PreventionNCT02351570
Health Prevention Programmes to Patients Through Their General Practitioners
An observational study of Prevention, run by Berlin School of Public Health at 1 site in Germany.
Trial summary
By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007 in §20 SGB V the health insurance schemes have received an enlarged action frame in the primary prevention and the operational health support. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention
- How many people
- 474 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite (see characteristics below) which are also part of the mail survey.
Who may be able to join
- Teaching doctors of the Institute for General Medicine at the Charite
- Aptitude and joy in teaching
- Specialist in general medicine, general practice internist or active internist
- Duration of establishment > 3 years
- More than 500 GKV-Versicherte / quarter
- Typical general practitioner spectrum without one-sided practice
Show all 9Show fewer
- Regular house visits
- Separate space for students
- Guarantee of the necessary number of hours
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berlin School of Public Health, Charite Universitätsmedizin Berlin
Berlin, State of Berlin, 13347
About this study
Official title: Offer and Mediation of §20 SGB V Health Prevention Programmes to Patients Through Their Treating General Practitioner - a Mixed Methods Study
By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007 in §20 SGB V the health insurance schemes have received an enlarged action frame in the primary prevention and the operational health support.
Through these paragraphs arises the possibility for citizens to let refund health-supporting programmes or health training of the health insurance schemes.
Read more
Doctor's recommendation is one of the most important predictors by therapy decisions of patients.
At the same time, primary prevention takes a very small part of the working hours of general practitioners.
Hence, is the aim of the present study to examine whether and how general practitioners could be incorporated in the mediation of prevention's offers.
To reach this aim, must be grasped first, to what extent general practitioners are already integrated into in the mediation of the primary prevention courses. There is up to now no information about whether general practitioners know about the GKV-improved prevention programmes for GKV-insured person and whether they are involved in their mediation. This research project will close this gap.
The aims of the study are:
- to explore the roll of primary prevention in the general practitioner's consultation
- to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
- to explore which primary prevention's programmes do general practitioners in their consultation recommend
- to analyse which factors play a role in the mediation
- to explore whether general practitioners with §20 are familiar.
This is a mixed methods study which combines a mail survey of all general practitioners in Berlin with focus groups of 25 general practitioners.
In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite.
After both methods are analyzed on their own, the triangulation of the interpretation of both data sets will be done to find possible answers of the study questions. Bi-directionality of results will contribute to find possible interpretations of the survey responses in the results of the focus group discussions, as well as the results of the focus groups discussions could be explained by the results of the survey (Flick).
Read the detailed description
Background In Germany 70% of the men and 50% of the women are overweight or obese. On account of the frequency of overweight, diabetes and other life style-related risk factors and the raised risk linked with it for chronic illnesses it has been initiated preventive measures.
By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007 in §20 SGB V the health insurance schemes have received an enlarged action frame in the primary prevention and the operational health support.
Through these paragraphs arises the possibility for citizens to let refund health-supporting programmes or health training of the health insurance schemes. Moreover programmes count to the support of physical activity, nutrition consultation, smoke weaning programmes or also learning of relaxation techniques. About two to three percent of all GKV insured person take part in primary-preventive courses and seminar offers.
Doctor's recommendation is one of the most important predictors by therapy decisions of patients.
At the same time, primary prevention takes a very small part of the working hours of general practitioners.
Hence, is the aim of the present study to examine whether and how general practitioners could be incorporated in the mediation of prevention's offers.
To reach this aim, must be grasped first, to what extent general practitioners are already integrated into in the mediation of the primary prevention courses. There is up to now no information about whether general practitioners know about the GKV-improved prevention programmes for GKV-insured person and whether they are involved in their mediation. This research project will close this gap.
The aims of the study are:
- to explore the roll of primary prevention in the general practitioner's consultation
- to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
- to explore which primary prevention's programmes do general practitioners in their consultation recommend
- to analyse which factors play a role in the mediation
- to explore whether general practitioners with §20 are familiar.
Methods
- Study design: This is a mixed methods study which combines a mail survey of all general practitioners in Berlin with focus groups of 25 general practitioners. The design arises from the study question, so that we grasp from the mail survey to what extent primary prevention in the general practitioner's practice a role plays and whether §20 is known among general practitioners. In the focus groups will be analyzed which role can or want general practitioners in the primary prevention take and to what extent they can perceive themselves as mediators with regard to the offer of §20 programms. Barriers as well as the role of the general practitioner in the primary prevention will be explored.
