# Presentation: 102562

## Using Clinical Decision Support Systems to Measure and Improve Quality of Care for Special Populations:The Elderly in the Long-term Care Setting

**Jerry H. Gurwitz, M.D.**
**Executive Director**
**Meyers Primary Care Institute**
**Chief, Division of Geriatric Medicine**
**University of Massachusetts Medical School**
**Worcester, Massachusetts**

**Notes:**
Dr. Atkinson, Dr. Lietman, members of the Society, and guests.  I would like to express my appreciation for this truly special honor.  I would also like to give special thanks to Bill Abrams who I consider a mentor, a colleague, and a friend.  Over the years, Bill has been a major force in stimulating my interest in the field of Geriatric Clinical Pharmacology.  As much as any other single individual, Bill was responsible for the establishment of the Merck/AFAR Fellowship in Geriatric Clinical Pharmacology which I  had the opportunity to benefit from and which has supported the training of 18 young investigators since its inception in 1988.   As many of you are aware, the Society yesterday awarded the first William B. Abrams Award in Geriatric Clinical Pharmacology.  This award  will continue to honor Bill for many years to come.  I’d  like to take this opportunity to thank Bill for his boundless and unselfish efforts on behalf of our Society and on behalf of the field of Clinical Pharmacology.

This morning, I will be discussing the topic of Geriatric Pharmacotherapy and I’d like to begin with a quote from a major figure in the history of modern medicine-  William Withering.

## It is much easier to write upon a disease than upon a remedy.  The former is in the hands of nature and a faithful observer with an eye of tolerable judgement cannot fail to delineate a likeness.  The latter will ever be subject to the whim, the inaccuracies and the blunder of mankind.William Withering (1741-1799)

## Case Study

-    E.G. is an 85 year-old female nursing home resident with a history of atrial fibrillation, stroke, dementia, and hypertension, who is receiving chronic therapy with warfarin.  Her primary care provider has been dosing her warfarin to maintain her at an INR of 2.0.

## Case Study

-    One evening, a covering physician is called with a report that the patient has developed a fever.  The patient is initiated on empiric antibiotic therapy with cephalexin (500 mg po TID for 7 days) to treat a presumed urinary tract infection.

## Case Study

-    The next morning the primary care physician is called with the previous day’s INR, 1.75.  He increases the daily warfarin dose from 4 mg to 5 mg per day.  He is not notified of the cephalexin ordered the previous evening by the covering physician.

## Case Study

-    One week later, the INR comes back at 13.8 and a covering physician is notified.  That evening’s warfarin dose is held.  The INR the following day is 16.1.  The warfarin continues to be held.  No vitamin K is administered.

## Case Study

-    The very next day the patient develops congestion and shortness of breath.  A chest x-ray reveals an infiltrate and the covering physician orders Augmentin 875 mg po q12 hours for 10 days.  The next day the patient passes tarry stool and omeprazole is initiated.

## Case Study

-    The following morning the patient’s hematocrit is 25 and her INR is 11.3.  The primary care physician is notified, and vitamin K 10 mg sc is administered for 3 days with a decrease in the INR to 0.9.  The physician writes that warfarin will not be reinitiated because anticoagulation has been difficult to control for unclear reasons.

## The Prescribing Casade

-    B.F. is an 80 year-old female nursing home resident with a history of Parkinson’s Disease treated with long-term Sinemet therapy (25-100 TID).  She has suffered occasional hallucinations attributed to the Sinemet therapy, which have recently increased in frequency.  The hallucinations sometimes involve large animals and can be quite terrifying.

## The Prescribing Cascade

-    The resident is initiated on olanzapine 2.5 mg at bedtime.  Due to agitation and continued hallucinations, the olanzapine dose is increased to 5 mg and lorazepam 0.5 mg po q4 hours prn is added to the medication regimen.  The hallucinations continue and the evening dose of olanzapine is increased to 7.5 mg.

## The Prescribing Cascade

-    The resident is noted by the nursing staff to be shaky and stiff, but no change is made in the olanzapine dose.  She becomes increasingly lethargic.  She is described as rigid and stooped over with ambulation and begins to have more difficulty with activities of daily living including bathing, dressing, toileting, and tranferring.  She begins to require a wheelchair.

## The Prescribing Cascade

-    The resident’s functional decline is attributed to Parkinson’s Disease...

