1

Eric MacLaughlin, Pharm.D., FCCP, BCPS Professor and Division Head of Adult Medicine,

Department of Pharmacy Practice Professor, Departments of Family and Internal Medicine

Planning to Demonstrate the Value of Your Clinical

Activities

Learning objectives •  Describe rationale (plural) for documenting

clinical activities •  Identify efficient/useful tools for documentation •  Apply relevant policies and procedures for

collecting and presenting clinical data •  Develop indicators that demonstrate clinical

acumen tailored to your practice site •  Describe documentation strategies that justify

your services

Quote on Documentation

“The palest ink is better than the sharpest memory.” - Chinese Proverb Describe the rationale

(plural) for documenting clinical activities

Documentation perspectives

Practice Site

Patient Care

School

Patient care documentation •  Accepted method for communication •  Plan patient care •  Demonstrate value •  Basis for financial reimbursement •  Legal/risk management •  Key in accreditation process •  Integral part of healthcare team

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Practice site

“Price is what you pay. Value is what you get.”

- Warren Buffet

Practice site perspectives •  Practice plans

– Contract for clinical services

•  Justification of costs/salary – Pharmacy budget savings – Health systems savings

Reducing drug costs •  I.V. product waste •  Medication utilization management

– Therapeutic interchange –  IV to PO switches – Medication-use evaluation

•  Formulary management – Formulary vs. non-formulary drug use – Drug restriction

•  Antibiotic stewardship ASHP Expert Panel on Medication Cost Management. Am J Health-Syst Pharm. 2008;65:1368-84.

Example economic studies Study Methods Intervention Outcome(s) Mutnick et al. 1997

Cost-benefit analysis of 4050 interventions in acute care hospital over 10 mo.

Optimized therapy (e.g., DI; kinetics consult, adjusted doses, TDM)

$464,833 estimate savings; extrapolated to $557,00/yr; ↓ of 372 days in LOS

Leape et al. 1999

Cost effectiveness/benefit analysis of 362 interventions, 125 pts

Attended rounds, consulted with focus on preventing prescribing errors

58 ADEs prevented; $270,000 savings/yr.

Van den Bemt et al. 2002

Cost-benefit analysis of 351 interventions; 1 teaching and 1 general hospital (Netherlands)

Reviewed Rx with focus on avoiding errors

Extrapolated savings of $432,830/yr; prevention of 18,252 errors

Adapted from: DeRijdt et al. Am J Health-Syst Pharm. 2008; 65:1161-72.

Practice site perspective: accreditation and quality

•  The Joint Commission –  Core Measures –  National Patient Safety Goals (NPSG)

•  Healthcare Effectiveness Data and Information Set (HEDIS)

–  Developed by National Committee for Quality Assurance (NCQA)

–  90% of health plans utilize –  Measures performance of care and service

The Joint Commission: http://www.jointcommission.org/ HEDIS & Quality Management: http://www.ncqa.org/tabid/59/Default.aspx

Practice site perspective: student clerkship justification

•  Time commitment •  Resources needed •  Paid vs. unpaid sites •  Staff continuing professional development •  Project/service development •  Patient care value/services •  Recruitment tool

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School perspective

School perspective

•  Varies depending on distribution of effort – Research, teaching, and/or practice focused?

•  Demonstration of clinical skills

– Administration interactions with practice site – Performance review – Promotion consideration

Promotion guidelines “Faculty on the non-tenure track, seeking advancement and promotion, are expected to demonstrate excellence in at least one of the three areas of: teaching, pharmacy practice, or administrative service; and proficiency in the other assigned performance areas….”

- TTUHSC Promotion Guidelines

“Appointment at the rank of associate professor (clinical-teaching track) requires clear and demonstrable evidence that the candidate, by independent effort, has developed a program of teaching, scholarly work, and clinical practice.”

- UCD Promotion Guidelines

Identify efficient and useful tools to document clinical

activities

•  Identify primary reasons for documentation Step 1:

•  Identify outcomes you plan to collect Step 2:

•  Select system(s) for data collection Step 3:

•  Determine how to present your data Step 4:

•  Identify primary reasons for documentation Step 1:

•  Meet time requirements of your position •  Have an impact on pharmacy budget •  Practice consistent with departmental goals •  Improve medication safety •  Improve care of patients

What do you want to show?

