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Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.

ABSTRACT: To identify challenges and solutions to the efficient conduct of a multisite, practice-based randomized controlled trial to improve nurses' adherence to personal protective equipment use in ambulatory oncology settings.The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a Web-based continuing education video.The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies.Noteworthy challenges included variation in human subjects' protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled Web conferences, site-based study champions, site visits by the principal investigator, and centrally based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials.Multisite studies of nursing personnel are rare and challenging to the existing infrastructure. These barriers can be overcome with strong engagement and planning.Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial.

SUBMITTER: Friese CR

PROVIDER: S-EPMC5334367 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.

Friese Christopher R CR Mendelsohn-Victor Kari K Ginex Pamela P McMahon Carol M CM Fauer Alex J AJ McCullagh Marjorie C MC

Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing 20170118 2

<h4>Purpose</h4>To identify challenges and solutions to the efficient conduct of a multisite, practice-based randomized controlled trial to improve nurses' adherence to personal protective equipment use in ambulatory oncology settings.<h4>Design</h4>The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Web-based feedback on hazardous drug exposures in the sites plus tailored messages to addre ...[more]

PMID: 28098951

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Project description:BackgroundThere is increasing recognition among trialists of the challenges in understanding how particular 'real-life' contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted.MethodsA collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection.Results and discussionFrom our experiences of the realities of conducting these evaluations, we identified six key 'lessons learned' about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and these approaches should help the identification of and reflection on possible overlaps between the evaluation and intervention.ConclusionThe lessons we have drawn point to the principle of reflexivity that, we argue, needs to become part of standard practice in the conduct of evaluations of complex interventions to promote more meaningful interpretations of the effects of an intervention and to better inform future implementation and decision-making.

Project description:BackgroundThe use of web-based methods to collect population-based health behavior data has burgeoned over the past two decades. Researchers have used web-based platforms and research panels to study a myriad of topics. Data cleaning prior to statistical analysis of web-based survey data is an important step for data integrity. However, the data cleaning processes used by research teams are often not reported.ObjectiveThe objectives of this manuscript are to describe the use of a systematic approach to clean the data collected via a web-based platform from panelists and to share lessons learned with other research teams to promote high-quality data cleaning process improvements.MethodsData for this web-based survey study were collected from a research panel that is available for scientific and marketing research. Participants (N=4000) were panelists recruited either directly or through verified partners of the research panel, were aged 18 to 45 years, were living in the United States, had proficiency in the English language, and had access to the internet. Eligible participants completed a health behavior survey via Qualtrics. Informed by recommendations from the literature, our interdisciplinary research team developed and implemented a systematic and sequential plan to inform data cleaning processes. This included the following: (1) reviewing survey completion speed, (2) identifying consecutive responses, (3) identifying cases with contradictory responses, and (4) assessing the quality of open-ended responses. Implementation of these strategies is described in detail, and the Checklist for E-Survey Data Integrity is offered as a tool for other investigators.ResultsData cleaning procedures resulted in the removal of 1278 out of 4000 (31.95%) response records, which failed one or more data quality checks. First, approximately one-sixth of records (n=648, 16.20%) were removed because respondents completed the survey unrealistically quickly (ie, <10 minutes). Next, 7.30% (n=292) of records were removed because they contained evidence of consecutive responses. A total of 4.68% (n=187) of records were subsequently removed due to instances of conflicting responses. Finally, a total of 3.78% (n=151) of records were removed due to poor-quality open-ended responses. Thus, after these data cleaning steps, the final sample contained 2722 responses, representing 68.05% of the original sample.ConclusionsExamining data integrity and promoting transparency of data cleaning reporting is imperative for web-based survey research. Ensuring a high quality of data both prior to and following data collection is important. Our systematic approach helped eliminate records flagged as being of questionable quality. Data cleaning and management procedures should be reported more frequently, and systematic approaches should be adopted as standards of good practice in this type of research.

Project description:Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.Clinicaltrials.gov Identifier: NCT00661817.

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Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.

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Lessons Learned From a Practice-Based, Multisite Intervention Study With Nurse Participants.

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