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

Area of Science:

• Nursing Research
• Health Services Research
• Clinical Trial Management

Background:

• Academic clinical trials are crucial for unbiased, cause-and-effect data but are often unfunded due to high costs.
• Initiatives for conducting unfunded clinical trials are essential for advancing academic research.
• Rogers' theory of diffusion of innovations provides a framework for implementing change in healthcare organizations.

Purpose of the Study:

• To describe the management of a non-funded, nurse-led, low-interventional clinical trial within a healthcare organization.
• To demonstrate the feasibility of conducting academic research with limited financial resources.

Main Methods:

• A low-intervention clinical trial was conducted using on-site human and material resources, integrated with an ongoing commercial trial.
• Rogers' theory guided the management of behavioral changes, identifying staff characteristics, motivations, and perceptions.
• Staff were categorized, and innovators/early adopters were engaged first, followed by late adopters, using knowledge and persuasion phases.

Main Results:

• The study was successfully conducted, meeting its aims without external funding or negative ethical impact on the commercial trial.
• Low costs were achieved as major expenses were covered by the parallel commercial trial.
• Effective management strategies ensured the trial's completion within the existing infrastructure.

Conclusions:

• Conducting low-intervention clinical trials with limited or no funding is a cost-effective strategy.
• This model is applicable for researchers with valuable academic questions but lacking external funding.
• The approach facilitates the generation of high-quality clinical research data in resource-constrained settings.