- Study population In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite (see characteristics below) which are also part of the mail survey. Characteristics of teaching doctors of the general medicine Charité Berlin:
- Aptitude and joy in teaching
- Specialist in general medicine, general practice internist or active internist
- Duration of establishment > 3 years
- More than 500 GKV-Versicherte / quarter
- Typical general practitioner spectrum without one-sided practice
- Regular house visits
- Separate space for students
- Guarantee of the necessary number of hours
- Procedure Survey For the data collection a standardized questionnaire was developed. A literature research as well as the objective of the study led the questionnaire development. After its completion the comprehensibility of the questionnaire was checked with cognitive interviews. Data collection All 1300 general practitioners in Berlin are written up by the service provider Data-B through the Berlin medical association. General practitioners will receive the validated questionnaire, a franked envelope and a franked postcard. The survey is conceived pseudonym. There will be no possibility to connect the questionnaire with personal data. The response rate by physician's survey rises if the survey is supported by professional associations or other prominent representatives of the field. Hence, the survey is supported by Professor Braun the Director of the Institute of General Medicine at the Charite Medical University in Berlin. Also the length of the questionnaire has influence on the response rate. This was considered in the development of the questionnaire. To raise further the response rate, we will apply the Dillman Method. This meant that we will send after three weeks a postcard reminder to the non-responders. Other two weeks later, we will send again, to those who have not answered, the questionnaire as well as the franked postcard. Those general practitioners that after 4 weeks haven't sent the postcard will be considered as non-responders. The franked postcard is to have an overview of which doctors have responded to the questionnaire. An identification number on the postcard allows the service provider Data-B to identify the doctor's address or practice. We collect for the service provider the identification number of the postcards. Data-B will send within two weeks a reminder to those whose number is not on the list. This procedure is carried out after two weeks once again, but this time with the questionnaire. Because this is the third and last contact, no postcard is included in this last mailing. The data of the questionnaire are administered by the BSPH and the address file by Data-B. With it is the pseundonymity of the survey guaranteed. For the BSPH is not possible to identify which physician has responded to which questionnaire. The study-staff will enter the date of the questionnaires in an Access data bank. To carry out the data analysis, the data bank will be then export to SPSS. Focus Groups In addition, five focus groups with five participants will be carried out. The focus groups are so structured that the different practice forms, group practice, practice with additional offers or practice with private patients are enclosed in the focus groups equally. So far possibly single focus groups will be composed from participants with different practice characteristic as well as age-mixed. Before the discussion, the participants of the focus groups are asked to fill out the questionnaire, so that it will be possible to get in contact the questionnaires with the focus groups. The questionnaires are filled and collected without personal data. Hence, it will not be possible to know which participant filled which questionnaire out. To be able to draw conclusion on the generalizability of the focus group's results, it will be possible to compare aggregated data of the focus groups with regard to the questionnaires with the data of the general practitioners in Berlin. A moderator will guide the group in the discussion and a coworker will be the observer, documenting the meeting. The focus-group process will be conducted based on a catalog of guiding questions (Annex) that will be given to the moderator at the beginning of the meeting. The Observer and the Moderator will write up a complete protocol immediately after the meeting. The discussions will be audio-recorded digitally. After the focus-group meeting, names and other person identifiable content will be erased from the audio-recording (by deleting or new recording) and the final audio-documents will be saved on a secure Charité Server. For each focus-group, characteristics of the practice, age structure and gender will be documented and assigned. Names of participants will not be saved.
- Data analysis
Questionnaire A descriptive statistical analysis of the collected data will be conducted using SPSS.
Focus group discussion The content of the focus groups will be analyzed based on the catalogue of guiding questions.
The analytical procedure includes assignment of codes and application of Grounded Theory. This open process of the analysis is chosen to allow identifying topics and relationships that might not be identified with a pure content analysis.
Triangulation After both methods are analyzed on their own, the triangulation of the interpretation of both data sets will be done to find possible answers of the study questions. Bi-directionality of results will contribute to find possible interpretations of the survey responses in the results of the focus group discussions, as well as the results of the focus groups discussions could be explained by the results of the survey (Flick).
Data confidentiality For the quantitative part of the study no person data or contact information (name, birthdates, address, phone number, email) will be collected. (see previous section). Gender and categories-based age are collected. The survey is anonymous at all stages of data collection, analysis and publication. Publications will include statistical analysis of conglomerated data. Adherence to German legislation of confidentiality is granted at all times.
Informed consent The response of completed questionnaires in the quantitative part of the study is valued as the informed consent. The postal card with the stamp of the practice allows Data-B to compare these with the Databank of names and addresses of physicians. There is impossible to identify questionnaire and practice at any time. The appearance for the focus group meeting is valued as the acceptance of participation.
The questionnaires and the digital recordings of the focus groups will be kept for 10 years at the Charité.
Ethic Committee In case that the "Datenschutzbeauftragte" of the Charity requires it, the approval of the ethic committee will be obtained. In any case the Ethic Committee will be informed of the study intended.
