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  • Measure Summary
  • NQMC:003500
  • Jan 2007

Bipolar disorder: the percentage of patients diagnosed with bipolar disorder and treated with lithium who have evidence of a lithium serum medication level with 12 weeks of beginning treatment.

STABLE (STAndards for BipoLar Excellence) performance measures. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. various p.

View the original measure documentation External Web Site Policy

This is the current release of the measure.

The measure developer reaffirmed the currency of this measure in September 2015.

Primary Measure Domain

Clinical Quality Measures: Process

Secondary Measure Domain

Does not apply to this measure

Description

This measure is used to assess the percentage of patients diagnosed with bipolar disorder and treated with lithium who have evidence of a lithium serum medication level within 12 weeks of beginning treatment.

Rationale

Side Effects of Lithium

  • Up to 75% of patients on lithium experience some side effects, but most are minor (polyuria; polydipsia, weight gain, cognitive problems, sedation or lethargy) and can be reduced or eliminated by dose adjustment or dosage schedule.
  • Tremor affects up to 65% of patients treated with lithium and a severe tremor may be a sign of toxicity. Nausea and diarrhea or blurred vision may also be side effects of toxicity.

Lithium Levels

  • Target lithium levels are generally 0.8-1.1 mmol/L.
  • Serum concentrations of 0.5 to 1.2 meq/L may be therapeutic according to individual patient response and side effects.
  • Patients can experience toxic effects with levels above 1.5 meq/L such as marked tremor, nausea and diarrhea, or blurred vision; levels above 2.0 meq/L have been associated with life-threatening side effects, such as neurotoxicity, delirium and encephalopathy.

Monitoring of Serum Lithium Levels

  • Lithium level monitoring is required due to the medication's narrow therapeutic index.
  • Check lithium level after initial dosage and after each dosage increase.
  • It is recommended to obtain serum levels approximately 5 days after a dosage adjustment as this is when the steady state is reached.
  • Long-term monitoring recommendations are to check every 3 to 6 months in patients with stable lithium levels and whenever the clinical status changes.

Evidence for Rationale

Freeman MP, Freeman SA. Lithium: clinical considerations in internal medicine. Am J Med. 2006 Jun;119(6):478-81. [70 references] PubMed External Web Site Policy

Practice guideline for the treatment of patients with bipolar disorder (revision). Am J Psychiatry. 2002 Apr;159(4 Suppl):1-50. [472 references] PubMed External Web Site Policy

Yatham LN, Kennedy SH, O'Donovan C, Parikh S, MacQueen G, McIntyre R, Sharma V, Silverstone P, Alda M, Baruch P, Beaulieu S, Daigneault A, Milev R, Young LT, Ravindran A, Schaffer A, Connolly M, Gorman CP. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: consensus and controversies. Bipolar Disord. 2005;7 Suppl 3:5-69. PubMed External Web Site Policy

Primary Health Components

Bipolar disorder; lithium serum level monitoring

Denominator Description

Patients diagnosed and treated for bipolar disorder with a lithium agent (see the related "Denominator Inclusions/Exclusions" field)

Numerator Description

Patients with a serum medication level within 12 weeks of beginning treatment with lithium (see the related "Numerator Inclusions/Exclusions" field)

Type of Evidence Supporting the Criterion of Quality for the Measure

  • A clinical practice guideline or other peer-reviewed synthesis of the clinical research evidence
  • A formal consensus procedure, involving experts in relevant clinical, methodological, public health and organizational sciences
  • One or more research studies published in a National Library of Medicine (NLM) indexed, peer-reviewed journal

Additional Information Supporting Need for the Measure

Unspecified

Extent of Measure Testing

  • The STABLE measures were developed using the RAND Appropriateness Method and have been shown to have content validity and face validity.
  • Data feasibility testing was performed to determine the availability of the data elements required in the measure numerator and denominator specifications.
  • Inter-abstractor reliability testing was performed to assess the data collection strategy. The data collection strategy included data collection forms; data dictionary references and abstractor instructions.
  • A field study was conducted to determine measure conformance in an appropriate convenience sample.

Refer to the references listed below for further information.

Evidence for Extent of Measure Testing

STABLE performance measures: data feasibility testing & results. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. 2 p.

STABLE performance measures: development process & validity ratings. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. 3 p.

STABLE performance measures: field study process & conformance findings. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. 3 p.

STABLE performance measures: inter-abstractor reliability testing & results. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. 2 p.

