Trial document





This trial has been registered retrospectively.
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  DRKS00011821

Trial Description

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Title

Primary Palliative Care in General Practice

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Trial Acronym

ALLPRAX

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URL of the Trial

https://www.mh-hannover.de/allprax.html

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Brief Summary in Lay Language

It is an important task of the healthcare system to provide good care for severely ill and dying people. Herein, general practitioners play a key role: mostly, they are the first contact for patients and their families, and they accompany them until the last phase of their lives.
This is the topic of the present study: how can end-of-life care in general practice be provided successfully? What will help general practitioners in fulfilling this important task? What are the needs of patients and their relatives? The aim of this project is to give answers to these questions and to develop targeted strategies for a better care.

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Brief Summary in Scientific Language

The focus of this project is on improving the provision of primary palliative care by general practitioners (GPs). While approximately 10-15% of the incurable, seriously ill or dying people will be in need of specialist palliative care, the vast majority can be adequately treated within generalist care. The strengthening of the GP’s role in palliative care, as well as ensuring close collaboration between specialist palliative care services and GPs have been identified as top priorities for the improvement of palliative care in Germany. Despite healthcare policy actions, diverse obstacles still exist to successful implementation of primary palliative care on a structural, process-, and economic level. Therefore, this project aims at addressing barriers and facilitators to primary palliative care delivery in general practice in Germany. The study follows a three-step approach; first, it aims at systematically analysing barriers and facilitators to primary palliative care provision by GPs using the theoretical framework of Normalisation Process Theory. Second, based on these outcomes, a tailored intervention package will be developed to enhance the provision of primary palliative care by GPs. Third, the intervention package will be implemented and evaluated in practice. The expected outcome will be an evidence-based model for successful implementation of primary palliative care delivery tailored to the German healthcare system, followed by a strategic action plan on how to improve current practice both on a local level and nationally.

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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

  •   DRKS00011821
  •   2017/12/04
  •   [---]*
  •   yes
  •   Approved
  •   7260, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   / 
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Health Condition or Problem studied

  •   Severe progressive conditions at the end of life;
  •   Z51.5 -  Palliative care
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Interventions/Observational Groups

  •   Organisational health services research study for the development and evaluation of service
    development statements and tailored interventions

    Methods: Mixed-methods project with three study phases:
    Theoretical phase (month 1 – 12): data collection using ethnographic field observation, secondary analysis of qualitative interviews; Critical Incident Technique; secondary analysis of health insurance funds and clinical routine data; medical chart review and document analysis
    Modelling phase (month 13-36): data collection and co-construction using Participatory Action Research and consensus building techniques (Delphi and Nominal Group Technique) Evaluation and implementation phase (month 37-60): secondary data analysis and ethnographic field observation for formative and summative evaluation of the intervention’s practicality, acceptance, its effect on quality of care and on patient-related outcomes.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Successful integration of primary palliative care in general practice (organisational ethnographic field research following the theoretical model of the "Normalization Process Theory"; NoMAD (assessment Instrument for the Evaluation of the implementation of complex interventions))

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Secondary Outcome

Place of death; hospital admissions; prescriptions and therapies (clinical routine data from medical charts); physical, psychological and
emotional well-being, as well as quality of treatments and care coordination (Palliative Outcome Scale POS; Quality of Dying and Death Questionnaire; Quality of End of Life Care Questionnaire; semi-structured interviews with patients and relatives); details in Table 2, p. 15 in the attached study protocol

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/02/20
  •   144
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

General Practices: according to the principles of Theoretical Sampling, general practices will be selected along different contrasting lines (e.g. urban - rural; single - joint practice)

Patients: patients in general practice in need of palliative care, who are able to give informed consent and whose general condition will allow for an interview

Relatives: patients' relatives who are able to give informed consent

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Exclusion Criteria

Patients whose general condition does not allow for an interview

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  PD Dr. rer. medic.  Stephanie  Stiel 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  PD Dr. rer. medic.  Stephanie  Stiel 
    • 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
  •   [---]*
  •   [---]*
  •   2022/01/31
  •   166
  •   166
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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.