Using Technology to Enhance

Transcription

1 Using Technology to Enhance Clinical Trial Accrual SWOG Spring Meeting Neal J. Meropol, MD Chief, Division of Hematology and Oncology University HospitalsCase Medical Center Case Western Reserve University May 2, 2014

2 The Problem Clinical trials are the evidence base for improving cancer care Clinical trials represent high quality cancer care However, Very few cancer patients take part in clinical trials

3 How many ypatients actually take part? California Cancer Registry < 1% Al Refaie et al. Annals Surgery 2011 NCI Sponsored Coop Group Trials Enrollment % of incident cancer cases enrolled Lower in racial/ethnic minorities, older patients Murthy et al. JAMA 2004 NCI Comprehensive Cancer Centers % median

4 Barriers at the Point of Care Logistical Physician Patient 4

5 Key Determinants of Accrual for Patients Awareness Access Eligibility The Decision

6 Influences on Clinical Trial Decision Making Patients Doctors Families Communities Healthcare Teams/Organizations

7 Overall Goal To optimize patient decision making about clinical trials by improving preparation for consideration of clinical trials as a treatment option 7

8 Theoretical Model Knowledge Barriers Attitudinal Barriers Preparation for Decision Making Physician Encounter The Decision Miller, SM; Diefenbach, M. C-SHIP: A cognitive-social health information processing approach to cancer. In: D. Krantz & A. Baum, editors. Perspectives in behavioral medicine. Lawrence Erlbaum: New Jersey; p O'Connor, AM et al. The Ottawa patient decision aids. Eff Clin Pract 1999; 2(4):

9 PRE ACT Survey to assess knowledge, attitudes, and values Automated Feedback: Values clarification and top barriers Tailored Video Library 9

10 Welcome Screen Thank you for your interest in the PRE-ACT study. We are asking you to take part in this study because you are coming in for your first appointment with your doctor. As part of this study, we will ask you to: Read and approve Informed Consent documents (Informed Consent, HIPAA Authorization) Fill out a survey (this takes about 20 minutes) Look at some educational materials (this takes about 15 minutes) Fill out a second survey (this takes about 15 minutes) Two weeks after you meet with your doctor, we will ask you to fill out one more survey. It should take about 15 minutes. If you have any questions or concerns about this study, you can call the study team at or them at preact@case.edu. You will see this contact information on every screen. Meropol et al. ASCO 2013

11 Sample PRE ACT Video Library Preparatory Education About Clinical Trials Mr. Doe, below is a list of video clips that you can watch to get information about clinical trials in general, and information about common misconceptions about clinical trials. Click an item in the list to view a video. When you are done watching videos, click the Back Button. After you view the videos selected just for you, you will be given the entire video library to watch at your convenience. What is standard treatment? Is taking part in a clinical i l trial voluntary? What is randomization? Is there a clinical trial for everyone? Are there ways to deal with transportation and financial issues? How will clinical trials affect my family? Meropol et al. ASCO 2013

12 PRE ACT was compared to NCI text in a randomized multicenter clinical trial of >1200 adult cancer patients PRE-ACT improves: Knowledge Attitudes Preparation More satisfaction with PRE-ACT vs. Control 12 Meropol et al. ASCO 2013

13 PRE ACT was compared to NCI text in a randomized multicenter clinical trial of >1200 adult cancer patients 13 Meropol et al. ASCO 2013

14 14 RESULTS

15 Demographics Demographic Control PRE-ACT Combined Male % 41.5% 41.5% Female % 58.5% 58.5% White % 89.1% 88.5% Non white % 10.9% 11.5% Highschool graduate or less 23.8% 23.3% 23.6% Some college or college graduate % % 7% % Metastatic disease % 44.8% 46.0% Non metastatic t ti disease % 55.2% 54.0% Meropol et al. ASCO 2013

