Trial document




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  DRKS00011062

Trial Description

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Title

Project to implement an adequate pain management in nursing homes

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Trial Acronym

PIASMA

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URL of the Trial

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Brief Summary in Lay Language

Up to 80% of nursing home residents experience pain at rest or pain on exertion. The prevalence of pain is rather high in residents who are able to communicate their pain but also in those who are not able to communicate or report pain (i.e. residents with progressed dementia, primarily). Especially nurses, who take an active and time-consuming part in everyday care, face the challenge to provide an adequate care of pain for residents, including end-of-life phases. Next to the specific knowledge and competencies regarding pain management strategies, special attention has to be given to the provision of palliative care structures and supply. It is evident that resident-targeted interventions in terms of nursing pain management incorporating palliative care are of essential importance. One can assume that such interventions are necessary to enable an optimal and high-quality care of nursing home residents regardless of residents ability to self-report pain or not. The PIASMA project aims to improve the pain situation fo residents in nursing homes. The focus lies on an analysis of the received pain management in place today and the pain situation of residents, the subsequent identification of areas requiring optimisation and the changes gradually resulting from a systemic intervention. In addition, it will be analysed to what extent palliative care needs are being included in applied nursing.

Primarily, the forthcoming research questions are pursued:

• Which changes in the nursing home residents' pain situation can be measured after and due to a non-medical intervention?
• How are the needs for palliative care ascertained and what are the consequences for the current practice of nursing pain management?

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Brief Summary in Scientific Language

Background.
The pain situation of residents of nursing homes represents a huge challenge in nursing and medical care not least due to the continuously high prevalence (Kalinowski et al., 2015). In German nursing homes a prevalence of pain of approx. 49% at rest and 67% on exertion must be assumed (Dräger et al., 2012; Lukas, Mayer, Onder, Bernabei, & Denkinger, 2015; Osterbrink et al., 2012). In addition to the burden for the individuals, untreated or insufficiently treated pain is also an economic burden (Dietl & Korczak, 2011). Especially the increasing number of residents of nursing homes suffering from various degrees of dementia entails new challenges for pain management. Next to the indisputable necessity of the adaption of instruments and pain assessment and documentation procedures against the background of different degrees of residents’ cognitive function it is furthermore evident that nursing homes have a special need for palliative care concepts (Becker-Ebel et al., 2012; Gerhard & Bollig, 2007; Knipping, 2007; Kojer & Schmidl, 2011).

Rationale and aims.
The PIASMA project aims to optimise multiprofessional pain management by integrating palliative care structures and concepts in the nursing homes (operator: Curanum AG) in Bavaria. The primary focus lies on an analysis of the received pain management in place today and the pain situation of residents, the subsequent identification of areas requiring optimisation and the changes gradually resulting from a systemic intervention. In addition, it will be analysed to what extent palliative care needs are being included in applied nursing, what percentage of residents die in nursing homes and what kind of palliative care measures are being carried out.

Design, methods and data collection.
As part of the cluster randomised controlled pre-test post-test intervention trial in 20 nursing homes (ten control and ten intervention facilities) structural data (assessment form on aggregated regulations, procedures, records on pain and palliative care mechanisms) and resident-specific documents (care records, medical characteristics, palliative care indicators) will be collected, the residents will be examined according to their cognitive skills (self-assessment/external assessment) and certified nurses will be interviewed online. The resident-specific data collection will be conducted by specifically trained study assistants.

Intervention.
The 12-month intervention phase includes advanced training for and the systematic implementation of pain nurses and pain care assistants, web-based training on chronic pain and dementia for nurses and, if necessary, GPs, the implementation of/instructions for the creation of treatment plans, resident-specific pain assessment mechanisms and the palliative care tool SPICT-DE for identifying residents potentially requiring palliative care as well as the implementation of interdisciplinary quality circles and specific expert training on ‘pain management’ and ‘palliative care’.

Time flow.
The initial data collection (pretest t0) will take place from November 2016 to April 2017. The intervention package will be implemented—successively planned for every nursing home—from April 2017 to February 2018. Consequently, the second data collection (posttest t1) will be conducted from November 2017 to April 2018. After completion of the trial, the interventional package will be implemented in all Bavarian Curanum AG facilities.

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Organizational Data

  •   DRKS00011062
  •   2016/10/20
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  •   yes
  •   Approved
  •   379-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   U1111-1187-3174 
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Health Condition or Problem studied

  •   Pain situation of old and oldest old nursing home residents with different degrees of cognitive impairment (i.e. early and later stages of dementia)
  •   R52.0 -  Acute pain
  •   R52.1 -  Chronic intractable pain
  •   R52.2 -  Other chronic pain
  •   R52.9 -  Pain, unspecified
  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   To assess the cognitive function of the nursing home residents, the Mini-Mental-State-Examination (MMSE) is used as the initial screening (Folstein, Folstein, & Fanjiang, 2001; Folstein, Folstein, & McHugh, 1975). Residents with MMSE-scores between 18-30 points are stratified as residents with no or mild cognitive impairment, those with MMSE-scores between 10-17 as residents with moderate cognitive impairment, and those with MMSE-scores between 0-9 as residents with severe cognitive impairment (Basler, 2007; Ivemeyer & Zerfaß, 2006). Within the respective study, two subsamples of nursing home residents are realized: Nursing home residents with a MMSE-score ranging from 10 to 30 points (assumed to be able to provide self-report) and nursing home residents with a MMSE-score ranging from 0-9 points (assumed not to be able to provide self-report). The first subsample will be surveyed with standardized questionnaires, the second group will be examined using standardized observational assessment tools.

