Trial document





This trial has been registered retrospectively.
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  DRKS00000575

Trial Description

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Title

An assessment for elderly patients in General Practice: Health priorities of the patients, Need of care from GP´s perspective and resulting interventions.

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Trial Acronym

PRISCUS TP5

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URL of the Trial

http://priscus.net/content.php?menuid=30&pos=3&sid=6b767430333737373330303031323835383333373235&kvt0377730001285833725=88585294347e467ca510731dfef6e832

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Brief Summary in Lay Language

Structured consultations: effective care in general practice

Consultations of General Practicitioners are mostly not designed for elderly people with a multitude of diseases and medical conditions, but for clearly defined acute problems.
A structured compilation of important complaints and problems of old age, also called assessment, may form the basis for a coordinated treatment planning between General Practitioner and patient. A guideline for such an assessment was deleveloped in an European concerted action (STEP).
This study examines, if the performance of an assessment and the following consultation have an positive influence on the patients perception of their health problems. Moreover the study will explore, which diagnostic and therapeutic measures will be initiated as a result of the assessment.
Participants are patients of general practice aged 72 years and over.

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Brief Summary in Scientific Language

The ageing society presents a challenge for general practice in Germany and most European countries. Structured and proactive approaches may help facing chronic diseases and multimorbidity in general practice. The regular use of a standardised geriatric assessment is one of the potential measures to improve the health care of elderly patients. The objective of this study is to describe how such a systematic examination in combination with the following patient-doctor consultation may affect the elderly patient’s perspective with regard to importance and severity of his or her health problems and which diagnostic and therapeutic procedures are initiated and accomplished consequently.
The study is designed as a controlled intervention study. Each arm is intended to consist of 44 general practitioners (GPs) and 440 of their elderly patients, respectively. Study nurses perform the Standardised Assessment for Elderly Patients in Primary Care (STEP assessment) in the practices. Subsequently, all patients rate importance and severity of their disclosed health problems, and they reassess these parameters for the initially found problems after three months. Only in the intervention group the GP is informed on the results of STEP and the patients´ ratings of importance and a consultation takes place subsequently. All actions deriving from this consultation will be documented within the observation period of three months. The controls receive usual care during this period. Data will be analysed cross-sectionally and longitudinally by uni- and multivariate analyses. In an embedded qualitative study, video-records of 36 patient-doctor consultations following the STEP assessment will be analysed with regard to the attention given to the disclosed problems and the process of problem discussion and decision making.
This study aims to demonstrate a sustainable benefit deriving from a standardised geriatric assessment combined with the consultation with regard to the patient’s perspective. Additionally, the knowledge of the patients` perspective on health problems in old age and interventions resulting from a geriatric assessment will add important clues for health care research and the handling of multimorbidity.

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Organizational Data

  •   DRKS00000575
  •   2010/10/07
  •   [---]*
  •   yes
  •   Approved
  •   4997, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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

  •   Health problems at old age
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Interventions/Observational Groups

  •   In both groups Study nurses perform the assessment and patients rate importance and severity of every health problem. Only in the intervention group patients and GPs get a list of the results of STEP and doctors additionally get to know the importance ratings of the patients concerning. Only in the intervention group a consultation based on the results takes place directly afterwards.




  •   After the assessment neither the patient nor GP receive the list of the health problems uncovered (but after three months). No consulation to discuss the results is scheduled after the assessment. In case of avertable dangerous events study nurses have to pursue a standardised procedure. During the follow up period patients receive medical care as usual.



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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

The main objective of this study is to explore the effects of a Standardised Assessment for Elderly Patients in Primary Care (STEP) in combination with the directly following consultation with regard to measurable changes in patient’s perspective concerning his health problems and as compared to a control group. The patients´perspective is explored by ratings of importance and severity (emotional affection and functional hindrance) on a four point-likert skale at baseline and after the follow-up period of three months.
In doing so we presume that most problems in older age are chronic conditions and will not vanish over time, but patients’ attitudes towards their problems may alter after discussing them with their GPs and possibly receiving further investigations and treatment.

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Secondary Outcome

Secondary aims are to
- describe the nature, quantity and patterns of health problems in older general practice patients as identified by STEP and therewith to depict multimorbidity in general practice.
- compare the patients´ perspective (patient’s ratings of importance) with the doctors´ perspective (doctors ratings of importance).
- describe the interventions (diagnostic and therapeutic procedures) following the assessment: quantity and underlying type of health problem, which lead to the planning of an intervention and the accomplishment.
- explore patient and doctor related factors that are associated with the initiation and accomplishment of interventions.

The embedded qualitative study evaluates videotapes of 36 doctor-patient consultations following the STEP assessment whith regard to
- Formal data (length of the consultation, length of discussion relating to every single health problem, order of the discussed health problems).
- Are all problems uncovered by STEP discussed? Which problems are not addressed? Which ones are always approached?
- How is the GP acting with regard to problems, which were unknown to him before?
- Is there a different handling of problems, which have been rated as (very) important by the patient and/ or doctor in comparison to those rated less important? Does the verbal discussion reproduce the importance ratings as documented in the questionnaire?
- Who is the player, who decides about further action and interventions, the patient or the doctor?
- To what extend is a patient centred approach implemented?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/07/16
  •   880
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- 72 years and over - capacity of visiting the GP´s practice
- telephone access at home
- signature of informed consent

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Exclusion Criteria

- severely impaired hearing
- current legal guardianship
- pre-existing diagnosis of severe dementia
- insufficient German language skills
- participation in another clinical study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin Medizinische Hochschule Hannover
    • Ms.  Prof. Dr. med.  Eva  Hummers-Pradier 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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    • Institut für Allgemeinmedizin Medizinische Hochschule Hannover
    • Ms.  Dr.  Gudrun  Theile 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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    • Institut für Allgemeinmedizin Medizinische Hochschule Hannover
    • Ms.  Dr.  Christiane   Müller 
    • Carl-Neuberg-Str.1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/27
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Trial Publications, Results and other Documents

  •   Disclosure of new health problems and intervention planning using a geriatric assessment in a primary care setting.Muller CA, Klaassen-Mielke R, Penner E, Junius-Walker U, Hummers-Pradier E, Theile G., Croat Med J. 2010 Dec;51(6):493-500.
  •   Prerequisites for a new health care model for elderly people with multiple morbidities: results and conclusions from 3 years of research in the PRISCUS consortium, Thiem U, Hinrichs T, Müller CA, Holt-Noreiks S, Nagl A, Bucchi C, Trampisch U, Moschny A, Platen P, Penner E, Junius-Walker U, Hummers-Pradier E, Theile G, Schmiedl S, Thürmann PA, Scholz S, Greiner W, Klaassen-Mielke R, Pientka L, Trampisch HJ, Z Gerontol Geriatr. 2011 Dec;44 Suppl 2:101-12.
  •   Multimorbid general practice patients - what's really important? Theile G, Müller CA. Praxis (Bern 1994). 2012 Dec 12;101(25):1621-6
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* This entry means the parameter is not applicable or has not been set.