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
Funded by NIH R01 AG019715
INTRODUCTION
• 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.
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
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
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
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.
Variables (continued)
• Patient Consequences: Adverse events as direct
consequence of TD (e.g., hemorrhage)
• Staff Consequences: Unprotected exposure to
body fluids, violence or physical harm.
• Resource Consequences: Additional resources
(procedures, therapies) as direct consequence of
the therapy disruption
DATA COLLECTION
PROCEDURES
• 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.
RESULTS
• ICU Profile: 49 ICUs: size 8 – 42 beds:
26 General, 12 MICUs, 11 SICUs
• Number of Patient-Days:
49,482
Unit range: 172 – 2,155 patient-days
Rates of TD Episodes and Devices
• # patient episodes with one or more TDs: 1,097
TD episode rate: 22.1 episodes/1000 days (0 to 102.4)
• Rates by ICUs:
- General = 23.6
MICU = 23.4
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
General = 33.1
Surgical = 26.0
Correlation of Unit-Level Risk Factors
with Unit-Level TD Rate
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
95% CI
- 0.51 to 0.02
- 0.37 to 0.19
- 0.37 to 0.20
- 0.28 to 0.29
Patient Factors At Time of the Disruption
(N = 1,097)
•
•
•
•
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)
• Medications 24 hours prior:
–
–
–
–
Narcotic
43%
Benzodiazepine
34%
Neuroleptic
14%
Neuromuscular blocking agent 1.6%
– Any of above:
70%
Percentage of episodes
Most Frequently Disrupted Devices
(N = 1097 episodes)
30
25
20
15
10
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Percentage of Devices
Device Restart Rates (> 40%)
100
80
60
40
20
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Patient Consequences:
Harm as Direct Result of Disruption (N = 1,097)
• None noted:
• Minor:
77.2%
15.9%
– No therapy or treatments required (bruising)
• Moderate:
6.0%
– Requires therapy, but harm not life threatening (e.g.,
sutures)
• Major:
0.9%
– Major medical/surgical procedures (e.g., blood
transfusions)
• Deaths:
-0-
Staff Consequences
• Unprotected exposure to blood/body fluids
74 ( 7%)
• Experienced violence (hitting, kicking, etc)
30 ( 3%)
• Physically injured
15 ( 1%)
Additional Treatment/ Resources
•
•
•
•
•
•
•
•
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