    Cluster randomised controlled trial (1:1 Intervention/Control): 10 nursing homes intervention group (Sampling frame 'intervention': approx. 1,100 residents)

    The intervention will comprise:

    •Adaption and/or preparation of written instructions
    •Online-based training for nurses regarding chronic pain
    •Training and implementation of Pain Nurses and Pain Care Assistants
    •Implementation of/instructions for the creation of treatment plans, resident-specific pain assessment mechanisms and the palliative care tool SPICT-DE
    •Implementation of interdisciplinary quality circles
    •Specific expert training on
    a) acceptable pain situation
    b) treatment plan
    c) pain assessment tools
    d) Best practice 'palliative care'
  •   Cluster randomised controlled trial (1:1 Intervention/Control): 10 nursing homes control group (Sampling frame 'control': approx. 1,100 residents)

    Control: Care 'as usual' without intervention (normal treatment procedures)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, assessor
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

A. The primary outcomes for residents able to perform self-assessment are the average pain intensity as maximum pain during the previous 24 hours, measured by means of the Numeric Rating Scale (NRS-11) as well as the percentage of residents who according to self-assessment report a stable pain situation and/or whose pain situation is marked as stable in the care records.
Primary outcomes (residents able to perform self-assessment):
- Pain intensity (maximum pain) (NRS-11) in terms of the Brief Pain Inventory (BPI) (Cleeland (1982); German version Radbruch et al. (1999); German, modified and validated nursing home version Budnick et al. (2016))
- Percentage of residents with documented (care records) or self-reported 'stable pain situations'

B. The primary outcome for residents unable to perform self-assessment is the amount of pain indicators collected by means of external assessment, measured according to Pain Assessment in Advanced Dementia (PAINAD) as well as the percentage of residents with stable pain situations according to external assessment performed by the nurses and/or whose pain situations are marked as stable in the care records.
Primary outcomes (residents not able to perform self-assessment):
- Cutoff>1 (relevant signs of pain) in terms of Pain Assessment in Advanced Dementia (PAINAD) (Warden, Hurley & Volicer (2003); German validated version Basler et al. (2006) and Schuler (2007))
- Percentage of residents with documented (care records) 'stable pain situations'
- Short-form questionnaire 'Surprise Question' (Moroni et al., 2014) as a proxy instrument rated by the nurses to screen the individual residents' palliative care requirements

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Secondary Outcome

A. Secondary outcomes and controls in the sample of residents who are able to perform self-assessment:
- Aggregated characteristics of nursing home structure (e.g. ratio nurses:residents, single/shared room)
- Regulations regarding pain therapy and palliative care (e.g. documentation forms, guidelines, procedures, palliative care concepts)
- Online-CASI of nurses regarding selected topics of pain management in those residents who are able to perform self-assessment
- Resident-specific sociodemographic, biometrical, nursing and medical characteristics from the electronic care records
- Scale physical and psychic pain interference in terms of the Brief Pain Inventory (BPI)
- EQ-5D-3L (The EuroQol Group, 1990; German version Oct. 2014)
- Geriatric Depression Scale (GDS-SF15) ((Yesavage et al., 1983); German version Gauggel & Birkner (1999) and validated in nursing homes by Allgaier et al. (2011))

B. Secondary outcomes and controls in the sample of residents who are not able to perform self-assessment:
- Aggregated characteristics of nursing home structure (e.g. ratio nurses:residents, single/shared room)
- Regulations regarding pain therapy and palliative care (e.g. documentation forms, guidelines, procedures, palliative care concepts)
- Online-CASI of nurses regarding selected topics of pain management in those residents who are not able to perform self-assessment (Pretest: 15/11-30/12/2016)
- Resident-specific sociodemographic, biometrical, nursing and medical characteristics from the electronic care records
- Neuropsychiatric Inventory (NPI-NH) (Cummings (1996, 1997; 1994); German NPI-NH Mapi Research Trust (2006), validated by Reuther et al. (2016))

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/02/01
  •   460
  •   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

Aged 60 or older, living permanently in the nursing home, written informed consent

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Exclusion Criteria

Short-term care and day care, congenital/permanent multi-handicap, insufficient knowledge/ability of German language (self-report), acute ailments, excessive impairment of the general state of health, life-threatening situations

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Addresses

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    • Curanum AG
    • Zirkus-Krone-Str. 10
    • 80335  München
    • Germany
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    • Curanum AG
    • Zirkus-Krone-Str. 10
    • 80335  München
    • Germany
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    • Institut für Pflegewissenschaft und -praxis
    • Mr.  Mag.  Patrick  Kutschar 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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    • Institut für Pflegewissenschaft und -praxis
    • Dr.  Irmela  Gnass 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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    • Institut für Pflegewissenschaft und -praxis, Paracelsus Medizinische Privatuniversität
    • Ms.  Mag.  Denise  Seidenspinner, MScN 
    • Strubergasse 21
    • 5020  Salzburg
    • Austria
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Sources of Monetary or Material Support

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    • Paracelsus Medizinische Privatuniversität
    • 5020  Salzburg
    • Austria
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    • Curanum AG
    • 80335  München
    • Germany
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    • Land Salzburg
    • 5020  Salzburg
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/26
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Trial Publications, Results and other Documents

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