## Measuring the quality of prescribing to the elderly?

- The Beers list
- List of 33 drugs
- Drugs that should _*always be avoided*_
- Drugs that are _*rarely appropriate*_
- Drugs with _*some indications*_, but that are often misused

## 11 drugs that should always be avoided in the elderly:

- Barbiturates
- Chlorpropamide
- Flurazepam
- Meperidine
- Meprobamate
- Pentazocine

- Belladonna alkaloids
- Dicyclomine
- Hyoscyamine
- Propantheline
- Trimethobenzamide

- Zhan et al. *JAMA*  2001

## Use of “Always Avoid” Drugs

**Percent **

## The Incidence and Preventability of Adverse Drug Events in Two Large Academic Long-term Care Facilities

*Funded by AHRQ*

**Notes:**
So... we are studying adverse drug events as accidents that will help us to understand the system level problems on which we could intervene to improve medication safety for nursing home residents.

## Adverse Drug Events

**Medication Errors**

**Preventable**

## Methods

- Study conducted in two large academic long-term care facilities
- Total of 1229 beds
- Time period:  2000-2001

**Notes:**
Every six weeks, an investigator reviewed charts on all patients looking for:   changes in medications and discontinuations   specific medications which might be used to treat an ade   unusual lab values   changes in symptoms and events which might be linked to an ade - lethargy,
     confusion, bleeding, falls, GI problems   hospitalizations and ER visits
Log books left at each nursing station - very few events reported that way
Classification process -    no explicit rules       determining whether ADE
       required explicit link to drug             included rating of confidence on 6 point scale - only used those with             upper levels    assigning level of severity       range: fatal, life-threatening, serious, significant                  examples: neuropsych event - if oversedation significant, if                  delirium serious;  hemorrhaghic event - if a bleed wignificant, if                  required transfusion or hospitalization serious; falls always serious    determining preventability        range:  no error, definitely not preventable, probably not preventable                    probably preventable, definitely preventable
ex of preventable:  resident has a documented prior allergy to a drug; resident is given the drug and has an ADE - called “preventable” because allergy was known (even if not easily found in the chart)

## Methods

- 	Drug-related incidents were detected using multiple methods:
- Review of nursing home records in monthly segments
- Computer-generated signals

**Notes:**
Every six weeks, an investigator reviewed charts on all patients looking for:   changes in medications and discontinuations   specific medications which might be used to treat an ade   unusual lab values   changes in symptoms and events which might be linked to an ade - lethargy,
     confusion, bleeding, falls, GI problems   hospitalizations and ER visits
Log books left at each nursing station - very few events reported that way
Classification process -    no explicit rules       determining whether ADE
       required explicit link to drug             included rating of confidence on 6 point scale - only used those with             upper levels    assigning level of severity       range: fatal, life-threatening, serious, significant                  examples: neuropsych event - if oversedation significant, if                  delirium serious;  hemorrhaghic event - if a bleed wignificant, if                  required transfusion or hospitalization serious; falls always serious    determining preventability        range:  no error, definitely not preventable, probably not preventable                    probably preventable, definitely preventable
ex of preventable:  resident has a documented prior allergy to a drug; resident is given the drug and has an ADE - called “preventable” because allergy was known (even if not easily found in the chart)

## Computer Generated Signals

- Abnormal laboratory results
- Elevated INRs, high potassium levels
- Medications (antidotes)
- Vitamin K, sodium polystyrene sulfonate
- Abnormal drug levels
- Phenytoin
- Digoxin

**Notes:**
Every six weeks, an investigator reviewed charts on all patients looking for:   changes in medications and discontinuations   specific medications which might be used to treat an ade   unusual lab values   changes in symptoms and events which might be linked to an ade - lethargy,
     confusion, bleeding, falls, GI problems   hospitalizations and ER visits
Log books left at each nursing station - very few events reported that way
Classification process -    no explicit rules       determining whether ADE
       required explicit link to drug             included rating of confidence on 6 point scale - only used those with             upper levels    assigning level of severity       range: fatal, life-threatening, serious, significant                  examples: neuropsych event - if oversedation significant, if                  delirium serious;  hemorrhaghic event - if a bleed wignificant, if                  required transfusion or hospitalization serious; falls always serious    determining preventability        range:  no error, definitely not preventable, probably not preventable                    probably preventable, definitely preventable
ex of preventable:  resident has a documented prior allergy to a drug; resident is given the drug and has an ADE - called “preventable” because allergy was known (even if not easily found in the chart)

