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The latest aggregation of patient attitudinal research.

The latest aggregation of patient attitudinal research.

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Acrp presentation 9.21.12 seattle Acrp presentation 9.21.12 seattle Presentation Transcript

  • Improving Enrollment through Patient Attitudinal Insight, Study Viability Assessments and Operational Best Practices ACRP Pacific Northwest Chapter September 2012 Meeting John Needham 215-348-3237 office 215-534-7421 mobile jneedham@needhamandco.com
  • Learning Objectives Review aggregated results from recent patient surveys:  What do patients think about trials  Where are they getting information about trials  What are their perceived barriers to joining  How has their disease affected their life and the relationship with their family  What are they expecting from the site in the way of retention efforts  How far are they willing to travel How we use this insight to better approach patients
  • A Recruitment Strategy is…a systematic process to review ourlessons learned, analyze the subjects’motives and potential barriers anddevelop a plan to generate predictableresults.
  • Uncover Barriers in Recruitment“What might get in the way of your participation?”  Logistical Barriers – time, transportation, cost  Attitudinal Barriers – what if randomized to their less preferred group  Social Barriers – quality and quantity of family support  Health Barriers – complicating co-morbid medical or emotional conditions  Work Barriers – job travel or anticipated job changes, schedule flexibility
  • Patient AttitudinalResearch Regarding Study Participation What have we learned and how can it help us enroll and keep patients
  • Maslow’s Hierarchy of Needs Being Needs Deficit Needs
  • Apply the Data to Our Strategy  Determine the recruitment difficulty level  Project enrollment ratios (time, money and staffing)  Shape awareness, patient education plan  Ensure relevance to your patient population  Prepare all the site staff  Understand what retention challenges will be
  • The Old Way: Interviews with 27 diabetes patients cost $140,000  Qualitative research conducted in Germany, Hong Kong and Colombia  In each country;  one focus group (each 90-120 minutes) with type 2 diabetes sufferers with chronic renal insufficiency and inadequate glycemic control  individual depth interviews (each 45-60 minutes) with type 2 diabetes sufferers with end-stage renal disease who have been on dialysis for at least 6 months and have inadequate glycemic control China, Hong Kong Colombia, Bogota • 1 focus group (5 respondents)• 1 focus group (6 respondents) • 2 individual depth interviews• 4 individual depth interviews Germany, Köln • 1 focus group (6 respondents) • 4 individual depth interviews
  • Newly Diagnosed Oncology Patients Most looking for “hope” and second opinion. Majority are diagnosed and begin treatment elsewhere; not treatment naive Do not know what a clinical trial is:  It’s what they do after the regular drug doesn’t work Hope they are not offered one so they don’t have to deal with those decisions  I don’t want to be a guinea pig Would participate if MD suggested  if the Dr. tells me to do it, I will
  • Currently Treated Oncology Patients Don’t understand purpose of trials  “Trials are what they do when they don’t know what to do with you? Standard treatment is best”  “I thought that was for rare diseases? I have regular old lung cancer.” Equate trials with experimentation  “I don’t want anything that hasn’t been tested.”  “Why should I waste the time I have left so somebody can monkey around with a new idea?”
  • Patients who did not participate in a Clinical Trial Being offered a trial means my condition is hopeless  “Thank goodness I didn’t get offered a trial, that means there is still hope for me.” Skeptical of science and scientific procedures  “Trials are for guinea pigs or the elderly who don’t have much time left anyway”  “I wouldn’t want to get a placebo and they do that to you without you knowing that.”
