Browsing by Author "Voils, Corrine I"
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Item Open Access A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol.(Preventive medicine, 2013-01) Voils, Corrine I; Coffman, Cynthia J; Yancy, William S; Weinberger, Morris; Jeffreys, Amy S; Datta, Santanu; Kovac, Stacey; McKenzie, Jamiyla; Smith, Rose; Bosworth, Hayden BObjective
This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C.Method
From 2007 to 2010, 255 outpatients with LDL-C>76 mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11 months.Results
Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/dL, 95% CI = -3.6, 8.3, p = 0.44), nor did the odds of meeting goal LDL-C (OR = 0.95, 95% CI = 0.6, 1.7; p = 0.87). Intakes of calories (p = 0.03), total fat (p = 0.02), and saturated fat (p = 0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p = 0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR = 1.2, 95% CI = 1.0, 1.5, p = 0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups.Conclusion
This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.Item Open Access An organizing framework for informal caregiver interventions: detailing caregiving activities and caregiver and care recipient outcomes to optimize evaluation efforts.(BMC geriatrics, 2011-11) Van Houtven, Courtney Harold; Voils, Corrine I; Weinberger, MorrisBackground
Caregiver interventions may help improve the quality of informal care. Yet the lack of a systematic framework specifying the targets and outcomes of caregiver interventions hampers our ability to understand what has been studied, to evaluate existing programs, and to inform the design of future programs. Our goal was to develop an organizing framework detailing the components of the caregiving activities and the caregiver and care recipient outcomes that should be affected by an intervention. In so doing, we characterize what has been measured in the published literature to date and what should be measured in future studies to enable comparisons across interventions and across time.Methods
Our data set comprises 121 reports of caregiver interventions conducted in the United States and published between 2000 and 2009. We extracted information on variables that have been examined as primary and secondary outcomes. These variables were grouped into categories, which then informed the organizing framework. We calculated the frequency with which the interventions examined each framework component to identify areas about which we have the most knowledge and under-studied areas that deserve attention in future research.Results
The framework stipulates that caregiver interventions seek to change caregiving activities, which in turn affect caregiver and care recipient outcomes. The most frequently assessed variables have been caregiver psychological outcomes (especially depression and burden) and care recipient physical and health care use outcomes.Conclusions
Based on the organizing framework, we make three key recommendations to guide interventions and inform research and policy. First, all intervention studies should assess quality and/or quantity of caregiving activities to help understand to what extent and how well the intervention worked. Second, intervention studies should assess a broad range of caregiver and care recipient outcomes, including considering whether expanding to economic status and health care use of the caregiver can be accommodated, to ease subsequent economic evaluations of caregiving. Third, intervention studies should measure a common set of outcomes to facilitate cross-time and cross-study comparisons of effectiveness.Item Open Access Barriers and Facilitators to Adoption of Genomic Services for Colorectal Care within the Veterans Health Administration.(J Pers Med, 2016-04-28) Sperber, Nina R; Andrews, Sara M; Voils, Corrine I; Green, Gregory L; Provenzale, Dawn; Knight, SaraWe examined facilitators and barriers to adoption of genomic services for colorectal care, one of the first genomic medicine applications, within the Veterans Health Administration to shed light on areas for practice change. We conducted semi-structured interviews with 58 clinicians to understand use of the following genomic services for colorectal care: family health history documentation, molecular and genetic testing, and genetic counseling. Data collection and analysis were informed by two conceptual frameworks, the Greenhalgh Diffusion of Innovation and Andersen Behavioral Model, to allow for concurrent examination of both access and innovation factors. Specialists were more likely than primary care clinicians to obtain family history to investigate hereditary colorectal cancer (CRC), but