Dataset Information

Outreach to diversify clinical trial participation: A randomized recruitment study.

ABSTRACT:

Background/aims

Racial and ethnic minorities remain underrepresented in clinical research, yet few recruitment strategies have been rigorously evaluated.

Methods

We experimentally tested whether targeted recruitment letters acknowledging diabetes health disparities and health risks specific to recipients' racial/ethnic group improved two metrics of trial participation: willingness to be screened and enrollment. This experiment was efficiently nested within a randomized clinical trial examining a preventive lifestyle intervention among women at high risk for diabetes. Pregnant women with gestational diabetes or impaired glucose tolerance (N = 445) were randomized to receive a targeted recruitment letter with health risk information specific to their racial/ethnic group (n = 216), or a standard letter with risk information for the general population (n = 229). All letters were bilingual in English and Spanish.

Results

The targeted as compared to the standard letter did not improve screening or enrollment rates overall or within separate racial/ethnic groups. Among Latina women who preferred Spanish, the targeted letter showed trends for improved screening (66.7% vs 33.3%, p = .06) and enrollment rates (38.9% vs 13.3%, p = .13). In contrast, among Latina women who preferred English, the targeted letter significantly lowered screening (29.6% vs 57.1%, p = .04) and showed trends for lowered enrollment rates (25.9% vs 50.0%, p = .07).

Conclusion

Results from this randomized study appear to suggest that recruitment letters with diabetes health risk information targeted to recipients' race/ethnicity may improve one metric of clinical trial participation among Latina women who prefer Spanish, but not English. Larger experimental studies, incorporating input from diverse participant stakeholders, are needed to develop evidence-based minority recruitment strategies.

SUBMITTER: Brown SD

PROVIDER: S-EPMC4424096 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Publications

Outreach to diversify clinical trial participation: A randomized recruitment study.

Brown Susan D SD Partee Paula N PN Feng Juanran J Quesenberry Charles P CP Hedderson Monique M MM Ehrlich Samantha F SF Kiernan Michaela M Ferrara Assiamira A

Clinical trials (London, England) 20150202 3

<h4>Background/aims</h4>Racial and ethnic minorities remain underrepresented in clinical research, yet few recruitment strategies have been rigorously evaluated.<h4>Methods</h4>We experimentally tested whether targeted recruitment letters acknowledging diabetes health disparities and health risks specific to recipients' racial/ethnic group improved two metrics of trial participation: willingness to be screened and enrollment. This experiment was efficiently nested within a randomized clinical tr ...[more]

PMID: 25644997

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Project description:ImportanceMailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results.ObjectiveCompare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years.Design, setting, and participantsPragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings.InterventionsRandom assignment to mailed FIT outreach (n = 2400), mailed colonoscopy outreach (n = 2400), or usual care with clinic-based screening (n = 1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach.Main outcomes and measuresPrimary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation).ResultsAll 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P < .001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P < .001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P < .08 and P < .13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P < .001 for both comparisons). There were no screening-related harms in any groups.Conclusions and relevanceAmong persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach.Trial registrationclinicaltrials.gov Identifier: NCT01710215.

Project description:ImportanceWidening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers.ObjectiveTo evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers.Design, setting, and participantsThis prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n = 399; control group, n = 308).InterventionsWe analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system.Main outcomes and measuresSelf-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff.ResultsThe intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P < .001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P < .001).Conclusions and relevanceProactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective.Trial registrationclinicaltrials.gov Identifier: NCT01156610.

