INTRODUCTION
Therapy Disruptions and Physical
Restraints in ICU Settings:
Implications for Quality Initiatives
Lorraine C. Mion, PhD, RN, FAAN
Ann F. Minnick, PhD, RN, FAAN
Rosanne Leipzig, MD, PhD
Cathy Catrambone, DNSc, RN
Mary E. Johnson, PhD, RN
• JCAHO, CMS, and FDA minimize use of physical
restraint in patient care.
• NQF: restraint is a nurse sensitive quality indicator.
• Majority of physical restraint use in hospitals is in
critical care.
• ICU RNs & MDs use physical restraint to prevent
patient-initiated therapy disruption of medical
devices; less often to keep from falling out of bed.
Funded by NIH R01 AG019715
INTRODUCTION
• Few studies have examined rate, contexts or
consequences of therapy disruption and/or
association with physical restraint.
• Society of Critical Care Medicine: more
knowledge is needed to enable an evaluation
of risk-to-benefit ratio of restraining versus
nonrestraining interventions in ICUs
METHODS
• Design: Prospective prevalence
• Settings: 49 adult ICUs from 39 hospitals
selected at random from 6 geographic areas of
U.S; average daily census > 99
–
–
–
–
–
–
Texas
New York
Illinois
Colorado
Ohio
Arizona
OBJECTIVES
• To describe the rate and contexts related to
TD in ICUs
• To examine factors associated with TD
rates in ICUs
• To describe the consequences of ICU TD to
patient and staff
Variables
• Outcome Variable:
disruption
Types and rate of therapy
– Rate = (# therapy disruption episodes/total patient days) x
1000.
• Unit-Level Contextual Variables: Census,
proportion of days: men, physical restraint (excludes
side rails), ventilator, and elderly.
• Patient-Level Contextual Variables:
Demographics, cognition, sedating medications,
presence of restraint at time of disruption.
DATA COLLECTION
PROCEDURES
Variables (continued)
• Patient Consequences: Adverse events as direct
consequence of TD (e.g., hemorrhage)
• 2003 - 2005
• Trained ICU RNs, daily rounds
• Therapy disruption ascertainment
– nurse initiated reporting card
– daily interview with nurses
– chart abstraction.
• Chart abstraction to describe disruption
episode, patient contextual variables, and
consequences.
• Staff Consequences: Unprotected exposure to
body fluids, violence or physical harm.
• Resource Consequences: Additional resources
(procedures, therapies) as direct consequence of
the therapy disruption
Rates of TD Episodes and Devices
RESULTS
• # patient episodes with one or more TDs: 1,097
TD episode rate: 22.1 episodes/1000 days (0 to 102.4)
• Rates by ICUs:
• ICU Profile: 49 ICUs: size 8 – 42 beds:
26 General, 12 MICUs, 11 SICUs
- General = 23.6
• Number of Patient-Days:
49,482
Unit range: 172 – 2,155 patient-days
- 0.51 to 0.02
- 0.37 to 0.19
- 0.37 to 0.20
- 0.28 to 0.29
General = 33.1
Surgical = 26.0
Patient Factors At Time of the Disruption
(N = 1,097)
Correlation of Unit-Level Risk Factors
with Unit-Level TD Rate
95% CI
Surgical = 16.1
• # devices terminated/disrupted: 1,638
• TD device rate: 33.1 devices/1000 days (0 to 168.9)
• Rates by ICUs:
– MICU = 39.8
Variable
r-value
(Proportion of days accounted for by)
Ventilator:
r = - 0.26
Men:
r = - 0.10
Age 65+:
r = - 0.09
Restraints:
r = 0.01
MICU = 23.4
•
•
•
•
Age:
63.2 (± 17.7)
Range: 11 – 98 years
Men:
57%
Day shift:
46%
Restraint at the time: 45%
• Alertness/Cognition
– Lethargic
27%
– Agitated/anxious 58%
– Disoriented
54%
• Occurred with patient fall
1.7%
Patient Factors At Time of the Disruption
(N = 1,097)
Percentage of episodes
Most Frequently Disrupted Devices
(N = 1097 episodes)
• Medications 24 hours prior:
–
–
–
–
Narcotic
43%
Benzodiazepine
34%
Neuroleptic
14%
Neuromuscular blocking agent 1.6%
– Any of above:
25
20
15
10
5
0
NG
70%
Device Restart Rates (> 40%)
Percentage of Devices
30
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yg
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IV
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ET
Patient Consequences:
Harm as Direct Result of Disruption (N = 1,097)
100
• None noted:
• Minor:
80
60
77.2%
15.9%
– No therapy or treatments required (bruising)
• Moderate:
40
6.0%
– Requires therapy, but harm not life threatening (e.g.,
sutures)
20
• Major:
0
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en
Te xyg
O
IV
ley AP ing
Fo CP ress
D
NG ctio
a
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ET l Li
P
tr a
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• Deaths:
-0-
Additional Treatment/ Resources
Staff Consequences
• Unprotected exposure to blood/body fluids
74 ( 7%)
• Experienced violence (hitting, kicking, etc)
30 ( 3%)
• Physically injured
15 ( 1%)
0.9%
– Major medical/surgical procedures (e.g., blood
transfusions)
•
•
•
•
•
•
•
•
Additional/new restraints
Additional/new sedation
X-ray/imaging
Increased monitoring
Dressings
Consultations
Surgical procedure
Labs
320 (29%)
219 (20%)
140 (13%)
84 ( 8%)
69 ( 6%)
42 ( 4%)
38 ( 3%)
31 ( 3%)
CONCLUSIONS
• TD not rare but varies among units
• No significant relationship by proportion of
men, elderly, ventilator, or use of physical
restraint
• Most experience no harm, but clinically
significant number incur minor to moderate
harm and/or need device restarted
• Further study to examine patient- and unitrisk factors