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Project to implement an adequate pain management in nursing homes

Project to implement an adequate pain management in nursing homes - PIASMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011062
Enrollment
460
Registered
2016-10-20
Start date
2017-02-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 R52.1 R52.2 R52.9 F45.41

Interventions

Group 1: 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
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

Sponsors

Curanum AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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))

Countries

Germany

Contacts

Public ContactDenise Seidenspinner, MScN

Institut für Pflegewissenschaft und -praxis, Paracelsus Medizinische Privatuniversität

denise.seidenspinner@pmu.ac.at00491771802583

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026