Effectiveness of the online-eLearning program KeepCoool at improving the vaccine cold chain in general practices.

BACKGROUND: Protecting vaccines from freeze damage is a poorly addressed problem. We describe the effectiveness of the eLearning KeepCoool on cold chain maintenance in general practices. METHODS: For this intervention study, temperatures of vaccine refrigerators were logged at one-minute intervals. Personnel from practices with cold chain breaches was offered the eLearning. The primary outcome was the intervention's effectiveness to achieve temperatures in the target range (2 to 8°C) in the sixth week (follow-up) compared to the first (baseline). Using continuous temperature data, a generalized additive model for location, scale and shape was estimated. RESULTS: The practice response rate was 38% (64 of 168). At baseline, 73% of the practices and 68% of the refrigerators (51 of 75) showed cold chain breaches. 47% of the practices (n = 22 with 24 refrigerators) participated in the eLearning (55 physicians and practice assistants). At follow-up, 17% of those refrigerators were in the target range continuously, 38% reached targets 95% of the time while always >0°C, and temperatures ≤0°C decreased by 63%. Based on 2 million temperature data, the average Euclidian distance based on regression showed a significant improvement (p<0.05). CONCLUSION: The eLearning KeepCoool improved the practices´ vaccine cold chain. It is freely available at https://keepcoool.ukbonn.de.

Optimizing blood pressure control by an Information Communication Technology-supported case management (PIA study): study protocol for a cluster-randomized controlled trial of a delegation model for general practices.

BACKGROUND: Longitudinal hypertension control prevents heart attacks, strokes, and other cardiovascular diseases. However, 49% of patients in German family medicine practices do not reach blood pressure (BP) targets (< 140/90 mmHg). Drawing on successful international approaches, the PIA study introduces the PIA information and communication technology system (PIA-ICT) for hypertension management in primary care. The PIA-ICT comprises the PIA-App for patients and the PIA practice management center for practices. Case management includes electronic communication with patients, recall, and stepwise medication adjustments following guidelines. The system supports a physician-supervised delegation model to practice assistants. General practitioners are qualified by eLearning. Patients learn how to obtain reliable BP readings, which they communicate to the practice using the PIA-App. METHODS: The effectiveness of the PIA-Intervention is evaluated in a cluster-randomized study with 60 practices, 120 practice assistants, and 1020 patients. Patients in the intervention group receive the PIA-Intervention; the control group receives usual care. The primary outcome is the BP control rate (BP < 140/90 mmHg) after 12 months. Using a mixed methods approach, secondary outcomes address the acceptance on behalf of physicians, practice assistants, and patients. This includes an evaluation of the delegation model. DISCUSSION: It is hypothesized that the PIA-Intervention will improve the quality of BP care. Perspectively, it may constitute an important health service model for primary care in Germany. TRIAL REGISTRATION: German Clinical Trials Register DRKS00012680. Registered on May 10, 2019.

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: 1) Meetings of peer support groups 2) Personalised telephone-based health coaching for patients with low literacy and/or low patient activation 3) Personalised patient feedback 4) A browser-based web portal METHODS: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. DISCUSSION: If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network ( https://www.drks.de/drks_web/setLocale_EN.do ) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given ( https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

Chronic stress in practice assistants: An analytic approach comparing four machine learning classifiers with a standard logistic regression model.

