Trial document




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  DRKS00004346

Trial Description

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Title

Randomized controlled clinical pilot study for the implementation of medical group visits in Germany following the CHCC-Model (Cooperative Health Care Clinics) for the treatment of patients with diabetes type II or hyper tonus in family practice

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Trial Acronym

[---]*

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URL of the Trial

http://www.gruppensprechstunde.de

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Brief Summary in Lay Language

In several countries group medical visits have been incorporated into primary care. Especially successful are medical group visits in the context of chronic disease treatment.
It is the primary purpose of the study to analyze whether or not medical group visits following the Cooperative Health Care Clinics-Modell can be implemented in Germany. For this purpose eight family physicians in Saxony-Anhalt invite patients, which chronically suffer either from diabetes type 2 or high blood pressure to take part in medical group visits. Intervention physicians will conduct medical group visits with the same group of twelve patients every second month. This will last over the study period of one year.
Hypothesis tested are;
1) Patients receiving care in medical group visits rate the quality of care received to be of the same level as patients, who receive care in one-on-one visits, rate the quality of their care.
2) Patients receiving care in medical group visits rate their satisfaction with the care received to be of the same height as patients, who receive care in one-on-one visits, rate their satisfaction in regards to the their care receive.
3) Physicians providing care in medical group visits rate the care provided to patients in group visits to be of the same quality as the care provided to patients in one-on-one visits.
4) Physicians describe their satisfactions with the provision of care in medical group visits to be of the same level compared to their satisfaction with the provision of care in one-on-one visits.
5) Patients treated in medical group visits attend as many medical appointments per year as patients receiving care in one-on-one visits.
To answer these hypothesis patients will be asked for their satisfaction and the quality of care received. At the end of the study the four intervention physicians will be asked to evaluate their care provided in medical group visits in comparison to the care they deliver in one-on-one visits.
Also the numbers of total visits will be set in comparison between patients receiving group visits and patients receiving one-on-one visits.


July 2nd 2013: All eight doctors involved in the study offer medical group visits to their patients. Thus there are no more control physicians; henceforth the third study arm (control patients treated in regular one on one visits by control physicians) is omitted.

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Brief Summary in Scientific Language

Group Visits (GV) were invented in North America to improve the care delivered by family physicians. They have proven to improve clinical outcomes, patient- as well as physician satisfaction and to result in effectiveness and efficiency gains in care delivery. Among a variety of GV-models Cooperative Health Care Clinics (CHCCs) were especially successful in the treatment of chronically ill patients.
By conducting an interventional cohort study we aim to analyze, if group visits following the CHCC-Model can be implemented in Germany. For this purpose eight family physicians will invite patients from their panel, which either suffer from diabetes mellitus type 2 or hyper tonus, to take part in GV.
It is always the same group of twelve patients, which come together in GV in a two-month rhythm. Since every intervention physician leads two groups a total of 182 (8 intervention physicians * 12 patients per group * 2 groups) patients compose the intervention patients in the study.
The control group is composed by patients of the intervention physicians, which are not cared for in group visits but in one-on-one visits.
Hypothesis tested are;
1) Patients receiving care in medical group visits rate the quality of care received to be of the same level as patients, who receive care in one-on-one visits, rate the quality of their care.
2) Patients receiving care in medical group visits rate their satisfaction with the care received to be of the same height as patients, who receive care in one-on-one visits, rate their satisfaction in regards to the their care receive.
3) Physicians providing care in medical group visits rate the care provided to patients in group visits to be of the same quality as the care provided to patients in one-on-one visits.
4) Physicians describe their satisfactions with the provision of care in medical group visits to be of the same level compared to their satisfaction with the provision of care in one-on-one visits.
5) Patients treated in medical group visits attend as many medical appointments per year as patients receiving care in one-on-one visits.
To answer these hypothesis patients will be asked for their satisfaction and the quality of care received. At the end of the study the four intervention physicians will be asked to evaluate their care provided in medical group visits in comparison to the care they deliver in one-on-one visits.
Also the numbers of total visits will be set in comparison between patients receiving group visits and patients receiving one-on-one visits.

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Organizational Data

  •   DRKS00004346
  •   2012/10/04
  •   [---]*
  •   yes
  •   Approved
  •   12-211, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   I10 -  Essential (primary) hypertension
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Patients of Intervention Physicians, treated in group visits every second month over the period of 12 month.
  •   Patients of Intervention Physicians, not treated in group visits but in regular one-on-one visits over the period of 12 month. The number of visits is not determined by the study protocol but by the need of the individual patient.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Acceptance for Group-Visits on the patients' and physicians' side:
Patient satisfaction (questionnaire)
Physician satisfaction (interview)

at the end of study

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Secondary Outcome

Family Physicians effectiveness: Number of family physician visits

counted by members of the physician office over the course of the study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2013/08/01
  •   384
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

I. patients chronically suffering from
a. diabetes, defined as an HbA1C level larger than 8,5 % or
b. hyper tonus, defined as a level of mmHg larger than 140/90; it is sufficient if either the systolic or diastolic blood pressure value is exceeded,
II. patients older than 55 years (born in or before 1957),
III. patients who visit their family physician most frequently, defined as 10 or more visits in connection with their chronic disease within the last 12 month,
IV. willingness to participate in medical group visits.

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Exclusion Criteria

I. patients are terminally ill,
II. patients, who are unable to follow a discussion respectively who are unable to actively participate in medical group visits – be it out of cognitive impairment, dementia, deafness insufficient language skills or other reasons,
III. patients, who’s discretion in regards to the medical information’s of other patients are in question,
IV. patients, who are not interested in sharing their medical histories or issues in a group with other patients,
V. patients, who do not have transportation means to attend group visits on a regular basis,
VI. patients, who for other reasons are unable to attend group visits on a regular basis,
VII. patients, who are unable to participate in the study over the entire course of the study,
VIII. patients, who at the same time participate in a second clinical trial or who just completed a different clinical trial,
IX. patients, who did not consented to the participate by signing the consent form

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Mr.  Diplom Gesundheitsökonom  Benedikt  Simon 
    • Spiegelstraße 56
    • 38820  Halberstadt
    • Germany
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    • Institut für Gesundheitsökonomie und Klinische Epidemiologie der Universität zu Köln (wissenschaftliche Begleitung)
    • Gleueler Str. 176-178
    • 50935  Köln
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Mr.  Diplom Gesundheitsökonom  Benedikt  Simon 
    • Spiegelstraße 56
    • 38820  Halberstadt
    • Germany
    end of 1:1-Block address scientific-contact
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  • start of 1:1-Block address public-contact
    • Diplom Gesundheitsökonom  Benedikt  Simon 
    • Spiegelstraße 56
    • 38820  Halberstadt
    • Germany
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Sources of Monetary or Material Support

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    • Mr.  Diplom Gesundheitsökonom  Benedikt  Simon 
    • Spiegelstraße 56
    • 38820  Halberstadt
    • Germany
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    • Kassenärztliche Vereinigung Sachsen-Anhalt
    • Doctor-Eisenbart-Ring 2 / PF 1664
    • 39120  Magdeburg
    • Germany
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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.