  • What is Most Importantto Potential ParticipantsSimilarity of Patient Responses in Different Therapeutic Areas
  • Which would most likely affect your decision to participate in a trial? HIV Patients 140 100% 90%Number of responses 117 120 80% 100 90 70% 80 60% 65 59 50% 55 60 50 40% 40 32 30% 20 20% 20 10% 0 0% ic ts n s n n in e er ct io is i ti o io Cl ov fe th at at fV i ca Ab n ns Ef O ur ti o ro ed yD pe de he ga be M m Si ft ud sti m ee Co lo le St ve Nu Fr ib Al In ss d Responses m re Po fro i qu Re ce Percentage an st Di
  • Over Active Bladder Patients Other Driving distance to the study clinic If this drug will do me any good Duration or how long the study will last Number of required study visitsScheduling study appointments in my already busy scheduleHaving to sit too long in the waiting room before being seen Getting to an appointment Birth control requirements Taking the medication correctly Possibility of receiving a placebo (sugar pill) Possible side effects of the study medication 0 20 40 60 80 100 120 140 160
  • Psoriasis Patients Decision to participate in clinical trial 40 35 30 25 20 15 10 5 0 n s n e r ud y ct s t io i sit t io nic ov he t fe sa fv ca cli ab ot fs ef n o i y e h o id e pe er ed ud th ngt e s om m b e m st lo fle ib l c nu fre ro m al s d f pos i re ce qu tan re dis
  • Which of the following would keep you interested in participatingin a study for a year or longer?HIV 120 107 103 101 100% Number of Responses 99 90% 100 86 83 80% 80 70% 60% 60 50% 40% 40 30% 20 20% 10% 0 0% g ts ts ice r kin ... tte en an ot e ar le tm cip rn th ws rp in rti de n po lo ne to pa in ve ap en ly em er th ra m g th tr on in rt m to en m fo M co ee co tm rs to Responses m up he in s to po uc rd of ty Ap ca Vo Percentage ut ni to ck tu in or ba Pr pp ed O Fe
  • Which would keep you interested in a study for 3 months or longer? USA OAB Patients Other Having access to my records the end of the study The hope of relief from my symptoms "Appreciation items" when completing milestones in the study (up to $50 total) Monthly newsletter containing OAB related information Telephone reminder prior to my next appointment Appointment reminder notice by mail or email "Thank you" letters after kept medical appointmentsOpportunity to meet other participants involved in the trial, in a group setting Free local or national support group membership 0 20 40 60 80 100 120 140 160 180 200
  • Which would keep you interested in a study for 3 months or longer? EU OAB Patients Other "Appreciation items" when completing milestones in the study "Thank you" letters after kept medical appointments Having access to my records and progress during the study Vouchers for travel expenses and parking Appointment reminder notice by mail or email Telephone reminder prior to my next appointment M onthly newsletter containing OAB related informationOpportunity to meet other participants involved in the trial, in a group setting Free local or national support group membership Regular access to a specialist doctor The possibility of relief from my symptoms 0 10 20 30 40 50 60
  • co m pe ns at e tra su ve pp l 10 15 20 25 30 35 0 5 ex or pe t gr ns ou es p m m em ee be to rs th hi p er pa rti ci "th pa an nt k s yo u" le Psoriasis Patients tte re rs m in de te rn le ot ic ph on e e re m m on in de th ly r ne w "a sl et pp te re ci r at io n ite m s" What would keep you interested in a 3 month trial ot he r
  • CareforPEAttitudinal Research Insights 420 responses in <1 week 10 countries OUS10% enrollment after 90% of timeAgency never tested message
  • Untested Image: Effective? Countries: Austria Belgium France Germany Italy NL Spain Sweden UK Bulgaria Czech Rep Hungary Poland Romania
  • Male Summary 78% experience with every partner Poland, Hungary responders youngest; Italy, US/UK oldest 84% have never tried OTC products Emotions:  Embarrassed  Insecure  Disappointed  Anxious  Frustrated  Let down  Angry
  • Female Summary Mixed results in comfort level talking about intimate details  Yes UK, Italy, Poland  No Germany, Netherlands, Hungary 72% do not help partner with PE Married 47%, living together 10%, not living together but monogamous 37% (varies) Emotions: disappointed, depressed, irritated, embarrassed, frustrated
  • Clarity Gained Opioid concern ~ 1/3 Yes vs. 2/3 No 2/3 of men feel they will not outgrow PE 2/3 seek info on the internet 10% of males tell friends; 40% of women do Italy, Hungary, Romania most hits: > 50 in 1 day Sweden, France, Czech Republic: single digits
  • Uncertainties Pharmacotherapy ~ 50/50 33% of males unwilling to speak with MD ~ 50% talk with partner; 28% partners try to help <10% have been in a trial Is this condition sufficiently urgent to join a study: 12% male and 23% female say PE strains their relationship
  • Looking Forward Target: >40 & married First time help seeker, not too afraid to talk Need open minded female partner; more common in major cities/ liberal? Messages: help each other, increase positive experience, decrease anxiety and sexual frustration
  • Surprise! Failed Image: why?
  • Patient Attitudinal Research www.Tiredofcrohns.com Completed in 6 days Google Word Search9,700 patients in Facebook Forum
  • In one word or two words can you describehow Crohns affects your quality of life Greatly, Badly , severely diminished  cannot walk, swelling of Unpredictability Colon NO ENERGY, run down , exhaustion,  terrifying tired  ruined my life 2 Disruptive, discomfort  debilitating balancing act  affects brain; depressing Daunting , challenging  Stress, stress and only stress inconvenient but my case is very mild  life stopped; destroyed always present  took away my freedom confined to my home a great  uncomfortable deal 2  Drastically restricting embarrassed  I try not letting it affect me too constantly tired and underweight much frustrated, irritable  Significantly, varies - not devastating now. What Life? I have a part-time life  definitely disabling more worried  completely and totally need to know where the bathrooms  limits it are  SELF DESTRUCTION painful and unpleasant  "Up/Down“ sexual problems  irritating & annoying cannot work, 2  scared
  • What would be one word to describe how your family feels about your Crohns concerned /worried 12  Uncomfortable supportive 6  terrified understanding/helpless 6  adjustment Sympathetic 5  not too much Sad 5  helpful hating 4  too much expenses on meds confused 3  nothing misunderstanding 2  considerate devastation 2  limited overwhelmed 2  frustration compassionate 2  IGNORANT empathetic  cancer would be better Acceptance  tired anxious  Wish we could make it disappear unfortunate  upset Inconvenient  Doesnt matter to them
  • Do you have concerns about receivinginfusion therapy (IVs) 40% 60%
  • Are you concerned or apprehensiveabout needles and or injections? 30% 70%
  • Where would be a good place to put messagesabout our clinical trial (pick 2)?