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Examples •  Second-year faculty

member preparing documentation of practice for annual review (and ultimately promotion)

•  Mid-level faculty

member demonstrating advancement of practice

•  Clinical specialist preparing to implement a new service or practice model

•  Pharmacist wanting to

justify continued services with an institution based upon contractual relationship

•  Identify outcomes you plan to collect Step 2:

•  Fundamental outcomes •  Standard pharmacy / patient care

outcomes •  Unique outcomes based on your practice

and/or teaching model

BE CREATIVE!

What outcomes are relevant to your institution?

•  Revenue generation •  Cost reduction •  Regulatory / credentialing •  Quality of care •  Decreased utilization •  Patient outcomes

•  Select system(s) for data collection Step 3:

Based upon current needs, how would you describe your

“ideal” documentation system?

Documentation Structure

Input Data System Outputs

Documentation Structure

Input Data System Outputs

•  Ease of use •  Paper versus electronic •  Mobility •  Accessibility

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Documentation Structure

Input Data System Outputs

•  Integration •  Cost of system / service •  Adaptable / customizable

Documentation Structure

Input Data System Outputs

•  How are cost data assigned? •  Have the benefits of the system been

described in published data? •  Can you generate reports that

demonstrate your desired outcomes?

Example Commercial Systems •  Clinical Measures (Gold Standard)

•  Clinical Xpert™ Pharmacy Intervention (Thomson Reuters)

•  Quantifi® (Pharmacy One Source®)

http://www.goldstandard.com/product/pricing-analysis-cost-control/clinical-measures/ http://thomsonreuters.com/content/healthcare/pdf/products/clinical_xpert_pharmacy_intervention http://pharmacyonesource.com/applications/quantifi/

•  Determine how to present your data Step 4:

•  Organized and logical •  Selective - only present useful data •  Self-descriptive •  Presentation method should fit data type •  Picture is worth a thousand words •  Ensure data leads to correct conclusions

Bottom Line

•  Qualitative outcomes good, but insufficient by themselves

•  Quantitative outcomes (primarily cost / value) – Cost avoided – Better care for same cost –  Increased reimbursement – Decrease in utilization

Case AB is a new clinical faculty member at XYZ University School of Pharmacy. As part of this position, 50% of his effort is spent providing clinical pharmacy services for a general inpatient service, for which the university is compensated. He has been collecting data regarding his clinical interventions and summarized these in his annual report. He has also provided specific example interventions that document his clinical expertise. He has plans to publish this data.

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Intervention report Clinical Pharmacy Recommendations FY 2011

Dat

e

Age

Gen

der

Inte

rven

tion

Dx

Inte

rven

tion

Type

Des

crip

tion

of

Inte

rven

tion

Pres

crib

er

Acc

epte

d?

01/14/11 68 Male Heart failure

Drug Discontinuation

Patient has systolic heart failure (estimated LVEF 38%) and was on lisinopril and diltiazem. Recommended to D/C diltiazem per AHA/ACC guidelines.

Smith, David Yes

01/14/11 68 Male Heart failure

Recommend Initial Therapy

Recommended starting metoprolol succinate 12.5 mg daily in a patient with HF and LVD, and titrate Q 2 wks as tolerated to target dose of 200 mg daily.

Smith, David

No, MD clue-less

Reflection

•  List the strengths, weakness, opportunities, and threats (SWOT analysis) for this new faculty’s documentation plan.

•  What data should/should not be collected? •  Are there any legal or institutional policies

that he should follow?

Apply relevant policies and procedures for collecting and

presenting clinical data

Health Insurance Portability and Accountability Act (HIPAA)

•  National standard for protection of records •  Covers individually identifiable personal

(protected) health information (PHI) •  Patients may find how PHI used •  Sets boundaries on use/release of records •  Safeguards health care providers follow •  Patient’s right to examine/obtain copy of

records and request corrections http://www.hhs.gov/ocr/privacy/hipaa/faq/about/187.html

Identifiable vs. De-Identifiable •  Data explicitly linked to

individual •  Could reasonably allow

identification of individual

http://privacyruleandresearch.nih.gov/pr_08.asp

Is IRB approval required when collecting patient data?

