ABSTRACT
BACKGROUND: Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. METHODS: This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs ("hospital-HHA" dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF's implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. DISCUSSION: As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. TRIAL REGISTRATION: This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .
Subject(s)
Heart Failure , Home Care Services , Patient Readmission , Humans , Heart Failure/therapy , United States , Patient Readmission/statistics & numerical data , Patient Transfer , Medicare , Patient Discharge , Quality Improvement , FemaleABSTRACT
Reducing cardiovascular disease disparities will require a concerted, focused effort to better adopt evidence-based interventions, in particular, those that address social determinants of health, in historically marginalized populations (ie, communities excluded on the basis of social identifiers like race, ethnicity, and social class and subject to inequitable distribution of social, economic, physical, and psychological resources). Implementation science is centered around stakeholder engagement and, by virtue of its reliance on theoretical frameworks, is custom built for addressing research-to-practice gaps. However, little guidance exists for how best to leverage implementation science to promote cardiovascular health equity. This American Heart Association scientific statement was commissioned to define implementation science with a cardiovascular health equity lens and to evaluate implementation research that targets cardiovascular inequities. We provide a 4-step roadmap and checklist with critical equity considerations for selecting/adapting evidence-based practices, assessing barriers and facilitators to implementation, selecting/using/adapting implementation strategies, and evaluating implementation success. Informed by our roadmap, we examine several organizational, community, policy, and multisetting interventions and implementation strategies developed to reduce cardiovascular disparities. We highlight gaps in implementation science research to date aimed at achieving cardiovascular health equity, including lack of stakeholder engagement, rigorous mixed methods, and equity-informed theoretical frameworks. We provide several key suggestions, including the need for improved conceptualization and inclusion of social and structural determinants of health in implementation science, and the use of adaptive, hybrid effectiveness designs. In addition, we call for more rigorous examination of multilevel interventions and implementation strategies with the greatest potential for reducing both primary and secondary cardiovascular disparities.
Subject(s)
Health Equity , Humans , Implementation Science , American Heart Association , Healthcare Disparities , Social ClassABSTRACT
Population cardiovascular health, or improving cardiovascular health among patients and the population at large, requires a redoubling of primordial and primary prevention efforts as declines in cardiovascular disease mortality have decelerated over the past decade. Great potential exists for healthcare systems-based approaches to aid in reversing these trends. A learning healthcare system, in which population cardiovascular health metrics are measured, evaluated, intervened on, and re-evaluated, can serve as a model for developing the evidence base for developing, deploying, and disseminating interventions. This scientific statement on optimizing population cardiovascular health summarizes the current evidence for such an approach; reviews contemporary sources for relevant performance and clinical metrics; highlights the role of implementation science strategies; and advocates for an interdisciplinary team approach to enhance the impact of this work.
Subject(s)
American Heart Association , Cardiovascular Diseases/therapy , Learning Health System/methods , Patient Care Team , Population Health , Cardiovascular Diseases/epidemiology , Humans , Learning Health System/standards , Patient Care Team/standards , United States/epidemiologyABSTRACT
BACKGROUND: Historically, race, income, and gender were associated with likelihood of receipt of coronary revascularization for acute myocardial infarction (AMI). Given public health initiatives such as Healthy People 2010, it is unclear whether race and income remain associated with the likelihood of coronary revascularization among women with AMI. METHODS: Using the Women's Health Initiative Study, hazards ratio (HR) of revascularization for AMI was compared for Black and Hispanic women vs White women and among women with annual income <$20,000/year vs ≥$20,000/year over median 9.5 years follow-up(1993-2019). Proportional hazards models were adjusted for demographics, comorbidities, and AMI type. Results were stratified by revascularization type: percutaneous coronary intervention and coronary artery bypass grafting(CABG). Trends by race and income were compared pre- and post-2010 using time-varying analysis. RESULTS: Among 5,284 individuals with AMI (9.5% Black, 2.8% Hispanic, and 87.7% White; 23.2% <$20,000/year), Black race was associated with lower likelihood of receiving revascularization for AMI compared to White race in fully adjusted analyses [HR:0.79(95% Confidence Interval:[CI]0.66,0.95)]. When further stratified by type of revascularization, Black race was associated with lower likelihood of percutaneous coronary intervention for AMI compared to White race [HR:0.72(95% CI:0.59,0.90)] but not for CABG [HR:0.97(95%CI:0.72,1.32)]. Income was associated with lower likelihood of revascularization [HR:0.90(95%CI:0.82,0.99)] for AMI. No differences were observed for other racial/ethnic groups. Time periods (pre/post-2010) were not associated with change in revascularization rates. CONCLUSION: Black race and income remain associated with lower likelihood of revascularization among patients presenting with AMI. There is a substantial need to disrupt the mechanisms contributing to race, sex, and income disparities in AMI management.
