Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial.

BACKGROUND: Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. METHODS: Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. DISCUSSION: Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00321789.

Validation of a questionnaire to assess self-reported colorectal cancer screening status using face-to-face administration.

PURPOSE: The aim of this study was to assess the accuracy of a National Cancer Institute (NCI)-developed colorectal cancer screening questionnaire. METHODS: We conducted 36 cognitive interviews and made iterative changes to the questionnaire to improve comprehension. The revised questionnaire was administered face-to-face to 201 participants. The primary outcome was agreement between questionnaire responses and medical records for whether or not a participant was up-to-date for any colorectal cancer screening test. RESULTS: Comprehension of descriptions and questions was generally good; however, the barium enema description required several revisions. The sensitivity of the questionnaire for up-to-date screening status was 94%, specificity 63%, and concordance 88%. CONCLUSIONS: The modified questionnaire was highly sensitive for determining if a person was up-to-date for any colorectal cancer screening test, although the specificity was low. Given the difficulty of obtaining all relevant records, self-report using this questionnaire is a reasonable option for identifying people who have undergone testing.

Barriers to full colon evaluation for a positive fecal occult blood test.

BACKGROUND: Failure to appropriately evaluate a positive cancer screening test may negate the value of doing that test. The primary aim of this study was to explore the factors associated with undergoing a full colon evaluation for a positive fecal occult blood test (FOBT) in a single Veterans Affairs center. METHODS: Medical records of consecutive patients ages > or = 50 years, who had a positive screening FOBT from March 2000 to February 2001, were abstracted. Patient demographics, dates of ordering and doing follow-up test(s), and adherence with scheduled procedures were collected. The primary outcome, full colon evaluation, was defined as having a colonoscopy or double-contrast barium enema plus flexible sigmoidoscopy completed within 12 months. RESULTS: The sample (N = 538) was 98% men (58% Caucasian, 29% African-American, and 13% unknown race). Approximately 77% of the patients were referred to gastroenterology. Ultimately, only 44% underwent full colon evaluation within 12 months. Approximately 20% of the patients failed to attend a scheduled procedure. Referral to gastroenterology and adherence to follow-up appointments were associated with full colon evaluation. There was no association between African-American versus Caucasian race and full colon evaluation. CONCLUSIONS: Less than half of the patients with a positive FOBT had a full colon evaluation within 12 months. Multiple failures were identified, including lack of referral for further testing and patient nonadherence. Although the overall performance in evaluating a positive colorectal cancer screening test was poor, no racial disparity was observed.