Spotlight Case May 2004

1
Spotlight Case May 2004

• Too Tight Control The Risks of Intensive
  Insulin Therapy

2
Source and Credits

• This presentation is based on the May 2004 AHRQ
  WebMM Spotlight Case in Medicine
• CME credit is available through the Web site
• See the full article at http//webmm.ahrq.gov
• Commentary by Haya Rubin, MD, PhD, The Johns
  Hopkins University Vera Fajtova, MD, Harvard
  Medical School
• Editor, AHRQ WebMM Robert Wachter, MD
• Spotlight Editor Tracy Minichiello, MD
• Managing Editor Erin Hartman, MS

3
Objectives

• At the conclusion of this educational activity,
  participants should be able to
• Appreciate the advantages and potential
  complications of intensive insulin therapy in the
  hospitalized patient
• List hospital-based safeguards available to
  prevent insulin-related hypoglycemia
• Understand the difference between efficacy and
  effectiveness with regards to results of clinical
  trials

4
Case Too Much of a Good Thing

• A 28-year-old man with insulin-dependent
  diabetes mellitus was admitted with hyperglycemia
  and an infected foot ulcer. Due to new hospital
  initiatives aimed at tighter glucose control, he
  was started on an insulin drip rather than
  subcutaneous (SQ) insulin. The patient
  eventually required 8 units of regular insulin
  per hour to maintain a fingerstick glucose in the
  180-220 mg/dL range.

5
Adverse Effects of Hyperglycemia

• Hyperglycemia gt 200 mg/dL is associated with more
  infections in patients undergoing clean surgery
• In vitro, ambient glucose gt 200 mg/dL reduces
  macrophage migration and phagocytosis

Pomposelli JJ, et al. J Parenter Enteral Nutr.
19982277-81 Rayfield EJ, et al. Am J Med.
198272439-50.
6
Intensive Insulin Therapy in the Critically Ill
Patient

• Wound infection rate decreased from 3 to 1
  using nurse-managed IV insulin protocol to keep
  blood glucose lt 200 mg/dL for 72 hours after
  heart surgery

Furnary AP, et al. Ann Thorac Surg.
199967352-62.
7
Intensive Insulin Therapy in the Critically Ill
Patient

• 1500 critically ill patients randomized to
• Intensive insulin therapy
• IV drip for BG gt 110 mg/dL, goal 80-110
• Traditional insulin therapy
• IV insulin reserved for BG gt 215 mg/dL
• Decreased morbidity and mortality in intensive
  insulin group

Van den Berghe G, et al. N Engl J Med.
20013451359-67.
8
Conventional vs. Intensive Therapy
Van den Berghe G, et al. N Engl J Med.
20013451359-67.
9
SQ Insulin for Non-Critically Ill Patients

• Physiologic control of glucose requires basal
  insulin and supplementation with fast-acting
  agent with meals
• New insulin analogs meet both basal and mealtime
  insulin needs
• Daily insulin Glargine for basal (no adjustment
  for NPO status)
• Insulin Aspart or Lispro with meals adjusted for
  nutritional intake

10
IV Insulin for Non-Critically Ill Patients

• IV intensive insulin therapy may result in more
  frequent hypoglycemia
• The use of intensive IV insulin has NOT been
  examined in the non-critically ill population

11
Case (cont.) Too Much of a Good Thing

• On hospital day 2, orthopedic surgery evaluated
  the patient and decided the wound needed surgical
  debridement. The orthopedic resident notified the
  cross-covering medicine resident that the patient
  would go to the OR the next day. In preparation
  for surgery, the orthopedic service made the
  patient NPO after midnight. At 2 am, when the
  nurse came to measure the hourly fingerstick, the
  patient was somnolent, tremulous, and
  diaphoretic, with a fingerstick glucose of 20
  mg/dL.

12
What Went Wrong?

• Communication breakdown
• Efficacy vs. Effectiveness

13
Communication Breakdown

• Orthopedic surgery wrote the NPO order medicine
  wrote the insulin drip order
• Having multiple providers write orders can result
  in errors and poor outcomes
• Delays in diagnosis or treatment
• Unnecessary or duplicative testing
• Potential role of hospitalist in streamlining
  order writing and communication

Pollack MM, et al. Crit Care Med. 2003311620-9
Wachter RM. Ann Int
Med. 1999130338-42.
14
Efficacy vs. Effectiveness

• Clinical trials often achieve lower rates of
  adverse events than seen in practice
• Patients rarely monitored as closely outside of
  trial
• Clinicians may apply therapy to patients excluded
  from trials
• Broadening inclusion criteria can lead to a
  lesser benefit in actual practice (effectiveness)
  than that seen in the trial (efficacy)

Katzan IL, et al. JAMA. 20002831151-8.
15
Intensive Insulin Therapy in the
Non-Critically-Ill Patient?

• Hypoglycemia is most common complication of any
  insulin therapy
• Oral intake in the perioperative population is
  variable increasing risk of hypoglycemia
• Clinical trials thus far have used strict
  protocols
• Broad use of intensive insulin therapy outside of
  intensive care setting requires safeguards be put
  in place

16
Improved Glycemic Control as a Quality
Improvement Measure

• Most quality improvement efforts focused on the
  underuse of effective therapies
• Institute for Healthcare Improvement suggests
  monitoring a single, central outcome to help make
  QI projects practical
• Must remember to consider the potential adverse
  effects of increased use and increase
  monitoring/surveillance accordingly

The Institute for Healthcare Improvement Web
site QualityHealthCare.org Web site.
17
Intensive Insulin Therapy in the
Non-Critically-Ill Patient

• Protocols should clearly outline
• Drip adjustment at specific blood glucose levels
• Alterations in rate and IV fluid type if patient
  is NPO
• Frequency of glucose monitoring

Lillis K. Health Manag Technol. 20032436-7
Bradley EH, et al. Jt Comm J Qual Saf.
200329409-15.
18
Potential Interventions to Improve Safety of
Intensive Insulin Therapy

• Automated order sets and preprinted order sheets
• Effective in reducing medication errors related
  to chemotherapy dosing
• Effective in ensuring appropriate therapy for
  myocardial infarction in emergency departments
• Where CPOE available, standard order sets for all
  patients with diabetes or with IV insulin drip
  ordered
• Automatic adjustments to drip and/or MD
  notification of change to NPO status (forcing
  function)

Lillis K. Health Manag Technol. 20032436-7
Bradley EH, et al. Jt Comm J Qual Saf.
200329409-15 Farbstein K, Clough J. Jt Comm J
Qual Improv. 200127123-37.
19
Case (cont.) Too Much of a Good Thing

• The patient was treated with 1 ampule of D50 and
  his insulin drip was held. He recovered
  completely from this event.

20
Take-Home Points

• Both IV and SQ insulin can be safe and effective
  in controlling blood glucose in hospitalized
  patients when standard protocols are followed
• Recent data support the practice of tighter
  control with IV insulin in the surgical ICU
• Unclear if these results generalize to patients
  outside of the ICU
• Safety in clinical trials differs from safety in
  practice

21
Take-Home Points

• Insulin drip protocols that have been tested
  should be implemented hospital-wide
• Various strategies (standard order sets, decision
  support, computerized forcing functions) can help
  prevent adverse events
• Quality improvement efforts that focus on tight
  control of physiologic parameters must
  incorporate efforts to monitor and prevent the
  most common adverse events of over-treatment