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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Germany

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:

  1. to explore the roll of primary prevention in the general practitioner's consultation
  2. to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
  3. to explore which primary prevention's programmes do general practitioners in their consultation recommend
  4. to analyse which factors play a role in the mediation
  5. 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:

  1. to explore the roll of primary prevention in the general practitioner's consultation
  2. to analyse which social institutions are responsible for primary prevention according to the general practitioner's opinion
  3. to explore which primary prevention's programmes do general practitioners in their consultation recommend
  4. to analyse which factors play a role in the mediation
  5. to explore whether general practitioners with §20 are familiar.

Methods

  1. 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.
  2. 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
  1. 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.
  2. 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.

  1. 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.

  1. First posted30 Jan 2015 (estimated)
  2. Study startNov 2010
  3. Primary completionFeb 2011
  4. Study completionMar 2011

Resources

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)
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

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.

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