electronic chronic pain questions (ecpq) - pfizer · 2017-03-24 · electronic chronic pain...

Electronic Chronic Pain Questions (eCPQ)

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Background Situation

• No structured, systematic means for capturing chronic pain data that is widely adopted*

‐ Viewed as a symptom of multiple conditions and never a disease in itself

‐ Internists and multiple HCP specialists diagnose and treat chronic pain conditions

‐ The 3 main types of pain are not easily assessed—no simple test or widely adopted PRO tool

‐ Multiple guidelines by painful condition and/or by class of drug (eg, for opioids)

• Validated scales for pain assessment are not broadly utilized

• Existing EHR data capture solutions offered by some EHR vendors fall short of health system needs

‐ Integrated delivery networks and medical groups view existing EHR pain modules as too long and cumbersome

‐ The modules are not used because they do not offer a clear path on integrationinto current workflows

The Problem With Capturing Chronic Pain Data Today

EHR, electronic health record; HCP, health care providers; PRO, patient-reported outcome.

*Masters ET et al. ISPOR CONNECTIONS. 2013;2(19):8-10.




Pain data are rarely recorded. When done, it is usually in the

open notes fields in most EHRs, making extraction,

reporting, and analysis difficult

Structured data fields exist for diabetes information

in most EHRs, making extraction, reporting, and

analysis easy

Diabetes patient visit to HCP

Captured

in structured data fields

HbA1c

Blood pressure

LDL

Retinopathy

Nephropathy

Neuropathy

NOT Captured

in structured data fields1

Pain severity or intensity2

Pain location and duration2

Impact of pain on patient’s

function, mood, and sleep2

Pathophysiologic type

of pain (nociceptive,

neuropathic, or sensory

hypersensitivity)2

Unlike Patient Data in Other Chronic Diseases, Chronic Pain Assessment and Data Are Not Captured Systematically in EHRs

1. Masters ET et al. ISPOR CONNECTIONS. 2013;2(19):8-10.

2. IOM. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.




Chronic Pain Conditions Can Be Classified Based Upon Type of Pain Pathophysiology

Three Main Typesof Pain Pathophysiology

NOCICEPTIVE

PAIN

NEUROPATHIC

PAIN

SENSORY

HYPERSENSITIVITY

Pain related to

damage of somatic or

visceral tissue, due to

trauma or inflammation

EXAMPLES:

rheumatoid arthritis,

osteoarthritis, gout

Pain related to

damage of peripheral

or central nerves

EXAMPLES:

painful diabetic

peripheral neuropathy,

postherpetic neuralgia

Pain without identifiable

nerve or tissue damage;

thought to result from

persistent neuronal

dysregulation

EXAMPLE:

fibromyalgia

Phillips K, Clauw DF. Best Pract Res Clin Rheumatol. 2011;25(2):141-154.




Types of Pain

First

line(based on

strength

of clinical

evidence)

Nonsteroidal anti-inflammatory

drugs (NSAIDs), acetaminophen1-5

Treatment of underlying

inflammatory condition may include

corticosteroids, biologics and

disease-modifying agents

Antiepileptic drugs,

serotonin-norepinephrine reuptake inhibitors,

tricyclic antidepressants1,3,5-8

Opioid

use

When other treatment options are inadequate,

opioids should be considered for the management of pain severe

enough to require daily, around-the-clock, long-term treatment3,5,6,8-12

Opioids should be avoided

in patients with sensory hypersensitivity13,14

Recommended Medication Classes forDifferent Conditions/Types of Chronic Pain

1. Phillips K, Clauw DJ. Best Pract Res Clin Rheumatol. 2011;25(2):141-154.

2. ACR Subcommittee on RA Guidelines. Arthritis Rheum. 2002;46(2):328-346.

3. Hochberg M et al. Arthritis Care Res (Hoboken). 2012;64(4):465-474.

4. Khanna D et al. Arthritis Care Res. 2012;64(10):1447-1461.

5. Passik SD. Mayo Clin Proc. 2009;84(7):593-601.

6. Dworkin RH et al. Pain. 2007;132(3):237-251.

7. Attal N et al. Eur J Neurol. 2010;17(9):1113-1123.

8. Carville SF et al. Ann Rheum Dis. 2008;67(4):536-541.

9. Chou R et al. J Pain. 2009;10(2):113-130.

10. VA//DoD. Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain.

Version 2.0. Washington, DC: US Dept of Veteran Affairs, US Dept of Defense; 2010.

