scholarly journals Use of electronic recruitment methods in a clinical trial of adults with gout

2020 ◽  
pp. 174077452095696
Author(s):  
Hailey N Miller ◽  
Jeanne Charleston ◽  
Beiwen Wu ◽  
Kelly Gleason ◽  
Karen White ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Response Rate ◽  
Cost Effective ◽  
Demographic Characteristics ◽  
Completion Rate ◽  
Patient Portal ◽  
Recruitment Methods

Background/aims: Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods. Methods: We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)–like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record–based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method. Results: Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record–based methods. Patient portal messaging, an electronic medical record–based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record–based methods ($60) were more cost-effective per response than non-electronic medical record–based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans. Conclusion: An electronic medical record–based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.

scholarly journals Electronic medical record–based cohort selection and direct-to-patient, targeted recruitment: early efficacy and lessons learned

2019 ◽  
Vol 26 (11) ◽  
pp. 1209-1217 ◽  
Author(s):  
Hailey N Miller ◽  
Kelly T Gleason ◽  
Stephen P Juraschek ◽  
Timothy B Plante ◽  
Cassie Lewis-Land ◽  
...  
Keyword(s):  
Medical Record ◽  
Electronic Medical Record ◽  
Response Rate ◽  
Target Population ◽  
Lessons Learned ◽  
Recruitment Strategy ◽  
Eligibility Criteria ◽  
Health Network ◽  
Recruitment Methods ◽  
Cohort Selection

Abstract Objective The study sought to characterize institution-wide participation in secure messaging (SM) at a large academic health network, describe our experience with electronic medical record (EMR)–based cohort selection, and discuss the potential roles of SM for research recruitment. Materials and Methods Study teams defined eligibility criteria to create a computable phenotype, structured EMR data, to identify and recruit participants. Patients with SM accounts matching this phenotype received recruitment messages. We compared demographic characteristics across SM users and the overall health system. We also tabulated SM activation and use, characteristics of individual studies, and efficacy of the recruitment methods. Results Of the 1 308 820 patients in the health network, 40% had active SM accounts. SM users had a greater proportion of white and non-Hispanic patients than nonactive SM users id. Among the studies included (n = 13), 77% recruited participants with a specific disease or condition. All studies used demographic criteria for their phenotype, while 46% (n = 6) used demographic, disease, and healthcare utilization criteria. The average SM response rate was 2.9%, with higher rates among condition-specific (3.4%) vs general health (1.4%) studies. Those studies with a more inclusive comprehensive phenotype had a higher response rate. Discussion Target population and EMR queries (computable phenotypes) affect recruitment efficacy and should be considered when designing an EMR-based recruitment strategy. Conclusions SM guided by EMR-based cohort selection is a promising approach to identify and enroll research participants. Efforts to increase the number of active SM users and response rate should be implemented to enhance the effectiveness of this recruitment strategy.

scholarly journals Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study

2019 ◽  
Vol 17 (1) ◽  
pp. 30-38 ◽  
Author(s):  
Timothy B Plante ◽  
Kelly T Gleason ◽  
Hailey N Miller ◽  
Jeanne Charleston ◽  
Kristen McArthur ◽  
...  
Keyword(s):  
Vitamin D ◽  
Health System ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Response Rate ◽  
Controlled Trial ◽  
Patient Portal ◽  
Message Content ◽  
Patient Portals ◽  
Trial Participants

Background/aim: Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content. Methods: The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health–sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content. Results: Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%; p = 0.005). Conclusion: Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants.

Cost-effectiveness analysis of neoadjuvant immune checkpoint inhibition (ICI) versus cisplatin-based chemotherapy (CBC) in muscle-invasive bladder cancer (MIBC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 419-419
Author(s):  
Ali Raza Khaki ◽  
Yong Shan ◽  
Richard Nelson ◽  
Sapna Kaul ◽  
John L. Gore ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Randomized Clinical Trials ◽  
Pathologic Complete Response ◽  
Weighted Average ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Sensitivity Analyses ◽  
Effectiveness Analysis

