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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
©2017 MFMER | slide-2
No Disclosures
©2017 MFMER | slide-3
Optimizing Opioid Prescribing for Mayo Clinic Surgical Patients
History and Progress to Date
©2017 MFMER | slide-4
2015-2016
©2017 MFMER | slide-5
Ann Surg. 2017;266;564-573.
©2017 MFMER | slide-6
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
©2017 MFMER | slide-7
0
20
40
60
80
100
120
140
160
180
200
0
200
400
600
800
1000
1200
1400
Sta
nd
ard
ize
d t
o
5m
g T
ab
s o
f O
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.
©2017 MFMER | slide-8
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.
©2017 MFMER | slide-9
2017
©2017 MFMER | slide-10
How should users of clinical practice guidelines be engaged in the dissemination, implementation, and clinical use of a guideline?
The Mayo Clinic Approach
©2017 MFMER | slide-11
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
©2017 MFMER | slide-12
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
©2017 MFMER | slide-13
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
©2017 MFMER | slide-14
https://www.prosci.com/adkar/adkar-model
©2017 MFMER | slide-15
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
©2017 MFMER | slide-16
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
©2017 MFMER | slide-17
Orthopedic Surgery
Implemented in Rochester in Summer 2017
©2017 MFMER | slide-18
Department of Orthopedic Surgery Prescribing Guidelines
©2017 MFMER | slide-19
Clin Orthop Relat Res.
2019 Jan;477(1):104-113.
Reduction and Standardization of Opioids Prescribed
©2017 MFMER | slide-20
Reduction and Standardization of Opioids Prescribed
Clin Orthop Relat Res.
2019 Jan;477(1):104-113.
©2017 MFMER | slide-21
Adherence to Guidelines
Clin Orthop Relat Res.
2019 Jan;477(1):104-113.
©2017 MFMER | slide-22
Meanwhile, in 2017…
©2017 MFMER | slide-23
Amount Optimal Amount
Prescribed to Prescribe
???
©2017 MFMER | slide-24
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.
©2017 MFMER | slide-25
Surgery Discharge
21 350
28-Question Phone Survey
• Opioids Consumed
• Refills
• Pre-operative Users
• Patient Experience
Weekly Query
Mean 26.9±4.2
Methods
©2017 MFMER | slide-26
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.
©2017 MFMER | slide-27
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.
©2017 MFMER | slide-28
20172018
©2017 MFMER | slide-29
Multidisciplinary teams of surgeons, pain medicine, residents,
nurses, pharmacists, and researchers…
©2017 MFMER | slide-30
Department of Surgery
Implemented in February 2018
©2017 MFMER | slide-31
©2017 MFMER | slide-32
©2017 MFMER | slide-33
Department of Surgery
Implemented in February 2018[Resident] Surgeon Champion: Cornelius Thiels, DO
©2017 MFMER | slide-34
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
©2017 MFMER | slide-35
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
©2017 MFMER | slide-36
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
©2017 MFMER | slide-37
2019
©2017 MFMER | slide-38
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
©2017 MFMER | slide-39
Available within “Ask Mayo Expert”
Content courtesy of Danny Whipple
©2017 MFMER | slide-40
Opioid Prescribing Reports and Dashboards Available
Content courtesy of Danny Whipple
©2017 MFMER | slide-41
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?
©2017 MFMER | slide-42
Opportunities for Long-Term Follow-Up
1. Longitudinal Administrative Claims
2. Mayo Clinic “Paneled Patients”
3. Rochester Epidemiology Project
©2017 MFMER | slide-43
Opportunities for Long-Term Follow-Up
1. Longitudinal Administrative Claims
2. Mayo Clinic “Paneled Patients”
3. Rochester Epidemiology Project
©2017 MFMER | slide-44
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
©2017 MFMER | slide-45
(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.
©2017 MFMER | slide-46
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
©2017 MFMER | slide-47
Opportunities for Long-Term Follow-Up
1. Longitudinal Administrative Claims
2. Mayo Clinic “Paneled Patients”
3. Rochester Epidemiology Project
©2017 MFMER | slide-48https://rochesterproject.org/
©2017 MFMER | slide-49
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
0
3
0
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
©2017 MFMER | slide-50
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
©2017 MFMER | slide-51
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
©2017 MFMER | slide-52
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
©2017 MFMER | slide-53
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
©2017 MFMER | slide-54
Opportunities for Long-Term Follow-Up
1. Longitudinal Administrative Claims
2. Mayo Clinic “Paneled Patients”
3. Rochester Epidemiology Project