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©2017 MFMER | slide-1 Identifying Research Gaps in Clinical Practice Guidelines for Prescribing Opioids for Acute Pain: The Mayo Clinic Perspective Elizabeth B. Habermann, PhD MPH Professor of Health Services Research Robert D. and Patricia E. Kern Scientific Director for Surgical Outcomes July 9, 2019

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©2017 MFMER | slide-1

Identifying Research Gaps in Clinical Practice Guidelines for Prescribing Opioids for Acute Pain:The Mayo Clinic Perspective

Elizabeth B. Habermann, PhD MPHProfessor of Health Services ResearchRobert D. and Patricia E. Kern Scientific Director for Surgical Outcomes

July 9, 2019

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©2017 MFMER | slide-2

No Disclosures

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Optimizing Opioid Prescribing for Mayo Clinic Surgical Patients

History and Progress to Date

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©2017 MFMER | slide-4

2015-2016

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Ann Surg. 2017;266;564-573.

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Methods

• Adults undergoing 25 common elective procedures (2013-2015):

• 7,651 adults

• 5,756 (75.2%) opioid naïve

ProceduresGENERAL SURGERY

1. Lap Cholecystectomy

2. Lap Initial Inguinal Hernia Repair

3. Initial Inguinal Hernia Repair

4. Ventral Hernia Repair

GENERAL SURGICAL ONCOLOGY

5. Simple Mastectomy

6. Breast Lumpectomy

7. Ileocecectomy

8. Laparoscopic LAR

9. VATS Wedge Resection

ORTHOPEDIC

10. Total Shoulder

11. Total Hip

12. Knee Arthroscopic Meniscectomy

13. Total Knee

14. Rotator Cuff Repair

SPINE

15. Lumbar Laminotomy

16. Lumbar Laminectomy

UROLOGY/GYNECOLOGY

17. Lap Hysterectomy

18. Vaginal Hysterectomy,

19. Lap Nephrectomy

20. Lap Prostatectomy

HEAD & NECK

21. Thyroid Lobectomy

22. Parathyroidectomy

23. Carotid Thromboendarterectomy

24. Parotid Gland Excision

25. Tonsillectomy

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0

20

40

60

80

100

120

140

160

180

200

0

200

400

600

800

1000

1200

1400

Sta

nd

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ize

d t

o

5m

g T

ab

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xyc

od

on

e

Pre

sc

rib

ed

Ora

l M

orp

hin

e E

qu

iva

len

ts (

OM

E) OME Prescribed in Opioid Naïve Patients

Ann Surg. 2017;266;564-573.

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Results

• 80.9% of opioid naïve patients were prescribed > 200 OME

• Wide variation of post-operative opioid prescribing observed across and within surgical procedures

Therefore:

• Opportunities exist to standardize and optimize prescribing

Ann Surg. 2017;266;564-573.

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©2017 MFMER | slide-9

2017

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How should users of clinical practice guidelines be engaged in the dissemination, implementation, and clinical use of a guideline?

The Mayo Clinic Approach

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Mayo Clinic Approach to Opioid Prescribing Guideline Development and Implementation

• Multidisciplinary teams were constructed per specialty

• Membership

• Surgeon Champion

• Health Services Researcher

• Data Analyst

• Pain Medicine Physician

• Nursing Administrator

• Pharmacist

• Health Systems Engineer

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Mayo Clinic Approach to Opioid Prescribing Guideline Development and Implementation

• Multidisciplinary teams were constructed per specialty

• Membership

• Surgeon Champion

• Health Services Researcher

• Data Analyst

• Pain Medicine Physician

• Nursing Administrator

• Pharmacist

• Health Systems Engineer

Guideline

Development

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Mayo Clinic Approach to Opioid Prescribing Guideline Development and Implementation

• Multidisciplinary teams were constructed per specialty

• Membership

• Surgeon Champion

• Health Services Researcher

• Data Analyst

• Pain Medicine Physician

• Nursing Administrator

• Pharmacist

• Health Systems Engineer

Guideline

Implementation

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https://www.prosci.com/adkar/adkar-model

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Guideline Development and Implementation

• Created framework for consistency and standardization

“prescribe the lowest amount ofthe lowest dose for the shortest duration”

with room for tailoring

https://www.prosci.com/adkar/adkar-model

Content courtesy of Danny Whipple

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Guideline Development and Implementation

Guideline Development

• Kickoff meeting with each specialty

• Multiple stakeholders with different roles

• Review historical prescribing

• What are your goals?

