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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137241
Other study ID # CRI 03-153
Secondary ID
Status Completed
Phase N/A
First received August 25, 2005
Last updated April 6, 2015
Start date July 2004
Est. completion date November 2005

Study information

Verified date October 2006
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse Veterans Affairs Medical Centers (Minneapolis, Portland, Durham, and West Los Angeles), and for specific groups based on age, race, education, and geographic location. The investigators' secondary objectives are to illustrate the potential significance of poor health literacy by linking estimates for those over 50 years old to colorectal cancer (CRC) screening data and examining variation in screening rates by health literacy levels. The investigators expect that people with lower health literacy skills will be less adherent to CRC screening guidelines.


Description:

BACKGROUND / RATIONALE:

Studies have shown that people with poor health literacy skills have significantly worse health status, greater risk for hospitalization, less knowledge about their health conditions, and are less likely to use preventative services. Little is known about the prevalence of low health literacy skills among veterans who use the VHA or the effect poor health literacy skills may have on complex preventative behaviors, such as screening for colorectal cancer (CRC). Understanding the distribution of health literacy skills among veterans and their effect on preventive behavior is critical for improving patient education, reducing health disparities, and promoting patient-centered care.

OBJECTIVE(S):

The primary objectives for this study are to develop an estimate of the prevalence of health literacy at four geographically diverse VAMCs (Minneapolis, Portland, Durham, and West LA), and for specific groups based on age, race, education, and geographic location. The secondary objectives are to link health literacy estimates for those 50 to 75 years old to CRC screening data, examine variation in guideline concordant screening rates by health literacy levels, and identify the mechanisms that may mediate or moderate the effect of health literacy on screening.

METHODS:

This observational study uses a time-sequential randomized design of 1440 veterans, stratified by age (<50, 50-75, >75), who have upcoming appointments in primary care clinics at the 4 study sites. Patients who are eligible (i.e., have at least 20/50 vision and are not demented) are asked to participate in a face-to-face structured survey with a study interviewer. The survey includes demographic data, functional status, social support, measures of attitudes and beliefs about health care providers, health insurers, medical care and the Short-Test of Functional Health Literacy in Adults (S-TOFHLA). For those between ages 50-75, knowledge of and attitudes towards CRC screening are also measured. Survey data are then matched to data from the CRC QUERI screening assessment and surveillance data system (CRS 02-162-1) to evaluate screening adherence.

STATUS:

Project work is ongoing.

IMPACT:

Findings from this study are expected to have a number of broad implications for research and practice within the VHA. This project will inform organizational changes aimed to improve the efficacy and efficiency of communication strategies and identify areas where interventions or system-level changes could be most effective; inform improvements in informed consent procedures, patient education, discharge summaries and prescription instructions; inform and improve the effectiveness of interventions and the Quality Enhancement and Research Initiative (QUERI) translation efforts; provide the basis for future longitudinal investigations into how health literacy changes over time; and, contribute to our understanding and amelioration of factors associated with health disparities.


Recruitment information / eligibility

Status Completed
Enrollment 1850
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

All veterans eligible for care at any of the study facilities (Minneapolis, LA, Durham, and Portland VA Medical Centers) who were scheduled to have at least one primary care visit during the 6-month study recruitment period.

Exclusion Criteria:

Patients were excluded who had: 1) Severe cognitive disorders, 2) Severe visual impairment, 3) Severe hearing impairment, 4) Significant difficulty understanding English

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: — View Citation

Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Saha S, Snyder A, Nugent S, Baines Simon A, Gralnek I, Provenzale D, van Ryn M. Variation in estimates of limited health literacy by assessment instruments and non-response bias. J Gen Intern Med. 2010 Jul; — View Citation

Griffin JM, Simon AB, Hulbert E, Stevenson J, Grill JP, Noorbaloochi S, Partin MR. A comparison of small monetary incentives to convert survey non-respondents: a randomized control trial. BMC Med Res Methodol. 2011 May 26;11:81. doi: 10.1186/1471-2288-11- — View Citation

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