# Abstract

 *Background*. In view of the adverse effects of using restraints, studies examining the use of restraint reduction programs (RRPs) are needed. *Objectives*. To investigate the effect of an RRP on the reduction of physical restraint rates in rehabilitation hospitals. *Methods*. A prospective quasi-experimental clinical trial was conducted. Demographic data, medical and health-related information on recruited patients from two rehabilitation hospitals, as well as facility data on restraint rates were collected. *Results*. The increase in the restraint rate in the control site was 4.3 times greater than that in the intervention site. Changes in the restraint mode, from continuous to intermittent, and the type of restraint used were found between the pre- and postintervention periods in both the control site and the intervention site. *Discussion*. Compared with that in the control site, the RRP in the intervention site helped arrest any increase in the restraint rate although it had no effect on physical restraint reduction. The shift of restraint mode from continuous to intermittent in the intervention site was one of the positive outcomes of the RRP. # 3. Results The samples in the two hospitals were first compared in terms of their demographic and clinical characteristics. The preintervention sample at the intervention facility was considerably older---mean age 75.4 (SD 10.7) versus 59.1 (SD 17.4) of the control facility (*P* < 0.001). The two samples were different in terms of the number of medical diagnosis, with the study site having a mean of 3.1 diagnoses (SD 1.5) versus the control site's mean of 1.8 diagnoses (SD 1.2) (*P* < 0.001); the mean MMSE score of the study site was 16.7 (SD 7.0) versus control site's 25.4 (SD 5.3) (*P* < 0.001); the mean MBI score was 12.7 (SD 5.5) in the study site versus control site's mean 15.1 score (SD 3.2) (*P* < 0.001). There were no significant differences found in all the other clinical and demographic variables. The postintervention sample at the study site remained considerably older, with a mean age of 74.8 (SD 10.6) versus 62.9 (SD 17.7) in the control site (*P* < 0.001). Again, the two samples were different in terms of the number of medical diagnosis, with the study site having a mean of 3.2 diagnoses (SD 1.5) versus control site's mean of 1.9 diagnoses (SD 1.2) (*P* < 0.001); the mean MMSE score of the study site was 16.4 (SD 7.2) versus control site's 24.4 (SD 6.5) (*P* < 0.001); the mean MBI score of the study site was 12.0 (SD 5.1) versus control site's mean 15.1 (SD 3.4) (*P* < 0.001). The two facilities were also significantly different in terms of their gender composition---49.0% males in the study site versus 34.8% males in the control site. No other significant differences were found in clinical and demographic variables between the two hospital samples in the post-intervention period. Then the baseline sample profile of the patients before the intervention in the study and control site were compared (Tables [1](#)(a) and [1](#)(b)). The control site had a significantly younger patient group than the study site (*P* < 0.001) in the nonrestrained patient group. This younger patient group probably resulted in the higher cognitive status as reflected in the significantly higher mean MMSE total score (*P* < 0.001) and the lower risk of fall as reflected in the lower Morse Fall Scale score (*P* < 0.001) ([Table 1(a)](#)). Restrained patients had a similar sample profile in both the study and control sites. However, significant differences were found in age (*P* < 0.01) in both the nonrestrained and restrained groups of patients between the study and control sites. A significant difference in the experiences of falling in hospital (*P* < 0.01) was also found in the nonrestrained patients ([Table 1(b)](#)). Last, the profiles of those who were restrained and nonrestrained were compared in each of the study sites. Tables [2](#)(a) and [2](#)(b) provide information about the categorical variables of the samples recruited during the pre- and postintervention period in both sites. Significant differences were found in the MBI score (*P* = 0.016) and vision (*P* < 0.001) in the study site in the postintervention period when compared with the preintervention period. The mean MBI score was worse (30.3 versus 31.5) while there were more people with normal vision (39.2% versus 51.2%) after intervention. For the control site, there were significant differences in the age (*P* = 0.039) and the Morse fall scale (*P* < 0.001) in the postintervention when compared with the pre-intervention phase. The mean age was older (59.1 versus 62.9) and the mean MFS score (20.7 versus 30.3) showed a slightly higher risk post-intervention. To answer the primary research question of whether a reduction in restraint rates had been attained in the post-intervention period, the prevalence of restraint was calculated. In the control site, the overall restraint rate (including both intermittent and continuous) significantly increased from 2.6 to 8.3% (*P* < 0.000). Both intermittent and continuous use of restraint were significantly increased in the postintervention