11. Manchikanti L et al. Pain Physician. 2012;15(3 suppl):S67-S116.

12. US FDA. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/

UCM367697.pdf. Accessed February 4, 2016.

13. Painter JT, Crofford LJ. J Clin Rheumatol. 2013;19(2):72-77.

14. Franklin GM. Neurology. 2014;83(14):1277-1284.

NEUROPATHIC PAIN1

Pain related to

damage of peripheral

or central nerves

Examples:

Painful DPN, PHN

NOCICEPTIVE PAIN1

Pain related to

damage of somatic or

visceral tissue, due to

trauma or inflammation

Examples:

RA, OA, gout

SENSORY

HYPERSENSITIVITY1

Pain without

identifiable nerve or

tissue damage; thought to

result from persistent

neuronal dysregulation

Example:

FM




Identifying the Key Concepts in Chronic Pain From Literature and Guidelines

Source Details

Pain

Ph

ysical F

un

ction

ing

So

cial F

un

ction

ing

Em

otio

nal

Fu

nctio

nin

g

Glo

bal

Imp

rovem

ent/

Tx S

atisfaction

Sym

pto

ms

and

AE

s

Sleep

/Fatig

ue

IMMPACT Turk et al 2003

• Core outcome recommendations for chronic pain clinical trials

• Consensus meeting with 27 experts from academia, government agencies, and pharmaceutical industry

(Supplemental)

IMMPACT Turk et al 2008

• IMMPACT patient input – focus groups to identify domains, survey to evaluate importance

S-TOPSHaroutiunian et al 2012

• University of Utah – Pain Management Center Treatment Outcomes in Pain Survey

National Pain Audit 2012

• UK audit – quality of specialist pain services for people with long-term pain

WHO 2008• Scoping document – treatment

guidelines for chronic pain

CPAIN • Chronic Pain Impact Network




Electronic Chronic Pain Questions (eCPQ) Module Overview

• A recommended set of questions to

help support chronic pain

assessment

• An electronic module/workflow

for data capture

• Based on existing guidelines

Objectives

• Designed to enable systematic, structured collection of discrete data

on pain in a format that allows for extraction, analysis, and aggregation

• Designed to enable physicians to more appropriately and efficiently

assess chronic pain and to help clinicians better diagnose, treat, and

monitor patients with chronic pain

• A clinical diagnostic tool or

treatment pathway

• A mobile device

What it IS What it IS NOT




Electronic Chronic Pain Questions (eCPQ)*

Score: ≥ 3Score: < 3

Consider

Neuropathic Pain

Consider

Nociceptive Pain

“Mostly Yes”Consider

Sensory Hypersensitivity

What was your

average pain over

the last week?

(0–10 NRS Scale)

Thinking of the past week…

How much did pain interfere with your usual activities?

How much did pain interfere with your sleep?

How much did pain interfere with your mood?

(0–10 NRS Scale for each item)

CHRONIC PAIN? PAIN INTENSITY & LOCATION IMPACT ON FUNCTION, SLEEP, & MOOD

No = Exit

Yes

Other information to help diagnose sensory hypersensitivity can be

derived from medical history and other eCPQ questions. It includes:

• Widespread pain from body map image / locations? (Y/N)

• Marked impairment of mood, sleep, and function? (Y/N)

• Medical history of ≥1 other sensory hypersensitivity condition? (Y/N)

PAIN QUALITY & TYPE

Where is your pain?

(Diagram)

Have you had

pain most days in

the past 3 months?