• What is realistic?

• How can we meet needs of patient without introducing unnecessary risk?

Guideline Implementation

• Tailored to each specialty

• Involve all stakeholders

• Varies per surgical specialty and by hospital

• Who prescribes? (surgeon, resident, APP?)

• Who discharges the patient?

• Nursing often sets expectations for discharge

• Pharmacy involvement and reinforcement

Content courtesy of Danny Whipple

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Orthopedic Surgery

Implemented in Rochester in Summer 2017

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Department of Orthopedic Surgery Prescribing Guidelines

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Clin Orthop Relat Res.

2019 Jan;477(1):104-113.

Reduction and Standardization of Opioids Prescribed

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Reduction and Standardization of Opioids Prescribed

Clin Orthop Relat Res.

2019 Jan;477(1):104-113.

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Adherence to Guidelines

Clin Orthop Relat Res.

2019 Jan;477(1):104-113.

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Meanwhile, in 2017…

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Amount Optimal Amount

Prescribed to Prescribe

???

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Survey of 2500 Recently Discharged Mayo Clinic Surgical Patients

• Goal:

• Determine how many opioids were used from what we know were prescribed

Ann Surg. 2018 Sep;268(3):457-468.

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Surgery Discharge

21 350

28-Question Phone Survey

• Opioids Consumed

• Refills

• Pre-operative Users

• Patient Experience

Weekly Query

Mean 26.9±4.2

Methods

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Opioid Utilization

61.5% Opioids Went Unused

77.3% of Patients had Leftover Opioids

55,199 pills remained unused at the time of survey!

(>1 million pills per/institution/year)

Ann Surg. 2018 Sep;268(3):457-468.

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Amount Opioids Prescribed vs ConsumedNaïve

Only

0 100 200 300 400 500 600 700

Carotid Endarterectomy

Parathyroidectomy

Arteriovenous Fistula Creation

MIS Partial Colectomy with Anastomosis

Carpel Tunnel Release

Breast Lumpectomy ± Sentinel Node

MIS Cholecystectomy

MIS Inguinal Hernia Repair

Ovarian Cancer Cytoreduction

Open Inguinal Hernia Repair

Simple Mastectomy ± Sentinel Node

MIS Hysterectomy

MIS Low Anterior Resection ± Diverting Ileostomy

MIS Prostatectomy

MIS Nephrectomy

Knee Arthroscopic Meniscectomy

Open Pancreaticoduodenectomy

MIS Lung Wedge Resection

Tonsillectomy

Rotator Cuff Surgery

Lumbar Laminotomy/Laminectomy

Open Lung Lobectomy

Lumbar Fusion

Total Hip

Total Knee

Median Amount Consumed (in OME) Median Amount Remaining (in OME)

a

Ann Surg. 2018 Sep;268(3):457-468.

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20172018

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Multidisciplinary teams of surgeons, pain medicine, residents,

nurses, pharmacists, and researchers…

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Department of Surgery

Implemented in February 2018

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Department of Surgery

Implemented in February 2018[Resident] Surgeon Champion: Cornelius Thiels, DO

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Discharge Prescription Amounts in OME

Pre-Guidelines

Median: 150

IQR: 75 – 225

Post-Guidelines

Median: 60

IQR: 37.5 – 112.5

20 Tabs Oxy 8 Tabs Oxy

Range of 150 Range of 75

p<0.001

>50% Reduction

in Opioids Prescribed(hundreds of thousands of fewer unused pills in the community)

Unpublished QI Data

↓ Amount ↓ Variation

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Post-Guideline Prescribing Levels

21%

38%

24%

17%

0%

5%

10%

15%

20%

25%

30%

35%

40%P

rop

ort

ion

of P

atien

ts

Low Dose Standard Dose High Dose Above Guidelines

Unpublished QI Data

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Summary of Impact

• Following implementation of opioid prescribing guidelines in MCR Department of Surgery

• Opioids prescribed dropped by ~50%

• Variation in opioid prescribing also decreased

• Refill rates remained stable for 12 of 13 procedures

• Guideline compliance is respectable for 12 of 13 procedures

Unpublished QI Data

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2019

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Where are we now?

