2006; 3: e19
- Effective engagement requires trust and being trustworthy.Med Care. 2018; 56: S6-S8
- Predictors of health care system and physician distrust in hospitalized cardiac patients.J Health Commun. 2014; 19: 44-60
Article Info
Footnotes
For editorial comment, see page 280
Grant Support: This study was supported by grant R01 HL109388 from the National Heart, Lung, and Blood Institute and in part by grant 2 UL1 TR000445-06 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funding agency was not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Potential Competing Interests: The authors report no potential competing interests.
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