## Methods

- Chart reviews were performed by trained clinical pharmacist investigators
- Incidents were classified by two independent physician reviewers:
- adverse drug event
- severity
- preventability

**Notes:**
Every six weeks, an investigator reviewed charts on all patients looking for:   changes in medications and discontinuations   specific medications which might be used to treat an ade   unusual lab values   changes in symptoms and events which might be linked to an ade - lethargy,
     confusion, bleeding, falls, GI problems   hospitalizations and ER visits
Log books left at each nursing station - very few events reported that way
Classification process -    no explicit rules       determining whether ADE
       required explicit link to drug             included rating of confidence on 6 point scale - only used those with             upper levels    assigning level of severity       range: fatal, life-threatening, serious, significant                  examples: neuropsych event - if oversedation significant, if                  delirium serious;  hemorrhaghic event - if a bleed wignificant, if                  required transfusion or hospitalization serious; falls always serious    determining preventability        range:  no error, definitely not preventable, probably not preventable                    probably preventable, definitely preventable
ex of preventable:  resident has a documented prior allergy to a drug; resident is given the drug and has an ADE - called “preventable” because allergy was known (even if not easily found in the chart)

## Results - Event Rates

**Adverse drug events**
- Events: **815**
- Rate: 9.8 per 100 resident-months
**Preventable adverse drug events**
- Events: **338**
- Rate: 4.1 per 100 resident-months

**Notes:**
In other words,     if you have 100 residents, 2 events per monthApproximately half of the events we found were judged preventable - high rate

## Adverse Drug Events (n=815)Preventable vs Non-Preventable

## Adverse Drug Events by Severity(n=815)

| Category | Number | Percentage |
| --- | --- | --- |
| Fatal | 4 | <1% |
| Life-threatening | 33 | 4% |
| Serious | 188 | 23% |
| Less serious | 590 | 72% |

## Preventability of Adverse Drug Events

- Of fatal, life-threatening
- & serious events

- Of less serious events

**Preventable**
**61%**

**Preventable**
**34%**

**Notes:**
Focus on preventable events 
High percent of the more serious events were preventable
(Compare to only 43% in the hospital-based study)

## Error Stage for Preventable ADEs(n=338 preventable ADEs)

| Category | Number | Percentage |
| --- | --- | --- |
| Ordering | 198 | 59% |
| Dispensing | 16 | 5% |
| Administration | 43 | 13% |
| Monitoring | 271 | 80% |

## Drug Categories

- Warfarin	              12%
- Atypical antipsych       12%
- Loop diuretics              10%
- Benzos (intermediate)   9%
- Opioids                          8%
- ACE inhibitors               8%
- Other antidepressants   7%
- Antiplatelets                   7%
- Insulin                            5%
- Laxatives                       5%

**Preventable events**

**Notes:**
Comparing non-preventable to preventable events   Antipsychotic drugs involved in substantial proportion of both types   anti-infectives primarily involved in non-preventable   anticoagulants, antidepressants, and sedatives/hypnotics important       components of preventable events but involved in fewer of the non-       preventable

## Event Categories - Preventable

**Neuropsychiatric  **          	     29%
**Hemorrhagic**                               16%
- Gastrointestinal                           16%
**Renal/electrolytes**                        12%
- Fall with injury                                5%
- Cardiovascular                               4%
- Fall without injury		         3%
- EPS                                                2%
- Syncope/dizziness                         2%

**Notes:**
Examples:

Comparing non-preventable to preventable events   similar proportion of each included neuropsychiatric problems   dermatologic and infectious symptoms primarily in the non-preventable     events
   falls and hemoorhages more substantial proportion of the preventable events

## Guiding Principles for Quality Measures

- Compelling importance
- Clear relevance to improving care
- Parsimony
- Reasonable administrative burden

**Notes:**
Study
   establishes the extent and seriousness of the problem
   clarifies the potential for prevention
   lays the ground work for determining what directions needed in designing        interventions 
We believe this is a very conservative estimate - tip of the iceberg, because:    used medical record review - limits in quality of nursing home records   strictly information entered or reported by providers   high end homes   rigid about definition of ADE - had to be strong evidence linking symptoms     to drug

## Guiding Principles for Development of Quality Measures

***	******Is it possible to arrive at a set of measures that are of compelling importance and which have clear relevance to care, and that are also scientifically valid, usable, and feasible?***

