MOBILE PATIENT-REPORTED OUTCOME (PRO) ASSESSMENT TO DRIVE ADHERENCE Heather Jim, PhD Moffitt Cancer Center heather.jim@moffitt.org

There are no conflicts to disclose

LEARNING OBJECTIVES

After reading and reviewing this material, the participant should be able to:

•   Describe the benefits of collecting PROs as part of clinical trials and standard care

•   Identify electronic methodologies for collecting PROs and other patient-generated data

•   Discuss ways in which PROs can contribute to recovery after cystectomy

PATIENT-REPORTED OUTCOMES

“Any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”

Disease Symptomatology

Treatment Side Effects Quality of Life

Kluetz et al., Clin Cancer Res 2016; 22:1553-8

•   Comparison of PROs versus provider ratings of symptom severity in 1,933 patient-provider dyads

PROVIDERS TEND TO UNDERESTIMATE PROS

Pain Fatigue Anorexia Dyspnea Diarrhea Patient 67 71 47 30 14 Provider 47 54 25 16 6

0

20

40

60

80 %

pre

vale

nce

Laugsand et al., Health Qual Life Outcomes 2010; 8:104

•   Comparison of PROs versus chart-abstracted CTCAE ratings for common symptoms in 163 patients receiving standard of care chemo

•   Examined ratings as predictors of risk of death and ER visits

TOXICITY REPORTS AND OUTCOMES

HR death p HR ER visit p Moderate fatigue Patient 1.46 .23 1.18 .48

Clinician 2.75 <.001 1.87 .004 Moderate pain Patient 1.47 .13 1.44 .09

Clinician 1.56 .08 1.84 .004

Basch et al., J Natl Cancer Inst 2009;101:1624–1632

PROS CAN IMPROVE CLINICAL BENEFIT

•   766 patients starting chemotherapy randomized to clinic-based symptom monitoring (n=441) or standard care (325) § Tablet or kiosk

•   Printed report for providers

•   Nurse alerts triggered for severe or worsening symptoms

•   Followed for 6 months

Basch et al., J Clin Oncol 2016; 34:557-65

PROS CAN IMPROVE CLINICAL BENEFIT

•   Improved one-year survival (75% vs. 69%)

•   Longer time on treatment (8.2 months vs. 6.3)

•   Fewer patients treated at the ER (34% vs. 41%)

-8

-6

-4

-2

0

Intervention Control Basch et al., J Clin Oncol 2016; 34:557-65

Change in QOL

PATIENT-REPORTED OUTCOMES MEASUREMENT SYSTEM (PROMIS)

•   Numerous symptoms assessed

•   Create web-based surveys through Assessment Center

•   Templates available through data management and patient portal software

•   Some measures will be available through EMR software

http://www.assessmentcenter.net/ac1/AssessmentCenter_Manual.pdf

PATIENT REPORTED OUTCOMES VERSION OF THE CTCAE (PRO-CTCAE)

https://healthcaredelivery.cancer.gov/pro-ctcae/

SYMPTOM MONITORING: FACILITATED BY TECHNOLOGY

http://www.pewinternet.org/2017/05/17/tech-adoption-climbs-among-older-adults/

Americans Use the Internet

Own a smartphone Own a tablet

≥ 18 years 90% 77% 51% ≥ 65 years 67% 51% 32%

PASSIVE ACTIVITY AND SLEEP MONITORING

Actigraph Link MiniMitter Actiwatches

R03 CA126775 R01 CA164109

Jim et al. Health Psychol 2013; 32: 768-774

Rosenberger et al. Med Sci Sports Exerc 2016; 48: 457-465 http://thewirecutter.com/reviews/best-fitness-tracker/

Passive Activity and Sleep Monitoring

Garmin Vivosmart HR FitBit Charge 2

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RECOVERY AFTER CYSTECTOMY •   Poorly controlled symptoms after cystectomy may

indicate complications

•   Complications occur in up to 50% of patients

•   Primary driver for hospital readmissons

•   Patients do not always report symptoms in a timely manner

•   Home-based symptom reporting with provider alerts may improve outcomes

Shabsigh et al. Eur Urol 2009;55:164-74

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AIM 1: SELECT RELEVANT ITEMS •   Aim: To identify clinically-important symptoms that

warrant home based monitoring

§  Selected symptoms from existing measures, literature, PRO-CTCAE

§  Clinician stakeholders ranked list, added symptoms

§  Collaborated with NCI to adapt PRO-CTCAE items

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AIM 1: SELECT RELEVANT ITEMS •   Nausea •   Vomiting

•   Diarrhea

•   Abdominal pain

•   Fatigue

•   Chills, sweats, feverish

•   Bleeding, redness, discharge at surgical site

AIM 2: CREATE INTERFACE

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AIM 3: USABLITY TESTING •   Evaluate patient perceptions of length of survey,

content, question comprehension, electronic interface in 10 patients

•   Pilot test during 6 week post-surgery period in 15 patients

•   Obtain feedback from 12 providers about clinical integration and utility

CONCLUSIONS •   Monitoring and managing PROs have the potential to:

§  Improve clinical benefit §  More accurately capture toxicity

•   New technology can facilitate collection of PROs and other patient-generated data

QUESTIONS?

Scientific American, November 1975