Subject(s)
Ethnicity , Myocardial Infarction , Female , Humans , Myocardial Infarction/epidemiology , Myocardial Infarction/surgery , Myocardial Revascularization , Postmenopause , White People , Women's HealthABSTRACT
BACKGROUND: Question prompt lists (QPLs) are an effective tool for improving communication during medical visits. However, no studies have attempted to correlate intentions related to question asking and actual questions asked during visits. Moreover, few studies have used QPLs with patients with heart failure (HF) or family companions who accompany them to visits. We examined the use of a previsit QPL for patients with HF and their family companions intended to enhance engagement in HF care. The aim of this research was to assess which questions from the QPL patients and companions selected most frequently to ask and compare this item with which questions were actually asked during the medical visit. METHODS AND RESULTS: This secondary analysis of QOLs and audiotaped visit data from a pilot study enrolled and consented patients with HF, family companions, and HF clinicians. A single group of 30 patients with HF and 23 family companions received the QPL to complete in the waiting room immediately before their cardiology visit. To meet our aims, we calculated the frequencies for each question selected and asked from the QPL, using data derived from completed prompt lists and audiotaped medical visits. A follow-up survey was administered 2 days after the appointment to assess differences in how participants filled out and used the prompt list. Patients and companions primarily selected and asked questions from the QPL regarding the management and treatment of the disease, general questions about HF, and questions about prognosis. Participants rarely asked questions about support for family and friends or health care team roles and responsibilities. Patients and companions did not ask many of the questions they reported wanting to ask. CONCLUSIONS: Prompt lists may empower patients and companions to communicate with their clinician by identifying important questions to help overcome patients' and companions' knowledge gaps. More research is needed to understand the true impact of prompt lists on patient-family-clinician communication and subsequent HF outcomes, and how best to implement them in clinical workflows to increase their potential usefulness.
Subject(s)
Heart Failure , Physician-Patient Relations , Friends , Heart Failure/diagnosis , Heart Failure/therapy , Humans , Patient Participation , Pilot Projects , Surveys and QuestionnairesABSTRACT
BACKGROUND The medical-legal partnership (MLP) is an innovative and proven-effective approach to addressing health-harming social needs that have legal remedies (e.g., housing concerns, intimate partner violence). Yet, few MLPs exist within outpatient primary care practices and in rural settings.METHODS We describe the impact of an MLP between Pisgah Legal Services and the Mountain Area Health Education Center, which serves rural North Carolina counties, over a 24-month period.RESULTS Overall, 629 cases were referred to the MLP. Three hundred seventy cases were opened and investigated by a lawyer. Three hundred sixty-four cases were closed (i.e., a resolution was reached), yielding 808 outcomes, with an average of 2.2 outcomes per case. Domestic violence/family law and housing were the main socio-legal concerns addressed by the MLP. Eighty-six (24%) of cases included at least 1 representation outcome; the success rate in representation cases was 90%.LIMITATIONS We did not examine the impact of the MLP on patient health outcomes, nor did we have comparative outcomes data for similar individuals with unmet social needs but who did not receive MLP services.CONCLUSIONS The MLP was successful in helping to address multiple social needs faced by patients that contribute to worse health status and outcomes. Monetary benefits to patients were $309,902 plus an additional $174,733 from tax returns and the Earned Income Tax Credit. The MLP lawyer provided education and training to support clinicians, learners, and community organizations. These data highlight the benefits of collaboration between health professionals and lawyers in advancing equity by addressing unmet social needs.