with limited detail; clinicians suggested templates to facilitate retrieval and documentation of family history according to guidelines. Clinicians identified advantage of molecular tumor analysis prior to genetic testing, but tumor testing was infrequently used due to perceived low disease burden. Support from genetic counselors was regarded as facilitative for considering hereditary basis of CRC diagnosis, but there was variability in awareness of and access to this expertise. Our data suggest the need for tools and policies to establish and disseminate well-defined processes for accessing services and adhering to guidelines.Item Open Access Challenges and strategies for implementing genomic services in diverse settings: experiences from the Implementing GeNomics In pracTicE (IGNITE) network.(BMC Med Genomics, 2017-05-22) Sperber, Nina R; Carpenter, Janet S; Cavallari, Larisa H; J Damschroder, Laura; Cooper-DeHoff, Rhonda M; Denny, Joshua C; Ginsburg, Geoffrey S; Guan, Yue; Horowitz, Carol R; Levy, Kenneth D; Levy, Mia A; Madden, Ebony B; Matheny, Michael E; Pollin, Toni I; Pratt, Victoria M; Rosenman, Marc; Voils, Corrine I; W Weitzel, Kristen; Wilke, Russell A; Ryanne Wu, R; Orlando, Lori ABACKGROUND: To realize potential public health benefits from genetic and genomic innovations, understanding how best to implement the innovations into clinical care is important. The objective of this study was to synthesize data on challenges identified by six diverse projects that are part of a National Human Genome Research Institute (NHGRI)-funded network focused on implementing genomics into practice and strategies to overcome these challenges. METHODS: We used a multiple-case study approach with each project considered as a case and qualitative methods to elicit and describe themes related to implementation challenges and strategies. We describe challenges and strategies in an implementation framework and typology to enable consistent definitions and cross-case comparisons. Strategies were linked to challenges based on expert review and shared themes. RESULTS: Three challenges were identified by all six projects, and strategies to address these challenges varied across the projects. One common challenge was to increase the relative priority of integrating genomics within the health system electronic health record (EHR). Four projects used data warehousing techniques to accomplish the integration. The second common challenge was to strengthen clinicians' knowledge and beliefs about genomic medicine. To overcome this challenge, all projects developed educational materials and conducted meetings and outreach focused on genomic education for clinicians. The third challenge was engaging patients in the genomic medicine projects. Strategies to overcome this challenge included use of mass media to spread the word, actively involving patients in implementation (e.g., a patient advisory board), and preparing patients to be active participants in their healthcare decisions. CONCLUSIONS: This is the first collaborative evaluation focusing on the description of genomic medicine innovations implemented in multiple real-world clinical settings. Findings suggest that strategies to facilitate integration of genomic data within existing EHRs and educate stakeholders about the value of genomic services are considered important for effective implementation. Future work could build on these findings to evaluate which strategies are optimal under what conditions. This information will be useful for guiding translation of discoveries to clinical care, which, in turn, can provide data to inform continual improvement of genomic innovations and their applications.Item Open Access Chronic disease management perspectives of colorectal cancer survivors using the Veterans Affairs healthcare system: a qualitative analysis.(BMC health services research, 2018-03) Zullig, Leah L; Goldstein, Karen M; Bosworth, Hayden B; Andrews, Sara M; Danus, Susanne; Jackson, George L; Provenzale, Dawn; Weinberger, Morris; Kelley, Michael J; Voils, Corrine IBackground
Colorectal cancer (CRC) is the third most commonly diagnosed cancer in the US. CRC survivors may have complex healthcare needs requiring care from both specialists and primary care. Our objective was to understand how CRC survivors perceive their survivorship care, especially management of their cardiovascular-related chronic diseases.Methods
We identified patients diagnosed with non-metastatic CRC between 10/1/2007 and 12/31/2015 at Veterans Affairs Medical Centers in North Carolina or Virginia. In 2016, we conducted telephone-based, semi-structured interviews to assess survivors' experiences with cancer survivorship and changes in health priorities. Interviews were conducted until thematic saturation was reached. Interviews were audio-recorded, transcribed, and coded.Results
