ORIGINAL ARTICLE
Interventions to address deficits of pharmacological pain management in nursing home residents – A cluster-randomized trial € nner1, A. Budnick2, R. Kuhnert1, I. Wulff2, S. Kalinowski2, P. Martus3, D. Dra €ger2, R. Kreutz1 F. Ko -Universit€atsmedizin Berlin, Germany 1 Institute of Clinical Pharmacology and Toxicology, Charite 2 Institute of Medical Sociology and Rehabilitation Science, Charit e- Universit€atsmedizin Berlin, Germany €bingen, Germany 3 Institute for Clinical Epidemiology and Applied Biometry, University Hospital Tu
Correspondence Reinhold Kreutz E-mail: [email protected] Funding sources This project was funded by the Federal Ministry of Education and Research of Germany (grant number 01ET1001A). Conflicts of interest None declared.
Accepted for publication 19 December 2014 doi:10.1002/ejp.663
Abstract Background: To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). Methods: This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD), respectively. Results: At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, nonsignificant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. Conclusions: NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved.
1. Introduction Pain in nursing home residents (NHR) remains an important research topic since deficits in pain management were revealed in several studies (Won et al., 2004; Dr€ager et al., 2013; K€ olzsch et al., 2012; Lapane © 2015 European Pain Federation - EFICâ
et al., 2013). Up to 84% of NHR are affected by pain worldwide (Takai et al., 2010) and about 50% in Germany (Dr€ ager et al., 2013; Osterbrink et al., 2012; Lukas et al., 2013). Previous studies indicated that about 25% of NHR receive no pain medication although they have pain (Won et al., 2004; K€ olzsch et al., 2012; Lapane et al., 2013). Persistent or Eur J Pain 19 (2015) 1331--1341
1331
€nner et al. F. Ko
Appropriate pain management in nursing home residents
What’s already known about this topic? • Deficits in pain management in nursing home residents have been reported in several countries including Germany. What does this study add?
• This is the first intervention study in Germany addressing general practitioners and nursing home staff to improve pain management. • A pain medication appropriateness scale was applied longitudinally. • The findings indicate that the use of multifaceted educational interventions is a first step to improve pain management and pain medication use in nursing home residents.
untreated pain is related to several consequences such as functional impairment, depression, falls or sleep disorders, which can eventually lead to a reduction in quality of life (The American Geriatrics Society, 2002). The therapeutic approach of pain treatment in older adults differs from treatment of younger patients, not only because of altered drug effects but also because the superior goal in the elderly is to maintain and improve quality of life. This is a challenging task for general practitioners (GPs), and requires individual medication decisions based on weighing the risks and benefits (The American Geriatrics Society, 2002). Several clinical guidelines to enhance pain management in older adults have been developed and disseminated (The American Geriatrics Society, 2002, 2009; Pergolizzi et al., 2008; Abdulla et al., 2013), and several studies were conducted to improve pain management in nursing homes (Herman et al., 2009), but approaches in Germany are lacking. In the context of this study, an ‘interdisciplinary guidance for pain management in nursing home residents’ (Wulff et al., 2012) was developed which specifically addresses all professions who assess and treat pain in NHR: GPs, pharmacists, nurses and administrators of nursing homes. In the presented trial, this guidance was used to develop multifaceted educational programs for GPs and nursing home staff. The aim of the current study was to compare the effect of these programs regarding the improvement of the average pain severity and the appropriateness of pain medication use between NHR who were treated by intensively trained GPs and nursing home staff and NHR who were treated by GPs and nursing home staff who received basic training.
