Table 1 Strategies to overcome barriers to implementing primary care pragmatic randomised controlled trials

Prescriber disagreement about recruitment across sites: clinical eligibility compared to trial suitability

• Prior to implementation, identify potential sources for disagreement, provide examples and workshop solutions with providers

• Throughout recruitment, facilitate a forum for providers to discuss with research team actual difficulties encountered

Potential negative impact of evaluated intervention on provider’s business revenue

• Identify and discuss potential impacts (immediate and long-term) with providers;

• If possible, ensure lost revenue adequately compensated

• Educate potential providers about the value of the intervention to public good

Highly mobile patients

• Consider provision of mobile recruitment services

Inadequate research infrastructure

• Ensure adequate physical space available for trial processes

• Understand information technology (IT) capacity at sites and use study systems that can integrate with pre-existing IT, thus minimising training requirements

• Consider using data extraction tools to minimise access time to information technology systems

• Ensure adequate remuneration to participants for time and service provided

• Consider provision of dedicated research coordinator at sites, particularly those already understaffed

Pre-existing workforce strains

• Adequately understand workforce-related issues at participating sites

• Ensure adequate personnel support is available and can respond to high staff turnover

• Ensure adequate training at practice level, and refresher training available and budgeted for

Potential miscommunication across multidisciplinary health services beyond primary care

• Provision of simple communication tools at the patient and practice levels that highlight patient involvement within the trial.

• Adequately educating patients and carers regarding about trial and need for communicating to all healthcare providers

• Identify participant multidisciplinary providers at enrolment and target trial communication strategies accordingly

Increased administrative burden relative to health service delivery and patient care demands

• Provide adequate research support to sites that can minimise administrative burden

• Consider automated procedures that ensure Good Clinical Practice compliance and can integrate with current health service processes

• Ensure site service delivery requirements are fully understood prior to implementatin

• Provide clear education about Good Clinical Practice

• Practice requirements and administrative needs prior to recruitment

High trial running costs

• Ensure adequate budget for provision of research support personnel at sites to maintain recruitment timelines, ease administrative burden to sites and reduce opportunity cost to sites

• Additional funding load to accommodate inadequate primary care research infrastructure

• In medium to long term establish a funding pool to invest in primary healthcare research infrastructure

Opportunity cost to participants

• Understand potential costs to participants prior to implementation

• Provide adequate remuneration to participants in light of actual time required for administration, including time spent with research nurses

• Ensure simple processes for sites to apply for and receive remuneration