The 25 participants were, on average, 64 years old and approximately 4 years post-CRC diagnosis at the time of interview; most were white (60%), male (92%), and diagnosed with colon cancer (64%) as opposed to rectal cancer. CRC survivors reported: (1) a shift in focus from surviving cancer to reducing cardiovascular disease risk (e.g., by managing weight); (2) challenges with taking medications for CVD-related conditions; (3) new recognition of the importance of engaging with primary care providers.Conclusions
Experiences with cancer shapes how survivors view their health. Management of cardiovascular-related chronic disease is important to veteran CRC survivors. There is a need to deliver cardiovascular disease risk reduction programs tailored for CRC survivors.Item Open Access Co-occurring reasons for medication nonadherence within subgroups of patients with hyperlipidemia.(Journal of behavioral medicine, 2019-04) Blalock, Dan V; Bosworth, Hayden B; Reeve, Bryce B; Voils, Corrine IMedication nonadherence is a significant clinical problem among individuals taking statins. Poor adherence is often attributable to several reasons, yet most adherence interventions target a single reason. Baseline data were examined from a randomized clinical trial of 236 patients with hyperlipidemia. A latent class analysis was then performed on patients reporting any nonadherence (n = 109). A 4-class solution provided the most optimal fit and differentiation of classes. Class 1 (N = 59, 54%) included patients who reported occasionally forgetting. Class 2 (N = 16, 14%) represented patients who were concerned about side effects. Class 3 (N = 17, 16%) represented patients who reported out-of-routine life events as contributing to nonadherence. Class 4 (N = 17, 16%) represented patients who endorsed a large number reasons indiscriminately. Class membership was almost uniformly unrelated to any patient demographic factors or treatment arm. Each cluster of reasons defining these patients may be best addressed through different intervention strategies.Item Open Access Community-based HCV screening: knowledge and attitudes in a high risk urban population.(BMC Infect Dis, 2014-02-10) Norton, Brianna L; Voils, Corrine I; Timberlake, Sarah H; Hecker, Emily J; Goswami, Neela D; Huffman, Kim M; Landgraf, Anneka; Naggie, Susanna; Stout, Jason EBACKGROUND: In an attempt to curtail the rising morbidity and mortality from undiagnosed HCV (hepatitis C virus) in the United States, screening guidelines have been expanded to high-risk individuals and persons born 1945-1965. Community-based screening may be one strategy in which to reach such persons; however, the acceptance of HCV testing, when many high-risk individuals may not have access to HCV specific medications, remains unknown. METHODS: We set out to assess attitudes about HCV screening and knowledge about HCV disease at several community-based testing sites that serve high-risk populations. This assessment was paired with a brief HCV educational intervention, followed by post-education evaluation. RESULTS: Participants (n = 140) were surveyed at five sites; two homeless shelters, two drug rehabilitation centers, and a women's "drop-in" center. Personal acceptance of HCV testing was almost unanimous, and 90% of participants reported that they would still want to be tested even if they were unable to receive HCV treatment. Baseline hepatitis C knowledge was poor; however, the brief educational intervention significantly improved knowledge and increased acceptability of testing when medical access issues were explicitly stated. CONCLUSIONS: Despite inconsistencies in access to care and treatment, high-risk communities want to know their HCV status. Though baseline HCV knowledge was poor in this population, a brief on-site educational intervention improved both knowledge and acceptability of HCV testing and care. These data support the establishment of programs that utilize community-based screening, and also provide initial evidence for acceptance of the implementation of the recently expanded screening guidelines among marginalized communities.Item Open Access DEVELOPING A THEORETICALLY INFORMED MEASURE TO DETECT AND ADDRESS SELF-REPORTED MEDICATION NONADHERENCE(ANNALS OF BEHAVIORAL MEDICINE, 2012-04) Voils, Corrine I; Maciejewski, Matthew; Hoyle, Rick; Reeve, Bryce; Gallagher, Patrick; Yancy, WilliamItem Open Access Food preferences and weight change during low-fat and low-carbohydrate diets.