1332 Eur J Pain 19 (2015) 1331--1341
2. Methods 2.1. Setting and study design This study was conducted in 12 nursing homes in Berlin, Germany, which were provided by one forprofit chain. Written consent was received by the senior manager. The design of a cluster-randomized controlled trial was chosen to avoid a contamination of the interventional effect as the interventions were conducted on the level of the nursing home (=cluster) (Wears, 2002). Hence, individual randomization of GPs or NHR appeared inappropriate. The allocation sequence was generated by an experienced statistician, and the complex enrolment of participants was conducted by two experienced researchers of the study team. Six nursing homes were randomly assigned to either the intervention group (IG) or control group (CG). The remaining six nursing homes had to be paired (4:2) before random assignment because the involved GPs of one practice treated NHR in four nursing homes and GPs of another practice cared for NHR in two nursing homes. The majority of the participating GPs was working in independent private practices and thus not employed by the owner of the nursing home. Based on previous data (Dr€ ager et al., 2013; K€ olzsch et al., 2012), a sample size of 96 NHR in each arm was calculated to detect a difference of 2.0 points (SD 3.0) (Wood et al., 2010) on the Numeric Rating Scale (NRS) between the IG and the CG. This calculation considered a power of 80%, a two-sided alpha of 0.05, and an estimated intraclass correlation coefficient (ICC) of 0.05. The calculation revealed that an ICC of 0.12 would still maintain the power of 80%. To enrol this number of subjects, it was estimated to screen about 1500 NHR taking into account a follow-up mortality rate of 10%, a prevalence of 50% for cognitive status (Mini Mental State Examination (MMSE) score (Folstein et al., 1975) ≥ 18) and a pain prevalence of 55%. The study is registered at the German section of the International Clinical Trials Registry Platform of the World Health Organization (DRKS-ID: DRKS00004239); it complies with the Declaration of Helsinki, and was approved by the local ethics committee (EA2/150/11).
2.2. Data collection Data were collected between February 2012 and December 2012. Personal interviews with NHR and the analysis of the nursing home medical records
© 2015 European Pain Federation - EFICâ
€nner et al. F. Ko
were conducted by trained interviewers at baseline (T0), after three (T1) and six (T2) months. A computer-assisted full medication inventory was completed using the Instrument for Database-assisted Online recording for Medication – IDOM (M€ uhlberger et al., 2003). All drugs were categorized according to the Anatomical Therapeutic Chemical (ATC) Classification. Pain medication included drugs classified as ATC ‘N02’ (Analgesics) and ‘M01A’ (Antiinflammatory and Antirheumatic Products, Non-Steroids) (WHO, 2012). The information about prescribed drugs including dosing and diagnoses were obtained from the nursing homes medical records.
2.3. Study population NHR were eligible to participate who were at least 65 years old, spent more than 3 months in the facility and had no or mild cognitive impairment (MMSE Score (Folstein et al., 1975) ≥18). Written informed consent was obtained from the residents or their legal representatives before data collection.
2.4. Interventions Two multifaceted education programs were developed by the interdisciplinary study team for the residents’ GPs and nursing home staff. Both programs were based on an interdisciplinary guidance (Wulff
Appropriate pain management in nursing home residents
et al., 2012) and focused on knowledge (basics of pain, pain assessment, non-drug therapy and drug therapy) and reflecting personal attitudes towards pain management in NHR and the collaboration between GPs and nurses (Figs. 1–2). This approach was chosen because previous studies reported that a lack of knowledge and poor attitudes represent major barriers for providing adequate pain management in nursing homes (Tarzian and Hoffmann, 2004). It is further supported by findings which suggest that self-awareness is the key in changing behaviour (Hicks, 2000) and knowledge itself does not easily lead to a change in action (Nazareth et al., 2002). All involved GPs were informed about the characteristics of the study prior to baseline data collection. Subsequently, an online course, requiring an estimated working time of 5–6 h, was offered for 6 weeks after T0 to the GPs of the IG, while the GPs of the CG could participate after the data collection was completed. Furthermore, GPs received reminders and a printed short version of the interdisciplinary guidance. Participants received Continuing Medical Education (CME) points after completion of the course. Of 92 GPs, 22 (23%) agreed to participate in the trial. Fourteen GPs practised in the IG and nine (64%) participated in the online course, while two of eight (25%) GPs of the CG participated.
Figure 1 Interactive online course for general practitioners with exercises and assessment of training success.