(Y/N)

ID PAIN® Screener

Did the pain feel like pins and needles? (Y/N)

Did the pain feel hot/burning? (Y/N)

Did the pain feel numb? (Y/N)

Did the pain feel like electrical shocks? (Y/N)

Is the pain made worse with the touch of clothing or bed sheets? (Y/N)

Is the pain limited to your joints? (Y/N)

“Sensory Hypersensitivity” or Fibromyalgia-like Pain

Did you have trouble thinking or remembering in the past week?

Were you sensitive to bright lights, loud noises, or smells in the past week?

(0–10 NRS Scale for each item)

*For the purposes of this presentation, the eCPQ questions have been paraphrased. NRS, numeric rating scale.




Prospective Psychometric Validation of eCPQ at William Beaumont Health

• Study Design: Prospective validation of eCPQ

in a primary care setting. This study had both

quantitative and qualitative components. No

investigational drugs, devices, or invasive

procedures were administered or evaluated as

part of this study.

• Quantitative Component:

‐ Study staff administered eCPQ

‐ Physician reviewed and discussed with patients

• Patients completed paper-based: POQ-SF; SF-36 Version

1 Acute; HADS; MOS Sleep Problem Index I; FSQ

‐ Patients invited to complete eCPQ online at home

• Qualitative Component:

‐ 1-on-1 interview following patients’ clinic visit

‐ Subset of study staff were invited to take part in

1-on-1 interview

• To assess the feasibility usability and potential

benefits of integrating the eCPQ into an

existing EHR system

• To evaluate the psychometric properties, test-

retest reliability and performance of the eCPQ

‐ Redundancy of Measurement

• Are any questions redundant

‐ Concurrent Validity

• Is the instrument measuring the purported construct that it

aims to measure

‐ Discriminative Validity

• Does the measure distinguish among groups known to

differ on a relevant dimension

Objectives Methods

FSQ, Fibromyalgia Survey Questionnaire; HADS, Hospital Anxiety and Depression Scale; MOS, Medical Outcomes Survey;

POQ-SF, Pain Outcomes Questionnaire-Short Form; SF-36, MOS 36-Item Short Form Health Survey.




Disposition of Study Subjects

Patients Consented/Enrolled

(N = 455)

Partially or Fully CompletedDataFax Packets

(n = 429)

Unique eCPQ IDs

(n = 397)

Partially or Fully Completed w/Demographic Data

(n = 419)

Unique eCPQ IDs w/ Partially or Fully Completed eCPQ Data in EHR

(n = 395)

eCPQ IDs w/ Partially or Fully Completed Web Survey #1

(n = 115)

eCPQ IDs w/ Partially or Fully Completed Web Survey #2

(n = 84)

eCPQ IDs w/ Partially or Fully Completed eCPQ Data

AND

Partially or Fully Completed DataFax Packets

(n = 392)

Lost Packet/Not in DataFax (n = 5)

Blank DataFax Packet (n = 21)

• Ran out of time (n = 5)

• Withdrew (n = 11)

• Went to ER (n = 2)

• Language barrier (n = 1)

• Unknown (n = 2)

No demographic data in packet (n = 10)

No eCPQ data (n = 2)

eCPQ not administered (n = 45)

Duplicate/triplicate IDs assigned (n = 13)

AnalysisSample

No DataFaxdata (n = 3)




Demographics of Study Subjects

Variable Total (N = 395)

Age, Years

Mean (SD) 43.4 (16.4)

Range (min, max) 18-95

Gender, n (%)

Female 269 (68.1)

Race, n (%)

White or Caucasian 277 (70.1)

Black or African American 53 (13.4)

Asian 16 (4.1)

Other 28 (7.1)

Missing 21 (5.3)

Employment, n (%)

Employed, Full-time 153 (38.7)

Employed, Part-time 54 (13.7)

Homemaker 36 (9.1)

Student 17 (4.3)

Unemployed 36 (9.1)

Retired 41 (10.4)