419 Background: Multiple single-arm clinical trials have shown promising pathologic complete response (pCR) rates with neoadjuvant ICIs in MIBC. However, ICIs remain costly. We conducted a cost-effectiveness analysis comparing neoadjuvant ICIs with CBC. Methods: We applied a decision analytic simulation model with a health care payer perspective and two-year time horizon to compare neoadjuvant ICIs vs CBC. For the primary analysis we compared pembrolizumab with dose dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC). We performed a secondary analysis with gemcitabine/cisplatin (GC) as CBC and exploratory analyses with atezolizumab or nivolumab/ipilimumab as ICIs (vs both ddMVAC and GC). We input pCR rates from trials (ICIs) or a weighted average of prior studies (CBC) and costs from average sales price. Outcomes of interest included costs, 2-year recurrence-free survival (RFS), and incremental cost-effectiveness ratio (ICER) of cost per 2-year RFS. A threshold analysis estimated a pCR rate or price reduction for ICI to be cost-effective and one-way and probabilistic sensitivity analyses were performed. Results: Results of the cost effectiveness analysis are shown in the table. The incremental cost of pembrolizumab compared with ddMVAC was $8,042 resulting in an incremental improvement of 0.66% in 2-year RFS for an ICER of $1,218,485 per 2-year RFS. A pCR of 71% or a 26% reduction in cost of pembrolizumab would render it more cost-effective with an ICER of $100,000 per 2-year RFS. GC required a 96% pembrolizumab cost reduction to achieve an ICER of $100,000 per 2-year RFS. Atezolizumab appeared to be more cost-effective than ddMVAC, even though the 2yr RFS was 0.66% worse. Conclusions: ICIs were not cost-effective as neoadjuvant therapies, except when atezolizumab was compared with ddMVAC. Pembrolizumab would approach cost-effective thresholds with 26% or 96% reduction in cost when compared to ddMVAC and GC, respectively. Randomized clinical trials, larger sample sizes and longer follow-up are required to better understand the value of ICIs as neoadjuvant treatments. [Table: see text]

Economic Evaluation of Ibrutinib Versus Acalabrutinib Versus Zanubrutinib for Patients with Relapsed or Refractory Mantle Cell Lymphoma

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 9-10
Author(s):  
Neda Alrawashdh ◽  
Ali McBride ◽  
Marion Slack ◽  
Ivo Abraham
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Phase I ◽  
Mantle Cell Lymphoma ◽  
Cell Lymphoma ◽  
Cost Effective ◽  
Health States ◽  
Mantle Cell ◽  
The Us ◽  
The Cost

Background . Refractory or relapsed mantle cell lymphoma (R/R MCL) is generally associated with poor outcomes; median overall survival (OS) is 4-5 years. First generation Bruton's tyrosine kinase inhibitor (BTKi) (Ibrutinib) and second generation BTKi (acalabrutinib and zanubrutinib) have led to significant improvements in efficacy and safety over conventional chemoimmunotherapy in treating R/R MCL. In the absence of direct head to head clinical trials compare between BTKi, indirect comparisons between the first and second BTKi generations show possible differences in safety and efficacy. We used existing evidence from phase I/II clinical trials for second BTKi generation to evaluate the cost-effectiveness of ibrutinib vs acalabrutinib vs zanubrutinib in treating patients with R/R MCL from the US payer perspective. Methods. A Markov model with two health states (progression-free [PF] and progression or death) was specified. Kaplan-Meier (KM) curves of PF survival (PFS) from the phase III trial by Dreyling et al. (Lancet 2016) for ibrutinib, the phase II trial by Wang et al. (Lancet 2018) for acalabrutinib, and the phase I/II trial by Tam et al. (Blood 2019) for zanubrutinib were fitted to exponential distributions to extract transition probabilities between the two health states for each drug. Wholesale acquisition costs (WAC) were obtained from RedBook and costs of adverse events management were derived from the literature. The analysis was conducted over a lifetime horizon with health utility outcomes and costs discounted at 3.5% per year after the first year. The cost and PFS life years (LYs) and PFS quality-adjusted LYs (QALYs) for each treatment, the incremental PFS LYs and PFS QALYs gained with acalabrutinib or zanubrutinib over ibrutinib, and the incremental cost-effectiveness ratio (ICER) and cost-utility ratio (ICUR) were estimated in both base and probabilistic sensitivity analyses (PSA: 100,000 simulations). Results. As detailed in the table, acalabrutinib and zanubrutinib were associated with better clinical outcomes than ibrutinib, with incremental PFS LYs gained of 1.61 and 0.98, and incremental PFS QALYs of 1.27 and 0.77, respectively. The incremental costs when comparing acalabrutinib and zanubrutinib with ibrutinib were $110,931and $64,624, respectively. In probabilistic analyses, the ICERs ($61,689/LYg for acalabrutinib; $53,438/LYg for zanubrutinib) and ICURs ($86,750/QALYg for acalabrutinib; $82,897/QALYg for zanubrutinib) were lower than the US willingness to pay (WTP) threshold of $100,000 to $150,000 per QALY for cancer treatment. At WTP of $100,000, the cost-effectiveness acceptability curves showed the probabilities of acalabrutinib, zanubrutinib, and ibrutinib being cost-effective to be 50%, 34%, and 16%, respectively. Conclusions. Acalabrutinib is more cost-effective compared with ibrutinib and zanubrutinib and improves health outcomes more in R/R MCL patients. This analysis using phase I/II trials should be validated as additional trial and real-world evidence about efficacy, safety, and associated health-related quality of life outcomes. Based on the current data, acalabrutinib offers the most cost-effective treatment option in R/R MCL. Disclosures McBride: Coherus BioSciences: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy. Abraham:Janssen: Consultancy; Coherus BioSciences: Research Funding, Speakers Bureau; Celgene: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Mylan: Consultancy; Rockwell Medical: Consultancy; Terumo: Consultancy.