© 2015 European Pain Federation - EFICâ
Eur J Pain 19 (2015) 1331--1341
1333
€nner et al. F. Ko
Appropriate pain management in nursing home residents
Figure 2 Interactive, multi-perspective workshop for nursing home staff with handouts *was also content of 45-min basic training.
For nursing home staff of the IG facilities, 1-day seminars (360 min) were conducted on-site by the nurse and pharmacist of the research team. Nursing home administrators were also encouraged to attend. The seminar included presentations, exercises and the opportunity for mutual exchange. Participants received printed material (advantages and disadvantages of analgesic drugs for the elderly, pain assessment strategies and non-drug approaches). Eleven seminars were conducted and 100 nursing home staff members (18 were members of management level) participated (79%). Nursing home staff of each CG facility was offered a 45-min presentation about general pain management and 69 (60%) nurses participated.
2.5. Measures 2.5.1. Pain Pain assessment was initiated by two dichotomous questions ‘are you in pain?’ and ‘are you occasionally in pain?’ and by applying the Brief Pain Inventory (BPI) (Radbruch et al., 1999). Average pain severity was determined with the BPI as the score on NRS. Persistent pain was defined as reporting pain in at least two measurements. The primary outcome was the reported average pain severity on the NRS within the last 24 h.
olzsch et al., 2013) and used in a non(PMASD) (K€ interventional cross-sectional study (K€ olzsch et al., 2012). The original PMAS tool and its German version PMASD consist of 10 criteria and evaluate several aspects of pain treatment in NHR (Table 3). This includes the assessment of the type of prescribed pain medication, dosages and dosing intervals for certain pain syndromes, laxative co-medication during opioid therapy and the prescription of high-risk drugs for the elderly. In addition to this objective evaluation, the subjective perception of pain severity and therapeutic success of the individual is also part of the PMAS evaluation. An extensive training for the evaluation of the PMASD tool was conducted prior to data analysis that included an introduction course in the use of the PMASD tool and the determination of the inter-rater reliability in a random sample of 71 individuals. The PMASD was applied once at each measuring point to NHR who reported pain according to the BPI and/or received pain medication. PMASD values
Interventions to address deficits of pharmacological pain management in nursing home residents – A cluster-randomized trial € nner1, A. Budnick2, R. Kuhnert1, I. Wulff2, S. Kalinowski2, P. Martus3, D. Dra €ger2, R. Kreutz1 F. Ko -Universit€atsmedizin Berlin, Germany 1 Institute of Clinical Pharmacology and Toxicology, Charite 2 Institute of Medical Sociology and Rehabilitation Science, Charit e- Universit€atsmedizin Berlin, Germany €bingen, Germany 3 Institute for Clinical Epidemiology and Applied Biometry, University Hospital Tu
Correspondence Reinhold Kreutz E-mail: [email protected] Funding sources This project was funded by the Federal Ministry of Education and Research of Germany (grant number 01ET1001A). Conflicts of interest None declared.
Accepted for publication 19 December 2014 doi:10.1002/ejp.663
Abstract Background: To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). Methods: This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD), respectively. Results: At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, nonsignificant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. Conclusions: NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved.
1. Introduction Pain in nursing home residents (NHR) remains an important research topic since deficits in pain management were revealed in several studies (Won et al., 2004; Dr€ager et al., 2013; K€ olzsch et al., 2012; Lapane © 2015 European Pain Federation - EFICâ
et al., 2013). Up to 84% of NHR are affected by pain worldwide (Takai et al., 2010) and about 50% in Germany (Dr€ ager et al., 2013; Osterbrink et al., 2012; Lukas et al., 2013). Previous studies indicated that about 25% of NHR receive no pain medication although they have pain (Won et al., 2004; K€ olzsch et al., 2012; Lapane et al., 2013). Persistent or Eur J Pain 19 (2015) 1331--1341
1331
€nner et al. F. Ko
Appropriate pain management in nursing home residents
What’s already known about this topic? • Deficits in pain management in nursing home residents have been reported in several countries including Germany. What does this study add?
