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Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students.

ABSTRACT: Recruitment of subjects is critical to the success of any clinical trial, but achieving this goal can be a challenging endeavor. Volunteer nurse and student enrollers are potentially an important source of recruiters for hospital-based trials; however, little is known of either the efficacy or cost of these types of enrollers. We assessed volunteer clinical nurses and health science students in their rates of enrolling family members in a hospital-based, pragmatic clinical trial of cardiopulmonary resuscitation education, and their ability to achieve target recruitment goals. We hypothesized that students would have a higher enrollment rate and are more cost-effective compared to nurses.Volunteer nurses and student enrollers were recruited from eight institutions. Participating nurses were primarily bedside nurses or nurse educators while students were pre-medical, pre-nursing, and pre-health students at local universities. We recorded the frequency of enrollees recruited into the clinical trial by each enroller. Enrollers' impressions of recruitment were assessed using mixed-methods surveys. Cost was estimated based on enrollment data. Overall enrollment data were analyzed using descriptive statistics and generalized estimating equations.From February 2012 to November 2014, 260 hospital personnel (167 nurses and 93 students) enrolled 1493 cardiac patients' family members, achieving target recruitment goals. Of those recruited, 822 (55%) were by nurses, while 671 (45%) were by students. Overall, students enrolled 5.44 (95% confidence interval (CI): 2.88, 10.27) more subjects per month than nurses (p?

SUBMITTER: Blewer AL

PROVIDER: S-EPMC4942370 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students.

Blewer Audrey L AL Li Jiaqi J Ikeda Daniel J DJ Leary Marion M Buckler David G DG Riegel Barbara B Desai Sunita S Groeneveld Peter W PW Putt Mary E ME Abella Benjamin S BS

Clinical trials (London, England) 20160419 4

<h4>Background/aims</h4>Recruitment of subjects is critical to the success of any clinical trial, but achieving this goal can be a challenging endeavor. Volunteer nurse and student enrollers are potentially an important source of recruiters for hospital-based trials; however, little is known of either the efficacy or cost of these types of enrollers. We assessed volunteer clinical nurses and health science students in their rates of enrolling family members in a hospital-based, pragmatic clinica ...[more]

PMID: 27094486

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Project description:BACKGROUND:Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. METHODS:The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. RESULTS:We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n?=?33, 61%), lack of health system support (n?=?16, 30%), and lack of support of individual decision-makers (n?=?11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators. CONCLUSIONS:Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Project description:BackgroundThe portability and multiple functionalities of mobile devices make them well suited for collecting field data for naturalistic research, which is often beset with complexities in recruitment and logistics. This paper describes the implementation of a research protocol using mobile devices to study nurses' exchanges of patient information at change of shift.MethodsNurses from three medical and surgical units of an acute care teaching hospital in Montreal, Canada, were invited to participate. On 10 selected days, participants were asked to record their handoffs using mobile devices and to complete paper questionnaires regarding these exchanges. Nurse acceptance of mobile devices was assessed using a 30-item technology acceptance questionnaire and focus group interviews. The principal feasibility indicator was whether or not 80 complete handoffs could be collected on each unit.ResultsFrom October to December 2017, 63 of 108 eligible nurses completed the study. Results suggest that the use of mobile devices was acceptable to nurses, who felt that the devices were easy to use but did not improve their job performance. The principal feasibility criterion was met, with complete data collected for 176, 84, and 170 of the eligible handoffs on each unit (81% of eligible handoffs). The research protocol was acceptable to nurses, who felt the study's demands did not interfere with their clinical work.ConclusionsThe research protocol involving mobile devices was feasible and acceptable to nurses. Nurses felt the research protocol, including the use of mobile devices, required minimal investment of time and effort. This suggests that their decision to participate in research involving mobile devices was based on their perception that the study protocol and the use of the device would not be demanding. Further work is needed to determine if studies involving more sophisticated and possibly more demanding technology would be equally feasible and acceptable to nurses.

Project description:IntroductionOpioids may be necessary for guideline-concordant acute perioperative pain management, but their use carries risks for unintended prolonged use and addiction. Guidelines recommend use of validated non-pharmacological pain care (NPPC) approaches in conjunction with prescribed opioids and other analgesics. Our protocol outlines a population-level, pragmatic trial that will test a bundled intervention comprised of an electronic health record (EHR) portal-based conversation guide, EHR clinical decision support (CDS), and a suite of self-management educational and support materials to encourage and advance NPPC use.MethodsWe are conducting a stepped-wedge, cluster-randomized pragmatic trial spanning seven surgical specialties across six geographically diverse locations within the Mayo Clinic Enterprise. Thirty two surgical practices across six locations (Rochester, Minnesota; Mankato, Minnesota; La Crosse, Wisconsin; Eau Claire, Wisconsin; Phoenix, Arizona; Jacksonville, Florida) comprise 22 distinct practice clusters that are randomly assigned to one of five steps using constrained randomization. Steps "go live" by initiating the intervention at 7-month intervals between March 2021 and July 2023. Patients over 18 years of age who are scheduled for qualifying procedures within "live" consenting practices are sent a Healing After Surgery guide via their patient portals pre-operatively, directing them to identify their preferred NPPC modalities among 13 approaches. These selections create CDS options for care teams to support patients with self-management materials that reinforce safe NPPC use.Planned outcomesPatients' clinical, demographic, and outcome data will be abstracted from the Epic EHR. Primary outcomes will be the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and physical functioning computer adaptive tests (CAT) collected at 1, 2, and 3 months postoperatively via the patient portal. We will mail printed versions of the 6-item PROMIS short forms to portal non-responders to minimize bias. Secondary outcomes will include the PROMIS anxiety CAT, opioid consumption, and self-reported NPPC use.Trial registrationClinicalTrials.gov identifier, NCT04570371.