Subject(s)
Health Personnel , Health Status , Humans , North Carolina , Income , LawyersABSTRACT
BACKGROUND: African American and Hispanic postmenopausal women have the highest risk for heart failure compared with other races, but heart failure prevalence is lower than expected in some national cohorts. It is unknown whether psychosocial factors are associated with lower risk of incident heart failure hospitalization among high-risk postmenopausal minority women. METHODS AND RESULTS: Using the Women's Health Initiative Study, African American and US Hispanic women were classified as high-risk for incident heart failure hospitalization with 1 or more traditional heart failure risk factors and the highest tertile heart failure genetic risk scores. Positive psychosocial factors (optimism, social support, religion) and negative psychosocial factors (living alone, social strain, depressive symptoms) were measured using validated survey instruments at baseline. Adjusted subdistribution hazard ratios of developing heart failure hospitalization were determined with death as a competing risk. Positive deviance indicated not developing incident heart failure hospitalization with 1 or more risk factors and the highest tertile for genetic risk. Among 7986 African American women (mean follow-up of 16 years), 27.0% demonstrated positive deviance. Among high-risk African American women, optimism was associated with modestly reduced risk of heart failure hospitalization (subdistribution hazard ratio 0.94, 95% confidence interval 0.91-0.99), and social strain was associated with modestly increased risk of heart failure hospitalization (subdistribution hazard ratio 1.07, 95% confidence interval 1.02-1.12) in the initial models; however, no psychosocial factors were associated with heart failure hospitalization in fully adjusted analyses. Among 3341 Hispanic women, 25.1% demonstrated positive deviance. Among high-risk Hispanic women, living alone was associated with increased risk of heart failure hospitalization (subdistribution hazard ratio 1.97, 95% confidence interval 1.06-3.63) in unadjusted analyses; however, no psychosocial factors were associated with heart failure hospitalization in fully adjusted analyses. CONCLUSIONS: Among postmenopausal African American and Hispanic women, a significant proportion remained free from heart failure hospitalization despite having the highest genetic risk profile and 1 or more traditional risk factors. No observed psychosocial factors were associated with incident heart failure hospitalization in high-risk African Americans and Hispanics. Additional investigation is needed to understand protective factors among high-risk African American and Hispanic women.
Subject(s)
Black or African American , Heart Failure , Ethnicity , Female , Heart Failure/diagnosis , Heart Failure/epidemiology , Hispanic or Latino , Humans , Postmenopause , Risk FactorsABSTRACT
Few studies examine the network structure and function of older women's health discussion networks. We sought to assess the feasibility and acceptability of collecting social network data via telephone from 72 women from the Women's Health Initiative study and to describe structural and functional characteristics. Women were socially connected and had dense networks. Women were emotionally close to network members, but their networks were not used to facilitate communication with health-care providers. One-third of network members was not influential on health-related decision-making. Collecting social network data via telephone is feasible and an acceptable, though un-preferred, mode of data collection.