• This is the first intervention study in Germany addressing general practitioners and nursing home staff to improve pain management. • A pain medication appropriateness scale was applied longitudinally. • The findings indicate that the use of multifaceted educational interventions is a first step to improve pain management and pain medication use in nursing home residents.
untreated pain is related to several consequences such as functional impairment, depression, falls or sleep disorders, which can eventually lead to a reduction in quality of life (The American Geriatrics Society, 2002). The therapeutic approach of pain treatment in older adults differs from treatment of younger patients, not only because of altered drug effects but also because the superior goal in the elderly is to maintain and improve quality of life. This is a challenging task for general practitioners (GPs), and requires individual medication decisions based on weighing the risks and benefits (The American Geriatrics Society, 2002). Several clinical guidelines to enhance pain management in older adults have been developed and disseminated (The American Geriatrics Society, 2002, 2009; Pergolizzi et al., 2008; Abdulla et al., 2013), and several studies were conducted to improve pain management in nursing homes (Herman et al., 2009), but approaches in Germany are lacking. In the context of this study, an ‘interdisciplinary guidance for pain management in nursing home residents’ (Wulff et al., 2012) was developed which specifically addresses all professions who assess and treat pain in NHR: GPs, pharmacists, nurses and administrators of nursing homes. In the presented trial, this guidance was used to develop multifaceted educational programs for GPs and nursing home staff. The aim of the current study was to compare the effect of these programs regarding the improvement of the average pain severity and the appropriateness of pain medication use between NHR who were treated by intensively trained GPs and nursing home staff and NHR who were treated by GPs and nursing home staff who received basic training.
1332 Eur J Pain 19 (2015) 1331--1341
2. Methods 2.1. Setting and study design This study was conducted in 12 nursing homes in Berlin, Germany, which were provided by one forprofit chain. Written consent was received by the senior manager. The design of a cluster-randomized controlled trial was chosen to avoid a contamination of the interventional effect as the interventions were conducted on the level of the nursing home (=cluster) (Wears, 2002). Hence, individual randomization of GPs or NHR appeared inappropriate. The allocation sequence was generated by an experienced statistician, and the complex enrolment of participants was conducted by two experienced researchers of the study team. Six nursing homes were randomly assigned to either the intervention group (IG) or control group (CG). The remaining six nursing homes had to be paired (4:2) before random assignment because the involved GPs of one practice treated NHR in four nursing homes and GPs of another practice cared for NHR in two nursing homes. The majority of the participating GPs was working in independent private practices and thus not employed by the owner of the nursing home. Based on previous data (Dr€ ager et al., 2013; K€ olzsch et al., 2012), a sample size of 96 NHR in each arm was calculated to detect a difference of 2.0 points (SD 3.0) (Wood et al., 2010) on the Numeric Rating Scale (NRS) between the IG and the CG. This calculation considered a power of 80%, a two-sided alpha of 0.05, and an estimated intraclass correlation coefficient (ICC) of 0.05. The calculation revealed that an ICC of 0.12 would still maintain the power of 80%. To enrol this number of subjects, it was estimated to screen about 1500 NHR taking into account a follow-up mortality rate of 10%, a prevalence of 50% for cognitive status (Mini Mental State Examination (MMSE) score (Folstein et al., 1975) ≥ 18) and a pain prevalence of 55%. The study is registered at the German section of the International Clinical Trials Registry Platform of the World Health Organization (DRKS-ID: DRKS00004239); it complies with the Declaration of Helsinki, and was approved by the local ethics committee (EA2/150/11).
2.2. Data collection Data were collected between February 2012 and December 2012. Personal interviews with NHR and the analysis of the nursing home medical records
© 2015 European Pain Federation - EFICâ
€nner et al. F. Ko
were conducted by trained interviewers at baseline (T0), after three (T1) and six (T2) months. A computer-assisted full medication inventory was completed using the Instrument for Database-assisted Online recording for Medication – IDOM (M€ uhlberger et al., 2003). All drugs were categorized according to the Anatomical Therapeutic Chemical (ATC) Classification. Pain medication included drugs classified as ATC ‘N02’ (Analgesics) and ‘M01A’ (Antiinflammatory and Antirheumatic Products, Non-Steroids) (WHO, 2012). The information about prescribed drugs including dosing and diagnoses were obtained from the nursing homes medical records.