- Conditions
- Prevention
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and practice of primary prevention in primary care
cross-sectional survey at one time point
Measured: immediatly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Christine Holmberg, Berlin School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351570
- Sponsor's protocol ID
- BSPH GP´s Prevention Programme
- Status last verified
- Jan 2015
- First submitted
- 27 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offer and Mediation of §20 SGB V Health Prevention Programmes to Patients Through Their Treating General Practitioner - a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT02351570
- Acronym / sponsor ID
- BSPH GP´s Prevention Programme
- Conditions
- Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Berlin School of Public HealthUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007 in §20 SGB V the health insurance schemes have received an enlarged action frame in the primary prevention and the operational health support.
Through these paragraphs arises the possibility for citizens to let refund health-supporting programmes or health training of the health insurance schemes.
Doctor's recommendation is one of the most important predictors by therapy decisions of patients.
At the same time, primary prevention takes a very small part of the working hours of general practitioners.
Hence, is the aim of the present study to examine whether and how general practitioners could be incorporated in the mediation of prevention's offers.
To reach this aim, must be grasped first, to what extent general practitioners are already integrated into in the mediation of the primary prevention courses. There is up to now no information about whether general practitioners know about the GKV-improved prevention programmes for GKV-insured person and whether they are involved in their mediation. This research project will close this gap.
The aims of the study are:
- to explore the roll of primary prevention in the general practitioner's consultation
- to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
- to explore which primary prevention's programmes do general practitioners in their consultation recommend
- to analyse which factors play a role in the mediation
- to explore whether general practitioners with §20 are familiar.
This is a mixed methods study which combines a mail survey of all general practitioners in Berlin with focus groups of 25 general practitioners.
In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite.
After both methods are analyzed on their own, the triangulation of the interpretation of both data sets will be done to find possible answers of the study questions. Bi-directionality of results will contribute to find possible interpretations of the survey responses in the results of the focus group discussions, as well as the results of the focus groups discussions could be explained by the results of the survey (Flick).
Detailed description
Background In Germany 70% of the men and 50% of the women are overweight or obese. On account of the frequency of overweight, diabetes and other life style-related risk factors and the raised risk linked with it for chronic illnesses it has been initiated preventive measures.
By the health reform GKV in 2000 as well as by the competitive strengthening law GKV in 2007 in §20 SGB V the health insurance schemes have received an enlarged action frame in the primary prevention and the operational health support.
Through these paragraphs arises the possibility for citizens to let refund health-supporting programmes or health training of the health insurance schemes. Moreover programmes count to the support of physical activity, nutrition consultation, smoke weaning programmes or also learning of relaxation techniques. About two to three percent of all GKV insured person take part in primary-preventive courses and seminar offers.
Doctor's recommendation is one of the most important predictors by therapy decisions of patients.
At the same time, primary prevention takes a very small part of the working hours of general practitioners.
Hence, is the aim of the present study to examine whether and how general practitioners could be incorporated in the mediation of prevention's offers.
To reach this aim, must be grasped first, to what extent general practitioners are already integrated into in the mediation of the primary prevention courses. There is up to now no information about whether general practitioners know about the GKV-improved prevention programmes for GKV-insured person and whether they are involved in their mediation. This research project will close this gap.
The aims of the study are:
- to explore the roll of primary prevention in the general practitioner's consultation
- to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
- to explore which primary prevention's programmes do general practitioners in their consultation recommend
- to analyse which factors play a role in the mediation
- to explore whether general practitioners with §20 are familiar.
Methods
- Study design: This is a mixed methods study which combines a mail survey of all general practitioners in Berlin with focus groups of 25 general practitioners. The design arises from the study question, so that we grasp from the mail survey to what extent primary prevention in the general practitioner's practice a role plays and whether §20 is known among general practitioners. In the focus groups will be analyzed which role can or want general practitioners in the primary prevention take and to what extent they can perceive themselves as mediators with regard to the offer of §20 programms. Barriers as well as the role of the general practitioner in the primary prevention will be explored.
