Trial document




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  DRKS00021231

Trial Description

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Title

Accompanying monitoring of primary care in GP practices during the COVID-19 pandemic

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Trial Acronym

COVIPRIM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to the COVID-19 pandemic, family doctors in particular are under immense pressure and have to do incredible things. In addition, the general conditions and challenges change every week. In the meantime, various regulations have been issued by governments to counteract the threatening supply bottlenecks in the health system. Projections predict that the capacities of clinics and hospitals to care for the sick in German-speaking countries will be scarce by the beginning of April at the latest. The role of general practitioners during a pandemic and the challenges they face have so far been studied mainly retrospectively. It was found that general practitioners are largely inadequately provided with protective clothing and in some cases are not sufficiently aware of the regional pandemic plans. Furthermore, it was shown that the role of the family doctors as first contact person is very demanding for them, since they are confronted with potentially infectious patients, some of whom are insufficiently protected, and they also see a responsibility for their family, which they do not want to endanger unnecessarily. In this insecure situation they are also confronted with fears of patients, staff and their own families. Other challenges include the need for rapid restructuring due to staff or colleague absences and technical innovations. Based on guideline interviews with family doctors, nine topics were identified. Based on this structure a questionnaire was developed. This questionnaire was checked for comprehensibility by 3 - 5 general practitioners. The recruitment of the participants is carried out via the email distribution list of professional associations and existing research and teaching networks of family doctors. The survey is conducted via the open source online tool LimeSurvey. Persons who have agreed to participate in a weekly survey in the first survey will be contacted weekly. Since each participant chooses a code that only he/she knows, it is possible to summarize the surveys belonging to one person longitudinally, but it is not possible to assign these answers to a specific person. This guarantees the anonymity of the respondents.
Evaluation: The questionnaire is evaluated descriptively. Primarily the extent of existing deficiencies and problems should be recognized. The aim of this project is to conduct a regular survey among Austrian and German general practitioners working in GP practices during the Covid-19 pandemic regarding their role in this pandemic, their specific challenges in this setting and their strategies developed during the pandemic. Potential deficiencies in care and possible obstacles such as lack of stakeholder support will also be identified. The resulting data should be published in weekly short surveys ("mood reports") from primary care.


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Brief Summary in Scientific Language

The COVID-19 pandemic has placed immense demands on primary care in particular, and it has had to do incredible things. In addition, the general conditions and challenges change every week. In the meantime, various regulations have been issued by governments to counteract the threatening supply bottlenecks in the health system. Projections predict that the capacity of clinics and hospitals to care for the sick in German-speaking countries will become scarce at the beginning of April at the latest. The role of primary care during a pandemic and the challenges it faces have so far been investigated either retrospectively or in hypothetical scenarios. It was found that the majority of primary care physicians are inadequately provided with protective clothing and in some cases are not sufficiently aware of regional pandemic plans. Furthermore, it was shown that the role of the family doctors as the first point of contact is very demanding for them, since they are confronted with potentially infectious patients, some of whom are insufficiently protected, and they also see a responsibility for their family, which they do not want to put in unnecessary danger. In this insecure situation they are also confronted with fears of patients, staff and their own families. Other challenges include the need for rapid restructuring due to staff or colleague absences and technical innovations. Methods: Based on semi-structured guideline interviews with family doctors, nine topics were identified. Based on this structure a questionnaire was developed. The questionnaire contains items that are only given once (e.g. items relating to the beginning of the pandemic) and items that can be given weekly. This questionnaire was checked for comprehensibility by 3 - 5 family doctors. The recruitment of the participants is carried out via the email distribution list of professional associations and existing family doctor research and teaching networks. The survey is conducted via the open source online tool LimeSurvey. Persons who have agreed to participate in a weekly survey in the first survey will be contacted weekly. Since each participant chooses a code that only he/she knows, it is possible to summarize the surveys belonging to one person longitudinally, but it is not possible to assign these answers to a specific person. This guarantees the anonymity of the respondents.
Evaluation: The questionnaire is evaluated descriptively. Primarily, the extent of existing deficiencies and problems is to be recognized. Therefore, the items are evaluated individually and no summary of the items is planned. For this reason, the answers are displayed in frequencies. In order to obtain a conclusion on the population, 95% confidence intervals are calculated for the frequencies. Possible group differences (e.g. ordination in the country vs. ordination in the city) are analysed exploratively by means of chi-square methods. The sample size results from the e-mail addresses available in the distribution lists. The aim of this project is to conduct a regular survey among Austrian and German general practitioners working in GP practices during the Covid-19 pandemic regarding their role in this pandemic, their specific challenges in this setting and their strategies developed during the pandemic. Potential deficiencies in care and possible obstacles such as lack of stakeholder support will also be identified. The resulting data should be published in weekly short surveys ("mood reports") from primary care.