Subject(s)
Social Networking , Social Support , Women's Health , Aged , Cross-Sectional Studies , Feasibility Studies , Female , Health Communication/methods , Health Knowledge, Attitudes, Practice , Humans , Middle Aged , Pilot Projects , Surveys and Questionnaires , TelephoneABSTRACT
BACKGROUND: We evaluated associations between perceived social support, social integration, living alone, and colorectal cancer (CRC) outcomes in postmenopausal women. METHODS: The study included 1431 women from the Women's Health Initiative who were diagnosed from 1993 through 2017 with stage I through IV CRC and who responded to the Medical Outcomes Study Social Support survey before their CRC diagnosis. We used proportional hazards regression to evaluate associations of social support (tertiles) and types of support, assessed up to 6 years before diagnosis, with overall and CRC-specific mortality. We also assessed associations of social integration and living alone with outcomes also in a subset of 1141 women who had information available on social ties (marital/partner status, community and religious participation) and living situation. RESULTS: In multivariable analyses, women with low (hazard ratio [HR], 1.52; 95% CI, 1.23-1.88) and moderate (HR, 1.21; 95% CI, 0.98-1.50) perceived social support had significantly higher overall mortality than those with high support (P [continuous] < .001). Similarly, women with low (HR, 1.42; 95% CI, 1.07-1.88) and moderate (HR, 1.28; 95% CI, 0.96-1.70) perceived social support had higher CRC mortality than those with high social support (P [continuous] = .007). Emotional, informational, and tangible support and positive interaction were all significantly associated with outcomes, whereas affection was not. In main-effects analyses, the level of social integration was related to overall mortality (P for trend = .02), but not CRC mortality (P for trend = .25), and living alone was not associated with mortality outcomes. However, both the level of social integration and living alone were related to outcomes in patients with rectal cancer. CONCLUSIONS: Women with low perceived social support before diagnosis have higher overall and CRC-specific mortality.
Subject(s)
Colorectal Neoplasms/mortality , Colorectal Neoplasms/psychology , Postmenopause/psychology , Rectal Neoplasms/mortality , Rectal Neoplasms/psychology , Aged , Female , Humans , Middle Aged , Multivariate Analysis , Proportional Hazards Models , Risk Factors , Social Integration , Social Support , Women's HealthABSTRACT
PURPOSE: In the United States, 42% of adults, and 81% of adults over 65 years of age live with multiple chronic condition (MCC). Current interventions to facilitate engagement in care focus primarily on the patient; however, many individuals with MCC manage and live with their conditions within the context of their family. This review sought to identify interventions used to facilitate patient and/or family engagement among adults with MCC. METHODS: We adhered as closely as possible to PRISMA guidelines and conducted a systematic scoping review using a modified approach by Arksey and O'Malley. We searched PubMed, Web of Science, and Scopus using terms related to MCC, patient and family engagement, and intervention. We included articles that: (1) were published in English; (2) were peer-reviewed; (3) described an engagement intervention (with or without a comparator); and (4) targeted individuals with MCC. We abstracted data from included articles and classified them using the Multidimensional Framework for Patient and Family Engagement in Health and Health Care, and the Classification Model of Patient Engagement. RESULTS: We identified 21 discrete interventions. Six (29%) were classified as having the highest degree of engagement. Eighteen (85%) focused on engagement at the direct care level. Only one was specifically designed to engage families. CONCLUSIONS: Many engagement interventions currently exist for adults with MCC. Few of these interventions foster the highest degree of engagement; most focus on engagement at the level of direct care and do not specifically target family member involvement.
Subject(s)
Chronic Disease/therapy , Family , Patient Participation , Social Support , Humans , United StatesABSTRACT
BACKGROUND: Practice facilitation is a promising strategy to enhance care processes and outcomes in primary care settings. It requires that practices and their facilitators engage as teams to drive improvement. In this analysis, we explored the practice and facilitator factors associated with greater team engagement at the mid-point of a 12-month practice facilitation intervention focused on implementing cardiovascular prevention activities in practice. Understanding factors associated with greater engagement with facilitators in practice-based quality improvement can assist practice facilitation programs with planning and resource allocation. METHODS: One hundred thirty-six ambulatory care small to medium sized primary care practices that participated in the EvidenceNow initiative's NC Cooperative, named Heart Health Now (HHN), fit the eligibility criteria for this analysis. We explored the practice and facilitator factors associated with greater team engagement at the mid-point of a 12-month intervention using a retrospective cohort design that included baseline survey data, monthly practice activity implementation data and information about facilitator's experience. Generalized linear mixed-effects models (GLMMs) identified variables associated with greater odds of team engagement using an ordinal scale for level of team engagement. RESULTS: Among our practice cohort, over half were clinician-owned and 27% were Federally Qualified Health Centers. The mean number of clinicians was 4.9 (SD 4.2) and approximately 40% of practices were in Medically Underserved Areas (MUA). GLMMs identified a best fit model. The Model presented as odd ratios and 95% confidence intervals suggests greater odds ratios of higher team engagement with greater practice QI leadership 17.31 (5.24-57.19), [0.00], and practice location in a MUA 7.25 (1.8-29.20), [0.005]. No facilitator characteristics were independently associated with greater engagement. CONCLUSIONS: Our analysis provides information for practice facilitation stakeholders to consider when considering which practices may be more amendable to embracing facilitation services.
