The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention.
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ABSTRACT:
SUBMITTER: Wilkins CH
PROVIDER: S-EPMC8634298 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Recruitment and retention are two significant barriers in research, particularly for historically underrepresented groups, including racial and ethnic minorities, patients who are low-income, or people with substance use or mental health issues. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death and disproportionately affects many underrepresented groups. The lack of representation of these groups in research limits the generalizability and applicability of clinical research and results. In this paper we describe our experience and rates of recruitment and retention of underrepresented groups for the Aides in Respiration (AIR) COPD Health Coaching Study. METHODS:A priori design strategies included minimizing exclusion criteria, including patients in the study process, establishing partnerships with the community clinics, and ensuring that the health coaching intervention was flexible enough to accommodate patient needs. RESULTS:Challenges to recruitment included lack of spirometric data in patient records, space constraints at the clinic sites, barriers to patient access to clinic sites, lack of current patient contact information and poor patient health. Of 282 patients identified as eligible, 192 (68%) were enrolled in the study and 158 (82%) completed the study. Race, gender, educational attainment, severity of disease, health literacy, and clinic site were not associated with recruitment or retention. However, older patients were less likely to enroll in the study and patients who used home oxygen or had more than one hospitalization during the study period were less likely to complete the study. Three key strategies to maximize recruitment and retention were identified during the study: incorporating the patient perspective, partnering with the community clinics, and building patient rapport. CONCLUSIONS:While the AIR study included design features to maximize the recruitment and retention of patients from underrepresented groups, additional challenges were encountered and responded to during the study. We also identified three key strategies recommended for future studies of COPD and similar conditions. Incorporating the approaches described into future studies may increase participation rates from underrepresented groups, providing results that can be more accurately applied to patients who carry a disparate burden of disease. TRIAL REGISTRATION:This trial was registered at ClinicalTrial.gov at identifier NCT02234284 on August 12, 2014. Descriptor number: 2.9 Racial, ethnic, or social disparities in lung disease and treatment.
| S-EPMC6385381 | biostudies-literature
Project description:BackgroundConducting longitudinal research studies with low-income and/or minority participants present a unique set of challenges and opportunities.PurposeTo outline the specific strategies employed to successfully recruit and retain participants in a longitudinal study of nutritional anticipatory guidance during early childhood, conducted with a low-income, ethnically diverse, urban population of mothers.MethodsWe describe recruitment and retention efforts made by the research team for the 'MOMS' Study (Making Our Mealtimes Special). The 'multilayered' approach for recruitment and retention included commitment of research leadership, piloting procedures, frequent team reporting, emphasis on participant convenience, incentives, frequent contact with participants, expanded budget, clinical staff buy-in, a dedicated phone line, and the use of research project branding and logos.ResultsBarriers to enrollment were not encountered in this project, despite recruiting from a low-income population with a large proportion of African-American families. Process evaluation with clinic staff demonstrated the perception of the MOMS staff was very positive. Participant retention rate was 75% and 64% at 6 months and 12 months post-recruitment, respectively. We attribute retention success largely to a coordinated effort between the research team and the infrastructure support at the clinical sites, as well as project branding and a dedicated phone line.ConclusionsSuccessful participant recruitment and retention approaches need to be specific and consistent with clinical staff buy in throughout the project.
| S-EPMC3070062 | biostudies-literature
Project description:BACKGROUND:Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. METHODS:This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. RESULTS:We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. CONCLUSIONS:We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies. TRIAL REGISTRATION:Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.
