An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial.

BackgroundColorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3-10% of the population has an increased risk for colorectal cancer due to family history and warrants more frequent or intensive screening. Yet, < 50% of that high-risk population receives guideline-concordant care. Systematic collection of family health history and decision support may improve guideline-concordant screening for patients at increased risk of colorectal cancer. We seek to test the effectiveness of a web-based, systematic family health history collection tool and decision support platform (MeTree) to improve risk assessment and appropriate management of colorectal cancer risk among patients in the Department of Veterans Affairs primary care practices.MethodsIn this ongoing randomized controlled trial, primary care providers at the Durham Veterans Affairs Health Care System and the Madison VA Medical Center are randomized to immediate intervention or wait-list control. Veterans are eligible if assigned to enrolled providers, have an upcoming primary care appointment, and have no conditions that would place them at increased risk for colorectal cancer (such as personal history, adenomatous polyps, or inflammatory bowel disease). Those with a recent lower endoscopy (e.g. colonoscopy, sigmoidoscopy) are excluded. Immediate intervention patients put their family health history information into a web-based platform, MeTree, which provides both patient- and provider-facing decision support reports. Wait-list control patients access MeTree 12 months post-consent. The primary outcome is the risk-concordant colorectal cancer screening referral rate obtained via chart review. Secondary outcomes include patient completion of risk management recommendations (e.g. colonoscopy) and referral for genetic consultation. We will also conduct an economic analysis and an assessment of providers' experience with MeTree clinical decision support recommendations to inform future implementation efforts if the intervention is found to be effective.DiscussionThis trial will assess the feasibility and effectiveness of patient-collected family health history linked to decision support to promote risk-appropriate screening in a large healthcare system such as the Department of Veterans Affairs.Trial registrationClinicalTrials.gov, NCT02247336 . Registered on 25 September 2014

Predictors of variation in serum IGF1 and IGFBP3 levels in healthy African American and white men.

Background—Individual variation in circulating insulin-like growth factor-I (IGF1) and its major binding protein, insulin-like growth factor binding protein-3 (IGFBP3) have been etiologically linked to several chronic diseases, including some cancers. Factors associated with variation in circulating levels of these peptide hormones remain unclear. Methods—Multiple linear regression models were used to determine the extent to which sociodemographic characteristics, lifestyle factors, personal and family history of chronic disease, and common genetic variants, the (CA)n repeat polymorphism in the IGF1 promoter and the IGFBP3 -202 A/C polymorphism (rs2854744) predict variation in IGF1 or IGFBP3 serum levels in 33 otherwise healthy African American and 37 white males recruited from Durham Veterans Administration Medical Center. Results—Predictors of serum IGF1, IGFBP3 and the IGF1:IGFBP3 molar ratio varied by race. In African Americans, 17% and 28% of the variation in serum IGF1 and the IGF1:IGFBP3 molar ratio, respectively, was explained by cigarette smoking and carrying the IGF1 (CA)19 repeat allele, respectively. Not carrying at least one IGF1 (CA)19 repeat allele and a high BMI explained 8% and 14%, respectively, of the variation IGFBP3 levels. These factors did not predict variation of these peptides in whites. Conclusion—If successfully replicated in larger studies, these findings add to recent evidence suggesting known genetic and lifestyle chronic disease risk factors influence IGF1 and IGFBP3 circulating levels differently in African Americans and whites

“I’ve been doing this for years”: the COVID-19 pandemic and family caregiver isolation and loneliness

