1. Effectiveness of a web-based education program to improve vaccine storage conditions in primary care (Keep Cool): study protocol for a randomized controlled trial.
- Author
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Thielmann A, Viehmann A, and Weltermann BM
- Subjects
- Checklist, Cold Temperature, Drug Stability, Drug Storage standards, Germany, Guideline Adherence, Humans, Immunization, Practice Guidelines as Topic, Practice Patterns, Physicians', Prospective Studies, Quality Improvement, Quality Indicators, Health Care, Research Design, Time Factors, Vaccines standards, Computer-Assisted Instruction methods, Drug Storage methods, Education, Medical, Continuing methods, Internet, Primary Health Care standards, Refrigeration standards, Vaccines therapeutic use
- Abstract
Background: Immunization programs are among the most effective public health strategies worldwide. Adequate vaccine storage is a prerequisite to assure the vaccines' effectiveness and safety. In a questionnaire survey among a random sample of German primary care physicians, we discovered vaccine storage deficits: 16% of physicians had experience with cold chain breaches either as an error or near error, 49 % did not keep a temperature log, and 21 % did not use a separate refrigerator for vaccine storage. In a recent feasibility study of 21 practice refrigerators, we showed that these were outside the target range 10.2% of the total time with some single refrigerators being outside the target range as much as 66.3% of the time. These cooling-chain deficits are consistent with the international medical literature, yet an effective, easy to disseminate, practice-centered intervention to improve storage conditions is lacking., Methods/design: This randomized intervention trial will be conducted in a random sample of primary care practices. Based on continuous temperature recordings over 7 days, all practices with readings outside the target range for vaccine storage (+2 °C to +8 °C) will be randomly allocated to a web-based education program or a waiting list control group. The practice physicians and their teams constitute the target population. Participants will be educated about best practices in vaccine storage and will receive a manual including storage checklists and templates for temperature documentation. In all practices, temperatures of the vaccine refrigerators will be monitored continuously using a data logger with a glycol probe as a surrogate for vaccine vial temperature. The effectiveness of the web-based education program will be determined after 6 months in terms of the proportion of refrigerators with vaccine vial temperatures within the target range (+2 °C to +8 °C) during 7-day temperature logging. Secondary outcome parameters include temperature monitoring, no critically low temperatures (≤ -0.5 °C), compliance with storage recommendations, knowledge of good vaccine storage conditions, and assignment of personnel as vaccine storage manager and backup., Discussion: Keep Cool will develop and evaluate a web-based education program to improve vaccine storage conditions in primary care and thereby ensure immunization safety and effectiveness., Trial Registration: DRKS00006561 (date of registration: 20 February 2015).
- Published
- 2015
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