Trial document





This trial has been registered retrospectively.
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  DRKS00015108

Trial Description

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Title

Optimal care at the end of life

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Trial Acronym

OPAL-NDS

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URL of the Trial

https://www.mhh.de/allgmed/opal

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Brief Summary in Lay Language

More than 880.000 people per year are dying in Germany [1]. About 10-15% of patients in their last phase of life need specialized palliative care (PC) while the large majority can be treated reasonable by a GP [2] [3] [4]. Primary PC is the basis of palliative supply concepts and does still show substantially deficits. A main difficulty is the early identification of patients with palliative needs by GPs, especially in patients with chronic progressive diseases. Recognition and introduction of the first steps in palliative supply is essential to gain appropriate PC for these patients [5] [6]. The research project OPAL contributes to an improvement in health care supply for patients with life-limiting, chronic progressive oncological and non-oncological diseases, according to SPICT, in several ways. The Supportive and Palliative Care Indicators Tool (SPICT) is a practical instrument which is geared to the patient's reality of life in their domestic environment. SPICT gains to initiate certain actions which could have positive effects on health supply by strengthening the patient's personal responsibility and shared decision making with general practitioners [7].
In addition needs and requirements of relatives are addressed which results in the detection and prevention of excessive demands e.g. in home care or psychosocial stress. Another goal is to improve access to palliative care as it is not equally available for all patients in need. Therefore OPAL has a big contribution to patient- and family centered care. This project puts needs and requirements of patients in the last phase of their life in center instead of single diagnoses.
Besides the overridden goal of an improvement in health care for patients with life-limiting, chronic progressive oncological and non-oncological diseases and their relatives the project is meant to improve the awareness for palliative needs and course of actions in general care and its interfaces.
There are the following investigations made within a mixed-methods design:
1. Experts interviews with stakeholders at the interfaces with general practice in the targeted region
2. Standard survey of GPs about care in the last phase of life
3. After-Death-Interviews with relatives of deceased patients of general practices
4. Analysis of clinical data of deceased patients as result of chronic progressive diseases in general practices
5. Secondary analysis of insurance-data of deceased patients
After the implementation and usage of SPICT in GPs and dialogues at health-conferences with stakeholders in the targeted region the investigations mentioned above are conducted a second time to evaluate differences in palliative care.

Literature:
[1] Statistisches Bundesamt: Todesursachen 2015. Wiesbaden; 2017
[2] Radbruch L., Payne S.: Standards und Richtlinien für Hospiz- und Palliativversorgung in Europa: Teil 1. Palliativmed 2011;12:2016-27.
[3] Nationale Akademie der Wissenschaft Leopoldina und Union der deutschen Akademie der Wissenschaften: Palliativversorgung in Deutschland Perspektiven für Praxis und Forschung. Halle (Saale), 2015.
[4] Radbruch, L. et al.: Europäische Empfehlungen zur Palliativversorgung und Hospizarbeit und ihre Umsetzung in Deutschland. Z Palliativmed 2011;12:175-83.
[5] Radbruch, L. et al.: Überversorgung kurativ- Unterversorgung palliativ? Analyse ausgewählter Behandlungen am Lebensende. Palliativversorgung- Faktencheck Palliativversorgung Modul 3. Gütersloh: Bertelsmann Stiftung, 2015.
[6] Kennedy, C. et al.: Diagnosing dying: An integrative literature review. BMJ Support Palliat Care 2014;4:263-70.
[7] Highet, G. et al.: Development and evaluation of the Supportive and Palliative Care Indicators Tool (SPICT). BMJ Support Palliat Care 2014;4:258-90.

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Brief Summary in Scientific Language

Each year more than 880.000 People are dying in Germany. About 10-15% of patients need specialized palliative care in the last phase of their life while the main population can be supplied appropriately by general practitioners [2] [3] [4]. In this general palliative care considerable deficits can still be detected e.g. no early realization of palliative arrangements [5]. A main barrier is the missing identification of patients with palliative needs, especially of patients with life-limiting, chronic progressive oncological and non-oncological diseases [6]. As there is no existing structured procedure to identify patients with potential benefit from palliative care, this obstacle is being addressed in OPAL.
The greater goal is the improvement of health care for patients with life-limiting, chronic progressive oncological and non-oncological diseases in consideration of the relative’s point of view. Further goals are 1. the strengthening of the awareness for palliative needs and course of actions in GPs care and its interfaces and 2. the specific identification of patients with potential benefit from palliative care. These aims should be reached by an region-wide implementation of a structured clinical decision support, the "Supportive and Palliative Care Indicators Tool" (SPICT) in GP care in a region in Lower Saxony with a mixed structure (urban and rural communities with heterogeneous health supply). The intervention focusses on GPs primary care because most of health care supply and the most important decisions for the target group happen in this sector. Furthermore this project addresses central interfaces with GPs care (nursing services, hospitals, medical specialist practices).
The following hypotheses should be verified:
1. Main hypothesis: The application of SPICT improves health care for patients with life-limiting, chronic progressive oncological and non-oncological diseases, according to SPICT.
2. Additional hypotheses:
a. SPICT is accepted as a clinical decision support by general practitioners and is being used in health care for patients with life-limiting, chronic progressive oncological and non-oncological diseases;
b. The use of SPICT increases the user’s awareness and sensibility for palliative situations;
c. The application of SPICT can influence GP’s practical supportive and palliative care planning.