period, with intermittent restraint use increasing from 0.2 to 3.3% (*P* < 0.001) and continuous restraint use increasing from 2.4 to 5% (*P* < 0.001) ([Table 3](#)). In the study site, there was no significant difference in the overall restraint rate between the pre- and postintervention periods although the overall restraint rate had a slightly upward trend from 11.5% to 13.6% (*P* = 0.405) postintervention. There was a significant increase in the use of intermittent restraint, from 0.7 to 5.1% (*P* < 0.001), but a significant decrease of continuous restraint from 10.8 to 8.5% (*P* < 0.001) ([Table 3](#)) was also recorded. We analyzed the subsample recruited into the RRC (those complex cases who were brought to the multidisciplinary team for discussion about their progress). In this subsample, we found that there was a significant increase of patients with their restraints taken off after RRC conference (0% versus 18.2%, *P* = 0.014). There was an insignificant but slight increase of intermittent restraint (from 14.5% to 18.2%, *P* = 0.317), and there was a significant decrease of continuous restraint after RRC conference (from 85.5% to 63.6%, *P* = 0.009). These data provided further evidence that there was a positive direction of changes in practice in the intervention site. There was a significant increase in the use of bedrails and lap tables and a significant decrease in the use of waist belts and jackets after intervention in the control site. The bed rail was the most common type of restraint (61.9%), followed by the jacket restraint and waist belt (both at 14.3%), with lap tables as the least common (9.5%) after intervention. In the study site, there was a decrease in the use of lap tables (from 48.0% to 39.2%) after intervention, but at the same time, there was an increase in the use of bed rails (43.3% to 51.8%) at the study site ([Table 2(b)](#)). Bed rail was the most common type of restraint, followed by lap table (39.2%) and jacket restraint (8.6%) in the postintervention period. Because any increase or decrease in physical restraint use may imply a concomitant change in the use of chemical restraint, the subjects' use of psychotropic medications were also examined. No significant differences were found in the use of psychotropic medications in the study site (*P* = 0.346) and the control site (*P* = 0.075) comparing pre- and postintervention data. Both sites had a low rate in the use of psychotropic drugs to begin with and remained as such after intervention. In the study site, only 3.3% of the subjects were prescribed psychotropic medications before intervention, and 2.3% were prescribed psychotropic drugs after intervention. In the control site, 2% of the subjects were on psychotropic medications, and none were prescribed (0%) after intervention. The staff profiles were examined to see if there might be the possibility of impacting on the study outcomes. In the intervention site, the staff response rate in the preintervention survey was 82.2% (*N* = 97) and 77.4% after intervention (*N* = 89). No significant differences were found in their gender (*P* = 0.535), years of clinical experience (*P* = 0.684), with or without on-the-job training about restraint use (*P* = 0.179) pre- and post-intervention. Also, no significant differences were found in terms of knowledge (*P* = 0.147), attitude (*P* = 0.071), and practice (*P* = 0.139) before and after intervention using Janelli et al.'s (1991) validated questionnaire. When further analysis were conducted, a subsample of nurses (of one unit) were found to have better knowledge after intervention (mean score results: 5.51 versus 6.23, *P* = 0.04). In the control site, the staff response rate before intervention was 51.5% (*N* = 17) and 77.8% after intervention (*N* = 28). No significant differences were found in their gender (*P* = 0.431), years of clinical experience (*P* = 0.516), and with or without on the job training about restraint use (*P* = 0.948). Moreover, no significant differences were found in terms of knowledge (*P* = 0.436) and attitude (*P* = 0.498). There was, however, a significant decrease in their practice score (from 38.41 to 36.43, *P* = 0.048). The problematic practice behaviors included item C7 (I tell family members why the patient is being restrained), C8 (I explain to the patient why the restraint is being applied), and C9 (I tell the patient when the restraint will be removed). When comparing nursing staff samples of between the study and control sites, there were no significant differences observed in their gender distribution (before intervention: *P* = 0.279 and after intervention: *P* = 0.348), years of clinical experience (before intervention: *P* = 0.369; after intervention: *P* = 0.055), and with or without on the job training about restraint use (before intervention: *P* = 0.153; after intervention: *P* = 0.176). No significant differences were found in terms of knowledge (*P* = 0.230) and attitude (*P* = 0.986). However, there was a significant difference in their mean practice score (38.41 versus 36.43, *P* = 0.037), with the control site having relatively poorer scores. ::::table-wrap