• Guidelines for postoperative opioid prescriptions have been implemented

• Orthopedic Surgery

• Department of Surgery

• Otorhinolaryngology

• Gynecologic Surgery

• Neurosurgery

• Ophthalmology

• Urology

• CV Surgery

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Available within “Ask Mayo Expert”

Content courtesy of Danny Whipple

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Opioid Prescribing Reports and Dashboards Available

Content courtesy of Danny Whipple

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Opportunities for Long-Term Follow-Up

What databases are suited for long-term follow-up of outcomes in patients with acute pain who received opioids for that pain?

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Opportunities for Long-Term Follow-Up

1. Longitudinal Administrative Claims

2. Mayo Clinic “Paneled Patients”

3. Rochester Epidemiology Project

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Opportunities for Long-Term Follow-Up

1. Longitudinal Administrative Claims

2. Mayo Clinic “Paneled Patients”

3. Rochester Epidemiology Project

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Opportunities for Long-Term Follow-Up

1. Longitudinal Administrative Claims

each with its own generalizability concerns

Examples:

• Medicare Fee-for-service Data

• Military Health Data Repository

• Private Hospital or Insurer Longitudinal Data

• Premier

• Truven

• Optum

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(BMJ 2019;365:l1849)Cohort:

We identified 524,318

patients meeting our

inclusion criteria, of whom

444,764 had at least 180

uncensored days of

follow-up.

Conclusion:

Tramadol use was

associated with a higher

risk of prolonged opioid

use in patients with an

acute episode of pain

compared with other short

acting opioids.

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Longitudinal Administrative Claims Data

Can be studied with claims

• Health services and conditions:

• Outpatient visits

• ED visits

• Hospital admissions and LOS

• Diagnoses and procedures

• With pharmacy data:

• Opioids prescribed

• Refills

Cannot be studied with claims

• Patient-reported pain scores*

• HCAHPS or other measures of patient experience*

• Opioids consumed

• Non-prescription medications or pain management strategies

• Pharmacogenomic data*

*may be available if claims linked to EHR or other data sources

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Opportunities for Long-Term Follow-Up

1. Longitudinal Administrative Claims

2. Mayo Clinic “Paneled Patients”

3. Rochester Epidemiology Project

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©2017 MFMER | slide-48https://rochesterproject.org/