BACKGROUND: Occupational stress is associated with adverse outcomes for medical professionals and patients. In our cross-sectional study with 136 general practices, 26.4% of 550 practice assistants showed high chronic stress. As machine learning strategies offer the opportunity to improve understanding of chronic stress by exploiting complex interactions between variables, we used data from our previous study to derive the best analytic model for chronic stress: four common machine learning (ML) approaches are compared to a classical statistical procedure. METHODS: We applied four machine learning classifiers (random forest, support vector machine, K-nearest neighbors', and artificial neural network) and logistic regression as standard approach to analyze factors contributing to chronic stress in practice assistants. Chronic stress had been measured by the standardized, self-administered TICS-SSCS questionnaire. The performance of these models was compared in terms of predictive accuracy based on the 'operating area under the curve' (AUC), sensitivity, and positive predictive value. FINDINGS: Compared to the standard logistic regression model (AUC 0.636, 95% CI 0.490-0.674), all machine learning models improved prediction: random forest +20.8% (AUC 0.844, 95% CI 0.684-0.843), artificial neural network +12.4% (AUC 0.760, 95% CI 0.605-0.777), support vector machine +15.1% (AUC 0.787, 95% CI 0.634-0.802), and K-nearest neighbours +7.1% (AUC 0.707, 95% CI 0.556-0.735). As best prediction model, random forest showed a sensitivity of 99% and a positive predictive value of 79%. Using the variable frequencies at the decision nodes of the random forest model, the following five work characteristics influence chronic stress: too much work, high demand to concentrate, time pressure, complicated tasks, and insufficient support by practice leaders. CONCLUSIONS: Regarding chronic stress prediction, machine learning classifiers, especially random forest, provided more accurate prediction compared to classical logistic regression. Interventions to reduce chronic stress in practice personnel should primarily address the identified workplace characteristics.

Correction to: IMPROVEjob - Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises - a study protocol of a cluster-randomised controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Improving knowledge on vaccine storage management in general practices: Learning effectiveness of an online-based program.

BACKGROUND: Adequate vaccine storage is a prerequisite for assuring effective vaccinations yet storage conditions in practices are frequently inadequate. The online learning program Keep Cool aims at improving knowledge on international best practices. This study evaluates the program's learning effectiveness focusing on key indicators for knowledge on vaccine storage, such as temperature target range (2 to 8 °C) and documentation requirements. METHODS: Participants were recruited from within a university teaching practice network. Knowledge was measured with an online-based questionnaire (11 correct items = optimal vaccine storage knowledge) which was completed before and after the online program. RESULTS: 60 physicians and practice assistants from 25 practices participated. The mean knowledge score was 5.6 correct answers (standard deviation [SD] 1.9), which increased to 9.8 (SD 1.2) after program participation (p < 0.001). The item with the highest net change addressed the need for twice-daily documentation of temperatures (+76.7%). Knowledge of the lower and upper temperature targets improved from 58% respectively 63% to 100% each. Optimal vaccine storage knowledge after participation (38% of participants) was associated neither with age, gender, occupational group nor practice type. CONCLUSION: The new online education program showed a high learning effectiveness regarding key indicators for the quality of vaccine storage management. Clinical Trial Registry Number: DRKS00006561.

IMPROVEjob - Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises - a study protocol of a cluster-randomised controlled trial.

BACKGROUND: Perceived high chronic stress is twice as prevalent among German general practitioners (GPs) and non-physician medical staff compared to the general population. The reasons are multi-factorial and include patient, practice, healthcare system and societal factors, such as multi-morbidity, the diversity of populations and innovations in medical care. Also, practice-related factors, like stressful patient-staff interactions, poor process management of waiting times and lack of leadership, play a role. This publicly funded study evaluates the effectiveness of the newly developed participatory, interdisciplinary, and multimodal IMPROVEjob intervention on improving job satisfaction among general practice personnel. The intervention aims at structural stress prevention with regard to working conditions and behavioural stress prevention for leaders and other practice personnel. METHODS: In this cluster-randomised controlled trial, a total of 56 general practices will be assigned to either (1) participation in the IMPROVEjob intervention or (2) the waiting-list control group. The IMPROVEjob intervention consists of the following elements: three workshops, a toolbox with supplemental material and an implementation period with regular contact to so-called IMPROVEjob facilitators. The first workshop, addressing leadership issues, is designed for physicians with leadership responsibilities only. The two subsequent workshops target all GP and non-physician personnel; they address issues of communication (with patients and within the team), self-care and team-care and practice organisation. During the 9-month implementation period, practices will be contacted by IMPROVEjob facilitators to enhance motivation. Additionally, the practices will have access to the toolbox materials online. All participants will complete questionnaires at baseline and follow up. The primary outcome is the change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018). Secondary outcomes obtained by questionnaires and - qualitatively - by facilitators comprise psychosocial working conditions including leadership aspects, expectations and experiences of the workshops, team and individual efforts and organisational changes. DISCUSSION: It is hypothesised that participation in the IMPROVEjob intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological wellbeing of personnel in general practices and prospectively in other small and medium sized enterprises. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00012677. Registered on 16 October 2019. Retrospectively, https://www.drks.de/drks_web/navigate.do?navigationId=trial. HTML&TRIAL_ID = DRKS00012677.