Subject(s)
Primary Health Care/standards , Quality Improvement , Cardiovascular Diseases/prevention & control , Humans , Patient Care Team/standards , Retrospective StudiesABSTRACT
BACKGROUND: Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants. METHODS: STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software. RESULTS: Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery. CONCLUSIONS: The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes. TRIAL REGISTRATION: NCT02560922 , registered September 25, 2015.
Subject(s)
Black or African American , Osteoarthritis , Adaptation, Psychological , Humans , Osteoarthritis/diagnosis , Osteoarthritis/therapy , Pain , TelephoneABSTRACT
Evidence of the effectiveness of community-based lifestyle behavior change interventions among African-American adults is mixed. We implemented a behavioral lifestyle change intervention, Heart Matters, in two rural counties in North Carolina with African-American adults. Our aim was to evaluate the effect of Heart Matters on dietary and physical activity behaviors, self-efficacy, and social support. We used a cluster randomized controlled trial to compare Heart Matters to a delayed intervention control group after 6 months. A total of 143 African-American participants were recruited and 108 completed 6-month follow-up assessments (75.5%). We used mixed regression models to evaluate changes in outcomes from baseline to 6-month follow-up. The intervention had a significant positive effect on self-reported scores of encouragement of healthy eating, resulting in an increase in social support from family of 6.11 units (95% CI [1.99, 10.22]) (p < .01). However, intervention participants also had an increase in discouragement of healthy eating compared to controls of 5.59 units (95% CI [1.46, 9.73]) among family (p < .01). There were no significant differences in changes in dietary behaviors. Intervention participants had increased odds (OR = 2.86, 95% CI [1.18, 6.93]) of increased frequency of vigorous activity for at least 20 min per week compared to control participants (p < .05). Individual and group lifestyle behavior counseling can have a role in promoting physical activity levels among rural African-American adults, but more research is needed to identify the best strategies to bolster effectiveness and influence dietary change. Trial Registration: Clinical Trials, NCT02707432. Registered 13 March 2016.
Subject(s)
Black or African American , Community Networks , Diet , Exercise , Health Promotion , Program Evaluation , Adult , Cluster Analysis , Female , Humans , Life Style , Male , Middle Aged , Rural PopulationABSTRACT
Health literacy is the degree to which individuals are able to access and process basic health information and services and thereby participate in health-related decisions. Limited health literacy is highly prevalent in the United States and is strongly associated with patient morbidity, mortality, healthcare use, and costs. The objectives of this American Heart Association scientific statement are (1) to summarize the relevance of health literacy to cardiovascular health; (2) to present the adverse associations of health literacy with cardiovascular risk factors, conditions, and treatments; (3) to suggest strategies that address barriers imposed by limited health literacy on the management and prevention of cardiovascular disease; (4) to demonstrate the contributions of health literacy to health disparities, given its association with social determinants of health; and (5) to propose future directions for how health literacy can be integrated into the American Heart Association's mandate to advance cardiovascular treatment and research, thereby improving patient care and public health. Inadequate health literacy is a barrier to the American Heart Association meeting its 2020 Impact Goals, and this statement articulates the rationale to anticipate and address the adverse cardiovascular effects associated with health literacy.
