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: Types and rate of therapy disruption –Rate = (# therapy disruption episodes/total patient days) x 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 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 = 39.8General = 33.1Surgical = 26.0

Correlation of Unit-Level Risk Factors with Unit-Level TD Rate Variabler-value95% CI (Proportion of days accounted for by) Ventilator: r = to 0.02 Men:r = to 0.19 Age 65+:r = to 0.20 Restraints:r = 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 –Lethargic27% –Agitated/anxious58% –Disoriented54% Occurred with patient fall 1.7%

Patient Factors At Time of the Disruption (N = 1,097) Medications 24 hours prior: –Narcotic43% –Benzodiazepine34% –Neuroleptic14% –Neuromuscular blocking agent 1.6% –Any of above:70%

Patient Consequences: Harm as Direct Result of Disruption (N = 1,097) None noted:77.2% Minor: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 restraints320 (29%) Additional/new sedation219 (20%) X-ray/imaging140 (13%) Increased monitoring 84 ( 8%) Dressings 69 ( 6%) Consultations 42 ( 4%) Surgical procedure 38 ( 3%) Labs 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 unit- risk factors