Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised,...

Area of Science:

• Clinical Trials Methodology
• Stroke Recovery Research
• Health Services Research

Background:

• Randomized controlled trials (RCTs) frequently struggle to meet recruitment targets.
• The EFFECTS trial, an academic-led RCT in Sweden, investigates fluoxetine for stroke recovery.
• The ERUTECC study was designed to address recruitment challenges within the ongoing EFFECTS trial.

Purpose of the Study:

• To evaluate the effectiveness of a structured teleconference re-visit combined with a commitment contract in enhancing patient recruitment for an ongoing RCT.
• To determine if this intervention can increase recruitment by 20% within 60 days post-intervention compared to the pre-intervention period.

Main Methods:

• ERUTECC is a randomized, stepped-wedge cluster trial embedded within the EFFECTS RCT.
• The intervention involves a structured teleconference re-visit and commitment contract for study personnel at participating centers.
• The study excludes the top five recruiting centers, focusing on those with potentially lower recruitment rates.

Main Results:

• The study hypothesizes that the ERUTECC intervention will significantly enhance recruitment rates.
• The primary outcome is a 20% increase in recruitment within 60 days post-intervention.

Conclusions:

• The ERUTECC study's findings could offer valuable insights for improving trial management in future research.
• Results may be generalizable to high-income Western countries and potentially applicable beyond stroke research.
• Successful implementation could lead to more efficient and effective clinical trial recruitment processes.