::: caption
(a) Sample profile before intervention (I)
:::

```
                 Nonrestrained            Restrained                                                                                 
```

______________________________________________________________________

Mean/SD Study site (*n* = 270) Control site (*n* = 142) *P*-value\* Study site (*n* = 128) Control site (*n* = 6) *P*-value\*
Age 74.18/10.88 54.69/17.36 \<0.001 78.03/9.88 69.67/14.43 0.16
MMSE 18.64/6.45 25.66/4.96 \<0.001 12.71/6.39 18.50/7.82 0.053
MBI 14.30/5.00 15.23/3.08 0.69 9.23/5.05 11.33/3.98 0.221
Morse Fall Scale 29.98/16.80 20.77/15.37 \<0.001 31.05/17.85 20.00/18.71 0.085

MMSE: Mini-Mental State Examination; MBI: Morse Fall Scale.:::: ::::table-wrap
::: caption
(b) Sample profile before intervention (II)
:::

______________________________________________________________________

```
                                     Nonrestrained            Restrained                                                                                 
                            %       Study site (*n* = 270)   Control site (*n* = 142)   *P*-value*   Study site (*n* = 128)   Control site (*n* = 6)   *P*-value*
```

Gender M 52.6 40.1 0.016 33.6 83.3 0.013
F 47.4 59.9 66.4 16.7\
Psychoactive drug Yes 1.9 2.1 0.855 6.3 0 0.528
No 98.1 97.9 93.8 100\
Vision Normal 39.6 43 0.514 38.3 33.3 0.807
Impaired 60.4 57 61.7 66.7\
Hearing Normal 84.1 88.7 0.2 80.8 83.3 0.862
Impaired 15.9 11.3 19.2 16.7\
History of fall in hospital Yes 99.3 95.1 0.006 100 100 N/A
No 0.7 4.9 0 0\
----------------------------- -------- ------------------------ -------------------------- ------------- ------------------------ ------------------------ -------------:::: ::::table-wrap
::: caption
(a) Sample profile of study and control sites (I)
:::

```
                                                                              Age              No. of diagnoses   MMSE           MBI                Morse fall scale
```

______________________________________________________________________

Intervention site Preintervention phase *n* = 398 Mean ± SD 75.42 ± 10.71 3.05 ± 1.45^a^ 16.74 ± 7.00 12.67 ± 5.54 30.33 ± 17.13
Median/range 77/31--100 3/1--7 17/0--30 13/0--20 25/0--80\
Postintervention phase *n* = 612 Mean ± SD 74.80 ± 10.57 3.15 ± 1.50^b^ 16.42 ± 7.15 11.99 ± 5.12 31.54 ± 17.13^a^\
Median/range 76/23--98 3/1--9 16/0--30 13/0--20 25/0--90\
*P*\* 0.200 0.286 0.375 0.016 0.239\
Control site Preintervention phase *n* = 148 Mean ± SD 59.14 ± 17.35 1.80 ± 1.159 25.37 ± 5.26 15.07 ± 3.20 20.74 ± 15.45
Median/range 64/17--88 1/1--7 27/0--30 15/4--20 15/0--80\
Postintervention phase *n* = 155 Mean ± SD 62.90 ± 17.73^c^ 1.93 ± 1.21 24.39 ± 6.53 15.07 ± 3.41 30.26 ± 16.91\
Median/range 67/15--93 2/1--7 27/4--30 16/3--20 25/0--75\
*P*\* 0.039 0.284 0.583 0.485 \<.001

MMSE: Mini-Mental State Examination; MBI: Morse Fall Scale.

\*Mann-Whitney *U* test, significant at 0.05.

^a^One missing subject.

^b^Three missing subjects.

