Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT...

Area of Science:

• Clinical Trials Methodology
• Public Health Research
• Health Informatics

Background:

• Pragmatic cluster randomized trials (CRTs) are crucial for evaluating interventions in real-world settings.
• Electronic databases offer a valuable resource for conducting large-scale clinical trials.
• Stroke secondary prevention is a significant public health concern requiring effective primary care strategies.

Purpose of the Study:

• To develop and evaluate methods for pragmatic cluster randomized trials within a primary care electronic database.
• To assess the effectiveness of a computer-delivered intervention for enhancing secondary stroke prevention in primary care.
• To provide methodological insights into implementing CRTs using electronic health records.

Main Methods:

• A cluster randomized trial (CRT) was implemented using the General Practice Research Database (GPRD) electronic patient records.
• General practices were randomized to receive a computer-delivered intervention or usual care.
• The intervention utilized electronic prompts to support adherence to stroke secondary prevention guidelines.

Main Results:

• The primary outcome was the difference in systolic blood pressure between intervention and control groups at 12 months.
• Secondary outcomes included differences in serum cholesterol, and prescribing of antihypertensive drugs, statins, and antiplatelet therapy.
• Analysis of decision-support tool utilization was also conducted.

Conclusions:

• The CRT demonstrated the effectiveness of a computer-delivered intervention in reducing stroke recurrence risk.
• The study offers methodological guidance for conducting CRTs in primary care electronic databases.
• This research contributes to improving secondary stroke prevention strategies in primary care settings.