Trial Description. DRKS-ID: DRKS Date of Registration in DRKS: 2010/02/12. PLEASE NOTE: This trial has been registered retrospectively.

Transcription

1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Improving the provision of pain treatment for nursing home residents through consistent pain assessment - implementation of an algorithm for pain assessment (NRS - VRS - BESD) in nursing homes Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language Up to now, around half of the elderly people living in nursing homes do not receive sufficient pain therapy. Many of the residents also show cognitive impairment. This significantly complicates pain recognition and therapy. Specifically-developed instructions on how to recognize and estimate pain in geriatric patients should find a solution to this problem. In total 6 nursing homes in Ulm, Heidelberg and Berlin are participating in the study. Three homes receive comprehensive training for the new instructions. The nurses choose the most appropiate pain assessment instrument depending on the given instructions and the cognitive ability of the participant. The remaining nursing homes form the control group and continue with the pain assessment and treatment as before. The numbers of identified patients suffering from pain, and consequently the therapy provided, should be measured before and after the implementation of the pain recognition instruction. The aim of the study is to improve the provision of pain therapy. Brief Summary in Scientific Language Up to 50 % of those elderly people living in nursing homes do not receive sufficient pain therapy. Around ¾ of all residents show more or less clear signs of cognitive impairment. This makes pain recognition and therapy considerably more difficult. On the strength of past experience regarding pain assessment in elderly, a graded assessment system depending on the cognitive ability is probably the best approach to sufficient pain registration. A newly designed three-step pain assessment algorithm for geriatric patients (Numeric Rating Scale [NRS], Verbal Rating Scale [VRS] and BESD [BEurteilung von Schmerzen bei Demenz] should be performed in the context of a sub-project of the SHELTER Study [Services and Health for Elderly in Long TERm care] for the first time. According to a waiting-control-design, 6 nursing homes will be split into interventional or control groups by random. After the basis assessment, the interventional group receives comprehensive training on pain including Page 1 of 6

2 implementation of the pain algorithm. The control group is also given instructions on the topic of pain, but without recommendations in terms of the pain algorithm. After six months, the control group also receives training on the pain algorithm, while the interventional group gets a recapitulation for consolidation. Documentation of the number of patients suffering from pain and their pain therapy will be conducted immediately before and 8 weeks after the training. If there is insufficient pain therapy, the implementation of the pain algorithm should improve pain recognition as well as the pain therapy. Nurses choose the most suitable pain assessment instrument based on their expertise. In addition, we will estimate the acceptance and practicability of the algorithm by the user. Pain recognition and therapy will therefore be improved in this way. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 127/09, Ethik-Kommission der Universität Ulm Secondary IDs Universal Trial Number (UTN): U Health condition or Problem studied ICD10: R52 - Pain, not elsewhere classified Interventions/Observational Groups Arm 1: Early-trained group (interventional group). Comprehensive training on pain with implementation of the algorithm for pain assessment in geriatric patients. Demonstration of the characteristics, strengths and limits of the different pain assessments of the algorithm (NRS, VRS und BESD). Arm 2: Late-trained group (control group). Training on pain but without specific recommendation about pain assessment and benefit of certain assessment scales. This group also receives training about the algorithm for assessment of pain after a monitoring period of 6 months. Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Page 2 of 6

3 Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: Single blind Who is blinded: [---]* Control: Active control Purpose: Diagnostic Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Primary Outcome Registration of the diagnostic benefit: rate of recognized patients suffering from pain measured through the number of documented pain patients, documentation forms or conducted pain therapy. Number of identified patients suffering from pain before and 8 weeks after the training. Secondary Outcome Registration of the therapeutic benefit: rate of treated patients suffering from pain measured through the number of documented pain therapy. Has there been a change in prescription behaviour? Has there been an increase in prescription rescue medication? Can we observe more patients with sufficient pain treatment (NRS Ü4)? Level of pain treated patients before and 8 weeks after the training. Acceptance and practicability of the algorithm by the carer? Implementation rate? Difficulties in practice? Estimation of the benefit? Qualitative analysis of the pain therapy. Are there implemented recommendations about an adequate therapy for elderly patients suffer from pain? Countries of recruitment DE Locations of Recruitment Recruitment Page 3 of 6

4 Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2009/10/01 Target Sample Size: 350 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 65 Years Maximum Age: no maximum age Additional Inclusion Criteria All residents, regadless of their cognitive ability Exclusion criteria Missing agreement Addresses Primary Sponsor a4c31306b6c a b e f2f4b e a a b7947 at drks.de Contact for Scientific Queries Page 4 of 6

5 Contact for Scientific Queries e2f4d4a746c d724b646f c7a a d at drks.de Contact for Public Queries e2f4d4a746c d724b646f c7a a d at drks.de Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) a4c31306b6c a b e f2f4b e a a b7947 at drks.de Page 5 of 6

6 Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2010/12/31 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. *** This entry means that data is not displayed due to insufficient data privacy clearing. Page 6 of 6