**Notes:**
Study
   establishes the extent and seriousness of the problem
   clarifies the potential for prevention
   lays the ground work for determining what directions needed in designing        interventions 
We believe this is a very conservative estimate - tip of the iceberg, because:    used medical record review - limits in quality of nursing home records   strictly information entered or reported by providers   high end homes   rigid about definition of ADE - had to be strong evidence linking symptoms     to drug

## Translating Quality Measures into Clinical Decision Support

**Complexity**

**Validity**

**Drug**
**Data**

**Drugs & Dx’s**

**Drugs, Dx’s**
**& Labs**

**Drugs, Dx’s, Labs**
**& Clinical Info **

## CPOE with Clinical Decision Support at Baycrest Centre for Geriatric Care in Toronto, Ontario

## Slide 33

## Slide 34

## The Big Question

***	******Can the types of errors and events that I shared with you be captured with a set of quality measures that can guide the development of computerized clinical decision support systems in the long-term care setting?***

**Notes:**
Study
   establishes the extent and seriousness of the problem
   clarifies the potential for prevention
   lays the ground work for determining what directions needed in designing        interventions 
We believe this is a very conservative estimate - tip of the iceberg, because:    used medical record review - limits in quality of nursing home records   strictly information entered or reported by providers   high end homes   rigid about definition of ADE - had to be strong evidence linking symptoms     to drug

## Quality Indicators for Appropriate Medication Use in Older AdultsAssessing Care of Vulnerable Elders (ACOVE)

- Warfarin:  INR should be monitored using standardized protocols
- Loop diuretics:  Check electrolytes within 1 week and at least annually
- Avoid chlorpropamide
- Avoid drugs with strong anticholinergic properties
- Avoid barbiturates
- Avoid meperidine
- ACE inhibitors:  Monitor renal function and potassium in patients on ACE inhibitors

**Notes:**
Study
   establishes the extent and seriousness of the problem
   clarifies the potential for prevention
   lays the ground work for determining what directions needed in designing        interventions 
We believe this is a very conservative estimate - tip of the iceberg, because:    used medical record review - limits in quality of nursing home records   strictly information entered or reported by providers   high end homes   rigid about definition of ADE - had to be strong evidence linking symptoms     to drug

## Quality Indicators for Appropriate Medication Use in Older AdultsAssessing Care of Vulnerable Elders (ACOVE)

- Document the indication for a new drug therapy
- Educate patients on the benefits and risks
- Maintain a current medication list
- Document response to therapy
- Periodically review ongoing need for therapy

**Notes:**
Study
   establishes the extent and seriousness of the problem
   clarifies the potential for prevention
   lays the ground work for determining what directions needed in designing        interventions 
We believe this is a very conservative estimate - tip of the iceberg, because:    used medical record review - limits in quality of nursing home records   strictly information entered or reported by providers   high end homes   rigid about definition of ADE - had to be strong evidence linking symptoms     to drug

## The Prescribing Cascade

**Drug 1**

**ADE**

**Drug 2**

**Notes:**
This figure describes THE PRESCRIBING CASCADE:  DRUG 1 CAUSES AN ADVERSE DRUG REACTION (ADR) THAT LEADS TO THE PRESCRIPTION OF DRUG 2.  As a general priniciple, the prescription of drugs solely for the purpose of treating drug side effects should be avoided  in elderly patients.  Now I can be convinced that in some rare circumstances, after a careful evaluation of the benefits vs the risks of the offending agent, an appropriate decision could be made by the prescriber to continue DRUG 1 and prescribe DRUG 2 to treat DRUG 1’s side effects.  However, what worries me is when little if any thought is given before prescribing DRUG 2 - no consideration of the absolute need for DRUG 1, no consideration of the possiblity of a reduction in dose, no consideration of an alternative therapy that may have a lower risk of adverse effects.   Most disturbing of all would be the prescription of DRUG 2 without recognition that the condition being treated is an adverse drug reaction.   The obvious worry for the elderly is that drug-induced symptoms might be misinterpreted as indicating the presence of a new disease or incorrectly attributed to the aging process  itself.

## DRUG 2

**DRUG 2**

** ****=**

**PROXY FOR ****ADE**

**Notes:**
A fundamental assumption underlying this work is that DRUG 2 can serve as a reasonable proxy or marker for an adverse drug reaction in the absence of any additional clinical information about the patient.