  • Where do you look on the Internet? Google it 12 Crohns sites support group, CCFA 10 Web MD 9 HealingWell.com 5 Facebook. 3 Inspire page 3 yahoo search 2 forums 2 mayo clinic, 2 online medical journals Cleveland Clinic, Johns Hopkins website Oley group medicinenet.com, livingwithcrohns, Crohns networks clinical trials.gov nacc nhs web, md junction support group
  • Are Crohn’s Suffers Athletes?
  • …or do they look like this?
  • Chronic PainPatient Attitudinal Research Google Word Search Facebook ad words
  • What is your age range? 51 - 80 124Age Ranges 36 - 50 91 18 - 35 44 Number of Responses
  • What type of doctor do you see regularlyfor your pain? 44, 12% Primary care 18, 5% Orthopedic specialist 151, 40% 37, 10% Pain management specialist Neurologist 89, 23% Psychiatrist 38, 10% Other
  • My pain feels like (fill in the blank): 5, 4% Prison; Constant pain throughout the body 11, 9% A constant toothache but in the lower back Someone is torturing me 14, 12% Im being crushed; every bone in my body is 39, 33% broken Throbbing; at times Excruciating 13, 11% Aggrevation; Unbearable; Controls Me I have been repeatedly run over by a semi. 10, 9% Or crushed with a hammer 7, 6% Fire, Burning, stabbing; Sharp Pains; 15, 13% Lightning; Hell 4, 3% Something I just want to go away and never come backComments with fewer than 4 responses:Terrible, unmanageable, unable to take much more, My head lives in a vicethat crushes my head near implosion, My body is literally falling apart,Sometimes Im dying, other times I wish I was, Stiffness and pain in myjoints, Liquid metal running through my neck and spine, Constant, extrememenstrual cramps as bad as "birth & labor" pain, Breaking in half at backtraveling down right leg; extreme leg pain, An axe splitting my head in two,rocks in my shoulders, neck, and lower back, spikes in joints, Death,
  • What one or two words describe how Chronic Pain affects your quality of life? 1, 1% Dibilitating / Tiring / Causes Fatigue 8, 5% 16, 9% Destroys / Ruins / No QOL / What Life? / Depressed 20, 12% I concider suicide everyday because of no end to pain ever I can not describe it but it ia always there Slows me down / Unable to do a16, 10% number of things now / ADL Worrysome 62, 37% Hate it; Sucks Excruiating 24, 14% Confining / Limiting / Feeling like a Prisoner Frustrating / Annoying / Stressful 3, 2% 14, 8% 1, 1% Driving/ Alertness / Availability 2, 1%
  • How far/long would you be willing to travelto be in a Chronic Pain clinical trial? 120 100 97 Number of Responses 80 60 63 59 40 20 21 0 < 15 minutes < 30 minutes Up to an hour More than an Distance / Time Traveled hour
  • What information could we provide you so you would be ableto make a good decision about whether a clinical trial is rightfor you? Check all that apply: An informational website my family doctor could review Information on what is required of me as a participant 134, 9% A list of the possible side effects 179, 12% Information on compensation such as travel costs 204, 14% 157, 11% I would like to speak to other study participants before enrolling and during the study I would like access to my medical records and any test results 137, 9% 202, 13% I would like information for my family so they understand the study Flexible office hours to accommodate our 120, 8% family schedule Information on my rights as a participant 156, 10% and the privacy of my medical records 156, 10% 65, 4% I would like to speak with a pain specialist whenever I have questions or need answers
  • What might impact your decision when consideringparticipation in a clinical study that lasts for about 3 months? Check all that apply: Location of Doctors office 36, 4% Length and number of office 126, 15% visits required for 206, 24% participation Effectiveness of study drug If my travel costs and parking141, 17% will be paid for 164, 19% How long each doctor visit will be 176, 21% Other
  • Where would you most likely learn about Chronic Pain Clinical Trials?120 108100 80 67 60 46 40 20 8 5 4 4 2 0 1 Facebook Local chapters Churches Newspaper Doctors office Pharmacy Health food Internet sites Grocery store networks of Chronic stores about Chronic pharmacy Pain suppport Pain aisle groups Places to learn about Chronic Pain Clinical Trials
  • Which image represents how the chronic pain makes you feel; which do you relate to? 32, 12% Chronic Pain 1 7, 3% 42, 16% Chronic Pain 2 Crushed by Pain Pain-Back 39, 15% 27, 11% Pain-Barbed Pain-Bolt Pain-Cracks7, 3% 47, 18% 15, 6% Pain-Masks 14, Stamp Out 5% 29, 11% Weight of World
  • COPD Responses
