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Correspondence
Reinhold Kreutz
E-mail: reinhold.kreutz@charite.de
Funding sources
This project was funded by the Federal Ministry of Education and Research of Germany
(grant number 01ET1001A).
Conflicts of interest
None declared.
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; Drager et al., 2013; K
olzsch et al., 2012; Lapane
2015 European Pain Federation - EFIC
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nner et al.
F. Ko
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).
nner et al.
F. Ko
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
Figure 1 Interactive online course for general practitioners with exercises and assessment of training success.
1333
nner et al.
F. Ko
Figure 2 Interactive, multi-perspective workshop for nursing home staff with handouts *was also content of 45-min basic training.
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.
nner et al.
F. Ko
3. Results
A total of 747 NHR fulfilled the inclusion criteria
(Fig. 3), and 239 (70% female, mean age 82.9,
8.1 years) NHR were studied at T0, while 206 and
177 were studied at T1 and T2 follow-up. Seven
interviews were discontinued and 16 deaths (6.7%)
occurred between T0 and T2. At T0, the study
groups did not significantly differ according to age,
sex, MMSE score or pain-associated diagnoses,
except osteoporosis (p = 0.007, Table 1). Furthermore, there were no differences regarding the proportion of NHR reporting pain or the mean average
pain severity on NRS (Table 2). However, at T0,
20.6% of NHR received no pain medication in IG
compared to 6.9% in CG (p = 0.009, Table 2). The
mean PMASD values were not significantly different,
although numerically lower (53.91 vs. 60.85) in IG
compared to CG (Table 2). All medication appropriateness criteria are presented in Table 3.
At T2, the proportion of NHR with persistent pain
was similar in the IG and CG (80.6% vs. 86.4%,
Table 2), while the mean average pain severity
tended to be lower in the IG compared to the CG
(1.59 vs. 2.45, p = 0.07, Table 2). The number of
NHR without pain medication use was significantly
reduced from 20.6% to 10.3% in the IG (p = 0.03),
while an increase, albeit small, from 6.9% to 8.7%
was observed in the CG (p = 0.62).
The inter-rater reliability of the PMASD was high
(r = 0.96, p < 0.001) and comparable to previous
studies (Hutt et al., 2006; K
olzsch et al., 2012). The
analysis of the mean PMASD values at T2 revealed a
non-statistically significant increase of 7.2 in the IG,
while the mean PMASD in the CG remained
unchanged ( 0.4, Table 2). Differences in the
PMASD values between T0 and T2 of each individual
NHR were calculated as a parameter reflecting longi 2015 European Pain Federation - EFIC
4. Discussion
This is the first study in Germany involving GPs and
nursing home staff to address the deficits in pain
treatment in NHR. Furthermore, the PMASD was
applied to NHR longitudinally for the first time. The
prevalence of pain observed in this study was higher
than in other studies conducted in Germany (Drager
et al., 2013; Osterbrink et al., 2012). However, the
mean average pain severity at baseline was 2.4 and
thus lower than expected in the power calculation.
Consequently, the aimed reduction in two points in
pain severity on the NRS would result in a complete
absence of pain. In this regard, the observed reduction to a severity level of 1.59 in the IG at T2 may
still represent a reasonable result. Nevertheless,
Eur J Pain 19 (2015) 1331--1341
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nner et al.
F. Ko
Figure 3 Diagram showing flow of clusters and nursing home residents through the cluster-randomized trial according to Campbell et al. (Campbell et al., 2004). NH, nursing home; NHR, nursing home resident; GP, general practitioner; MMSE, Mini Mental State Examination. apart I: seminar
on pain management in nursing homes for nursing staff; part II: online course for GPs; part III: short presentation for nursing staff; part IV: short
presentation at recruiting meeting for GPs.
almost two-thirds of NHR were affected by inappropriate pain medication use indicating the need for
improved pain treatment in agreement with other
recent studies (Hutt et al., 2006; Dr
ager et al., 2013;
K
olzsch et al., 2012). At T0, PMASD values in the IG
were numerically lower compared to the CG. This
observation was related to the higher proportion of
NHR that did not receive any pain medication,
although they reported pain.
1336 Eur J Pain 19 (2015) 1331--1341
nner et al.
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p-value
83.58 [81.2385.93]
86 (71.1)
23.47 [22.7924.15]
82.5 [80.1184.88]
81 (68.6)
23.89 [23.1624.61]
0.54a
0.70b
0.43a
5
10
11
7
(4.1)
(8.3)
(9.1)
(5.8)
8
12
22
8
ICC
0.077
0.004
0.25b
0.51b
0.007b
0.76b
(6.8)
(10.2)
(18.6)
(6.8)
MMSE, Mini Mental State Examination; CI, confidence interval; ICC, Intraclass correlation coefficient, a negative ICC results from a greater variance
within the cluster compared to the variance between the clusters.
a
Linear mixed-effect model.
b
Pearsons v2 with Rao & Scott adjustment.