(Appetite, 2016-08-01) McVay, Megan A; Voils, Corrine I; Geiselman, Paula J; Smith, Valerie A; Coffman, Cynthia J; Mayer, Stephanie; Yancy, William SUNLABELLED: Understanding associations between food preferences and weight loss during various effective diets could inform efforts to personalize dietary recommendations and provide insight into weight loss mechanisms. We conducted a secondary analysis of data from a clinical trial in which participants were randomized to either a 'choice' arm, in which they were allowed to select between a low-fat diet (n = 44) or low-carbohydrate diet (n = 61), or to a 'no choice' arm, in which they were randomly assigned to a low-fat diet (n = 49) or low-carbohydrate diet (n = 53). All participants were provided 48 weeks of lifestyle counseling. Food preferences were measured at baseline and every 12 weeks thereafter with the Geiselman Food Preference Questionnaire. Participants were 73% male and 51% African American, with a mean age of 55. Baseline food preferences, including congruency of food preferences with diet, were not associated with weight outcomes. In the low-fat diet group, no associations were found between changes in food preferences and weight over time. In the low-carbohydrate diet group, increased preference for low-carbohydrate diet congruent foods from baseline to 12 weeks was associated with weight loss from 12 to 24 weeks. Additionally, weight loss from baseline to 12 weeks was associated with increased preference for low-carbohydrate diet congruent foods from 12 to 24 weeks. Results suggest that basing selection of low-carbohydrate diet or low-fat diet on food preferences is unlikely to influence weight loss. Congruency of food preferences and weight loss may influence each other early during a low-carbohydrate diet but not low-fat diet, possibly due to different features of these diets. CLINICAL TRIAL REGISTRY: NCT01152359.Item Open Access Invisible partners in care: Snapshot of well-being among caregivers receiving comprehensive support from Veterans Affairs.(Health science reports, 2019-03) Miller, Katherine EM; Lindquist, Jennifer H; Olsen, Maren K; Smith, Valerie; Voils, Corrine I; Oddone, Eugene Z; Sperber, Nina R; Shepherd-Banigan, Megan; Wieland, G Darryl; Henius, Jennifer; Kabat, Margaret; Van Houtven, Courtney HaroldBackground and aims
Since May 2011, over 23 000 caregivers of Veterans seriously injured on or after September 11, 2001 have enrolled in the Program of Comprehensive Assistance for Family Caregivers (PCAFC). PCAFC provides caregivers training, a stipend, and access to health care. The aim of this study is to describe the characteristics of caregivers in PCAFC and examine associations between caregiver characteristics and caregiver well-being outcomes.Methods
We sent a web survey invitation to 10 000 PCAFC caregivers enrolled as of September 2015. Using linear and logistic regressions, we examine associations between PCAFC caregiver characteristics and caregiver outcomes: perceived financial strain, depressive symptoms (Center for Epidemiologic Studies Depression Scale [CESD-10]), perceived quality of Veteran's Veterans Health Administration (VHA) care, and self-reported caregiver health.Results
We had complete survey data for 899 respondents. Since becoming a caregiver, approximately 50% of respondents reported reducing or stopping work. Mean time spent providing care was 3.8 years (median 3, IQR 1-5) with an average of 4.9 weekdays (median 5, IQR 5-5) and 1.9 weekend days (median 2, IQR 2-2). The mean CESD-10 score was 8.2 (median 7, 4-12), at the cutoff for screening positive for depressive symptoms. A longer duration of caregiving was associated with having 0.08 increase in rating of financial strain (95% CI, 0.02-0.14). Caregiver rating of the Veteran's health status as "fair" or better was a strong predictor of better caregiver outcomes, ie, self-reported caregiver health. However, higher levels of education were associated with worse caregiver outcomes, ie, lower global satisfaction with VHA care, higher CESD-10 score, and higher rating of financial strain.Conclusions