^c^One missing subject.:::: ::::table-wrap
::: caption
(b) Sample profile of study and control sites (II)
:::

______________________________________________________________________

```
                            Study site            Control site                                                                                                      
                            Before intervention   After intervention   (*X^2^*)    Before intervention   After intervention   (*X^2^*)                              
                            *n* = 398             %                   *n* = 612   %                    *P*-value            *n* = 148   %     *n* = 155   %     *P*-value
```

Gender\
M  185 46.5 300 49 0.43 62 41.9 54 34.8 0.207
F 213 53.5 312 51 86 58.1 101 65.2\
Psychoactive drug\
Yes 13 3.3 14 2.3 0.346 3 2 0 0 0.075
No 385 96.7 598 97.7 145 98 155 100\
Vision\
Normal  156 39.2 308 51. 2 \<0.001 63 42.6 68 43.9 0.819
Impaired  242 60.8 293 48.8 85 57.4 87 56.1\
Hearing\
Normal 330 82.9 502 83.5 0.729 131 88.5 132 85.2 0.389
Impaired 68 17.1 99 16.5 17 11.5 23 14.8\
Restraint status\
Never^a^  270 67.8 309 50.5 \<0.001 142 95.9 134 86.5 0.01
Intermittent^b^ 36 9 147 24 4 2.7 9 5.8\
Continuous^c^ 92 23.1 152 24.8 2 1.4 12 7.7\
Type of restraint\
Lap table 61 48 118 39.2 0.334 0 0 2 9.5 0.008
Vest 11 8.7 26 8.6 1 16.7 3 14.3\
Wrist 0 0 1 0.3   --- --- --- ---\
Pelvic belt --- --- --- --- 2 33.3 0 0\
Waist belt --- --- --- ---   2 33.3 3 14.3\
Mittens --- --- --- --- 1 16.7 0 0\
Others (bed rails) 55 43.3 156 51.8 0 0 13 61.9\
History of fall in hospital\
Yes 2 0.5 6 1 0.402 7 4.7 10 6.5 0.515
No 396 99.5 606 99 141 95.3 145 93.5

______________________________________________________________________

*P*-values: a versus b in Control site: \<0.001, b versus c: \<0.001, a
versus c: \<0.001.

*P*-values: a versus b in Study site: \<0.001, b versus c: \<0.001, a
versus c: 0.013.:::: ::::table-wrap
::: caption
Comparison of the pre- and postintervention restraint rates in the study
and control sites.
:::

```
                       Study site              Control site                                                                                     
```

______________________________________________________________________

```
                       Preintervention phase   Postintervention phase                          Preintervention phase   Postintervention phase   
                       *n* = 463               *n* = 562                *P*-value (*t*-test)   *n* = 305               *n* = 310                *P*-value (*t*-test)
                       M (%) ± SD              M (%) ± SD                                      M (%) ± SD              M (%) ± SD               
```

Intermittent restraint\
A/D 0.6 ± 0.02 7.1 ± 0.08 \<0.001 0.4 ± 0.01 6.3 ± 0.05 \<0.001
P/D   0.7 ± 0.02 3.7 ± 0.05 \<0.001\
N   1.0 ± 0.02 2.8 ± 0.04 \<0.001 0.0 ± 0.00 0.4 ± 0.02 0.019
Overall    0.7 ± 0.02 5.1 ± 0.07 \<0.001 0.2 ± 0.01 3.3 ± 0.05 \<0.001
Continuous restraint\
A 10.7 ± 0.12 8.3 ± 0.07 0.001 4.2 ± 0.03 6.6 ± 0.05 \<0.001
P  11.6 ± 0.15 7.6 ± 0.07 \<0.001\
N   10.0 ± 0.12 10.5 ± 0.07 0.592 0.6 ± 0.02 3.5 ± 0.03 \<0.001
Overall 10.8 ± 0.13 8.5 ± 0.07 \<0.001 2.4 ± 0.03 5.0 ± 0.05 \<0.001

A/D: am shift for Study site; or day shift for Control site.

P/D: pm-shift for Study site; or day-shift for Control site.

N: night-shift.

*n*: number of shifts.

\*restraint rate: the number of patients being restrained/the total
number of patients in the ward per shift.::::


Extracted trial result:
Outcome: Restraint frecuency (continuous)
Intervention: After restraint reduction program
Comparator: Before restraint reduction program
Intervention group size: 562
Intervention mean: 13.6
Intervention standard deviation: 0.07
Comparator group size: 463
Comparator mean: 11.5
Comparator standard deviation: 0.13
Notes: Added intermittent and continuous numbers from study site