The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention.
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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:Clinical trials worldwide were disrupted when the COVID-19 pandemic began in early 2020. Most intervention trials moved to some form of remote implementation due to restrictions on in-person research activities. Although the proportion of remote trials is growing, they remain the vast minority of studies in part due to few successful examples. Our team transitioned Goals for Reaching Optimal Wellness (GROWell), an NIH-funded (R01NR017659) randomized control trial (RCT; ClinicalTrials.gov identifier NCT04449432) originally designed as a hybrid intervention, into a fully remote clinical trial. GROWell is a digital dietary intervention for people who enter pregnancy with overweight or obesity. Primary outcomes include gestational weight gain and six-month postpartum weight retention. Strategies that we have tested, refined, and deployed include: (a) use of a HIPAA-compliant, web-based participant recruitment and engagement platform; (b) use of a HIPAA-compliant digital health platform to disseminate GROWell and conduct study visits (c) interconnectivity of these two platforms for seamless recruitment, consent, enrollment, intervention delivery, follow-up, and study team blinding; (d) detailed SMS messages to address initial challenges with protocol adherence; (e) email notifications alerting the study team about missed participant surveys so they can follow-up; (f) remuneration using email gift cards with recipient choice of vendor; and (g) geotargeting social media campaigns to improve participation of Black Indigenous and People of Color Communities. These strategies have resulted in screen failure rates improving by 7%, study task adherence improving by an average of 20-30% across study visits, and study completion rates of 82%. Researchers may consider some or all of these approaches in future remote mHealth trials.
| S-EPMC9515527 | biostudies-literature
Project description:ObjectivePerson-centered care is a key quality indicator and central to promoting integrated and recovery-oriented services. Person-centered care planning (PCCP) is a manualized intervention promoting the collaborative cocreation of a recovery-oriented care service plan on the basis of an individual's most valued life goals. This cluster randomized controlled trial tested the effect of PCCP training on person-centered care delivery in community mental health clinics.MethodsFourteen clinic sites were randomly assigned to receive either PCCP training (N=7; experimental condition) or service planning as usual (N=7; control condition). Data were collected from online surveys, and service plans were completed by 60 provider teams. The Person-Centered Care Planning Assessment Measure was administered via chart review at baseline, 12 months, and 18 months, and surveys were used to measure supervision, implementation leadership, and program type. The main effect was examined with linear mixed-effects regression models, with observations over time.ResultsAnalyses controlling for service user and program characteristics revealed that at 12 months, the group assigned to PCCP training showed significant improvements in delivering person-centered care compared with the control group (b=1.10, SE=0.50, p=0.03). At 18 months, this effect was even more pronounced (b=1.47, SE=0.50, p=0.01), representing a medium-to-large effect size of d=0.71 (95% confidence interval=0.23-1.20).ConclusionsThese findings indicate that training providers in PCCP increases provider competency in delivering person-centered care. Using an objective measure of person-centered care, the authors show that a comprehensive training strategy can target both the philosophical shift and the technical skills needed to promote client recovery.
| S-EPMC8192424 | 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