Visual inspection of vaccine storage conditions in general practices: A study of 75 vaccine refrigerators.

INTRODUCTION: Adequate vaccine storage is a prerequisite to assure vaccine effectiveness and tolerability. In this context, maintaining the cold chain (2°C to 8°C) is the paramount objective. To establish quality-ensured cold chain maintenance, compliance with several structural and procedural aspects is necessary. MAIN OBJECTIVE: The aim of this publication is to assess the quality of vaccine refrigerator management in general practices. METHODS: This study describes baseline results of an intervention study. To evaluate the quality of vaccine refrigerator management, visual inspections were conducted of refrigerators used to store vaccines in general practices of a German teaching practice network. The study instrument was a checklist with ten quality criteria based on international best practices for vaccine storage. A data logger recorded refrigerator temperatures for 7 days. We analyzed associations between reaching more than half (6+) of the ten quality criteria and temperature data. RESULTS: The study included 64 of 168 practices (38.1% response rate) with 75 refrigerators. No practice fulfilled all 10 quality criteria. On average, 4.7 (standard deviation = 1.9) criteria were met. The most frequent deficits were: no drawers/bins/baskets for vaccines (81.3%), no temperature logbook near refrigerator (75.0%), no temperature recording device in the center of the refrigerator (54.0%), vaccines boxes with contact to outer walls (46.3%), and refrigerator unsuitable for vaccine storage (44.6%). Refrigerators with better management (≥6 quality criteria) were more likely to have temperatures in the target range (62.5% vs. 27.5%, p = 0.008). CONCLUSION: We identified a large number of avoidable vaccine storage errors. Effective strategies, e.g. web-based programs, to improve vaccine storage conditions in general practices are needed.

Vaccine cold chain in general practices: A prospective study in 75 refrigerators (Keep Cool study).

INTRODUCTION: Protecting vaccines from freeze damage is considered one of the most poorly addressed problems in vaccine management. Freezing may impair the potency especially of adsorbed vaccines. The Keep Cool study aims at ensuring optimal vaccine storage conditions in general practices. This publication analyses the baseline data using standardised temperature recordings. METHODS: This prospective study in German general practices analysed 7-day temperature recordings of refrigerators used for vaccine storage. Temperatures were recorded continuously using a standardised data logger with an accuracy of ±0.4 °C. The prevalence rates of refrigerators within the target range (2 to 8 °C) and of those reaching critically low temperatures (≤0 °C) were calculated. In addition, the cumulative time and the duration of single episodes beyond the target range were computed. To assess for structural deficits, the prevalence of refrigerators with a cycling of >5 °C was determined. Generalised linear mixed models were applied to analyse correlating factors between the dependent variables 'within temperature range' and 'reaching critically low temperatures' with practice characteristics. RESULTS: The study included 64 of 168 practices (38.1% response rate) with 75 refrigerators. The prevalence of refrigerators with temperatures within the target range was 32.0% (n = 24), and 14.7% (n = 11) reached critically low temperatures <0 °C. 44.0% of refrigerators (n = 33) showed temperatures >8 °C and 28.0% (n = 21) <2 °C. Of the 168 hours recorded per refrigerator, the average cumulative time >8 °C was 49 hours, <2 °C 75 hours and ≤0 °C 74 hours. The longest consecutive period of critically low temperatures was 168 hours (mean: 39±53). The prevalence of refrigerators with a cycling range of >5 °C was 29.3%. CONCLUSION: Given the importance of immunisation, the results of our study call for action, as two-thirds of the refrigerators exhibited cold chain breaches and 15% reached critically low temperatures threatening vaccine potency.

