Using Electronic Paent-Reported Outcomes to Monitor and ... · Ethan Basch, MD, MSc University of...

UsingElectronicPa0ent-ReportedOutcomestoMonitorandManageSymptomsinCancerCare Ethan Basch, MD, MSc University of North Carolina, USA June 2018

Background

 Symptomsarecommonamongpa0entswithcancer• Diseaseismorbid,treatmentsaretoxic• Interferewithphysicalfunc0oninganddailyac0vi0es• Frequentlyleadtoemergencyandhospitalvisits

 Symptommanagementisacornerstoneofqualitycareinoncologyprac0ce(andotherchroniccondi0ons)

Standard Approach to Symptom Monitoring

REACTIVEAPPROACH

LimitedTime

Forgettodiscuss

ReluctancetoContact

ProblemsConnec0ng

Alternative: Systematic Symptom Monitoring Using Electronic Patient-Reported Outcomes

e-Reminder

Symptoms

e-Alert

Reports

PROACTIVEAPPROACH

Research Findings

• Cliniciansunawareofuptohalfofpa0ents’symptoms• Systema0csymptommonitoringwithePROsclosesthisgap• Pa0entswillingandabletoself-report• Clinicianstrustpa0ent-reportede-informa0on

Basch:NEJM2010;362:865;Snyder:QualLifeRes2012:1305;Kotronoulas:JCO2014;32:1480;Detmar:JAMA2002;288;3027;Velikova:JCO2004;22:714

•  Integra0onofelectronicpa0ent-reportedoutcomessystemsinoncologycarecanalertcliniciansaboutsymptoms,improvecommunica0on,andsymptomcontrol

Kotounoulas:JCO,2014

• Usualcarevs.computer-basedsymptomques0onnaireatoncologyvisits

• Results:SymptomsdiscussedmoreoNenduringvisits;significantlyimprovedqualityoflifeinthegroupthatself-reportedsymptoms

Velikova:JCO,2004

Early Patient Self-Reporting System   U.S.Na0onalCancerIns0tuteCTCAEScale-Example:Pain

Early Patient Self-Reporting System   Example:ShortnessofBreath(Dyspnea)

Email Alert to Clinical Nurse

Printed Report to Oncologist at Clinic Visit

Patients longitudinally reporting PRO symptoms (N~400): •  Mostpa0entsself-reportatanygivenclinicvisit

• Nursesrespondwith“clinicalac0ons”to75%ofautomatedemailalerts(counselling,suppor0vemedica0ons,referralstoER,chemotherapydosemodifica0ons,imaging)

Feasibility in Routine Cancer Care

Basch:JClinOncol:2005,2007,2016

Patient Feedback on Using ePRO Systems

Agree Disagree Unsure

Easy to use 98% 2% -

Useful 94% 6% -

Easier to remember symptoms at clinic visits 94% 5% -

Improved discussions with my doctor/nurse 90% 10% -

Improves communication with doctor and nurse 75% 10% 15%

Would like to continue using 96% 4% -

Would recommend to other patients 98% 2% -

Improved quality of my care 65% 10% 25%

Clinician Feedback on ePRO Systems Survey of MDs & RNs

Discuss PRO reports with patients 90%

PROs accurately reflect patient clinical status 90%

PROs are useful during treatment for adverse event monitoring 95%

PROs are a potential source of research-grade data 90%

“STAR” Study: ePRO Impact on Clinical Outcomes

Pa0entsreceivingchemotherapyformetasta0cbreast,lung,GU,GYNcanceratMSKCC

INTERVENTIONARMSelf-report12commonsymptoms• Priorto/betweenvisits,byweb• Weeklyemailreminderstopa0ents• Alertstonurses(byemail)• Reportstooncologists(atvisits)

CONTROLARM“Standard”symptommonitoring

RANDOMIZE

Outcomes

- QOL

- ERvisits

- Survival

TreatmentdisconRnuaRon,withdrawal,hospice,death

StraRfiedbylevelofpriorcomputeruseRandomized2:1forthosew/oprioruse

Basch:JAMA,2017;JCO2016;ASCO2017

Results

 766pa0entsenrolledbetweenJune2007andJanuary2011

 OverallsurvivalanalysisJune2016• Medianfollow-up7years• 517/766(67%)par0cipantshaddied