Literature:
[2] Radbruch L., Payne S.: Standards und Richtlinien für Hospiz- und Palliativversorgung in Europa: Teil 1. Palliativmed 2011;12:2016-27.
[3] Nationale Akademie der Wissenschaft Leopoldina und Union der deutschen Akademie der Wissenschaften: Palliativversorgung in Deutschland Perspektiven für Praxis und Forschung. Halle (Saale), 2015.
[4] Radbruch, L. et al.: Europäische Empfehlungen zur Palliativversorgung und Hospizarbeit und ihre Umsetzung in Deutschland. Z Palliativmed 2011;12:175-83.
[5] Radbruch, L. et al.: Überversorgung kurativ- Unterversorgung palliativ? Analyse ausgewählter Behandlungen am Lebensende. Palliativversorgung- Faktencheck Palliativversorgung Modul 3. Gütersloh: Bertelsmann Stiftung, 2015.
[6] Kennedy, C. et al.: Diagnosing dying: An integrative literature review. BMJ Support Palliat Care 2014;4:263-70.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00015108
  •   2019/01/22
  •   [---]*
  •   yes
  •   Approved
  •   8038_BO_K_2018, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   01VSF17028  (Förderkennzeichen/ support code Innovationsfond G-BA)
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Health Condition or Problem studied

  •   Patients with life-limiting, chronic progressive oncological and non-oncological diseases, being in general practitioners care in the chosen Region.
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Interventions/Observational Groups

  •   a. Stakeholder in the targeted health region, experts interviews for

    (t=0) Exploration the health region. Infrastructure, care experiences, care situation and cooperation between different actors in this field of care (n=15) and
    (t=1) Analogue to the exploration, process evaluation. Process of the intervention, implications for daily care at the interfaces of general care including barriers and facilitating factors of the implication and it’s consolidation (same sample).
  •   b. Standard survey of the general practitioners about

    (t=0) Care in the last phase of life by the German version of “General Practice End-of-Life Care Index”, GP-EoLC-I (n=50) and
    (t=1) Care in the last phase of life by the German version “General Practice End-of-Life Care Index”, GP-EoLC-I (same sample).
  •   c.After-Death-Interviews with relatives of deceased patients of general practices about
    (t=0) GPs care at the end of life (n=25) and
    (t=1) GPs care at the end of life (n=25).
  •   d.Analysis of clinical data of deceased patients as result of chronic progressive diseases in general practices about
    (t=0) central indicators for quality of care at the end of life and
    (t=1) central indicators for quality of care at the end of life.
  •   e. Secondary analysis of AOK-data (lower Saxony) of deceased and insured patients about
    (t=0) central indicators for quality of care at the end of life and
    (t=1) central indicators for quality of care at the end of life.
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

a.) Optimized care at the end of life- General practitioners perspective: GP-EoLC-I, written survey of the project’s general practitioners – Dimensions: clinical practice of the general practitioners, organization of palliative care (t=0 six months pre interventionem, t=1 six month post-interventionem)

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Secondary Outcome

a. Optimized care in the last phase of life – relatives perspective

Situation of care, involvement in therapeutical decisions, Advanced-Care-Planning, consideration of therapeutic preferences, preferred place of living in the end of life and place of death, after- death- interviews (t0 six month pre interventionem, t1 six month post interventionem)

b. Optimized care of patients at the end of life
(Palliative-) Care- Indicators at the end of life, similar to the Bertelsmann-Stiftung’s facts-checking (2015) about routine data of the GP practice in the health region (t0 six month pre interventionem, t1 six month post interventionem) and AOK-data for a regional comparative analysis (t0 twelve month pre interventionem, t1 twelve month post interventionem)

- Chemotherapy while the last month of life of cancer patients,
- PEG-device while the last three month of life of dementia-patient,
- Number of hospital stays and days of hospital care in the last 6 month of life,
- Number of patients with EBM-treatments within AAPV,
- Number of SAPV-first-prescription’s and SAPV-first-prescription’s within the last three days of life,
- Average duration of SAPV-treatments,
- Number of patients who deceased in hospital

c. Acceptance and usage of SPICT:
Number of cases in GP practice, where SPICT was used to assess the palliative situation, analysis of documents of patient files (6 month post interventionem)

d. GP’s awareness and sensibility for palliative situations:
Number of patients, who are eligible for palliative care, number of AAPV-cases and SAPV-prescriptions, analysis of documents of patients files and GKV-data (t0 six month pre interventionem, t1 post interventionem)

e. Effectiveness- practical consequences for GPs:
Number of initiate interventions for patients with life-limiting, chronic progressive oncological and non-oncological diseases, e.g. medication review, Advanced-Palliative-Care, structured survey of demand, prescription of SAPV, analysis of documents of patient files (six month post interventionem)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/10/01
  •   115
  •   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

a. General practitioners
Located GPs in targeted region, who are registered in the region within the duration of the project (independent by sex)

b. Deceased patients of targeted GPs practice
Deceased as a result of life-limiting, chronic progressive oncological and non-oncological diseases within period of observation and while in GPs care, age > 18 (independent of sex)

c. Remained relatives of deceased patients in GPs practice
Age > 18 and direct contact to deceased patient in the last phase of life (independent of sex)

d. Stakeholder in health region
Employed at least 1 year at interface to GPs practice (nursing service, nursing homes, hospitals, surgery) (independent of sex)

e. Health insurance data
Patient deceased as a result of life-limiting, chronic progressive oncological and non-oncological diseases within ZIP-Code of the targeted Region in 2016/2017 (t=0) or 2019/2020 (t=1), continuously assured, age > 18 (independent of sex)

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Exclusion Criteria

b. and e.: Sudden death, which is not related to a life-limiting, chronic progressive oncological and non-oncological disease (e.g. traffic accident, heart attack without diagnosis of coronary heart disease)

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Dr. med.  Kambiz  Afshar 
    • Car-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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  • start of 1:1-Block address public-contact
    • Medizinische Hochschule Hannover
    • Mr.  Dr. med.  Kambiz  Afshar 
    • Car-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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* This entry means the parameter is not applicable or has not been set.