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Quality improvement vs. research

•  Quality improvement (QI) –  Improve current practice –  Internal use only –  Action within standards of care

•  Research: –  Systematic investigation –  Research development, testing, and evaluation –  Contribute to generalizable knowledge –  Desire to publish/present results

Patient Safety, Quality Improvement: http://patientsafetyed.duhs.duke.edu/module_a/not_qi/research.html DHHS: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102.

Intervention to decrease catheter-related bloodstream infections in ICU

•  Study of checklists to reduce hospital-acquired blood stream infections in ICU

•  Quality improvement project •  Impressive results:

–  Infection rate per 1000-catheter days decreased from 7.7 at baseline to 1.4 at 18 mo (p<0.002)

–  1500 infection-related deaths prevented –  Prevented 80,000 hospitalization days –  Estimated savings of $175 million

Pronovost et al., N Engl J Med. 2006;355:2725-2732. Kuehn, BM. JAMA. 2008;299:1005-1006.

•  Department of Health and Human Services (DHHS) halted study

•  Ordered study sites to stop transmitting data •  Stated Johns Hopkins University IRB incorrectly

classified study as “exempt” •  All participating hospitals ordered to complete

IRB process

Pronovost et al., N Engl J Med. 2006;355:2725-2732. Kuehn, BM. JAMA. 2008;299:1005-1006.

General rules on research approval

•  QI projects used internally do not need IRB approval

•  Must involve human subjects and be generalizable

•  Know institutional rules

Get institutional approval if plan to present or publish results

Additional tips for confidentiality

•  Remove patient identifiers! •  Do not include provider names •  Know institutional policies

– Collect data? – What fields? – What can you report?

•  Keep data secure

Back to case

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Develop indicators that demonstrate clinical acumen tailored to your practice site

Anticoagulation example A Fib/Flutter,

39%

AVR, 6% MVR, 15%

DVT, 24%

TIA/Stroke, 5% CAD, 4% Other, 7%

Percentage (%) of Patients

Anticoagulation caseload

0

20

40

60

80

100

120

140

160

Jan Feb Mar Apr May June July Aug Sep Oct Nov

Num

ber o

f Pat

ient

s

Initial Follow-up

Anticoagulation performance

39%

62%

0

10

20

30

40

50

60

70

Prior to Service After Service

Perc

ent (

%) T

ime

in T

hera

peut

ic

Ran

ge

Time in Therapeutic Range

Example Caseload Profile

Caseload Analysis Parameter Jan 2008 – March 2009

M.D. #1 M.D. #2 M.D. #3 Pharm.D.

Number of Patient Encounters 2813 2451 2581 2340* Patients/Clinic Session (mean) 11.9 11.5 11.6 11.4* Median Age 58 60 60 62 Average A1c 7.5 7.4 7.5 8.1 Encounters 2.4 2.1 2.2 2.4 Mean number of active outpatient meds/patient

6.9 6.6 5.6 10.1

Mean pharmacy cost/patient 160.90 171.50 131.90 245.75 *Pharmacotherapy clinic open 4 half days/week. Numbers extrapolated to full time for comparison to MDs (10 half days/week)

Example Diabetes Documentation

10.16

8.75 8.38

8.12 7.92

7

7.5

8

8.5

9

9.5

10

10.5

11

Baseline 3 months 6 Months 9 months 12 Months

A1c

(%)

Change in Average A1c for Patients with Primary Diagnosis of Diabetes (n=228)

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Salary justification example

-$118,510

$215,103

$94,354

$190,947

-$150,000

-$100,000

-$50,000

$0

$50,000

$100,000

$150,000

$200,000

$250,000

Salary Expense A1c improvement

MD visits avoided

Net savings

NCQA Calculator

•  Quality Dividend CalculatorTM •  Assess impact on productivity and

absenteeism – Alcoholism - Depression – Asthma - Diabetes – Hypertension - Smoking – Heart disease – Child care

http://www.ncqa.org/tabid/181/Default.aspx

Additional NCQA calculators: HTN example

HTN pts

# with BP <140/90

# of deaths saved/ 10 yr

# strokes saved/yr

# major CV events saved/ 10

yr

Cost for stokes

saved/year (2004 cost)

Cost for major CV

events saved/ per 10 years (2004

cost)

10,000 7,800 188 12 293 $265,056 $5,426,653

Personal communication, Chester B. Kaiser Permanente Colorado.