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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

A defined data set can be made available after completion of the study by request to the director of the study

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Organizational Data

  •   DRKS00021231
  •   2020/04/02
  •   [---]*
  •   yes
  •   Approved
  •   20-619 , Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Challenges of the Covid 19 pandemic in primary care
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Interventions/Observational Groups

  •   Questionnaire survey of general practitioners with panel practice Method: Based on semi-structured guideline interviews with general practitioners, nine subject areas were identified. Based on this structure a questionnaire was developed. The questionnaire contains items that are only given once (e.g. items relating to the beginning of the pandemic) and items that can be given weekly. This questionnaire was checked for comprehensibility by 3 - 5 family doctors. The recruitment of the participants is carried out via the email distribution list of professional associations and existing family doctor research and teaching networks. The survey is conducted via the open source online tool LimeSurvey. Persons who have agreed to participate in a weekly survey in the first survey will be contacted weekly. Since each participant chooses a code that only he/she knows, it is possible to summarize the surveys belonging to one person longitudinally, but it is not possible to assign these answers to a specific person. This guarantees the anonymity of the respondents.
    Evaluation: The questionnaire is evaluated descriptively. Primarily, the extent of existing deficiencies and problems is to be recognized. Therefore, the items are evaluated individually and no summary of the items is planned. For this reason, the answers are displayed in frequencies. In order to obtain a conclusion on the population, 95% confidence intervals are calculated for the frequencies. Possible group differences (e.g. ordination in the country vs. ordination in the city) are analysed exploratively by means of chi-square methods. The sample size results from the e-mail addresses available in the distribution lists.

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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of this project is to conduct a regular survey among Austrian and German general practitioners working in GP practices during the Covid-19 pandemic regarding their role in this pandemic, their specific challenges in this setting and their strategies developed during the pandemic.

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Secondary Outcome

Potential shortcomings in supply and any obstacles such as lack of stakeholder support will also be recorded. The data generated from this should be published in weekly short surveys ("mood reports") from primary care

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/04/03
  •   2000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   24   Years
  •   no maximum age
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Additional Inclusion Criteria

General practitioners working as family doctors in individual, group practices or primary care units in Germany and Austria.

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Exclusion Criteria

General practitioner with private practice

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Addresses

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    • Paracelsus Medizinische Privatuniversität Institut für Allgemeinmedizin
    • Ms.  Univ. Prof. Dr.  Maria  Flamm 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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    • Medizinische Universität Graz Institut für Allgemeinmedizin
    • Ms.  Univ. Prof.Dr.  Andrea  Siebenhofer-Kroitzsch 
    • Auenbruggerplatz 20
    • 8036  Graz
    • Austria
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    • Goethe-Universität Frankfurt am Main Institut für Allgemeinmedizin
    • Ms.  Dr. rer. med. M. Sc. PH  Karola  Mergenthal 
    • Theodor-Stern-Kai 7
    • D-60590 
    • Germany
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    • Paracelsus Medizinische Privatuniversität Institut für Allgemeinmedizin
    • Ms.  Dr.  Dagmar  Schaffler 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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    end of 1:1-Block address contact scientific-contact
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    • Paracelsus Medizinische Privatuniversität Institut für Allgemeinmedizin
    • Ms.  Dr  Dagmar  Schaffler 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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Sources of Monetary or Material Support

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    • Paracelsus Medizinische Privatuniversität
    • Ms.  Univ. Prof. Dr.  Maria  Flamm 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.