Slide (New Jersey):  Since the 1980s, we have used the state of New Jersey as our laboratory for performing much of this work. 

## Case-Control Study Design

**Drug Exposure:**
**Yes or No?**

**Drug Exposure:**
**Yes or No?**

**BEGIN**

**Cases**
**(ADE)**

**Controls**

**CLASSIFY/COMPARE**

**Notes:**
We use Medicaid data to perform observational studies.  We employ traditional epidemiologic methods - primarily case-control and cohort study designs.  This figure describes the case-control study design.  In this type of study, we actually begin at the end with people who have experienced a particular outcome of interest - these are the cases.  In our studies, cases are defined by the use of a drug that we believe to be a proxy or marker for an adverse drug reaction or ADR.  We also identify controls who are not receiving this particular drug treatment.  Then we search back into the past of the cases and controls for another drug exposure that might be related to the adverse drug reaction.

## The Prescribing Cascade

**Metoclopramide**

**Extrapyramidal Effects**

**Levodopa Rx**

**Notes:**
Let me give you some specific examples.  The first study involves the drug metoclopramide.  Since metoclopramide first became available as a gastric motility agent, there have been numerous reports in the literature of unwanted extrapyramidal side effects including drug-induced parkinsonian symptoms.  Idiopathic Parkinson’s Disease is certainly seen with greater frequency in older patients.  However, it would be very problematic if drug-induced parkinsonian symptoms were  misinterpreted as Parkinson’s Disease.  Levodopa therapy is relatively specific to the treatment of idiopathic Parkinson’s Disease.  So, in this study we employed levodopa therapy as a proxy for the occurence of this event.

## Case-Control Study Design

**Metoclopramide:**
**Yes or No?**

**Metoclopramide:**
**Yes or No?**

**BEGIN**

**L-dopa**
**Rx**

**Controls**

**CLASSIFY/COMPARE**

## Results

- Metoclopramide users were over three times more likely to begin use  of  L-dopa therapy compared with non-users (OR=3.09; 95% CI 2.25 to 4.26).

**Notes:**
Our results - We found that metoclopramide users were over three times more likely to begin levodopa therapy as compared with non-users of metoclopramide.

## Likelihood of L-dopa Treatment by Metoclopramide Dose

**Notes:**
Furthermore, we observed a clear dose-response relationship.  We found that the risk increased dramatically with increasing daily dose of metoclopramide.  In this figure, daily dose of metoclopramide is on the horizontal axis.  Risk for the initiation of levodopa therapy is on the vertical.  Those patients treated with more than 20 mg of metoclopramide per day had a risk of being initiated on levodopa therapy that was 5.3 times greater than patients not using this medication.  Keep in mind that metoclopramide’s labeling indicates that it can be prescribed in a dosage of up to 60 mg per day.

## Conclusion

- Metoclopramide confers an increased risk for the initiation of treatment generally reserved for the managment of idiopathic Parkinson’s disease.

**Notes:**
In summary, we found that metoclopramide use confers an increased risk for the initiation of a treatment generally reserved for the management of idiopathic Parkinson’s Disease.  Such polypharmacy may represent the misdiagnosis of Parkinson’s Disease in older patients suffering drug-induced parkinsonian symptoms.

## The Prescribing Cascade

**Drug 1**

**ADE**

**Drug 2**

**Notes:**
This figure describes THE PRESCRIBING CASCADE:  DRUG 1 CAUSES AN ADVERSE DRUG REACTION (ADR) THAT LEADS TO THE PRESCRIPTION OF DRUG 2.  As a general priniciple, the prescription of drugs solely for the purpose of treating drug side effects should be avoided  in elderly patients.  Now I can be convinced that in some rare circumstances, after a careful evaluation of the benefits vs the risks of the offending agent, an appropriate decision could be made by the prescriber to continue DRUG 1 and prescribe DRUG 2 to treat DRUG 1’s side effects.  However, what worries me is when little if any thought is given before prescribing DRUG 2 - no consideration of the absolute need for DRUG 1, no consideration of the possiblity of a reduction in dose, no consideration of an alternative therapy that may have a lower risk of adverse effects.   Most disturbing of all would be the prescription of DRUG 2 without recognition that the condition being treated is an adverse drug reaction.   The obvious worry for the elderly is that drug-induced symptoms might be misinterpreted as indicating the presence of a new disease or incorrectly attributed to the aging process  itself.