| S-EPMC5870194 | biostudies-literature
Project description:Background: Delivering person-centered care is a key component of health care reform. Despite widespread endorsement, medical and behavioral health settings struggle to specify and measure person-centered care objectively. This study presents the validity and reliability of the Person-Centered Care Planning Assessment Measure (PCCP-AM), an objective measure of the extent to which service planning is person-centered. Methods: Based upon the recovery-oriented practice of person-centered care planning, the 10-item PCCP-AM tool rates service plans on the inclusion of service user strengths, personal life goals, natural supports, self-directed actions and the promotion of community integration. As part of a large randomized controlled trial of person-centered care planning, service plans completed by community mental health clinic providers were rated using the PCCP-AM. Reliability was tested by calculating inter-rater reliability across 168 plans and internal consistency across 798 plans. To test concurrent validity, PCCP-AM scores for 84 plans were compared to expert rater scores on a separate instrument. Results: Interrater reliability for each of the 10 PCCP-AM items as measured by Kendall's W ranged from W = 0.77 to W = 0.89 and percent of scores within ± 1 point of each other ranged from 85.7 to 100%. Overall internal consistency as measured by Cronbach's alpha across 798 plans was α = 0.72. Concurrent validity as measured by Kendall's W ranged from W = 0.55 to W = 0.74 and percent of item scores within ± 1 point of expert rater scores ranged from 73.8 to 86.8%. Conclusions: Findings demonstrated that the 10-item PCCP-AM was a valid and reliable objective measure of person-centered care. Using the service plan as an indicator of multiple domains of person-centered care, the measure provides a valuable tool to inform clinical supervision and quality improvement across programs. More psychometric testing is needed to strengthen the measure for research purposes.
| S-EPMC8365091 | biostudies-literature
Project description:In daily academic life, students are exposed to a wide range of potentially stressful situations which could negatively affect their academic achievement and their health. Among the factors that could be weakened by academic stress, attention has been paid to expectations of self-efficacy, which are considered one of the most important determinants for student engagement, persistence, and academic success. From a proactive perspective, research on academic stress has emphasized the importance of coping strategies in preventing harmful consequences. In recent years, there has been a growing interest in discovering the extent to which individuals are able to combine different coping strategies and the adaptive consequences this flexibility entails. However, studies using this person-centered approach are still scarce in the academic context. On that basis, this current study had two objectives: (a) to examine the existence of different profiles of university students based on how they combined different approach coping strategies (positive reappraisal, support seeking, and planning) and (b) to determine the existence of differences in general expectations of self-efficacy between those coping profiles. A total of 1,072 university students participated in the study. The coping profiles were determined by latent profile analysis (LPA). The differences in the self-efficacy variable were determined using ANCOVA, with gender, university year, and degree type as covariates. Four approach coping profiles were identified: (a) low generalized use of approach coping strategies; (b) predominance of social approach coping approaches; (c) predominance of cognitive approach coping approaches; and (d) high generalized use of approach coping strategies. The profile showed that a greater combination of the three strategies was related to higher general self-efficacy expectations and vice versa. These results suggest that encouraging flexibility in coping strategies would help to improve university students' self-efficacy.
| S-EPMC7248269 | biostudies-literature
Project description:Background/aimsThe Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.MethodsRecruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.ResultsCompletion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.ConclusionOverall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.
| S-EPMC7664172 | biostudies-literature
Project description:The Losartan Effects on Emphysema Progression (LEEP) trial was designed to test the hypothesis that losartan slows progression of emphysema in chronic obstructive pulmonary disease (COPD) patients (NCT00720226). It was conducted by the Pulmonary Trials Cooperative consortium, in collaboration with the American Lung Association Airways Clinical Research Centers network. We describe the design of the trial and challenges for recruitment and follow-up of participants. LEEP is a placebo-controlled, parallel randomized trial, allocation ratio of 1:1, with a planned sample size of 220. Primary eligibility criteria were mild emphysema based on high-resolution computed tomography (HRCT) scans with 5% to 35% voxels <-950 Hounsfield units (HU), airway obstruction based on spirometry, and not taking an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor. Participants received either losartan or placebo for 48 weeks. A total of 2779 individuals were screened to enroll 220 eligible participants at 26 clinical sites, all located in the continental United States. Recruitment took 45% longer than planned (32 months versus 22 months), with an average accrual rate of 6.7 participants per month. Recruitment challenges included identification of eligible participants who were not already taking or who did not have an established clinical indication for an angiotensin receptor blocker or ACE inhibitor drug and recalls of contaminated lots of losartan by the Food and Drug Administration. A number of recruitment initiatives were launched in response. Recruitment was completed in February 2020, just prior to a nationwide shutdown of research activities due to the coronavirus disease 2019 (COVID-19) pandemic.