Subject(s)
Cardiovascular Diseases/prevention & control , Health Literacy , American Heart Association , Humans , Patient Education as Topic , Prevalence , Primary Prevention , Risk Factors , Secondary Prevention , United StatesABSTRACT
BACKGROUND: Racial disparities in blood pressure (BP) control persist, but whether differences by race in antihypertensive medication intensification (AMI) contribute is unknown. OBJECTIVE: To compare AMI by race for patients with elevated home BP readings. METHODS: This prospective cohort study followed adult patients from 6 rural primary care practices who used home BP monitoring (HBPM) and recorded/reported values. For providers, AMI was encouraged when mean HBPM systolic blood pressure (SBP) values were ⩾135 mm Hg; patients received phone-based coaching on HBPM technique and sharing HBPM findings. AMI was assessed between baseline and 12 months using defined daily dose (DDD) and summed to create a total antihypertensive DDD value. RESULTS: A total of 217 patients (mean age = 61.4 ± 10.2 years; 66% female; 57% black) provided usable HBPM data. Among 90 (41%) intensification-eligible hypertensive patients (ie, mean HBPM SBP values for 6-months ⩾135 mm Hg), mean total antihypertensive DDD was increased in 61% at 12 months. Blacks had significantly higher mean DDD at baseline and 12 months, but intensification (+0.72 vs +0.65; P = 0.83) was similar by race. However, intensification was greater in males than females (+1.1 vs +0.39; P = 0.031). Reduction in mean SBP following intensification was greater in white versus black patients (-8.2 vs -3.9 mm Hg; P = 0.14). Conclusion/Relevance: Treatment intensification in HBPM users was similar by race, differed significantly by gender, and may produce a greater response in white patients. Differential AMI in HBPM users does not appear to contribute to persistent racial disparities in BP control.
Subject(s)
Antihypertensive Agents/therapeutic use , Black or African American , Blood Pressure Monitoring, Ambulatory/methods , Blood Pressure/drug effects , Hypertension/diagnosis , Adult , Aged , Algorithms , Blood Pressure Monitoring, Ambulatory/statistics & numerical data , Contraindications , Female , Humans , Hypertension/drug therapy , Hypertension/ethnology , Male , Middle Aged , Prospective Studies , Race Factors , Sex FactorsABSTRACT
BACKGROUND: African Americans living in the rural south have the highest prevalence of cardiovascular disease (CVD) risk in the United States. Given this geographic and racial disparity, intervention implementation needs to be evaluated for effectiveness and feasibility with African Americans in the rural south. METHODS: The trial developed out of a community-based participatory research partnership, Project GRACE, and community partners who are collaborators throughout the study. Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from PREMIER, an evidence-based treatment targeting multiple CVD risk factors. 140 participants will be recruited through 8 community- or faith-based organizations to participate in the intervention. Through matched pair randomization, organizations will be randomized to begin immediately after baseline data collection (Arm 1) or delayed 6 months (Arm 2). Data collection will occur at baseline, 6, 12, and 18 months. The primary outcome is change in body weight. In addition to assessing effectiveness, the study will also evaluate process and feasibility outcomes through quantitative and qualitative data collection. DISCUSSION: This study will contribute to CVD prevention research and likely have a positive impact on the rural, African American community where the trial occurs. Our study is unique in its use of community partnerships to develop, implement, and evaluate the intervention. We expect that this approach will enhance the feasibility of the trial, as well as future dissemination and sustainability of the intervention. TRIAL REGISTRATION: Clinical Trials, NCT02707432 . Registered 13 March 2016.
Subject(s)
Behavior Therapy/methods , Black or African American , Cardiovascular Diseases/prevention & control , Preventive Health Services/methods , Rural Health Services , Cardiovascular Diseases/ethnology , Community-Based Participatory Research , Data Collection , Female , Humans , Male , Program Evaluation , Randomized Controlled Trials as Topic , Risk Factors , Risk Reduction Behavior , Rural Population , Southeastern United StatesABSTRACT
BACKGROUND: The Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA. METHODS: A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities' Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies. RESULTS: The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61-86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62-66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m2 (SD = 8.2), was higher than all other studies (30-34 kg/m2). STAART participants' mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7-17). CONCLUSIONS: Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants' high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach. TRIAL REGISTRATION: NCT02560922.