Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial.

Abstract

Background: Clinical trials are known to provide cause-and-effect results and data with low levels of bias. However, a lack of funding for clinical trials, which are considered expensive, means that academic sponsors are rarely able to conduct them. Academic trials are considered highly relevant for the valuable results they provide for clinical questions. This is why initiatives to conduct unfunded clinical trials have been identified as an important issue to pay attention to in future studies. Therefore, we present our initiative through Rogers' theory, which is highlighted in the literature for diffusing innovative change across organizations.

Objective: The purpose of this paper was to describe our case regarding management for conducting a nonfunded nurse-led clinical trial based on our previous low-interventional clinical trial across a specific health organization and with nurses.

Methods: We conducted a low-intervention, nonexternally funded clinical trial using the human and material resources available on site. We managed our trial in a clinical trial unit where there were staff, sources, and ongoing commercial clinical trials. We conducted our trial based on an ongoing commercial trial, and, to do so, we needed behavioral changes. We relied on Rogers' theory, and we identified strengths and barriers to change by analyzing actors' characteristics, perceptions of the situation, motivation, and information. Afterward, we divided the staff according to their characteristics related to innovation and change into permanent staff (research staff with a culture of change) and nonpermanent staff (nursing staff with occasional attendance and resistance to change). First, we preselected only those nurses who were more aware of change (innovators and pioneers) to participate in our trial to avoid a massive rejection, and later, we asked others to join (late adopters). We followed Rogers' phases. For research staff who were aware of the funding, we focused on the "persuasion phase," while for nursing staff, we mixed the "knowledge and persuasion phases" and used pioneers and early adopters as a positive example for other nurses as well as nonfinancial incentives (persuasion). Our trial consisted of different methods of vein cannulation, which was performed in the ongoing commercial trial. Thus, the entire development of our low-interventional clinical trial was conducted without interfering at any point with the parallel commercial clinical trial.

Results: Our management allowed effective conduct of our study, and we met our aims without external funding and without ethical impact during the commercial clinical trial. Costs remained low, primarily because the major expenses were covered by the commercial clinical trial as an inherent part of its design.

Conclusions: Our initiative to conduct a low-intervention clinical trial with no or limited funding was cost-effective. This initiative can be used by researchers with valuable academic research questions who do not have the external funding to conduct studies.

Trial registration: ClinicalTrials.gov NCT04027218; https://clinicaltrials.gov/study/NCT04027218.

International registered report identifier (irrid): RR1-10.2196/56062.