Chronic stress, work-related daily challenges and medicolegal investigations: a cross-sectional study among German general practitioners.

BACKGROUND: The prevalence of chronic stress among German general practitioners (GPs) was shown to be twice as high as in the general population. Because chronic stress negatively influences well-being and poor physician well-being is associated with poor patient outcomes, targeted strategies are needed. This analysis focuses on work-related factors associated with high chronic stress in GPs. METHODS: This cross-sectional study measured chronic stress among German GPs using the validated and standardized Trier Inventory for the Assessment of Chronic Stress (TICS-SSCS). Based on the TICS, GPs were categorized as either having low strain (≤ 25th percentile) or high strain (≥ 75th percentile) due to chronic stress. Questions on work-related challenges assessed the frequency and the subjectively perceived strain of single challenges. For exploratory analyses, these items were combined to dichotomous variables reflecting challenges that are common and that cause high strain. Variables significant in bivariate analyses were included in a multivariate logistic regression model analyzing their association with high chronic stress. RESULTS: Data of 109 GPs categorized as having low strain (n = 53) or high strain (n = 56) due to chronic stress were analyzed. Based on bivariate analyses, challenges regarding personnel matters, practice software, complexity of patients, difficult patients, care facilities, scheduling of appointments, keeping medical records up-to-date, fee structures, and expectations versus reality of care were included in the regression model. Keeping medical records up-to-date had the strongest association with high chronic stress (odds ratio 4.95, 95% confidence interval 1.29-19.06). A non-significant trend showed that medicolegal investigations were more common among GPs with high chronic stress. CONCLUSIONS: This exploratory research shows that chronic stress is predominantly associated with administrative challenges. Treatment documentation, which represents a legal safeguard and is closely linked to existential concerns, has the strongest influence.

Self-care for common colds: A European multicenter survey on the role of subjective discomfort and knowledge about the self-limited course - The COCO study.

INTRODUCTION: Common colds are the most frequently encountered disease worldwide and the most frequent reason for self-care. According to the cross-sectional European Common Colds study (COCO), patients use as many as 12 items on average for self-care. Little is known about the influence of discomfort and knowledge on self-care for common colds. MAIN OBJECTIVE: To understand the influence of patients' discomfort during a cold and their knowledge about the self-limited disease course on the use of self-care measures. MATERIALS AND METHODS: This COCO analysis included 2,204 patients from 22 European primary care sites in 12 countries. Each site surveyed 120 consecutive adults with a 27-item questionnaire asking about patients' self-care, subjective discomfort during a cold (discomfort: yes/no), and knowledge about the self-limited course (yes/no). Country-specific medians of the number of self-care items served as a cut-off to define high and low self-care use. Four groups were stratified based on discomfort (yes/no) and knowledge (yes/no). RESULTS: Participants' mean age was 46.5 years, 61.7% were female; 36.3% lacked knowledge; 70.6% reported discomfort. The group has discomfort/no knowledge exhibited the highest mean item use (13.3), followed by has discomfort/has knowledge (11.9), no discomfort/no knowledge (11.1), and no discomfort/has knowledge (8.8). High use was associated with discomfort (OR 1.8; CI 1.5-2.2), female gender (OR 1.7; 1.4-2.0), chronic pain/arthritis (OR 1.6; 1.2-2.1), more years of education (OR 1.3; 1.1-1.6), age <48 years (OR 1.3; 1.0-1.5), and lack of knowledge (OR 1.2; 1.0-1.4). DISCUSSION: Counseling on common colds should address patients' discomfort and soothing measures in addition to providing information on the natural disease course.

Prevalence of chronic stress in general practitioners and practice assistants: Personal, practice and regional characteristics.