Clinical trial eligibility determination using an oncology electronic medical record system interfaced to a caBIG-certified trial database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6626-6626
Author(s):  
J. W. Goldwein ◽  
M. Van Der Pas ◽  
L. Tis ◽  
R. Nickens ◽  
R. Comis
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Performance Status ◽  
Stage Iv ◽  
Clinical Trial Registration ◽  
Record System ◽  
Eligibility Determination ◽  
Stage Iv Breast Cancer

6626 Background: One reason for the low numbers of patients entered on cancer clinical trials is the difficulty and inconvenience encountered in determining whether patients are eligible. The introduction of electronic medical record (EMR) systems in cancer facilities provides a means by which clinical parameters may be electronically collected and compared against clinical trial eligibility criteria, with the potential to facilitate eligibility determination. We hereby describe a widely utilized EMR system interfaced to a caBIG-certified searchable clinical trials database which facilitates eligibility determination. Materials and Methods: MOSAIQ is a widely utilized oncology- specific EMR system that is operational in radiation and medical oncology facilities world-wide. During the routine course of patient care, clinical trial eligibility parameters such as diagnosis, stage, age, and performance status are entered into defined data fields within the EMR. Trialcheck is an independently maintained caBIG bronze level certified database that lists thousands of clinical trials from Cooperative Groups, NCI/PDQ, the pharmaceutical industry and trials being conducted exclusively at particular oncology facilities. TrialCheck registrants can screen trials for patient eligibility as well as filter and track the status of trials that have been activated at their facility. In addition, a real-time, secure Internet interface between MOSAIQ and TrialCheck extracts eligibility parameters from a patient record, sends that information to TrialCheck, and returns a listing of matched clinical trials. Results: In a test screen of 4 MOSAIQ EMR patients against 257 TrialCheck clinical trials, the system matched a patient with Stage IV breast cancer to 7 available trials in less 2 seconds, a patient with Stage IIIB colon cancer to 3 trials in 5 seconds, a Stage IV prostate cancer to 5 trials in 4.4 seconds, and a patient with stage II esophageal cancer to 2 trials in 3.7 seconds. Conclusion: This product demonstrates a novel and innovative solution to one of the problems inherent in the clinical trial registration process in an efficient, reliable and secure manner. No significant financial relationships to disclose.

scholarly journals Enhancing Diversity in Oncology Clinical Trials: Findings of a Case Study in Improving Black Patient Representation in a Multiple Myeloma Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3008-3008
Author(s):  
Sudip Bhandari ◽  
Charles Lagor ◽  
Judith Mueller ◽  
Warren Whyte ◽  
Samuel Heilbroner
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trials ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Health Disparity ◽  
Black Patient ◽  
The United States ◽  
Black Patients ◽  
Car T

Abstract Background: Black patients are underrepresented in multiple myeloma (MM) clinical trials. Despite the promise of Real-World Data (RWD), little research exists on RWD's usage to address this health disparity. In collaboration with a large pharmaceutical partner, we used RWD from commercial datasets (ConcertAI's Electronic Medical Record and claims datasets) aimed at identifying sites with a large Black patient population. We recommended including these sites in a recent clinical trial of Chimeric Antigen Receptor T cell (CAR-T) therapy for MM patients. Methods: We used the following criteria to identify promising sites: (1) high Black patient density, (2) access to a CAR-T accredited parent organization within 100 miles, (3) a hematologist/oncologist who treats MM patients, and (4) a history of treating MM patients with a Proteasome Inhibitor (PI) and Lenalidomide (Len) in the first line of therapy. For (1), sites were ranked using the lower 95% confidence interval for the percent of Black MM patients at the site. For (4), only sites with at least five MM patients who received PI and Len were included. Our data sources were: ConcertAI's Electronic Medical Record (EMR) and claims datasets to link each patient to a site, and Google maps API to identify the CAR-T center nearest each oncology site. The patients in our data sets were not identifiable, and our research was conducted in compliance with the Health Insurance Portability and Accountability Act. After having identified and filtered promising sites, we curated individual candidates in the order of Black patient density. The purpose of curation was to validate a final list of sites. Results: We identified 17 promising clinical trial sites affiliated with 16 healthcare systems in the mid-west, mid-Atlantic, southeastern, and southwestern regions of the United States (table 1). Our RWD captured an average of 141 MM patients (range: 6-791) who were treated at the 17 sites from 2015-2020. Thirty-nine percent of the patients were Black (range: 13-67%). This percentage was three times the recruitment rate of black patients in MM trials in the US (13%). On average, the sites were 44 miles driving distance (range: 0.8-96 miles) from the closest CAR-T center, had eight hematology/medical oncology specialists on staff (range: 1-17), and had previous interventional trial experience (13 sites had experience with MM trials). All of the identified sites were community-based sites, and none of the sites were previously identified by our pharmaceutical partner. Conclusions: We demonstrated that RWD can be leveraged to identify clinical trial sites with a high potential for Black patient recruitment, thereby addressing a known health disparity problem within multiple myeloma (MM) clinical trials. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