Healthcare Incentives Improvement Institute®

•  Non-profit organization •  Developed programs:

– Measure outcomes – Reduce care defects – Promote team approach to care – Payment incentives around quality – Reward excellence

•  Bridges to Excellence®

•  PROMETHEUS Payment® http://www.hci3.org/

Bridges to Excellence® (BTE) •  Multi-stake holder program •  Advance “pay-per-performance” •  Measures quality of care for chronic diseases •  Provide incentives

– Preferred network tiering – Fee schedule increases – Annual incentive bonus –  Increased local and national reputation – Directory listings

http://www.hci3.org/what_is_bte

PROMETHEUS Payment®

•  Provider Payment Reform for Outcomes, Margins, Evidence, Transparency Hassle-reduction, Excellence, Understandability and Sustainability

•  Payment around comprehensive episode of medical care

•  Improved care/outcomes rewarded •  Encourages team approach to care

http://www.hci3.org/what_is_prometheus

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Summary'of'Intervention'Data'2007Based&upon&Replicon®&Timesheet&Data:

Total&Number&of&Interven1ons&Resul1ng&in&Drug&Therapy&Order&Changes: 1243Average&Number&of&Interven1ons&per&Service&Day: 8.5Average&Number&of&Pa1ents&Evaluated&per&Service&Day: 10.6Time&on&Service&(in&weeks)&: 36

Cost6Avoidance'Data'for'Database'Documented'Interventions'(90%'capture'rate)OrderPChanging&Interven1ons QTY Cost&Value Total Notes,&ReferencesSevere&ADR's&Iden<fied&and&Resolved 16 $4,685.00 $103,070.00 Reference&A

ADR's&Prevented&or&Detected&Early* 34 $2,342.50 $79,645.00 Reference&A*

Drug&Added&or&Changed 333 241.91 $80,556.03 Reference&B

Drug&Discon<nued 295 241.91 $71,363.45Dose&Adjustments 183 241.91 $44,269.53 Reference&B

IV/PO&Switch&(nonXan<bio<c) 63 $180.00 $11,340.00 Reference&B

IV/PO&Switch&(an<bio<c) 13 $1,706.00 $22,178.00

Cost&value&=&($100&+&$10.00&nsg&admin&etc)&x&avg&3&days&addl&tx&+&1&day&LOS&(50%&conserva<ve&es<mate&from&literature&@&$1376),&Ref&B,C

Monitoring&&Recommenda<on/&NonXdrug&Order&Change 93 $66.56 $6,190.08 Reference&B

TDM&X&recommend&monitoring& 40 $66.56 $2,662.40 Reference&B

TDM&X&interpret&monitoring&(only&incl&dose&adjustments) 43 $241.91 $10,402.13 Reference&B

Total&Number&of&OrderPChanging&Interven1ons: 1113NonPCost&Related&Interven1ons 73 NAPt&Counseling,&Med&History,&Reconcillia<on 24Formal&DI&Ques<on&/&Inservice 27Con<nuity&of&Care 4Nutri<on 18

Total&Documented&CostPAvoidance: $360,313.17Extrapolated&CostPAvoidance&for&total&#&interven1ons:& $402,398.27

*ADR's&only&included&blackbox&warnings,&absolute&and&severe&rela<ve&contraindica<ons.&&A&probability&adjustment&of&0.5&is&included&for&conserva<ve&es<ma<on.(i.e.&34&ADR's&prevented&@$4,685.00*&0.5)

References:A&&&Bates&DW,&Spell&N,&Cullen&DJ,&et&al.&&The&costs&of&adverse&drug&events&in&hospitallized&pa<ents.&&JAMA&1997;277:307X11.B&&Clinitrend®&Sokware !(exact!inputs!available!upon!request)C&&Ramirez&JA,&Srinath&L,&Ahkee&S,&et&al.&&Early&switch&from&intravenous&to&oral&cephalosporins&in&the&treatment&of&hospitallized&pa<ents&with

&&&&&communityXacquired&pneumonia.&&Arch&Intern&Med.&1995;155:1273X6.