Table 2 Prevalence of pain, mean average pain, analgesic drug use and appropriateness of pain medication.
T0
Total sample
Affected by paina,
n (%)
Reporting pain,
n (%)
Persistent painb,
n (%)
Mean average
painc [95% CI]
PMASD sampled
T2
Intervention
group
n = 121
Control
group
n = 118
p-value
ICC
Intervention
group
n = 89
Control
group
n = 88
p-value
100 (82.6)
95 (80.5)
0.73e
73 (82.0)
72 (81.8)
0.98e
88 (72.7)
87 (73.7)
0.88e
58 (65.9)
62 (70,5)
0.43e
50 (80.6)
57 (86.4)
0.37e
2.43 [1.892.97]
n = 92
of PMASD
score T0 to
T2 [95% CI]
(17.4)
(34.8)
(27.2)
(20.6)
[48.3759.45]
(63.0)
2.46 [1.93.03]
0.94f
0.02
1.59 [0.992.19]
2.45 [1.873.03]
n = 87
n = 68
n = 69
7
38
36
6
60.85
11
25
25
7
61.07
6
28
29
6
60.47
(8.0)
(43.7)
(41.4)
(6.9)
[55.1566.54]
53 (60.9)
0.009e,
0.11f
0.01
0.73e
(16.2)
(36.8)
(36.8)
(10.3)
[54.2967.85]
39 (57.3)
8.09 [0.9615.22]
(8.7)
(40.6)
(42.0)
(8.7)
[53.7167.23]
39 (56.5)
3.09 [ 3.76 to 9.95]
0.07f
0.01
0.80e,g
0.90f
0.01
0.92e
0.34f
CI, confidence interval; ICC, intraclass correlation coefficient; PRN, pro re nata; PMASD, Pain Medication Appropriateness Scale; range:
(highly inappropriate) to 100.0 (very appropriate).
a
Affected by pain was defined as reporting pain and/or receiving pain medication.
b
Persistent pain was defined as reporting pain in at least two measuring points.
c
Mean average self-reported pain severity in the last 24 h on Numeric Rating Scale (NRS, range 010).
d
PMASD was applied when NHR reported pain in BPI and/or received pain medication.
e
Pearsons v2 with Rao & Scott adjustment.
f
Linear mixed-effect model.
g
Compared any medication use to no medication use.
ICC
0.01
16.7
GPs who practised in this nursing home also practised in another nursing home facility in which
the appropriateness of pain medication did not
Eur J Pain 19 (2015) 1331--1341
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nner et al.
F. Ko
T2
Control
group (%)
Between
group
p-valueb
Intervention
group (%)
Control
group (%)
Between
group
p-valueb
Intra
group
p-value IGc
PMAS criteriona
Intervention
group (%)
1.
2.
3.
4.
5.
6.
7.
179
21
81
25
98
175
116
58.7
83.3
61.6
30.0
33.3
47.2
62.3
75.9
80.0
69.1
60.0
41.5
53.5
60.0
0.05
0.88
0.56
0.15
0.30
0.38
0.78
137
21
50
20
70
127
83
70.6
33.3
70.0
20.0
40.0
66.1
60.0
76.8
77.8
56.7
50.0
37.5
60.0
60.5
0.35
0.13
0.43
0.07
0.84
0.50
0.96
0.06
0.22
0.45
1.0
0.34
0.08
1.0
46
55.6
64.3
0.55
29
50.0
60.0
0.70
1.0
179
47.8
46.0
0.85
137
47.8
43.5
0.67
0.77
PRN, Pro re nata (as needed); Results imply appropriate prescribing (Hutt et al., 2006), i.e. Item 16: scores = 3; item 7: scores = 2 and 3; item 8/
9: scores 1, 2 and 3; item 10: score = 0.
a
Criterion was evaluated if applicable.
b
Pearsons v2 with Rao & Scott adjustment.
c
McNemars test.
Figure 4 PMASD values of all nursing home facilities at T0, T1 and T2. IG, Intervention group; CG, Control group. aNHR were treated by the same
GPs.
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Author contributions
F.K. led GP part of the intervention and co-led nurse part
of intervention, conducted data ascertainment and analyses
of medication and documentation, led interpretation of the
data, primary manuscript author. A.B. led study design
and subject acquisition, coordinator of the trial, participated in analyses of the data and preparation of the manuscript. Ro.K. calculated and analysed data and participated
in preparation of the manuscript. I.W. led nurse part of
intervention and co-led GP part of the intervention,
participated in preparation of the manuscript. S.K. participated in preparation of the manuscript. P.M. conducted
the sample size calculation and participated in preparation
of the manuscript. D.D. and R.K. are principal investigators
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