  • Do you feel that your Doctor understands your condition?32% 34% a. Not as concerned as I would like b. Yes c. No 34%
  • Do you feel that you have received Are you looking for new treatmentenough information from your Doctor, options or different medicationsclinic, support group or the internet to which may perform better than yourhelp you manage your condition? current prescription? 70% 63% 60% 60% 50% 40% 37% 40% 30% 20% 10% 0% a. Yes b. No a. Yes b. No
  • Are you experiencing unwanted side Are your side effects unpleasanteffects from your current medication? enough to interest you other medical therapies?49% 50% a. Yes 51% 50% No b. No Yes
  • How would you feel about joining a research study in which you will be required to stop using your current medication; some patients will receive the study drug and some may be given a placebo (sugar pill) ? 43% 22% 17% 18%a. No thanks, my symptoms b. Id be willing to change c. Not sure. Id need more d. I need to check with my are too severe my current medication to information before deciding doctor first join the study
  • What are your top 3 reasons for consideringa clinical trial? My current drug is not working well enough I don’t like the side Its too late for me, but Other (please be 15% effects of my current Id participate to help specific) drug others 7% 7% 19% I can not afford the prescriptions and this is a way for me to get treatment 5%I know someone who was in a trial and it helped COPD prevents me from 4% My doctor thought it participating in certain would be a good idea physical activities 6% 37%
  • What are your top 3 concerns about enrolling in a clinical trial? Other (please be Possible side effects of specific) Driving distance to the the study medication 2% study clinic 18% 17% Possibility ofIf this drug will do me receiving a placebo any good 18% 15% Taking the medication correctlyDuration or how long 1% the study will last 6% Number of required Having to sit too long in study visits Scheduling study the waiting room before Getting to an 8% appointments in my being seen appointment already busy schedule 5% 7% 3%
  • Whose recommendation about a clinical trialwould you respect the most? The internet Other (please be 5% specific) What I see 7% on TV shows like Oprah 0% Pharmacist 1% A previous trial participant 9% One of my friends 1% Family doctor (GP) 16% Pulmonologist 61% A nurse 0%
  • Where do you look for or find most of your health information? RA Crohns COPD Depression OAB43% 42% 38% 31% 28% 23% 21% 18% 18% 18% 16% 13% 12% 10% 10% 5% 6% 6% 4% 2% 0%The Internet Doctor Books or Newpaper Support Groups Magazines Articles
  • Would a dedicated website for the study keep you interested in participating? 87% 87% 76% Psoriasis COPD OAB HIV 69% 31% 24% 13% 13% Yes No
  • The Recruitment Metaphor1 Fish where the fish are.2 Know what they are biting on.3 Know who the Keepers are. 4 Find the best fishermen.
  • Participants have expectations: What are the potential side effects Speak to the PI at every visit All travel / parking expenses provided A strong desire to meet other participants Create a supportive website just for the study participants A mechanism to tell friends about the study Progress reports and lab results through the trial on how they are responding to treatment
  • Most Important to Potential Participants Regardless of the condition, addressing potential side effects with a potential participant is of paramount importance Participants need user friendly literature about the study to share with their family and their family doctor Participants want to talk with specialists or providers on an on-going basis if they are going to remain in a study
  • Proven Solution #1 Possible side effects sheet Taken from protocol Handed to each participant
  • Select the Best Image
  • Which Images Resonate with Patients
  • Which Would You Select
  • What is Wrong with this DiabetesRepresentation?
  • Which better represents OAB?
  • What image would get your attention so you might considerlearning more about a Crohns clinical study?
  • What image would get your attention so you might considerlearning more about a Crohns clinical study? 28% 16% 9.5% 8%
  • RA Survey Results-Images
  • Survey Results-Images
  • Survey Results-Images
  • Survey Results-Images 47/163 = 29% 19/163 = 12% 9/163 = 6%
  • Examples of a CROs Branding Will this help Enrollment?72
  • Study Identity – Important, butWill these Tools help Enroll patients? Wallet Welcome Appointment Card Letter Distraction items for study visits Emergency Card Backpack for study medication
  • Question and Answers Content Discussion