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Goodhue

Wabasha

Winona

MowerFillmore

HoustonFaribault

Steele

Freeborn

RiceLe Sueur

Nicollet

Brown

WasecaBlue

EarthWatonwa

n

Martin

Dodge

MINNESOTA

WIS

CO

NS

IN

Olmsted

Buffalo

Barron

Eau

Claire

Dunn

Chippew

a

Trempeal

eau

Pepin

Springfield

Sleepy

EyeNew Ulm

Searles

HanskaComfrey

Mayo Clinic Rochester

Mayo Clinic Health System

Olmsted Medical Center

Olmsted County

Public Health ServicesZumbro Valley Health Center

REP

Collaborators

La

Crosse

Lafayette

Nicollet

St. Peter

N

or

th

M

a

n

k

at

o

Cleveland

Le Sueur

Waterville

Waseca

Montg

omery

New

Richland

Waldorf

Janesville

Owatonna

Ellendale

MedfordMorristown

Warsaw

NerstrandFaribault

NorthfieldLonsdale

Blooming

Prairie

Mankato

St. Clair

Good

ThunderVernon

Center

AmboyMapleton

Lake

Crystal

St. James

Lewisville

Butterfield

Odin

MadeliaLa Salle

West

Concord

KassonClaremont

Hayfield

Byron

Eyota

Stewartville Chatfield

Roc

hest

er

Oronoco

Red

Wing

Cannon

FallsFrontenac

GoodhueDennison

KenyonPine

Island

WanamingoZumbrota

Plainview

Elgin

Millville

Wabasha

Mazeppa

Zumbro

Falls

Lake

City

Alma

Gilmanton

Mondovi

Nelson

Waumandee

Fountain

City

Buffalo

City

Granada

Fairmont

DunnellCeylon

Northrop

Truman

Trimont

Sherburn

Minnesota

Lake

Wells

Kiester

Blue

Earth

Bricelyn

EastonWinnebago

Albert Lea

Glenville

Alden

Twin

Lakes

Clarks

Grove

GenevaHartland

Freeborn

Le Roy

Adams

Rose

Creek

Grand

Meadow

Racine

Brownsdale

Austin

Lanesboro

Harmony

Preston

Mabel

Fountain

Rushford

Spring

Valley

Wykoff

Goodview

St. Charles

Lewiston

Minnesota

City

Altura

Dakota

Hokah

Spring

Grove

Brownsville

Eitzen

Houston

La Crescent

Caledonia

Holmen

Bango

West

Salem

St.

Joseph

Onalaska

Brice

Prairie

La Crosse

Pepin

Stockholm

Durand

Arkansaw

Ettrick

Arcadia

Pigeon

Falls

Independence

Trempealeau

Galesville

Dodge

Whitehall

Osseo

Eleva

Strum

Fairchild

Augusta

Altoona

Eau

Claire

Fall

Creek

Almena

Haugen

Prairie

Farm

Rice

Lake

Barron

ChetekDallas

Cumberland

Turtle

Lake

Stanley

Bloomer

Lake

Hallie

Lake

Wissota

Cadott

New Auburn

Holcombe

Boyd

Cornell

Chippewa

FallsColfax

Menomonie

Tainter

Lake

Elk

Mound

Knapp

Boyceville

Wheeler

Downsville

Ridgeland

Le Center

Winona

Dodge

Center

Jim

Falls

Cameron

Miles0 5 1

0

2

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3

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4

0

Rochester Epidemiology Project

• Funded by the NIH for over 50 years

• A collaboration between health care providers in Minnesota and Wisconsin

• ~60% coverage of a 27-county region of MN and WI

• 700,000 records

Content courtesy of the Rochester Epidemiology Project team

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Age 30 35 40 45 50 55 60

Medical visit dates: In region Out of region

Person

Residency timeline

In region

Implied in region

Out of region

Implied out of region

Unknown

Residency timelines

St. Sauver et al., Int J Epidemiol 2012; Rocca et al., Int J Epidemiol 2018

Content courtesy of the Rochester Epidemiology Project team

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Uses of the census enumeration1966 1970 1975 1980 1985 1990 1995

2000 2005

Enumeration Enumeration

Controls

for case-control

studies

Referent

subjects

for cohort

studiesPrevalence

and incidenceTime, place, and person

St. Sauver et al., Int J Epidemiol 2012; Rocca et al., Int J Epidemiol 2018

Content courtesy of the Rochester Epidemiology Project team

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Olmsted

Medical

Center

Mayo ClinicOther

providers

State and

national

death records

Demographi

cs

RX

Procedure

s

Diagnose

s

Person

Medical visit

dates

Age 30 35 40 45 50 55 60

Linkage across care-providers

St. Sauver et al., Int J Epidemiol 2012; Rocca et al., Int J Epidemiol 2018

Content courtesy of the Rochester Epidemiology Project team

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Type of data

Medical

diagnoses

and surgical

proceduresICD codes

Prescriptions of drugs RxNorm, NDF-RT codes

Life habits

Laboratory testsLOINC codes

Immunizations

Services and

proceduresICD and CPT codes

Demographic

data

Biological

specimens

on ≈10%

Content courtesy of the Rochester Epidemiology Project team

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Opportunities for Long-Term Follow-Up

1. Longitudinal Administrative Claims

2. Mayo Clinic “Paneled Patients”

3. Rochester Epidemiology Project

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Thank You

[email protected]

@ebhabermann