ADR Prevention / Treatment

4%

Drug Addition, or Change

28%

Drug Discontinuation

25%

Drug Dosing 16%

Change Route 6% Monitoring and

Non-Drug 8%

Therapeutic Drug Monitoring

7%

Other 6%

Interventions by Frequency

ADR Prevention /

Treatment, $183

Drug Addition, or Change, $81

Drug Discontinuation,

$71 Drug Dosing, $44

Change Route, $33

Monitoring and Non-Drug, $6

Therapeutic Drug Monitoring,

$13

Interventions by Cost Average patients per service day 2010-2011

0

2

4

6

8

10

12

14

16

18

20

July Aug Sept Oct Nov Dec

No.

of p

atie

nts

2010 2011

Specific Interventions Tied to Improved Outcomes

Tight Glycemic Control 107 Other Sepsis Bundle Interventions 173 Post ACS Medication Initiation 14 Initiate DVT Prophylaxis 28 Sedation Weaning/Agent 51 Initiate Stress Ulcer Prophylaxis 7

Interventions by Disease Type

Demonstration of Practice Expertise

Empiric Selection 39

Change per C&S 21

De-escalation 65

Pharmacokinetics 115

Change to PO 13

Dosing 42 Other 7

Infectious Diseases-Specific Interventions

How would you convert these “pharmacy-focused” outcomes into “system-focused” outcomes?

11

CDC 12 Steps to Prevent Antimicrobial Resistance

•  Prevent Infection – Vaccinate – Remove catheters

• Diagnose and treat effectively – Target the pathogen

• Use antimicrobials wisely – Antimicrobial control (e.g. IV to PO, formulary) – Use local data – Treat infection, not contamination / colonization

http://www.cdc.gov/drugresistance/Healthcare/ha/12steps_HA.htm

NPSG 07.03.01 Prevent of HCA Infections from MDR Pathogens

Type of Intervention: Number

Remove catheter 5

Appropriately target the pathogen 35

Effective antibiotic control 32

Avoid treating colonization/contamination 13

Vaccinate* 2

Deescalate (primarily discontinuation) 41

Joint Commission National Patient Safety Goals

* Highly effective nursing driven protocol at our institution

NPSG 03.05.01 Anticoagulation

Anticoagulation Goals: Interventions % at Goal

Baseline / Current Coagulation Status 23 96

Resolve food drug interactions 14 92

Patient Education Provided / Documented

34 98

Anticoagulation-related ADR reporting 5 NA

Joint Commission National Patient Safety Goals

Example - Leapfrog Initiative Quality Measures

•  Acute Myocardial Infarction – Aspirin at arrival and discharge – ACEI or ARB for LVSD – Smoking cessation advice / counseling – Beta blocker at discharge – Primary PCI within 90 minutes – Readmissions –  Length of stay

http://www.leapfroggroup.org/

Example - Leapfrog Initiative Quality Measures

•  Pneumonia – Pneumococcal vaccination – Blood cultures within 24 hours – Smoking cessation advice / counseling –  Initial antibiotic within 6 hours –  Influenza vaccination – Readmissions –  Length of stay

http://www.leapfroggroup.org/

Reflection

• Reflect on your clinical practice and list at least 5 outcome measures that you could document to demonstrate your clinical acumen.

12

Describe documentation strategies that justify your

clinical services

Scholarship

•  Tool to document practice excellence •  External validation of clinical practice •  Peer review

– Abstracts – Case-reports – Review articles – Original research

•  Serves to advance reputation

Effect of Pharmacist Initiated Home Blood Pressure Monitoring

on Hypertension

Mehos BM, et al. Pharmacotherapy 2000;20:1384-1389.

Reduction in Warfarin ADEs Requiring Hospitalization After

Implementation of a Pharmacist-Managed Anticoagulation Service

Locke C, et al. Pharmacotherapy 2005;25:685–689.

