Trial document




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  DRKS00013972

Trial Description

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Title

Process optimization by interdisciplinary and cross-sectoral care using the example of patients with hip and knee prostheses

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Trial Acronym

PROMISE

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URL of the Trial

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Brief Summary in Lay Language

Due to the demografic change, the implantation of approximately 400,000 hip and knee prostheses per year is one of the most frequent operation conducted in germany.
The world´s most common and most important operative indication is arthrosis. In Germany, in the group of people older than 65 years, almost half of women and a third of men
are affected.
PROMISE is a scientific study to optimize treatment of adult patients with hip or knee arthrosis.
This study investigates wether an optimized care process leads to a sustainable improvement (with regard to patient satisfaction, low complication rates, efective service provision) in the
operative treatment of patients with hip or knee arthrosis. In the frame of the treatment concept, cooperation between various therapists of different specialties as well as with the patient is a key factor. PROMISE also investigates, wether this optimized collaboration leads to an improvement in the identification of pre-existing conditions and based on this, wether clinical outcome can be improved.

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Brief Summary in Scientific Language

Prospective, multicenter epidemiological study to investigate wether an optimized care process leads to a sustainable improvement with regard to the operative treatment of patients with hip or knee arthrosis.

[Amendment 1 dated May 02, 2019:
- change of sample size
- change of the primary endpoint
- change of the secondary endpoints]

[Amendment 2 dated August 19, 2019:
- additional parameters (e.g. details of implants used in surgery)]

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013972
  •   2018/03/23
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  •   yes
  •   Approved
  •   837.533.17 (11367), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   All patients included will be treated according to the new optimized care process.
    PROMISE is a process-orientated project, which combines different treatment pathways based upon the "Enhanced Recovery Concept". Enhanced recovery is a multiprofessional treatment approach which involves the patient as an active partner in the therapy process and tends to post-operative independence and activity as early as possible.
    Characteristic of PROMISE is the interdisciplinary, cross-sectoral treatment concept comprising:
    1. Quality assurance of service provision according to best practice in each institution
    2. A cross-sectoral optimized care process, starting with indication, treatment until post-hospital phase including step by step harmonized actions and measures such as operation, pain management, diagnosis and therapy of complications as well as care, rehabilitation and outpatient services.
    3. Strong interdisciplinary interactions between the following sections:
    - surgery
    - anaesthesia, patient blood management
    - patient training
    - care
    - physical therapy
    - psychosomatics
    - haemostaseology
    - geriatrics
    4. The active involvement of the patients in the healing process
    5. Data collection and quality assurance with the use of a database.
    Taget group of this new care process are people with indication for operative treatment of hip and knee arthrosis. Patients of the test group will be treated according to the new care process.

    Data collection is done by means of questionnaires, interviews and secondary data at the following timepoints:
    1. At the the beginning of the study
    2. 1 week before operation
    3. At the day of operation
    4. After discharge from hospital
    5. After discharge from rehabilitation center
    6. 3 months after discharge from hosptial
    7. 6 months after discharge from hospital
    8. 12 months after discharge from hospital
  •   The comparison group consists of selected data obtained from an anonymized data set, provided by the health insurance involved in the project. These patients are treated in other hospitals for the same indication, but they are not subjected to the new care process.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The overall objective of this study is to investigate, wether an optimized care process leads to a an sustainable improvement with regard to the operative treatment of patients with hip or knee arthrosis. Data collection is done by means of questionnaires, interviews and secondray data.
The working hypothesis assumes that an optimized cross-sectoral cooperation leads to an improvement in the identification of pre-existing conditions and due to this, wether clinical outcome can be improved.
This is reflected in the primary endpoint:
Presence of chronic pain. The primary outcome is the proportion of patients with reported chronic pain 12 months after surgery. This proportion will be compared with data obtained from literature.

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Secondary Outcome

The following secondary endpoints are regarded as an important priority:

1. Amount of identified pre-existing conditions
2. Extent of physical activity
3. Usage of medical service(s)
4. Quality of life
5. Interactions between partners as substantial parameter within the process.

The amount of identified pre-existing conditions will be expressed as a variable, indicating the proportion of patients with known pre-existing conditions. This proportion will be compared with data obtained from literature.

Extent of physical activity will be compared with reference data obtained from literature.

Usage of medical service will be compared with data obtained from the control group, provided from the participating health insurance.

Quality of life will be taken into account with regard to evaluation of the effect of the new care process.

Source data are questionnaires, interviews and secondary data.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/03/27
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Indication for the operative treatment of arthrosis for the purpose of hip or knee replacement according to standardized criteria
2. Ability of the patient to understand nature and extent of individual requirements when participating in the new care process

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Exclusion Criteria

1. Life expectancy less than 1 year (for example in case of advanced cancer)
2. Exclusion criteria for a selective surgical procedure
3. Medical or psychological reasons not to participate in the study or which do not allow written consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Univ.-Prof. Dr.  Ulrich  Förstermann 
    • Obere Zahlbacher Str. 63
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin der Johannes Gutenberg Universität Mainz - Zentrum für Orthopädie und Unfallchirurgie (ZOU)
    • Mr.  Univ.-Prof. Dr.  Philipp  Drees 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin der Johannes Gutenberg Universität Mainz - Zentrum für Orthopädie und Unfallchirurgie
    • Ms.  Birgit  Mehl 
    • Langemneckstraße 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss, Innovationsfonds
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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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.