BACKGROUND: The majority of studies investigating stress in primary care have focused either on general practitioners (GPs) or practice assistants (PAs), but did not measure stress on a practice level. We analyzed the prevalence of chronic stress for both professional groups and on a practice level and investigated personal, practice, and regional characteristics. METHODS: Chronic stress was measured in GPs and PAs from 136 German practices using the standardized, self-administered TICS-SSCS questionnaire (12 items). Based on a sum-score, participants per professional group were categorized as having low or high strain due to chronic stress (≤ 25th and ≥ 75th percentile of the study population´s distribution, respectively). For a cluster-level analysis, the mean of all practice means was used to categorize low- and high-stress practices. The intra-class correlation coefficient (ICC) was calculated using ANOVA. Prevalence Ratios (PR) were used to compare low versus high strain due to stress, stratified for personal, practice and regional characteristics. RESULTS: The response rate was 74.1% (n = 137/185). Data from 214 GPs (34.1% female), 500 PAs (99.4% female), and 50 PAs in training (98.0% female) were analyzed. Chronic stress was highest in female GPs (median 19, IQR (interquartile range) 11.5), followed by PAs (16, IQR 12.25) and male GPs (15, IQR 10). On a practice level, 26.3% of the practice personnel reported a high stress level. We observed an overall ICC of 0.25, with higher ICCs when stratifying by professional group (PAs: ICC 0.36, GPs in group practices: ICC 0.51). High chronic stress was observed as the number of working hours per week increased (GPs: PR 2.03, 95% CI 1.16-3.56; PAs: PR 2.02, 95% CI 1.22-3.35). There were no differences for practice type (solo/group) and the various regional characteristics. CONCLUSION: Personal and practice characteristics were associated with chronic stress in GPs, PAs, and on a practice level. The high ICCs indicate a need for stress-reduction strategies geared at both professions on a practice level.

Relevance of clerkship characteristics in changing students' interest in family medicine: a questionnaire survey.

OBJECTIVES: Exposure to family medicine (FM) can serve to promote students' interest in this field. This study aimed at identifying clerkship characteristics which decrease or increase students' interest in FM. DESIGN: This cross-sectional questionnaire study analysed students' clerkship evaluations between the years 2004 and 2014. Descriptive statistics were used to compare four predefined groups: (1) high interest in FM before and after the clerkship (Remained high), (2) poor interest before and after the clerkship (Remained low), (3) poor interest before the clerkship which improved (Increased) and (4) high interest before the clerkship which decreased (Decreased). SETTING: Students' evaluations of FM clerkships in the fourth of 6 years of medical school. PARTICIPANTS: All questionnaires with complete answers on students' interest in FM and its change as a result of the clerkship (2382 of 3963; 60.1%). The students' mean age was 26 years (± 3.9), 62.7% (n=1505) were female. OUTCOME MEASURE: The outcome was a change in students' interest in FM after completing the clerkship. RESULTS: Interest in FM after the clerkship was as follows: 40.1% (n=954) Remained high, 5.5% (n=134) Remained low, 42.1% (n=1002) Increased and 12.3% (n=292) Decreased. Students with decreased interest had performed a below-average number of learning activities (4 vs 6 activities). A total of 45.9% (n=134 of 292) of the students with decreased interest reported that the difficulty of the challenge was inadequate for their educational level: 81.3% (n=109) felt underchallenged and 18.7% (n=25) overchallenged. CONCLUSIONS: In more than 50% of cases, the clerkship changed the students' interest in FM. Those with decreased interest were more frequently underchallenged. We observed an increase in FM if at least six learning activities were trained. Our findings stress the importance of well-designed FM clerkships. There is a need for standardised educational strategies which enable teaching physicians to operationalise educational requirements.

Self-Care for Common Colds by Primary Care Patients: A European Multicenter Survey on the Prevalence and Patterns of Practices-The COCO Study.

