title: Effectiveness of a web-based education program to improve vaccine storage conditions in primary care (Keep Cool): study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  DRKS00006561 (date of registration: 20 February 2015).
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. Anika.Thielmann@uk-essen.de.
authors.forename: Anika
authors.initials: A
authors.lastname: Thielmann
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. Anja.Viehmann@uk-essen.de.
authors.forename: Anja
authors.initials: A
authors.lastname: Viehmann
authors.affiliation: Institute for General Medicine, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. Birgitta.Weltermann@uk-essen.de.
authors.forename: Birgitta M
authors.initials: BM
authors.lastname: Weltermann
mesh_terms: D057189:Checklist; D003080:Cold Temperature; D003194:Computer-Assisted Instruction / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods* / Q000592:standards; D004502:Education, Medical, Continuing / Q000379:methods*; D005858:Germany; D019983:Guideline Adherence; D006801:Humans; D007114:Immunization; D020407:Internet; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D011320:Primary Health Care / Q000592:standards; D011446:Prospective Studies; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D012034:Refrigeration / Q000592:standards; D012107:Research Design; D013997:Time Factors; D014612:Vaccines / Q000592:standards / Q000627:therapeutic use*
chemical_list: D014612:Vaccines