2.3. Study population NHR were eligible to participate who were at least 65 years old, spent more than 3 months in the facility and had no or mild cognitive impairment (MMSE Score (Folstein et al., 1975) ≥18). Written informed consent was obtained from the residents or their legal representatives before data collection.
2.4. Interventions Two multifaceted education programs were developed by the interdisciplinary study team for the residents’ GPs and nursing home staff. Both programs were based on an interdisciplinary guidance (Wulff
Appropriate pain management in nursing home residents
et al., 2012) and focused on knowledge (basics of pain, pain assessment, non-drug therapy and drug therapy) and reflecting personal attitudes towards pain management in NHR and the collaboration between GPs and nurses (Figs. 1–2). This approach was chosen because previous studies reported that a lack of knowledge and poor attitudes represent major barriers for providing adequate pain management in nursing homes (Tarzian and Hoffmann, 2004). It is further supported by findings which suggest that self-awareness is the key in changing behaviour (Hicks, 2000) and knowledge itself does not easily lead to a change in action (Nazareth et al., 2002). All involved GPs were informed about the characteristics of the study prior to baseline data collection. Subsequently, an online course, requiring an estimated working time of 5–6 h, was offered for 6 weeks after T0 to the GPs of the IG, while the GPs of the CG could participate after the data collection was completed. Furthermore, GPs received reminders and a printed short version of the interdisciplinary guidance. Participants received Continuing Medical Education (CME) points after completion of the course. Of 92 GPs, 22 (23%) agreed to participate in the trial. Fourteen GPs practised in the IG and nine (64%) participated in the online course, while two of eight (25%) GPs of the CG participated.
Figure 1 Interactive online course for general practitioners with exercises and assessment of training success.
© 2015 European Pain Federation - EFICâ
Eur J Pain 19 (2015) 1331--1341
1333
€nner et al. F. Ko
Appropriate pain management in nursing home residents
Figure 2 Interactive, multi-perspective workshop for nursing home staff with handouts *was also content of 45-min basic training.
For nursing home staff of the IG facilities, 1-day seminars (360 min) were conducted on-site by the nurse and pharmacist of the research team. Nursing home administrators were also encouraged to attend. The seminar included presentations, exercises and the opportunity for mutual exchange. Participants received printed material (advantages and disadvantages of analgesic drugs for the elderly, pain assessment strategies and non-drug approaches). Eleven seminars were conducted and 100 nursing home staff members (18 were members of management level) participated (79%). Nursing home staff of each CG facility was offered a 45-min presentation about general pain management and 69 (60%) nurses participated.
2.5. Measures 2.5.1. Pain Pain assessment was initiated by two dichotomous questions ‘are you in pain?’ and ‘are you occasionally in pain?’ and by applying the Brief Pain Inventory (BPI) (Radbruch et al., 1999). Average pain severity was determined with the BPI as the score on NRS. Persistent pain was defined as reporting pain in at least two measurements. The primary outcome was the reported average pain severity on the NRS within the last 24 h.
olzsch et al., 2013) and used in a non(PMASD) (K€ interventional cross-sectional study (K€ olzsch et al., 2012). The original PMAS tool and its German version PMASD consist of 10 criteria and evaluate several aspects of pain treatment in NHR (Table 3). This includes the assessment of the type of prescribed pain medication, dosages and dosing intervals for certain pain syndromes, laxative co-medication during opioid therapy and the prescription of high-risk drugs for the elderly. In addition to this objective evaluation, the subjective perception of pain severity and therapeutic success of the individual is also part of the PMAS evaluation. An extensive training for the evaluation of the PMASD tool was conducted prior to data analysis that included an introduction course in the use of the PMASD tool and the determination of the inter-rater reliability in a random sample of 71 individuals. The PMASD was applied once at each measuring point to NHR who reported pain according to the BPI and/or received pain medication. PMASD values