Background. Patients use self-care to relieve symptoms of common colds, yet little is known about the prevalence and patterns across Europe. Methods/Design. In a cross-sectional study 27 primary care practices from 14 countries distributed 120 questionnaires to consecutive patients (≥18 years, any reason for consultation). A 27-item questionnaire asked for patients' self-care for their last common cold. Results. 3,074 patients from 27 European sites participated. Their mean age was 46.7 years, and 62.5% were females. 99% of the participants used ≥1 self-care practice. In total, 527 different practices were reported; the age-standardized mean was 11.5 (±SD 6.0) per participant. The most frequent self-care categories were foodstuffs (95%), extras at home (81%), preparations for intestinal absorption (81%), and intranasal applications (53%). Patterns were similar across all sites, while the number of practices varied between and within countries. The most frequent single practices were water (43%), honey (42%), paracetamol (38%), oranges/orange juice (38%), and staying in bed (38%). Participants used 9 times more nonpharmaceutical items than pharmaceutical items. The majority (69%) combined self-care with and without proof of evidence, while ≤1% used only evidence-based items. Discussion. This first cross-national study on self-care for common colds showed a similar pattern across sites but quantitative differences.

Self-Care Practices for Common Colds by Primary Care Patients: Study Protocol of a European Multicenter Survey-The COCO Study.

Background. Self-care for common colds is frequent, yet little is known about the spectrum, regional differences, and potential risks of self-care practices in patients from various European regions. Methods/Design. We describe the study protocol for a cross-sectional survey in 27 primary care centers from 14 European countries. At all sites, 120 consecutive adult patients, who visit their general practitioner for any reason, filled in a self-administered 27-item questionnaire. This addresses patients' self-care practices for common colds. Separately, the subjective level of discomfort when having a common cold, knowing about the diseases' self-limited nature, and medical and sociodemographic data are requested. Additionally, physicians are surveyed on their use of and recommendations for self-care practices. We are interested in investigating which self-care practices for common colds are used, whether the number of self-care practices used is influenced by knowledge about the self-limited nature of the disease, and the subjective level of discomfort when having a cold and to identify potential adverse interactions with chronic physician-prescribed medications. Further factors that will be considered are, for example, demographic characteristics, chronic conditions, and sources of information for self-care practices. All descriptive and analytical statistics will be performed on the pooled dataset and stratified by country and site. Discussion. To our knowledge, COCO is the first European survey on the use of self-care practices for common colds. The study will provide new insight into patients' and general practitioners' self-care measures for common colds across Europe.

Effectiveness of a web-based education program to improve vaccine storage conditions in primary care (Keep Cool): study protocol for a randomized controlled trial.

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).

Vaccination management and vaccination errors: a representative online-survey among primary care physicians.

BACKGROUND: Effective immunizations require a thorough, multi-step process, yet few studies comprehensively addressed issues around vaccination management. OBJECTIVES: To assess variations in vaccination management and vaccination errors in primary care. METHODS: A cross sectional, web-based questionnaire survey was performed among 1157 primary physicians from North Rhine-Westphalia, Germany: a representative 10% random sample of general practitioners (n = 946) and all teaching physicians from the University Duisburg-Essen (n = 211). Four quality aspects with three items each were included: patient-related quality (patient information, patient consent, strategies to increase immunization rates), vaccine-related quality (practice vaccine spectrum, vaccine pre-selection, vaccination documentation), personnel-related quality (recommendation of vaccinations, vaccine application, personnel qualification) and storage-related quality (storage device, temperature log, vaccine storage control). For each of the four quality aspects, "good quality" was reached if all three criteria per quality aspect were fulfilled. Good vaccination management was defined as fulfilling all twelve items. Additionally, physicians' experiences with errors and nearby-errors in vaccination management were obtained. RESULTS: More than 20% of the physicians participated in the survey. Good vaccination management was reached by 19% of the practices. Patient-related quality was good in 69% of the practices, vaccine-related quality in 73%, personnel-related quality in 59% and storage-related quality in 41% of the practices. No predictors for error reporting and good vaccination management were identified. CONCLUSIONS: We identified good results for vaccine- and patient-related quality but need to improve issues that revolve around vaccine storage.