Trial document




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  DRKS00016886

Trial Description

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Title

Study on advance care planning in care dependent community-dwelling older persons in Germany: a cluster-randomised controlled trial

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Trial Acronym

STADPLAN

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URL of the Trial

https://uol.de/avp/forschung/

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Brief Summary in Lay Language

Older individuals appreciate the chance to communicate on future care wishes, but most do not have this opportunity. Advance care planning (ACP) is a process of discussing future health care preferences for the case of lost capacity.
We aim to evaluate an ACP program in German care dependent community-dwelling older persons, compared to a written information broschure.
Methods: A cluster-randomised controlled trial of 12 months’ duration will be conducted in 3 German study sites. 16 home care services will be included in the intervention and 16 in the control group (each with 30 participants; n=960). ACP will be delivered by a trained nurse facilitator of the respecting home care service. Communication will include a proxy decision-maker. Primary endpoint is patient activation, operationalised by the Patient Activation Measure. Secondary endpoints include proportion of people with advance directives, hospitalisation, quality of life as well as depression and anxiety. Costs will also be collected alongside the trial for an economic evaluation and a comprehensive process evaluation will be done.
Expected results: This will be one of the first randomised controlled trials on the effectiveness and costs of ACP in community-dwelling older persons and the first one in Germany.

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Brief Summary in Scientific Language

Background: Older individuals appreciate the chance to communicate on future care wishes, but most do not have this opportunity. Advance care planning (ACP), a process of discussing future health care preferences, extends a person’s autonomy to a phase in life where they become incapacitated.
Goals: We aim to evaluate an ACP program in care dependent community-dwelling older persons, which has been proven effective in other settings and countries, compared to optimised usual care. Following the UK Medical Research Council’s (MRC) guidance for developing and evaluating complex interventions, we will adapt the program Respecting Choices.
Methods: A cluster-randomised controlled trial of 12 months’ duration will be conducted in 3 German study sites. Using external concealed randomisation, 16 home care services will be included in the intervention and 16 in the control group (each with 30 participants; n=960). ACP will be delivered by a trained nurse facilitator of the respecting home care service. Communication will include a proxy decision-maker. Primary endpoint is patient activation, operationalised by the Patient Activation Measure (PAM-13). Secondary endpoints include proportion of people with advance directives, hospitalisation, quality of life as well as depression and anxiety. Costs will also be collected alongside the trial for an economic evaluation and a comprehensive process evaluation will be done.
Expected results: This will be one of the first randomised controlled trials on the effectiveness and costs of ACP in community-dwelling older persons and the first one in Germany.

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

No

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Description IPD sharing plan:

The study protocol and the anonymised study data or information about them can be requested after finishing of data collection.

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Organizational Data

  •   DRKS00016886
  •   2019/06/04
  •   [---]*
  •   yes
  •   Approved
  •   2019-024, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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

  •   care dependent older patients
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Interventions/Observational Groups

  •   Advance Care Planning, offered by nurses working in home care services
  •   Optimized usual care, comprising a written information broschure regarding advance care planning issues
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Other
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Patient activation (PAM-13 D)
Measurement times:
Baseline: August 2019
T1: April 2020
T2: September 2020

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Secondary Outcome

1. Hospital Anxiety and Depression Scale (HADS-D) - T0, T1, T2;
2. Veterans Health Study Scale (VR-12) - T0, T1, T2;
3. ACP-Engagement Survey (4 items) - T0, T2;
4. Hospitalization and institutionalizing - T0, T1, T2;
5. Mortality - T0, T1, T2;
6. Usage of medical advice regarding ACP and completion rate of advance directives and health care proxies - T0, T1, T2

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
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Recruitment

  •   Actual
  •   2019/05/28
  •   960
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

30 Randomized patients of each home care service aged 60 years and older, with German skills and a dementia screening scale score of 5 or lower (n=960). Recruitment will be done by two or more nurses of each participating home care service.

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Exclusion Criteria

Home care services specialized in children care, palliative care or intensive care.

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Addresses

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    • Department für Versorgungsforschung der Universität Oldenburg
    • Mr.  Prof. Dr.  Falk  Hoffmann 
    • Ammerländer Heerstraße 114-118
    • 26129  Oldenburg
    • Germany
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    • Universität Halle-Wittenberg, Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Änne  Kirchner 
    • Magdeburger Straße 8
    • 06097  Halle (Saale)
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion für Forschung und Lehre in der Pflege
    • Ms.  Katharina  Silies 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Universität Oldenburg, Department für Versorgungsforschung
    • Ms.  Rieke  Schnakenberg 
    • Ammerländer Heerstraße 114-118
    • 26129  Oldenburg
    • Germany
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    • Universität Oldenburg, Department für Versorgungsforschung
    • Ms.  Rieke  Schnakenberg 
    • Ammerländer Heerstraße 114-118
    • 26129  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.