- Study population In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite (see characteristics below) which are also part of the mail survey. Characteristics of teaching doctors of the general medicine Charité Berlin:
- Aptitude and joy in teaching
- Specialist in general medicine, general practice internist or active internist
- Duration of establishment > 3 years
- More than 500 GKV-Versicherte / quarter
- Typical general practitioner spectrum without one-sided practice
- Regular house visits
- Separate space for students
- Guarantee of the necessary number of hours
- Procedure Survey For the data collection a standardized questionnaire was developed. A literature research as well as the objective of the study led the questionnaire development. After its completion the comprehensibility of the questionnaire was checked with cognitive interviews. Data collection All 1300 general practitioners in Berlin are written up by the service provider Data-B through the Berlin medical association. General practitioners will receive the validated questionnaire, a franked envelope and a franked postcard. The survey is conceived pseudonym. There will be no possibility to connect the questionnaire with personal data. The response rate by physician's survey rises if the survey is supported by professional associations or other prominent representatives of the field. Hence, the survey is supported by Professor Braun the Director of the Institute of General Medicine at the Charite Medical University in Berlin. Also the length of the questionnaire has influence on the response rate. This was considered in the development of the questionnaire. To raise further the response rate, we will apply the Dillman Method. This meant that we will send after three weeks a postcard reminder to the non-responders. Other two weeks later, we will send again, to those who have not answered, the questionnaire as well as the franked postcard. Those general practitioners that after 4 weeks haven't sent the postcard will be considered as non-responders. The franked postcard is to have an overview of which doctors have responded to the questionnaire. An identification number on the postcard allows the service provider Data-B to identify the doctor's address or practice. We collect for the service provider the identification number of the postcards. Data-B will send within two weeks a reminder to those whose number is not on the list. This procedure is carried out after two weeks once again, but this time with the questionnaire. Because this is the third and last contact, no postcard is included in this last mailing. The data of the questionnaire are administered by the BSPH and the address file by Data-B. With it is the pseundonymity of the survey guaranteed. For the BSPH is not possible to identify which physician has responded to which questionnaire. The study-staff will enter the date of the questionnaires in an Access data bank. To carry out the data analysis, the data bank will be then export to SPSS. Focus Groups In addition, five focus groups with five participants will be carried out. The focus groups are so structured that the different practice forms, group practice, practice with additional offers or practice with private patients are enclosed in the focus groups equally. So far possibly single focus groups will be composed from participants with different practice characteristic as well as age-mixed. Before the discussion, the participants of the focus groups are asked to fill out the questionnaire, so that it will be possible to get in contact the questionnaires with the focus groups. The questionnaires are filled and collected without personal data. Hence, it will not be possible to know which participant filled which questionnaire out. To be able to draw conclusion on the generalizability of the focus group's results, it will be possible to compare aggregated data of the focus groups with regard to the questionnaires with the data of the general practitioners in Berlin. A moderator will guide the group in the discussion and a coworker will be the observer, documenting the meeting. The focus-group process will be conducted based on a catalog of guiding questions (Annex) that will be given to the moderator at the beginning of the meeting. The Observer and the Moderator will write up a complete protocol immediately after the meeting. The discussions will be audio-recorded digitally. After the focus-group meeting, names and other person identifiable content will be erased from the audio-recording (by deleting or new recording) and the final audio-documents will be saved on a secure Charité Server. For each focus-group, characteristics of the practice, age structure and gender will be documented and assigned. Names of participants will not be saved.
- Data analysis
Questionnaire A descriptive statistical analysis of the collected data will be conducted using SPSS.
Focus group discussion The content of the focus groups will be analyzed based on the catalogue of guiding questions.
The analytical procedure includes assignment of codes and application of Grounded Theory. This open process of the analysis is chosen to allow identifying topics and relationships that might not be identified with a pure content analysis.
Triangulation After both methods are analyzed on their own, the triangulation of the interpretation of both data sets will be done to find possible answers of the study questions. Bi-directionality of results will contribute to find possible interpretations of the survey responses in the results of the focus group discussions, as well as the results of the focus groups discussions could be explained by the results of the survey (Flick).
Data confidentiality For the quantitative part of the study no person data or contact information (name, birthdates, address, phone number, email) will be collected. (see previous section). Gender and categories-based age are collected. The survey is anonymous at all stages of data collection, analysis and publication. Publications will include statistical analysis of conglomerated data. Adherence to German legislation of confidentiality is granted at all times.
Informed consent The response of completed questionnaires in the quantitative part of the study is valued as the informed consent. The postal card with the stamp of the practice allows Data-B to compare these with the Databank of names and addresses of physicians. There is impossible to identify questionnaire and practice at any time. The appearance for the focus group meeting is valued as the acceptance of participation.
The questionnaires and the digital recordings of the focus groups will be kept for 10 years at the Charité.
Ethic Committee In case that the "Datenschutzbeauftragte" of the Charity requires it, the approval of the ethic committee will be obtained. In any case the Ethic Committee will be informed of the study intended.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study all general practitioners of Berlin (n=1300) will be mailed. Participants for the focus groups are invited from the pool of teaching doctors of the Institute for General Medicine at the Charite (see characteristics below) which are also part of the mail survey.
Key inclusion criteria (9 listed)
- Teaching doctors of the Institute for General Medicine at the Charite
- Aptitude and joy in teaching
- Specialist in general medicine, general practice internist or active internist
- Duration of establishment > 3 years
- More than 500 GKV-Versicherte / quarter
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence and practice of primary prevention in primary care
Time frame: immediatly
cross-sectional survey at one time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention, run by Berlin School of Public Health at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and practice of primary prevention in primary care (time frame: immediatly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.