| S-EPMC8686851 | biostudies-literature
Project description:Background/aimsWe present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care.MethodsSite selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems.ResultsThe study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks.ConclusionGlycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.
| S-EPMC10524662 | biostudies-literature
Project description:Little is known about variation in individual cytokines/cytokine profiles for a large healthy, pediatric population. When cytokines in a healthy group are not abnormally high as in a disease state, it is challenging to determine appropriate statistical strategies. The aims of the study were (1) to describe variation among cytokine concentrations and profiles in healthy adolescent girls, (2) to illustrate utility of data reduction approaches novel to cytokine research, (variable-centered [principal factor analysis, PFA], person-centered [latent profile analysis, LPA]), and (3) to demonstrate utility of such methods in linking cytokine profiles to health outcomes (e.g., depressive, anxiety symptoms).Serum was analyzed for 13 cytokines representing adaptive and innate immune responses in 262 girls (age = 11, 13, 15, and 17 years).There was great variation in cytokine concentrations. PFA revealed a four-factor solution explaining 73.13% of the shared variance among 13 cytokines (e.g., factor 1 included interleukin [IL]-4, IL-13, IL-5, interferon gamma; 26.65% of the shared variance). The LPA supported classifying girls into subgroups characterized by "high overall" (7.3% of sample), "high adaptive" (26.7%), "high innate" (21%), or "low overall" (45%) cytokine levels. Factors and profiles were useful in describing individual differences in depressive/anxiety symptoms (e.g., factor 1 positively associated with depressive symptoms but negatively with trait anxiety; increased depressive symptoms or trait anxiety was associated with greater likelihood of being in the "high adaptive" group).Healthy girls showed differences in cytokine levels and patterns of variation and important associations with psychological variables. PFA and LPA offer novel approaches useful for examining cytokine panels in healthy populations.
| S-EPMC4927350 | biostudies-other
Project description:BACKGROUND:Recruitment and retention challenges are very common in mental health randomised trials. Investigators utilise different methods to improve recruitment or retention. However, evidence of the effectiveness and efficiency of these strategies in mental health has not been synthesised. This systematic review is to investigate and assess the effectiveness and cost-effectiveness of different strategies to improve recruitment and retention in mental health randomised trials. METHODS AND MATERIALS:MEDLINE, EMBASE, the Cochrane Methodology Register and PsycINFO were searched from beginning of record up to July 2016. Randomised trials involving participants with mental health problems which compared different strategies for recruitment or retention were selected. Two authors independently screened identified studies for eligibility. RESULTS:A total of 5,157 citations were identified. Thirteen articles were included, 11 on recruitment and 2 on retention. Three randomised controlled trials compared different recruitment strategies, none of which found statistically significant differences between the interventional recruitment strategies and the routine recruitment methods. Retrospective comparisons of recruitment methods showed that non-web-based advertisement and recruitment by clinical research staff each have advantages in efficiency. Web-based adverts had the lowest cost per person recruited (£13.41 per person recruited). Specialised care referral cost £183.24 per person, non-web-based adverts cost £372.03 per patient and recruitment via primary care cost £407.65 for each patient. Financial incentives, abridged questionnaires and pre-notification had a positive effect on retention rates. CONCLUSION:The recruitment studies included showed differences in strategies, clinical settings, mental health conditions and study design. It is difficult to assess the overall effectiveness of any particular recruitment strategy as some strategies that worked well for a particular population may not work as well for others. Paying attention to the accessibility of information and consent materials may help improve recruitment. More research in this area is needed given its important implications.
| S-EPMC6114918 | biostudies-literature