Higher depressive symptoms among longer duration caregivers, coupled with high rates of reductions in hours worked, suggest interventions are needed to address the long-term emotional and financial needs of these caregivers of post-9/11 Veterans and identify subpopulations at risk for worse outcomes.Item Open Access Prescriber continuity and medication availability in older adults with cardiometabolic conditions.(SAGE Open Med, 2018) Maciejewski, Matthew L; Hammill, Bradley G; Voils, Corrine I; Ding, Laura; Bayliss, Elizabeth A; Curtis, Lesley H; Wang, VirginiaBackground: Many older adults have multiple conditions and see multiple providers, which may impact their use of essential medications. Objective: We examined whether the number of prescribers of these medications was associated with the availability of medications, a surrogate for adherence, to manage diabetes, hypertension or dyslipidemia. Methods: A retrospective cohort of 383,145 older adults with diabetes, hypertension or dyslipidemia in the US Medicare program living in 10 states. The association between the number of prescribers of cardiometabolic medications in 2010 and medication availability (proportion of days with medication on hand) in 2011 was estimated via logistic regression, controlling for patient demographic characteristics and chronic conditions. Results: Medicare beneficiaries with diabetes, hypertension and/or dyslipidemia had an average of five chronic conditions overall, obtained 10-12 medications for all conditions and most often had one prescriber of cardiometabolic medications. In adjusted analyses, the number of prescribers was not significantly associated with availability of oral diabetes agents but having more prescribers is associated with increased medication availability in older Medicare beneficiaries with dyslipidemia or hypertension. Conclusion: The incremental addition of new prescribers may be clinically reasonable for complex patients but creates the potential for coordination problems and informational discontinuity over time. Health systems may want to identify complex patients with multiple prescribers to minimize care fragmentation.Item Open Access Primary care physician decision making regarding severe obesity treatment and bariatric surgery: a qualitative study.(Surg Obes Relat Dis, 2016-05) Funk, Luke M; Jolles, Sally A; Greenberg, Caprice C; Schwarze, Margaret L; Safdar, Nasia; McVay, Megan A; Whittle, Jeffrey C; Maciejewski, Matthew L; Voils, Corrine IBACKGROUND: Less than 1% of severely obese US adults undergo bariatric surgery annually. It is critical to understand the factors that contribute to its utilization. OBJECTIVES: To understand how primary care physicians (PCPs) make decisions regarding severe obesity treatment and bariatric surgery referral. SETTING: Focus groups with PCPs practicing in small, medium, and large cities in Wisconsin. METHODS: PCPs were asked to discuss prioritization of treatment for a severely obese patient with multiple co-morbidities and considerations regarding bariatric surgery referral. Focus group sessions were analyzed by using a directed approach to content analysis. A taxonomy of consensus codes was developed. Code summaries were created and representative quotes identified. RESULTS: Sixteen PCPs participated in 3 focus groups. Four treatment prioritization approaches were identified: (1) treat the disease that is easiest to address; (2) treat the disease that is perceived as the most dangerous; (3) let the patient set the agenda; and (4) address obesity first because it is the common denominator underlying other co-morbid conditions. Only the latter approach placed emphasis on obesity treatment. Five factors made PCPs hesitate to refer patients for bariatric surgery: (1) wanting to "do no harm"; (2) questioning the long-term effectiveness of bariatric surgery; (3) limited knowledge about bariatric surgery; (4) not wanting to recommend bariatric surgery too early; and (5) not knowing if insurance would cover bariatric surgery. CONCLUSION: Decision making by PCPs for severely obese patients seems to underprioritize obesity treatment and overestimate bariatric surgery risks. This could be addressed with PCP education and improvements in communication between PCPs and bariatric surgeons.Item Open Access Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.(Contemporary clinical trials, 2023-02) Ulmer, Christi S; Bosworth, Hayden B; Zervakis, Jennifer; Goodwin, Kaitlyn; Gentry, Pamela; Rose, Cynthia; Jeffreys, Amy S; Olsen, Maren K; Weidenbacher, Hollis J; Beckham, Jean C; Voils, Corrine IBackground
Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi.Methods
In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life.Conclusion
Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care.Clinical trials
Gov identifier
NCT03727438.Item Open Access Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.(Contemp Clin Trials, 2013-07) Corsino, Leonor; Lin, Pao-Hwa; Batch, Bryan C; Intille, Stephen; Grambow, Steven C; Bosworth, Hayden B; Bennett, Gary G; Tyson, Crystal; Svetkey, Laura P; Voils, Corrine IObesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed.Item Open Access Self-reported medication nonadherence predicts cholesterol levels over time.(Journal of psychosomatic research, 2019-03) Blalock, Dan V; Zullig, Leah L; Bosworth, Hayden B; Taylor, Shannon S; Voils, Corrine IObjective