scholarly journals Delivering a Pilot Smoking Cessation Program through the Patient Portal of an Electronic Medical Record (EMR) at a Patient-Centered Medical Home (PCMH)

2016 ◽  
Vol 7 (1) ◽  
Author(s):  
Amanda M Singrey ◽  
Kristin A Casper ◽  
Nicole V Brown ◽  
Bella H Mehta
Keyword(s):  
Smoking Cessation ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Medical Home ◽  
Lessons Learned ◽  
Smoking Cessation Program ◽  
Original Research ◽  
Patient Centered Medical Home ◽  
Patient Portal ◽  
Patient Centered

Pharmacists are providing clinical services in nontraditional practice settings including the patient-centered medical home (PCMH). PCMHs strive to improve patient outcomes in a number of ways, including through innovative use of health information technology (HIT) and by encouraging patients to take an active role in their health care. This paper describes a pharmacist-directed smoking cessation program at a PCMH that utilizes HIT to engage patients in the smoking cessation process and lessons learned from implementation of the program to guide other pharmacists considering implementing a similar program. Secure messaging through the patient portal of the electronic medical record (EMR) can be an effective way to deliver a smoking cessation program for appropriately selected patients and aligns with PCMH standards as the program uses HIT to engage patients in self-management.   Type: Original Research

scholarly journals P232 Assessing effectiveness and patient perceptions of a novel electronic medical record for the management of inflammatory bowel disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S281-S281
Author(s):  
P Kaazan ◽  
T Li ◽  
W Seow ◽  
J Bednarz ◽  
J Pipicella ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Chronic Disease ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Medical Records ◽  
Data Capture ◽  
Patient Portal ◽  
Specific Data ◽  
Qualitative Feedback ◽  
Inflammatory Bowel

Abstract Background There is an increasing prevalence of chronic disease worldwide, resulting in multiple management challenges. Inflammatory bowel disease (IBD) is an exemplar chronic disease requiring optimal longitudinal coordinated care. We propose that Crohn’s Colitis Care (CCCare), a novel IBD-specific electronic medical record intended to improve IBD care is effective and acceptable to patients. We aimed to assess both the effectiveness of CCCare for data capture and patients’ acceptability of CCCare. Methods Methods: The study was conducted at two tertiary Australian hospitals with dedicated IBD services: Royal Adelaide Hospital and Liverpool Hospital. The effectiveness of CCCare was examined by comparing IBD-specific data completeness between pre-existing medical records and CCCare. Acceptability was assessed with quantitative and qualitative feedback through the CCCare patient portal and with standardized paper-based questionnaires administered to a convenience sample of IBD clinic patients in two unmatched pre-CCCare and post-CCCare exposure cohorts. Descriptive statistics and multivariable regression models were applied to specifically examine overall ratings of CCCare acceptability using a 10-point numeric scale; factors associated with acceptability before exposure to the system and whether exposure or security concerns influenced its acceptability. Results In all 73 cases reviewed, there was data gain when using structured CCCare fields compared to IBD documentation in usual medical records. Acceptability assessment through the patient portal feedback of 287 patients showed that the majority were very likely to recommend it to others (score, 8.56 ± 2.2 on a scale of 0–10). Common themes of concern among the 22 respondents with qualitative feedback were related to the novelty and limited experience of CCCare. Study questionnaires indicated that the overall acceptability in the combined cohort (n=310) was very high (8.4 ± 2.1; scale of zero to ten) with more than three-quarters of patients rating acceptability as at least 8 out of 10. Self-reported information technology (IT) literacy was positively associated with acceptability. Exposure had a small positive affect on acceptability while the level security concerns had little impact on acceptability. Conclusion The IBD-specific electronic medical record CCCare is effective in facilitating enhanced completeness of IBD-specific data capture in comparison to pre-existing medical records. It is highly acceptable to patients, especially those with reasonable IT literacy. Patient concerns about privacy and security of EMRs did not significantly influence acceptability.

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