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Enrollment Challenges in Critical Care Nursing Research.

ABSTRACT: Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.Two years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity.Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P = .02).Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.

SUBMITTER: Sole ML

PROVIDER: S-EPMC6015765 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Enrollment Challenges in Critical Care Nursing Research.

Sole Mary Lou ML Middleton Aurea A Deaton Lara L Bennett Melody M Talbert Steven S Penoyer Daleen D

American journal of critical care : an official publication, American Association of Critical-Care Nurses 20170901 5

<h4>Background</h4>Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.<h4>Objective</h4>To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.<h4>Methods</h4>Two years' worth of recruitment and enrollment data from an oral ...[more]

PMID: 28864436

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Project description:BACKGROUND:In most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative. OBJECTIVE:To address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study. METHODS:This survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research. RESULTS:Between January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa = 0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion. CONCLUSION:The majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed.

Project description:ObjectiveTo characterise the research profile of UK critical care physiotherapists including experience, training needs, and barriers and enablers to engagement in critical care research. 'Research' was defined broadly to encompass activities related to quantitative and qualitative studies, service evaluations, clinical audit and quality improvements.DesignClosed-question online survey, with optional free-text responses.SettingUK critical care community.ParticipantsUK critical care physiotherapists, regardless of clinical grade or existing research experience.Results268 eligible survey responses were received during the 12-week study period (21 incomplete, 7.8%). Respondents were based in university-affiliated (n=133, 49.6%) and district general (n=111, 41.4%) hospitals, and generally of senior clinical grade. Nearly two-thirds had postgraduate qualifications at master's level or above (n=163, 60.8%). Seven had a doctoral-level qualification. Respondents reported a range of research experience, predominantly data acquisition (n=144, 53.7%) and protocol development (n=119, 44.4%). Perceived research training needs were prevalent, including topics of research methods, critical literature appraisal, protocol development and statistical analysis (each reported by ≥50% respondents). Multiple formats for delivery of future research training were identified. Major barriers to research engagement included lack of protected time (n=220, 82.1%), funding (n=177, 66.0%) and perceived experience (n=151, 56.3%). Barriers were conceptually categorised into capability, opportunity and motivation themes. Key enabling strategies centred on greater information provision about clinical research opportunities, access to research training, secondment roles and professional networks.ConclusionsUK critical care physiotherapists are skilled, experienced and motivated to participate in research, including pursuing defined academic research pathways. Nonetheless wide-ranging training needs and notable barriers preclude further involvement. Strategies to harness the unique skills of this profession to enhance the quality, quantity and scope of critical care research, benefiting from a multiprofessional National Clinical Research Network, are required.

Project description:PurposeTo examine the activities, concerns, and expectations of critical care nurses and professional critical care nursing organizations worldwide.DesignA descriptive survey methodology was used. This study is the fifth worldwide quadrennial review of its type to monitor variations in critical care nursing needs and provide robust evidence to inform policy related to critical care nursing practice.MethodsThe fifth World Federation of Critical Care Nurses international survey of critical care nursing organizations was emailed to potential participants from countries with critical care nursing organizations or known critical care nurse leaders. Data were collected online. Responses were entered into SPSS version 23 software (IBM Corp., Armonk, NY, USA) and analyzed by geographical region and national wealth group.FindingsEighty-two national representative respondents participated in the survey, of whom two thirds (n = 56, 68%) had an established critical care nursing organization in their country. The five most important issues identified were working conditions, teamwork, staffing levels, the need for formal practice guidelines and competencies, and wages. The top five critical care nursing organization services that were considered to be of most importance were professional representation, as well as provision of workshops and education forums, national conferences, practice standards and guidelines, and local conferences. The most important contributions expected from the World Federation of Critical Care Nurses were standards for clinical practice and professional practice, international conferences, professional representation, and study and education grants.ConclusionsThe results highlight priority areas for critical care nursing and reinforce the need to address factors that can inform critical care nursing policy and practice. Results of this survey should be incorporated into strategic action plans at the national and international levels.Clinical relevanceNursing leaders, policymakers, and other interested stakeholders should consider these findings when planning critical care workforce requirements. Interested parties should work collaboratively to inform recommendations for further policy and action.

Project description:BACKGROUND: Defining what constitutes a resident care unit in nursing home research is both a conceptual and practical challenge. The aim of this paper is to provide evidence in support of a definition of care unit in nursing homes by demonstrating: (1) its feasibility for use in data collection, (2) the acceptability of aggregating individual responses to the unit level, and (3) the benefit of including unit level data in explanatory models. METHODS: An observational study design was used. Research (project) managers, healthcare aides, care managers, nursing home administrators and directors of care from thirty-six nursing homes in the Canadian prairie provinces of Alberta, Saskatchewan and Manitoba provided data for the study. A definition of care unit was developed and applied in data collection and analyses. A debriefing session was held with research managers to investigate their experiences with using the care unit definition. In addition, survey responses from 1258 healthcare aides in 25 of the 36 nursing homes in the study, that had more than one care unit, were analyzed using a multi-level modeling approach. Trained field workers administered the Alberta Context Tool (ACT), a 58-item self-report survey reflecting 10 organizational context concepts, to healthcare aides using computer assisted personal interviews. To assess the appropriateness of obtaining unit level scores, we assessed aggregation statistics (ICC(1), ICC(2), ?², and ?²), and to assess the value of using the definition of unit in explanatory models, we performed multi-level modeling. RESULTS: In 10 of the 36 nursing homes, the care unit definition developed was used to align the survey data (for analytic purposes) to specific care units as designated by our definition, from that reported by the facility administrator. The aggregation statistics supported aggregating the healthcare aide responses on the ACT to the realigned unit level. Findings from the multi-level modeling further supported unit level aggregation. A significantly higher percentage of variance was explained in the ACT concepts at the unit level compared to the individual and/or nursing home levels. CONCLUSIONS: The statistical results support the use of our definition of care unit in nursing home research in the Canadian prairie provinces. Beyond research convenience however, the results also support the resident unit as an important Clinical Microsystem to which future interventions designed to improve resident quality of care and staff (healthcare aide) worklife should be targeted.

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Enrollment Challenges in Critical Care Nursing Research.

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Enrollment Challenges in Critical Care Nursing Research.

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