Self-report measures of medication nonadherence are frequently adapted to new clinical populations without evidence of validity. We evaluated the predictive validity of a medication nonadherence measure previously validated in patients with hypertension among patients taking cholesterol-reducing medications.Method
This secondary analysis involves data from a randomized trial (VA HSR&D IIR 08-297) conducted at the Durham Veterans Affairs Medical Center. At baseline, 6-months, and 12-months, serum cholesterol was obtained and participants (n = 236) completed a 3-item measure of extent of nonadherence to cholesterol-reducing medications. Two cross-lagged panel models with covariates, in addition to growth curve analysis, were used to examine the predictive utility of self-reported nonadherence on concurrent and future cholesterol levels, while accounting for potential reverse-causation.Results
Extent of nonadherence items produced reliable scores across time and fit a single-factor model (CFI = 0.99). Nonadherence, and changes in nonadherence, moderately predicted future cholesterol values, and changes in cholesterol values (7 of 9 longitudinal associations were significant at p < .05; B's ranged from 0.16 to 0.35). Evidence for reverse associations was weaker (3 of 9 longitudinal associations were significant at p < .05; B's ranged from 0.16 to 0.36).Conclusion
Analyses support the predictive validity of this medication nonadherence measure over the competing reverse-causation hypothesis.Item Open Access Systematic review and metasummary of attitudes toward research in emergency medical conditions(Journal of Medical Ethics, 2014-01-01) Limkakeng, Alexander T; de Oliveira, Lucas Lentini Herling; Moreira, Tais; Phadtare, Amruta; Garcia Rodrigues, Clarissa; Hocker, Michael B; McKinney, Ross; Voils, Corrine I; Pietrobon, RicardoEmergency departments are challenging research settings, where truly informed consent can be difficult to obtain. A deeper understanding of emergency medical patients' opinions about research is needed. We conducted a systematic review and meta-summary of quantitative and qualitative studies on which values, attitudes, or beliefs of emergent medical research participants influence research participation. We included studies of adults that investigated opinions toward emergency medicine research participation. We excluded studies focused on the association between demographics or consent document features and participation and those focused on non-emergency research. In August 2011, we searched the following databases: MEDLINE, EMBASE, Google Scholar, Scirus, PsycINFO, AgeLine and Global Health. Titles, abstracts and then full manuscripts were independently evaluated by two reviewers. Disagreements were resolved by consensus and adjudicated by a third author. Studies were evaluated for bias using standardised scores. We report themes associated with participation or refusal. Our initial search produced over 1800 articles. A total of 44 articles were extracted for full-manuscript analysis, and 14 were retained based on our eligibility criteria. Among factors favouring participation, altruism and personal health benefit had the highest frequency. Mistrust of researchers, feeling like a 'guinea pig' and risk were leading factors favouring refusal. Many studies noted limitations of informed consent processes in emergent conditions. We conclude that highlighting the benefits to the participant and society, mitigating risk and increasing public trust may increase research participation in emergency medical research. New methods for conducting informed consent in such studies are needed.Item Open Access The role of psychological science in efforts to improve cardiovascular medication adherence.(The American psychologist, 2018-11) Bosworth, Hayden B; Blalock, Dan V; Hoyle, Rick H; Czajkowski, Susan M; Voils, Corrine IPoor adherence to cardiovascular disease medications carries significant psychological, physical, and economic costs, including failure to achieve therapeutic goals, high rates of hospitalization and health care costs, and incidence of death. Despite much effort to design and evaluate adherence interventions, rates of adherence to cardiovascular-related medications have remained relatively stagnant. We identify two major reasons for this: First, interventions have not addressed the time-varying reasons for nonadherence, and 2nd, interventions have not explicitly targeted the self-regulatory processes involved in adherence behavior. Inclusion of basic and applied psychological science in intervention development may improve the