Project description:BackgroundEvery year, hundreds of thousands of inpatients die from cardiac arrest and sepsis, which could be avoided if those patients' risk for deterioration were detected and timely interventions were initiated. Thus, a system is needed to convert real-time, raw patient data into consumable information that clinicians can utilize to identify patients at risk of deterioration and thus prevent mortality and improve patient health outcomes. The overarching goal of the COmmunicating Narrative Concerns Entered by Registered Nurses (CONCERN) study is to implement and evaluate an early warning score system that provides clinical decision support (CDS) in electronic health record systems. With a combination of machine learning and natural language processing, the CONCERN CDS utilizes nursing documentation patterns as indicators of nurses' increased surveillance to predict when patients are at the risk of clinical deterioration.ObjectiveThe objective of this cluster randomized pragmatic clinical trial is to evaluate the effectiveness and usability of the CONCERN CDS system at 2 different study sites. The specific aim is to decrease hospitalized patients' negative health outcomes (in-hospital mortality, length of stay, cardiac arrest, unanticipated intensive care unit transfers, and 30-day hospital readmission rates).MethodsA multiple time-series intervention consisting of 3 phases will be performed through a 1-year period during the cluster randomized pragmatic clinical trial. Phase 1 evaluates the adoption of our algorithm through pilot and trial testing, phase 2 activates optimized versions of the CONCERN CDS based on experience from phase 1, and phase 3 will be a silent release mode where no CDS is viewable to the end user. The intervention deals with a series of processes from system release to evaluation. The system release includes CONCERN CDS implementation and user training. Then, a mixed methods approach will be used with end users to assess the system and clinician perspectives.ResultsData collection and analysis are expected to conclude by August 2022. Based on our previous work on CONCERN, we expect the system to have a positive impact on the mortality rate and length of stay.ConclusionsThe CONCERN CDS will increase team-based situational awareness and shared understanding of patients predicted to be at risk for clinical deterioration in need of intervention to prevent mortality and associated harm.Trial registrationClinicalTrials.gov NCT03911687; https://clinicaltrials.gov/ct2/show/NCT03911687.International registered report identifier (irrid)DERR1-10.2196/30238.

Project description:ImportanceSmartphone dispatch of volunteer responders to nearby out-of-hospital cardiac arrests (OHCAs) has emerged in several emergency medical services, but no randomized clinical trials have evaluated the effect on bystander use of automated external defibrillators (AEDs).ObjectiveTo evaluate if bystander AED use could be increased by smartphone-aided dispatch of lay volunteer responders with instructions to collect nearby AEDs compared with instructions to go directly to patients with OHCAs to start cardiopulmonary resuscitation (CPR).Design, setting, and participantsThis randomized clinical trial assessed a system for smartphone dispatch of volunteer responders to individuals experiencing OHCAs that was triggered at emergency dispatch centers in response to suspected OHCAs and randomized 1:1. The study was conducted in 2 main Swedish regions: Stockholm and Västra Götaland between December 2018 and January 2020. At study start, there were 3123 AEDs in Stockholm and 3195 in Västra Götaland and 24 493 volunteer responders in Stockholm and 19 117 in Västra Götaland. All OHCAs in which the volunteer responder system was activated by dispatchers were included. Excluded were patients with no OHCAs, those with OHCAs not treated by the emergency medical services, and those with OHCAs witnessed by the emergency medical services.InterventionsVolunteer responders were alerted through the volunteer responder system smartphone application and received map-aided instructions to retrieve nearest available public AEDs on their way to the OHCAs. The control arm included volunteer responders who were instructed to go directly to the OHCAs to perform CPR.Main outcomes and measuresOverall bystander AED attachment, including those attached by volunteer responders and lay volunteers who did not use the smartphone application.ResultsVolunteer responders were activated for 947 patients with OHCAs. Of those, 461 were randomized to the intervention group (median [IQR] age of patients, 73 [61-81] years; 295 male patients [65.3%]) and 486 were randomized to the control group (median [IQR] age of patients, 73 [63-82] years; 312 male patients [65.3%]). Primary outcome of AED attachment occurred in 61 patients (13.2%) in the intervention arm vs 46 patients (9.5%) in the control arm (difference, 3.8% [95% CI, -0.3% to 7.9%]; P = .08). The majority of AEDs were attached by lay volunteers who were not using the smartphone application (37 in intervention arm, 28 in control). There were no significant differences in secondary outcomes. Among the volunteer responders using the application, crossover was 11% and compliance to instructions was 31%. Volunteer responders attached 38% (41 of 107) of all AEDs and provided 45% (16 of 36) of all defibrillations and 43% (293 of 666) of all CPR.Conclusions and relevanceIn this study, smartphone dispatch of volunteer responders to OHCAs to retrieve nearby AEDs vs instructions to directly perform CPR did not significantly increase volunteer AED use. High baseline AED attachement rate and crossover may explain why the difference was not significant.Trial registrationClinicalTrials.gov Identifier: NCT02992873.

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Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students.

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Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students.

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