Background: Family caregivers are family members or friends of care recipients who assist with activities of daily living, medication management, transportation, and help with finances among other activities. As a result of their caregiving, family caregivers are often considered a population at risk of experiencing increased stress, isolation, and loneliness. During the COVID-19 pandemic in the US, social isolation and decrease in social activities were a top concern among older adults and their family caregivers. Using secondary analysis of survey data as part of a multi-site implementation trial of a caregiver skills training program, we describe differences in caregiver experiences of loneliness before and during the COVID-19 pandemic. Methods: Health and wellbeing surveys of family caregivers were collected on 422 family caregivers of veterans before and during COVID-19. Logistic regression modeling examined whether the loneliness differed between caregiver groups pre vs during COVID-19, using the UCLA 3-item loneliness measure. Rapid directed qualitative content analysis of open-ended survey questions was used to explore the context of how survey responses were affected by the COVID-19 pandemic. Results: There were no significant differences in loneliness between caregivers pre vs during COVID-19. In open-ended responses regarding effects of COVID-19, caregivers described experiencing loneliness and social isolation; why they were unaffected by the pandemic; and how caregiving equipped them with coping strategies to manage negative pandemic-related effects. Conclusion: Loneliness did not differ significantly between pre vs during COVID-19 caregivers. Future research could assess what specific characteristics are associated with caregivers who have resiliency, and identify caregivers who are more susceptible to experiencing loneliness. Understanding caregiver loneliness could assist other healthcare systems in developing and implementing caregiver support interventions

Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

Abstract Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT0106054

“I’ve been doing this for years”: the COVID-19 pandemic and family caregiver isolation and loneliness

BackgroundFamily caregivers are family members or friends of care recipients who assist with activities of daily living, medication management, transportation, and help with finances among other activities. As a result of their caregiving, family caregivers are often considered a population at risk of experiencing increased stress, isolation, and loneliness. During the COVID-19 pandemic in the US, social isolation and decrease in social activities were a top concern among older adults and their family caregivers. Using secondary analysis of survey data as part of a multi-site implementation trial of a caregiver skills training program, we describe differences in caregiver experiences of loneliness before and during the COVID-19 pandemic.MethodsHealth and wellbeing surveys of family caregivers were collected on 422 family caregivers of veterans before and during COVID-19. Logistic regression modeling examined whether the loneliness differed between caregiver groups pre vs during COVID-19, using the UCLA 3-item loneliness measure. Rapid directed qualitative content analysis of open-ended survey questions was used to explore the context of how survey responses were affected by the COVID-19 pandemic.ResultsThere were no significant differences in loneliness between caregivers pre vs during COVID-19. In open-ended responses regarding effects of COVID-19, caregivers described experiencing loneliness and social isolation; why they were unaffected by the pandemic; and how caregiving equipped them with coping strategies to manage negative pandemic-related effects.ConclusionLoneliness did not differ significantly between pre vs during COVID-19 caregivers. Future research could assess what specific characteristics are associated with caregivers who have resiliency, and identify caregivers who are more susceptible to experiencing loneliness. Understanding caregiver loneliness could assist other healthcare systems in developing and implementing caregiver support interventions

Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument.

BackgroundClinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs.Objectives1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure.DesignCross-sectional analysis of randomized trial data.PatientsSix hundred and thirty-six primary care patients with hypertension.Measurements1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP).ResultsWe identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP.ConclusionsWe identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension

The effectiveness of personalized coronary heart disease and stroke risk communication.

BackgroundCurrent guidelines recommend global risk assessment to guide vascular risk factor management; however, most provider-patient communication focuses on individual risk factors in isolation. We sought to evaluate the impact of personalized coronary heart disease and stroke risk communication on patients' knowledge, beliefs, and health behavior.MethodsWe conducted a randomized controlled trial testing personalized risk communication based on Framingham stroke and coronary heart disease risk scores compared with a standard risk factor education. A total of 89 patients were recruited from primary care clinics and followed up for 3 months. Outcomes included the following: risk perception and worry, risk factor knowledge, risk reduction preferences and decision conflict, medication adherence, health behaviors, and blood pressure.ResultsParticipants had a very low understanding of numeric information, high perceived risk for stroke or myocardial infarction, and high proportion of medication nonadherence. Patients' ability to identify vascular risk factors increased with personalized risk communication (mean 1.8 additional risk factors, 95% CI 1.3-2.2) and standard risk factor education (mean 1.6 additional risk factors, 95% CI 1.1-2.1) immediately after the intervention but was not sustained at 3 months. Patients in the personalized group had less decision conflict than the standard risk factor education group over intended risk reduction strategies (5.9 vs 10.1, P = .003). There was no appreciable impact of either communication strategy on medication adherence, exercise, smoking cessation, or blood pressure.ConclusionsPersonalized risk communication was preferred by patients and had a small impact on risk reduction preferences and decision conflict but had no impact on patient beliefs or behavior compared with standard risk factor education