efficacy and effectiveness of behavioral interventions to improve adherence. In this article, we use a taxonomy of time-based phases of adherence-including initiation, implementation, and discontinuation-as context within which to review illustrative studies of barriers to adherence, interventions to improve adherence, and self-regulatory processes involved in adherence. Finally, we suggest a framework to translate basic psychological science regarding self-regulation into multicomponent interventions that can address multiple and time-varying barriers to nonadherence across the three adherence phases. The field of psychology is essential to improving medication adherence and associated health outcomes, and concrete steps need to be taken to implement this knowledge in future interventions. (PsycINFO Database Record (c) 2018 APA, all rights reserved).Item Open Access The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model.(Patient education and counseling, 2011-07) Voils, Corrine I; Yancy, William S; Weinberger, Morris; Bolton, Jamiyla; Coffman, Cynthia J; Jeffreys, Amy; Oddone, Eugene Z; Bosworth, Hayden BObjective
Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial.Methods
This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months.Results
Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%.Conclusion
In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols.Practice implications
To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention.Item Open Access Understanding the Context for Long-Term Care Planning.(Med Care Res Rev, 2016-06) Broyles, Ila H; Sperber, Nina R; Voils, Corrine I; Konetzka, R Tamara; Coe, Norma B; Van Houtven, Courtney HaroldEvolving family structure and economic conditions may affect individuals' ability and willingness to plan for future long-term care (LTC) needs. We applied life course constructs to analyze focus group data from a study of family decision making about LTC insurance. Participants described how past exposure to caregiving motivated them to engage in LTC planning; in contrast, child rearing discouraged LTC planning. Perceived institutional and economic instability drove individuals to regard financial LTC planning as either a wise precaution or another risk. Perceived economic instability also shaped opinions that adult children are ill-equipped to support parents' LTC. Despite concerns about viability of social insurance programs, some participants described strategies to maximize gains from them. Changing norms around aging and family roles also affected expectations of an active older age, innovative LTC options, and limitations to adult children's involvement. Understanding life course context can inform policy efforts to encourage LTC planning.Item Open Access Validation of a measure of family experience of patients with serious illness: the QUAL-E (Fam).(Journal of pain and symptom management, 2014-12) Steinhauser, Karen E; Voils, Corrine I; Bosworth, Hayden B; Tulsky, James AContext
Family members of seriously ill patients experience significant burden as they advocate with providers and participate in key decisions for loved ones. Most assessments focus on patient experience, yet family members' own quality of experience is central to comprehensive care.Objectives
This study validated a measure of the quality of family experience, the QUAL-E (Fam), in palliative care.Methods
We enrolled family members of terminally ill patients admitted to general medicine services at two hospitals. Items were based on foundational work originally done for the patient instrument, QUAL-E, and interviews of family members of terminally ill patients. Cognitive interviewing was used to refine items, which then underwent formal testing factor analysis. In the first sample, we assessed factor structure. A subsequent sample established predictive validity and test-retest reliability.Results
The initial item pool was reduced to a four-domain, 35-item scale and administered to the validation sample. Further analyses produced a final brief scale comprising 17 items, demonstrating appropriate convergent and divergent validity. Test-retest reliability demonstrated expected levels of stability in a highly changeable population. The scale provides an assessment of family experience and includes subscales assessing relationship with health care provider and completion. Additional scale items assess symptom experience and issues of preparation.Conclusion
The QUAL-E (Fam) is a companion instrument to the patient QUAL-E measure of quality of life at the end of life and is part of a package of assessment tools that can help evaluate the entire patient experience and contribute to quality care.