Basch:JAMA,2017;JCO2016;ASCO2017

Quality of Life

•  Assessedat6months,comparedtobaseline

•  Comparedtostandardcare,31%morepa0entsintheself-repor0ngarmexperiencedQOLbenefits(P<0.001)

1

53%38% 36% 28%

29%

28%53%

51%

18%34%

11%21%

0%

100%

UsualCare STAR UsualCare STAR

Improved

Unchanged

Worsened

P<0.001>6 PointsP=0.0059

Patie

nts(%)

PROUsualCare

1

53%38% 36% 28%

29%

28%53%

51%

18%34%

11%21%

0%

100%

UsualCare STAR UsualCare STAR

Improved

Unchanged

Worsened

P<0.001>6 PointsP=0.0059

Patie

nts(%)

PROUsualCare StandardCare

Self-Repor0ng

16%

15%

Emergency Room Visits •  Comparedtostandardcare,7%fewerpa0entsintheself-repor0ngarmvisitedtheEmergencyRoom,withdurableeffectsthroughoutthestudy(P=0.02)

Overall Survival •  Comparedtostandardcare,mediansurvivalwas5monthslongeramongpa0entsintheself-repor0ngarm(31.2vs.26.0months)(P=0.03)

•  Remainedsignificantinmul0variableanalysis:Adjustedhazardra0o0.832(95%CI;0.696,0.995)

•  5-yearabsolutesurvivalbenefitof8%

New Generation of Systems

AutomatedTelephoneSystemsMobileWeb

What can I do to manage my sleep problems? Tips to help you sleep:

x Tell your cancer care team about problems that are getting in the way of your sleep. Getting treatment to lower side effects such as pain or bladder or bowel problems may help you sleep better.

x Set good bedtime habits.

o Go to bed only when sleepy, in a quiet and dark room, and in a comfortable bed.

o Go to bed and wake up at the same time. o Avoid napping if possible. o Make sure your bedroom is not overly hot or cold. o Stop watching television or using devices with

screens a couple of hours before going to bed. � Devices like: iPads, laptops, and smart phones.

o Don’t drink or eat a lot starting about 2-3 hours before bedtime.

o Exercising too close to bedtime may make sleep more difficult.

� Exercise before 2:00pm promotes sleep. o Don’t watch the clock at night. o Keep out pets who wake you up.

x Don’t stay awake in bed for more than 5-10 minutes. If you do not fall asleep, get out of bed, sit in a chair in the dark until you are sleepy. It’s okay if this happens several times a night.

x Avoid caffeine after midday. Also cigarettes, alcohol and some ‘over-the-counter’ medications may interfere with sleep.

x Sleep medicine may be prescribed by your cancer care team for a short period if other strategies don’t work.

x Cognitive behavioral therapy (CBT) and/or relaxation therapy may help. For example, a CBT therapist can help you learn to change negative thoughts and beliefs about sleep into positive ones.

o Muscle relaxation, guided imagery, and self-hypnosis may help.

Ongoing ePRO Trial in Routine Cancer Care

 PRO-TECTU.S.na0onaltrial–currentlyenrollingpa0ents•  1000pa0entsreceivingcancertreatmentacrossU.S.communityoncologysites•  Evalua0ngprocessesforintegra0ngPROsintoworkflow

PATIENT

PROSYSTEM

CLINICIANS RESEARCHERS HEALTHCARESYSTEMS

FUTUREPATIENTS

PATIENTCARE

REALWORLDEVIDENCE

QUALITYASSESSMENT

DECISIONMAKING

SELF-EFFICACY

Resources for Health Systems/Clinics

User’sGuidetoIntegraEng

PaEent-ReportedOutcomesinElectronicHealthRecords

(2017)

hops://www.pcori.org/sites/default/files/PCORI-JHU-Users-Guide-To-Integra0ng-Pa0ent-

Reported-Outcomes-in-Electronic-Health-Records.pdf

User’sGuidetoImplemenEngPaEent-ReportedOutcomesAssessmentinClinicalPracEce

(2015)

hop://www.isoqol.org/UserFiles/2015UsersGuide-Version2.pdf

Summary of ePRO Use in Routine Care  Integra0onofpa0ent-reportedsymptomsintocancercareisfeasibleandisassociatedwithclinicalbenefits

 Thisapproachmaybeconsideredforinclusionasapartofstandardsymptommanagementtoimproveandmeasurequalityofcare

 Futureeffortsshouldfocusonstrategiesforimplemen0ngself-repor0ngintoclinicalworkflowandelectronichealthrecords