Feedback GAP: pragmatic,cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care

Background

Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets.

Methods

A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The ‘usual feedback’ arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed.

Results

Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes.

Discussion

Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention.

Trial registration

ClinicalTrials.gov NCT00996645

     

Oxidative-damage effect of Fe3O4 nanoparticles on mouse hepatic and brain cells in vivo

To assess the biological safety of Fe3O4 nanoparticles （NPs）, the oxidative-damage effect of these NPs was studied. Twenty-five Kunming mice were exposed to Fe3O4 NPs by intraperitoneai injection daily for 1 week at doses of 0, 10, 20, and 40 mg.kg1. Five Kunming mice were also injected with 40 mg.kg 1 ordinary Fe3O4 particles under the same physiological conditions. Biomarkers of reactive oxygen species （ROS）, glutathione （GSH）, and malondialdehyde （MDA） in the hepatic and brain tissues were detected. Results showed that no significant difference in oxidative damage existed at concentrations lower than 10 mg.kg i for NPs compared with the control group. Fe3O4 NP concentration had obvious dose-effect relationships （P〈 0.05 or P 〈 0.01） with ROS level, GSH content, and MDA content in mouse hepatic and brain tissues at〉20 mg.kg 1 concentrations. To some extent, ordinary Fe3O4 particles with 40mg.kg -1 concentration also affected hepatic and brain tissues in mice. The biological effect was similar to Fe3O4 NPs at 10 mg. kg-1 concentration. Thus, Fe3O4 NPs had significant damage effects on the antioxidant defense system in the hepatic and brain tissues of mice, whereas ordinary Fe3O4 had less influence than Fe3O4 NPs at the same concentration.