16 Top 5 Knowledge Barriers at Baseline Item Most clinical trials involve a placebo (sugar pill). Side effects in clinical trials are usually worse than with standard treatments. Standard treatments are the best treatments currently known for a cancer. Informed Consent mainly protects researchers from lawsuits. % Incorrect/Unsure 75.5% 65.2% 61.9% 59.9% 9% Patients in clinical trials must get their care at different places from patients getting standard 58.7% treatments. Meropol et al. ASCO 2013

17 Top 5 Attitude Barriers at Baseline Item % Agree I'm afraid of the side effects I'll have on a clinical trial. 51.9% I'm Im worried that the treatment I'd Id receive on a clinical trial wouldn't work for me. 41.5% I'm Im afraid I'll Ill get a sugar pill (placebo) instead of real medicine on a clinical trial. I'm Im afraid that my health insurance won't pay for a clinical trial. I wouldn't ask about clinical trials unless my doctor brought them up first. 39.3% 38.7% 38.1% Meropol et al. ASCO 2013

18 Knowledge about Clinical Trials Mean Arm Test correct (n) (of 19) SD p-value Control Pre (573) Post < PRE-ACT Pre (505) Post < Arm Mean change SD Control PRE-ACT p-value Meropol et al. ASCO 2013

19 Attitudinal Barriers 28 items; Higher score = more agreement with barriers Arm Mean Test (n) (1-5) SD Control Pre (570) Post PRE-ACT Pre (504) Post Arm Mean change SD Control PRE-ACT p-value < p-value < < Meropol et al. ASCO 2013

20 Preparation for Decision Making Higher score = greater preparedness Arm Mean Test (n) (0-100) SD Control Pre (578) Post PRE-ACT (506) Pre Post p-value < < Arm Mean change SD Control PRE-ACT p-value 0.09 Meropol et al. ASCO 2013

21 PRE ACT Program Satisfaction Question PRE- ACT Mean (SD) Control Mean (SD) Favors PRE-ACT p-value How satisfied are you with the amount of information you received? (1-5 most satisfied) 3.74 (0.77) 3.60 (0.79) How satisfied are you with the way the information was presented to you? (1-5 most satisfied) 3.86 (0.79) 3.65 (0.84) < Did this program help you feel more prepared to consider clinical trials as a way to treat your cancer? (1-5 a great deal) 3.62 (0.92) 3.43 (0.89) Which of the following best describes your feelings about the length of this program? (1, reasonable; 2, a little long; 3, much too long) 1.31 (0.52) 1.53 (0.63) < Did you find this program useful for making your decision about treatment for cancer? (1, yes; 2, no) 1.22 (0.41) 1.28 (0.45) 0.02

22 Conclusions Computer based approaches to patient education before the oncologist visit can improve knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. PRE ACT is more effective than NCI text in improving knowledge and reducing attitudinal barriers PRE ACT is associated with greater patient satisfaction than NCI text alone 22

23 Barriers at the Point of Care Logistical Physician Patient 23

24 Overall Goal To improve efficiency and accuracy of clinical trial ilidentification ifi i at point of care by automating the extraction of clinical information and matching to clinical i l trial ileligibility ibili

25 Clinical Trials Identification Approaches CT repositories and search engines (e.g. clinicaltrials.gov) Manual searching Manual data entry Patient entry database Critical mass of patients/studies required Automated matching fromelectronic medical records 25

26 Mobile Apps

27 Traditional Screening Physician evaluates patient and collects data Physician thinks about clinical trials Access clinical trials database Identify potential studies for disease/stage Assess eligibility Contact research staff 27

28 Manual Screening For Clinical Trials Penberthy et al. Contemporary Clin Trials 2010; 31:

29 What is Trial Prospector? An automated tool that extracts clinical and research eligibility data, runs a matching algorithm and displays clinical trial eligibility results at the point of care Hypothesis: Trial Prospector will Be accurate 29 Save time Be appealing to physicians Ultimately result in improved access and accrual to clinical trials