Project description:ImportanceColorectal cancer (CRC) screening is effective but remains underused in federally qualified health centers (FQHCs).ObjectiveTo assess the effectiveness of a centralized CRC screening outreach intervention involving mailed fecal immunochemical testing (FIT) outreach and patient navigation to colonoscopy after abnormal results of FIT.Design, setting, and participantsA pragmatic randomized clinical trial was conducted, using intention-to-treat analysis. Participants were enrolled from July 6, 2020, to September 17, 2021, and analyses were performed from July 6, 2023, to January 31, 2024. The study was conducted at independent FQHCs comprising 12 clinical delivery sites in North Carolina. The outreach intervention was centralized at an academic cancer center. Active individuals aged 50 to 75 years at average risk for CRC and not current with screening per US Preventive Services Task Force recommendations were included.InterventionIn addition to usual care, intervention participants received mailed screening outreach materials including an introductory letter, FIT kit packet with instructions and return postage, and 2 reminder letters if needed. Intervention participants with positive results of mailed FIT were offered navigation to facilitate follow-up colonoscopy completion. Control participants received usual care alone.Main outcomes and measuresThe primary outcome was completion of a US Preventive Services Task Force-recommended CRC screening test within 6 months determined by electronic health record review. Secondary outcomes were colonoscopy completion within 6 months after positive FIT results and detection of advanced colorectal neoplasia, defined as advanced adenoma or CRC.ResultsA total of 4002 participants were included (mean [SD] age, 59.6 [6.8] years; 2256 [56.4%] female; 364 (9.1%) Hispanic; 1082 [27.0%] non-Hispanic Black; 2288 [57.2%] non-Hispanic White; 1198 [29.9%] commercially insured; 617 [15.4%] Medicaid; 1227 [30.7%] Medicare; and 960 [24.0%] uninsured), with 2001 randomized to each group. Compared with controls, intervention participants were more likely to complete screening within 6 months of randomization (30.0% vs 9.7%; difference, 20.29 percentage points; 95% CI, 17.85-22.73 percentage points). The intervention was effective in all insurance types. In the intervention arm, 33 of 48 participants with positive FIT results (68.8%) completed follow-up colonoscopy within 6 months compared with 8 of 18 participants (44.4%) in the control arm (difference, 24.3 percentage points; 95% CI, -2.13 to 50.74 percentage points). Advanced colorectal neoplasia was detected in 29 intervention participants (1.4%) and 15 control participants (0.7%) (difference, 0.68 percentage points; 95% CI, 0.05-1.35 percentage points).Conclusions and relevanceIn this randomized clinical trial of centralized screening outreach intervention in diverse patients served by independent FQHCs, CRC screening completion and advanced colorectal neoplasia detection were substantially increased. Future studies should examine the cost and scalability of this intervention in this context.Trial registrationClinicalTrials.gov Identifier: NCT04406714.

Project description:ObjectiveTo evaluate whether opt out framing, messaging incorporating behavioral science concepts, or electronic communication increases the uptake of hepatitis C virus (HCV) screening in patients born between 1945 and 1965.DesignPragmatic randomized controlled trial.Setting43 primary care practices from one academic health system (Philadelphia, PA, USA) between April 2019 and May 2020.ParticipantsPatients born between 1945 and 1965 with no history of screening and at least two primary care visits in the two years before the enrollment period.InterventionsThis multilevel trial was divided into two studies. Substudy A included 1656 eligible patients of 17 primary care clinicians who were randomized in a 1:1 ratio to a mailed letter about HCV screening (letter only), or a similar letter with a laboratory order for HCV screening (letter+order). Substudy B included the remaining 19 837 eligible patients followed by 417 clinicians. Active electronic patient portal users were randomized 1:5 to receive a mailed letter about HCV screening (letter), or an electronic patient portal message with similar content (patient portal); inactive patient portal users were mailed a letter. In a factorial design, patients in substudy B were also randomized 1:1 to receive standard content (usual care), or content based on principles of social norming, anticipated regret, reciprocity, and commitment (behavioral content).Main outcome measuresProportion of patients who completed HCV testing within four months.Results21 303 patients were included in the intention-to-treat analysis. Among the 1642 patients in substudy A, 19.2% (95% confidence interval 16.5% to 21.9%) completed screening in the letter only arm and 43.1% (39.7% to 46.4%) in the letter+order arm (P<0.001). Among the 19 661 patients in substudy B, 14.6% (13.9% to 15.3%) completed screening with usual care content and 13.6% (13.0% to 14.3%) with behavioral science content (P=0.06). Among active patient portal users, 17.8% (16.0% to 19.5%) completed screening after receiving a letter and 13.8% (13.1% to 14.5%) after receiving a patient portal message (P<0.001).ConclusionsOpt out framing and effort reduction by including a signed laboratory order with outreach increased screening for HCV. Behavioral science messaging content did not increase uptake, and mailed letters achieved a greater response rate than patient portal messages.Trial registrationClinicalTrials.gov NCT03712553.

Dataset Information

Outreach to diversify clinical trial participation: A randomized recruitment study.

Background/aims

Methods

Results

Conclusion

Publications

Outreach to diversify clinical trial participation: A randomized recruitment study.

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