State of Use

Current routine use

Current Use

Internal quality improvement

Measurement Setting

Ambulatory/Office-based Care

Behavioral Health Care

Professionals Involved in Delivery of Health Services

Advanced Practice Nurses

Physicians

Psychologists/Non-physician Behavioral Health Clinicians

Least Aggregated Level of Services Delivery Addressed

Individual Clinicians or Public Health Professionals

Statement of Acceptable Minimum Sample Size

Unspecified

Target Population Age

Age greater than or equal to 18 years

Target Population Gender

Either male or female

National Quality Strategy Aim

Better Care

National Quality Strategy Priority

Making Care Safer
Prevention and Treatment of Leading Causes of Mortality

IOM Care Need

Getting Better

Living with Illness

IOM Domain

Effectiveness

Safety

Case Finding Period

Unspecified

Denominator Sampling Frame

Patients associated with provider

Denominator (Index) Event or Characteristic

Clinical Condition

Diagnostic Evaluation

Encounter

Patient/Individual (Consumer) Characteristic

Therapeutic Intervention

Denominator Time Window

Does not apply to this measure

Denominator Inclusions/Exclusions

Inclusions
Patients 18 years of age or older with an initial or new episode of bipolar disorder

AND

Documentation of a diagnosis involving bipolar disorder; to include at least one of the following:

  • Codes 296.0x; 296.1x; 296.4x; 296.5x; 296.6x; 296.7; 296.80; 296.81; 296.82; 296.89; 301.13 documented in body of chart, such as, a pre-printed form completed by a clinician and/or codes documented in chart notes/forms
  • Diagnosis or impression documented in chart indicating bipolar disorder
  • Use of a screening/assessment tool for bipolar disorder with a score or conclusion that patient has bipolar disorder and indication that this information is used to establish or substantiate the diagnosis

AND

Documentation of treatment with a lithium (lithium carbonate; lithium citrate)

Exclusions
Exclude case from denominator population if clinician requests patient to obtain serum lithium level but then subsequently documents that the patient failed to comply with clinician request.

Exclusions/Exceptions

Unspecified

Numerator Inclusions/Exclusions

Inclusions
Documentation of reference to serum blood levels in chart must include:

  • Documentation that serum blood levels were requested

AND

  • Results, or information about results, were obtained and placed/documented in the patient record

AND

Timeframe:
Documented results or narrative reference to results are recorded within 12 weeks of date of first order for lithium.

Exclusions
Unspecified

Numerator Search Strategy

Fixed time period or point in time

Data Source

Administrative clinical data

Paper medical record

Type of Health State

Does not apply to this measure

Instruments Used and/or Associated with the Measure

Unspecified

Measure Specifies Disaggregation

Does not apply to this measure

Scoring

Rate/Proportion

Interpretation of Score

Desired value is a higher score

Allowance for Patient or Population Factors

Unspecified

Standard of Comparison

Internal time comparison

Original Title

Bipolar disorder: monitoring lithium serum levels.

Measure Collection Name

Standards for Bipolar Excellence (STABLE) Performance Measures

Submitter

Center for Quality Assessment and Improvement in Mental Health - Clinical Specialty Collaboration

Developer

STABLE Project National Coordinating Council - Clinical Specialty Collaboration

Funding Source(s)

AstraZeneca LLP, Wilmington, Delaware, provided financial sponsorship for the STABLE Project. They did not otherwise participate in the development of either the measures or toolkit.

Composition of the Group that Developed the Measure

The STABLE National Coordinating Council (NCC) External Web Site Policy was comprised of national experts in bipolar disorder, psychiatry, primary care, and performance improvement. The NCC guided and directed the STABLE Project. NCC members agreed to serve with the understanding that the STABLE Performance Measures and Resource Toolkit would be fully transparent and available without cost in the public domain.

EPI-Q, Inc. External Web Site Policy, is a consulting company providing practice-based outcomes research, pharmacoeconomic studies, and quality improvement services. EPI-Q managed the STABLE Project.

Financial Disclosures/Other Potential Conflicts of Interest

Unspecified

Adaptation

This measure was not adapted from another source.

Date of Most Current Version in NQMC

2007 Jan

Measure Maintenance

Unspecified

Date of Next Anticipated Revision

Unspecified

Measure Status

This is the current release of the measure.

The measure developer reaffirmed the currency of this measure in September 2015.

Source(s)

STABLE (STAndards for BipoLar Excellence) performance measures. Boston (MA): Center for Quality Assessment and Improvement in Mental Health; 2007. various p.

Measure Availability

Source available from the Center for Quality Assessment and Improvement in Mental Health (CQAIMH) Web site External Web Site Policy.

For more information, contact CQAIMH at E-mail: cqaimh@cqaimh.org; Web site: cqaimh.org/index.html External Web Site Policy.

Companion Documents

The following is available:

NQMC Status

This NQMC summary was completed by ECRI Institute on January 10, 2008. The information was verified by the measure developer on April 14, 2008.

This NQMC summary was retrofitted into the new template on June 27, 2011.

The information was reaffirmed by the measure developer on September 30, 2015.

Copyright Statement

The STABLE materials published on this Web site are copyrighted by CQAIMH. They may be used for research, teaching, and quality measurement/improvement activities – provided the following:

  • The materials are not sold, distributed or licensed for commercial purposes.
  • CQAIMH's copyright is acknowledged in reproductions of these materials.
  • Modifications to the materials are not made without CQAIMH's permission.

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