On Disability 33 (8.4)

Other 5 (1.3)

Missing 20 (5.1)

Variable Total (N = 395)

Education

Elementary/Primary School 5 (1.3)

Secondary/High School 109 (27.6)

Some College 115 (29.1)

College Degree 101 (25.6)

Postgraduate Degree 33 (8.4)

Other 12 (3.0)

Missing 20 (5.1)




5.7

1.1

4.7 4.6

4.0

2.02.2

1.7

0.2

1.1 1.20.9

0.4 0.4

Average Pain (Q2)

ID Pain Score (Q4)

UsualActivites

(Q5.1)

Sleep(Q5.2)

Mood(Q5.3)

Thinking/Remembering

(Q6)

Hyper-sensitivity

(Q7)

Chronic Pain

No Chronic Pain

Mean Scores for eCPQ Questions 2–7 Among Subjects whoSelf-Reported Chronic Pain for Most Days or Every Day for the Past 3 Months on Question 1 and Those who Did not Self-Report Chronic Pain

*

*

*

**

* *

*P <0 .0001.

In addition, nearly 19% of patients with chronic pain had

an ID Pain score of 3 (likely indicative of neuropathic pain),

whereas only 1.7% of patients without chronic pain had an ID Pain score of 3




15.4

26.2

4.1

8.2

6.1

14.5

0.6

3.9

% Meeting Moderate Depression

Cutpoint (>11)

% MeetingModerate Anxiety

Cutpoint (>11)

% MeetingSevere Depression

Cutpoint (>15)

% MeetingSevere AnxietyCutpoint (>15)

Chronic Pain (n=195)

No Chronic Pain (n=179)

Percentage of Subjects with HADS Scores Indicating Moderate or Severe Depression and Anxiety Among Those Who Self-Reported Chronic Pain Versus Those Who Did not Report Chronic Pain

*

*

*

†

* P < 0.05.

† P = 0.08.




Psychometric Validation: Conclusions

eCPQ displayed concurrent validity by aligning with ancillary measures

eCPQ showed evidence of being a valid, reliable and reproducible measure for identifying patients

experiencing chronic pain

Patients and staff generallyviewed the eCPQ favorably




Patient completes paper

eCPQ in waiting room when

checking in at each visit

Nurse/MA inputs

patient answers into

eCPQ form in EHR

Provider can see individual

longitudinal eCPQ results

during each patient visit

eCPQ Workflow Case ExampleImplementation at a large integrated pain clinic in the Midwest

Office feedback: Does not interrupt normal workflow

and takes only a few minutes

Integration into GE Centricity EHR System

• Results beneficial at individual patient visits, as well as from a population perspective

‐ Periodically (every 6 months) eCPQ aggregate results analyzed from an entire clinic population perspective

‐ Results provide information on how well clinic is managing patients with chronic pain, (pain, functioning, mood, and sleep)

Note: This is one example of how an office has implemented the eCPQ into its EHR system; the process can be customized for

individual practices, institutions, and EHR systems.




• eCPQ was designed to address an existing gap in collecting data in patients with chronic pain

‐ ID Pain questionnaire helps to identify the pain type

• Developed in a multicenter study of 586 patients with chronic pain of nociceptive, mixed, or neuropathic etiology

• Validated in a multicenter study of 308 patients

‐ Additional questions, combined with other information already collected, help to identify patients with sensory hypersensitivity conditions such as fibromyalgia

• This portion of the eCPQ is currently under further study

• Psychometric validation of eCPQ in 397 patients with chronic pain was completed in the primary care setting (Beaumont Health)

• Used in a number of different settings, easy to complete, well received by patients and staff

‐ Allows clinicians to efficiently identify patients with chronic pain and systematically assess and monitor their symptoms over time

‐ May help to enhance patient care, facilitate patient-provider communication, and improve evidence-based treatment planning

Summary



electronic chronic pain questions (ecpq) - pfizer · 2017-03-24 · electronic chronic pain...

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