30 Methods Trial Prospector uses artificial intelligence and natural language processing to match thclinical i l ti trial eligibility ibilit to clinical information from multiple data sources Trial Prospector is platform agnostic andhipaa compliant, to permit future dissemination Clinical criteria for matching include: demographics, diagnosis, TNM stage, stage grouping, metastasis, and the three most recent lab values (CBC, renal function, liver tests, coagulation) 30

31 Trial Prospector Components and User Access Physician Secure Web Based Access Demography, Diagnosis, TNM, Stage Grouping, Metastatic Status Oncology Database TP User Interface Matching Algorithm Lab Database Last 3 Lab Values Automated Data Retrieval TP Database Eligibility Cit Criteriai Clinical Trial Database Parchman et al. ASCO Meeting Abstracts June 2013:

32 Trial Prospector Search Screen xxxx xxxx xxxx xxxx xxxx xxxx Parchman et al. ASCO Meeting Abstracts June 2013:

33 xxxx xxxx Update Option Protocol Document Eligibility Checklist Exclusion Report Parchman et al. ASCO Meeting Abstracts June 2013:6538

34 Use Feedback Pilot Study GI Oncology Clinic TP Deployment 60 New Patient Visits Clinical Patient Evaluation Patient Specific Survey SummaryExperience Survey Parchman et al. ASCO Meeting Abstracts June 2013:

35 User Experience Physician Survey Results for the Trial Prospector Group Did you review a TP report for this patient? To your knowledge was the information provided by TP accurate? Did TP save you time in identifying potential clinical trials? Would you recommend utilizingtp for eligibility screening? Trial Prospector (60) Yes Parchman et al. ASCO Meeting Abstracts June 2013: No 29 (72.5%) 11 (27.5%) 22 (75.9%) 7 (24.1%) 16 (57.1%) 12 (42.9%) 25 (89.3%) 3 (10.7%)

36 Summary Experience Survey Did TP allow you to spend more time with your patients? Did TP make it easier to find eligible ibl clinical trials for your patients? Did TP help you communicate with patients about clinical trials? Did TP make it easier to review protocols and eligibility checklists? Yes No 2 (18.2%) 9 (81.8%) 8 (72.7%) 3 (27.3%) 2 (18.2%) 9 (81.8%) 9 (81.8%) 2 (18.2%) Is TP easy to use and navigate? 11 (100%) 0 Is the TP interface visibly pleasing? 10 (90.9%) 1 (9.1%) Would you recommend TP to other Physicians? Parchman et al. ASCO Meeting Abstracts June 2013: (81.8%) 2 (18.2%)

37 Conclusions Trial Prospector is a point of care application that is a feasible and accurate means to screen patients for clinical trials in a busy outpatient oncology clinic Physicians generally found Trial Prospector to be easy to use and would recommend its use for clinical trial eligibility ibilit screening Program enhancements (e.g. functionality, user interface) and further testing areunderway 37

38 Study Team Supported by NCI R01 CA University Hospitals Seidman Cancer Center/Case Western Sarah Fulton Tyler Kinzy Tasnuva Liu Seunghee Margevicius i Neal Meropol Dawn Miller Mark Schluchter Karmanos Cancer Institute Terrance Albrecht Robert H. Lurie Comprehensive Cancer Center, Northwestern Al Bowen Benson, III Cancer Support Community Joanne Buzaglo Fox Chase Cancer Center Michael Collins (MCW) Brian Egleston Linda Fleisher (CHOP) Sharon Manne (CINJ) Dave Poole Suzanne Miller Ei Eric Ross Yu Ning Wong Cleveland Clinic Anne Flamm International Myeloma Foundation Michael Katz Fight Colorectal Cancer Nancy Roach

39 Study Team Jill Barnholtz Sloan Sarah Fulton Robert Lanese Patrick Mergler Neal J Meropol Dawn Miller Andrew Parchman Satya Sahoo Shiaqiang Tao James Warfe GQ Zhang Supported by NIH UL1TR000439, P30CA

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