3* 3^

14

10

0 2 4 6 8

10 12 14 16

Total no. ADE No. pts. Experiencing ADE

Num

ber o

f eve

nts

RPh Managed (n=420) Usual Care (n=420)

*p=0.0153 ^p=0.0962

Effectiveness of pharmacist-administered diabetes education

and management services Before

Enrollment After

Enrollment Difference

A1c (%)*^ 9.5 7.8 -1.7% (p<0.05) Mean BP (mmHg) 141/79 135/75 -6/-4 (p=0.007)

LDL* 114 112 -2 (p>0.05) Aspirin use (%) 34 73 214 (p<0.001)

Ragucci KR, et al. Pharmacotherapy. 2005;25:1809-16.

* Achieved values to qualify for NCQA diabetes recognition ^ Based on estimated cost savings of $820 for each 1% A1c reduction, cost avoidance calculated as $59,040

Mortality Reduction Benefits of a Comprehensive Cardiac Care (CCC) Program

for Pts with Occlusive CAD

Merenich JA, et al. Pharmacotherapy. 2007;27(10):1370-1378

0

0.25

0.5

0.75

1

0 2 4 6 8 10

Cum

mul

ativ

e Su

rviv

al

Analysis time (years)

Early CCC Delayed CCC Intermittent CCC No CCC

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Documentation of pharmacists’ interventions in an emergency department and associated cost avoidance

Pharmacist Interventions Documented during the Study Period Drug information 362 Patient information" 77"Dosage adjustment 353 Change route" 66"Nursing question 316 Discontinue drug therapy" 58"Formulary interchange 181 Toxicology" 43"Initiate drug therapy 180 Allergy" 40"Order clarification 164 Duplication" 8"Change to alternative drug 157 Drug interaction" 2"Compatibility issue 143 Total! 2150!

Adapted from: Lada P, et al. Am J Health-Syst Pharm. 2007;64:63-8.

Intervention type No. Intervention($) Probability $* Drug interaction/incompatibility 334 1,647 0.54 297,053"Therapeutic recommendation 523 1,188 0.44 273,383"ADE prevented 48 1,098 0.44 23,190"Medication error prevented 488 1,375 0.65 436,150"Total 1,393 …. ….. 1,209,776"* Extrapolated one-year cost avoidance $3,089,328

Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Care Unit

Leape LL, et al. JAMA. 1999;282(3):267-270

0 5

10 15 20 25 30 35 40 45 50

Study Control Study Control

Phase 1 Phase 2

Rate per 1000 pt

days

All ADRs Prevented at Ordering

Reflection

•  Reflect on your clinical practice and write down at least 3 topics that could be translated into a research or project

Acknowledgement

•  Krystal Haase, Pharm.D., FCCP

Questions? Eric.MacLaughlin@ttuhsc.edu

Documentation  Reflection   Clinical Pharmacy Recommendations FY 2011

Date

Age

Gend

er

Inte

rven

tion

Dx

Inte

rven

tion

Type

Desc

riptio

n of

In

terv

entio

n

Pres

crib

er

Acce

pted

?

01/14/11 68 Male Heart failure Drug DC

Patient has systolic heart failure (estimated LVEF 38%) and was on lisinopril and diltiazem. Recommended to D/C diltiazem per AHA/ACC guidelines.

Smith, David Yes

01/14/11 68 Male Heart failure

Recommend Initial Therapy

Recommended starting metoprolol succinate 12.5 mg daily in a patient with HF and LVD, and titrate Q 2 wks as tolerated to target dose of 200 mg daily.

Smith, David

No, MD clue-less

 

1. List  the  strengths,  weakness,  opportunities,  and  threats  (SWOT  analysis)  for  this  new  faculty’s  documentation  plan.                      

2. What  data  should/should  not  be  collected?                      

3. Are  there  any  legal  or  institutional  policies  that  should  be  followed?  

 

• Reflect  on  your  clinical  practice  and  list  at  least  5  outcome  measures  that  you  could  document  to  demonstrate  your  clinical  acumen:  

                                       

• Reflect  on  your  clinical  practice  and  write  down  at  least  3  topics  that  could  be  translated  into  a  research  or  project