Exploring willingness of elder Chinese in Houston to participate in clinical research

AbstractBackground and objectivesInadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation.DesignIn this mixed methods study, a semi-structured interview, including the TIMRS were administered to 30 adults of Chinese ancestry aged 50 years or older recruited from a Chinese community center. Interviews were conducted in English, Mandarin and Cantonese and independently coded and analyzed using thematic content analysis. TIMRS scores were calculated for participants.ResultsParticipants were 70% female, 70% were 60 or elder, all were foreign born and on average lived in the US for 21.8 years. Participants perceived risks to research participation and preferred language concordant research staff. Interviewees were more willing to participate if they perceived personal and community health-related benefits. The overall TIMRS score was 23.9 (±5.0), lower than the overall TIMRS for Whites in a previous study (P < 0.001).ConclusionsThe barriers and facilitators to research participation confirmed previous research among Asians. Our participant TIMRS scores were consistent with decreased levels of trust observed in the original TIMRS study for African Americans as compared and lower than Whites. Employing strategies that utilize language concordant staff who build trust with participants may aid in recruiting elder Chinese, especially if the research is personally relevant to those being recruited

Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites). RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials\u27 recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio \u3c 1, 0.8 (adjusted 95%CL 0.4,1.8). In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in (3/4) of studied trials. Physician-investigators\u27 participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts.TRIAL REGISTRATION ClinicalTrials.govNCT01911208

Demographic disparities in receipt of care at a comprehensive cancer center

Abstract Background National Cancer Institute cancer centers (NCICCs) provide specialized cancer care including precision oncology and clinical treatment trials. While these centers can offer novel therapeutic options, less is known about when patients access these centers or at what timepoint in their disease course they receive specialized care. This is especially important since precision diagnostics and receipt of the optimal therapy upfront can impact patient outcomes and previous research suggests that access to these centers may vary by demographic characteristics. Here, we examine the timing of patients' presentation at Moffitt Cancer Center (MCC) relative to their initial diagnosis across several demographic characteristics. Methods A retrospective cohort study was conducted among patients who presented to MCC with breast, colon, lung, melanoma, and prostate cancers between December 2008 and April 2020. Patient demographic and clinical characteristics were obtained from the Moffitt Cancer Registry. The association between patient characteristics and the timing of patient presentation to MCC relative to the patient's cancer diagnosis was examined using logistic regression. Results Black patients (median days = 510) had a longer time between diagnosis and presentation to MCC compared to Whites (median days = 368). Black patients were also more likely to have received their initial cancer care outside of MCC compared to White patients (odds ratio [OR] and 95% confidence interval [CI] = 1.45 [1.32–1.60]). Furthermore, Hispanics were more likely to present to MCC at an advanced stage compared to non‐Hispanic patients (OR [95% CI] = 1.28 [1.05–1.55]). Conclusions We observed racial and ethnic differences in timing of receipt of care at MCC. Future studies should aim to identify contributing factors for the development of novel mitigation strategies and assess whether timing differences in referral to an NCICC correlate with long‐term patient outcomes

Exploring willingness of elder Chinese in Houston to participate in clinical research

Background and objectives: Inadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation. Design: In this mixed methods study, a semi-structured interview, including the TIMRS were administered to 30 adults of Chinese ancestry aged 50 years or older recruited from a Chinese community center. Interviews were conducted in English, Mandarin and Cantonese and independently coded and analyzed using thematic content analysis. TIMRS scores were calculated for participants. Results: Participants were 70% female, 70% were 60 or elder, all were foreign born and on average lived in the US for 21.8 years. Participants perceived risks to research participation and preferred language concordant research staff. Interviewees were more willing to participate if they perceived personal and community health-related benefits. The overall TIMRS score was 23.9 (±5.0), lower than the overall TIMRS for Whites in a previous study (P < 0.001). Conclusions: The barriers and facilitators to research participation confirmed previous research among Asians. Our participant TIMRS scores were consistent with decreased levels of trust observed in the original TIMRS study for African Americans as compared and lower than Whites. Employing strategies that utilize language concordant staff who build trust with participants may aid in recruiting elder Chinese, especially if the research is personally relevant to those being recruited

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach

Abstract Background Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers’ ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. Methods The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. Results The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Conclusions Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience

Design of a Cluster-randomized Minority Recruitment Trial: RECRUIT

Background: Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. Methods: We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. Results: RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values \u3e 0.17). Conclusion: RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT’s innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic’s specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses

Examining disparities in large‐scale patient‐reported data capture using digital tools among cancer patients at clinical intake

Abstract Background Patient‐reported data can improve quality of healthcare delivery and patient outcomes. Moffitt Cancer Center (“Moffitt”) administers the Electronic Patient Questionnaire (EPQ) to collect data on demographics, including sexual orientation and gender identity (SOGI), medical history, cancer risk factors, and quality of life. Here we investigated differences in EPQ completion by demographic and cancer characteristics. Methods An analysis including 146,142 new adult patients at Moffitt in 2009–2020 was conducted using scheduling, EPQ and cancer registry data. EPQ completion was described by calendar year and demographics. Logistic regression was used to estimate associations between demographic/cancer characteristics and EPQ completion. More recently collected information on SOGI were described. Results Patient portal usage (81%) and EPQ completion rates (79%) were consistently high since 2014. Among patients in the cancer registry, females were more likely to complete the EPQ than males (odds ratio [OR] = 1.17, 95% confidence interval [CI] = 1.14–1.20). Patients ages 18–64 years were more likely to complete the EPQ than patients aged ≥65. Lower EPQ completion rates were observed among Black or African American patients (OR = 0.59, 95% CI = 0.56–0.63) as compared to Whites and among patients whose preferred language was Spanish (OR = 0.40, 95% CI = 0.36–0.44) or another language as compared to English. Furthermore, patients with localized (OR = 1.16, 95% CI = 1.12–1.19) or regional (OR = 1.16, 95% CI = 1.12–1.20) cancer were more likely to complete the EPQ compared to those with metastatic disease. Less than 3% of patients self‐identified as being lesbian, gay, or bisexual and <0.1% self‐identified as transgender, genderqueer, or other. Conclusions EPQ completion rates differed across demographics highlighting opportunities for targeted process improvement. Healthcare organizations should evaluate data acquisition methods to identify potential disparities in data completeness that can impact quality of clinical care and generalizability of self‐reported data