RECRUITMENT The Sites PerspectiveCharisse SpenceResearch Manager – Geelong Cardiology Research Unit - Barwon Health

INTRODUCTION

1.Recruitment Planning

2.Recruitment Strategies

3.Successful Implementation

4.Evaluating Recruitment Success

5.Recruitment Trouble Shooting

6.The key to successful recruitment

1. RECRUITMENT PLANNING

FEASIBILITY – Study Selection

• Careful selection at the feasibility stage is paramount

• Good understanding of the protocol is essential

ASK YOURSELF

• Do you have the patient population? Do some research. Review available databases at your institution. i.e. establish annual /monthly hospital admission numbers for this participant population

• Will you realistically meet your targets?

FEASIBILITY – Study Selection

• Will it compete with other studies? Avoid studies that are exactly the same. However, its OK to conduct studies that have similarities and will complement each other. Look for the subtle differences.

• Have you got the manpower to recruit the participants?Annual leave, LSL, ? Need to employ staff

• Review previous study experiences, what worked what didn't, liaise with relevant specialty areas

• Don’t be afraid to decline the study.

http://www.troll.me/meme/serious-dog/page/1/

FEASIBILITY – Study Selection

FEASIBILITY - Budget

• Having adequate funds to aid recruitment is essential

• Brainstorm recruitment strategies at feasibility

• Incorporate Recruitment strategies into your budget

• Consider if the study requires a select population? Ensure the budget covers the screening time they will necessitate

• Don’t let distance be a hindranceEstablish adequate travel reimbursement

FEASIBILITY - Budget

Hospital Access/Parking – Reduce the Burden (make it as easy as possible for patients to attend visits)

• Parking reimbursement

• Petrol reimbursement

• Taxi transfers – Cab Charges

(Have the costs fixed within the budget - avoid

complicated ‘separate’ invoicing and tracking, they are

time consuming)

FEASIBILITY - Budget

• If the study is amenable to advertising, incorporate

‘advertising’ costs into your budget.

• Would recruitment be better enabled with the

involvement of additional healthcare professionals?

Ensure there is adequate provision for

education sessions/ meetings/ seminars/ SIV’s.

http://blog.dwolla.com/7-smart-tools-for-tracking-your-finances/

Ensuring funds to cover Recruitment

2. RECRUITMENT STRATEGIES

STRATEGIES – Early Approval

GOLD STANDARD…….in a perfect world!• Avoid Ethics/Governance approval from eating into your

recruitment time• Depending on the study… pre-screen where possible..• Aim to have patients lined up ready to call• Send consents as soon as RGO approval granted• Aim for first patient in as soon as possible post SIVREMEMBER• Australia may be added later than other countries• ROW may have rapid enrolment• Enrolment may become stratified • Studies can close prematurely• Recruit early and recruit swiftly

STRATEGIES – Participant Selection

• Long studies – will retention be a problem?

• Multiple Visits – working/retired/distance?

• Multiple bloods/procedures

• Evidence of non-compliance…Beware

• Debility/Mobility - Support Network?

STRATEGIES - Study Population

OUTPATIENT trials

• Traditional Advertising

• Refined data base searches at an Institutional level

INPATIENT trials

• Acute Studies “Round the clock screening”

• Ward rounds

• Electronic Alerts via EMD when patients with certain medical

conditions present

• Recruit registrars/ ward nursing staff

• Visual reminders around the ward “call me if…..”

STRATEGIES - Utilise Resources

OPTIMISE TECHNOLOGY AND AVAILABLE RESOURCES

• HIS/ Medical Records /EMR Searches

• IT / coding refined searches

• Surgical Lists / Ward handover sheets

• Daily Ward rounds – Face to face interaction is

invaluable

STRATEGIES - Utilise Resources

BE CREATIVE APPROVED ADVERTISEMENTS………

NOT JUST FOR NEWSPAPERS

• Pathology centres / Medical imaging

• GP waiting rooms /Outpatient Departments

• Bowls Clubs / Golf clubs

• Retirement villages

LOOK AT ALTERNATIVE FORMS OF ADVERTISING…………..

STRATEGIES – Banner Advertising – Really?

• http://www.impactbnd.com/blog/10-laughable-reasons-to-transition-from-outbound-marketing-memes

http://www.impactbnd.com/blog/10-laughable-reasons-to-transition-from-outbound-marketing-memes

STRATEGIES – Banner Advertising – YES!

Banner ads are often rectangular and located at the top/side/bottom of a web page. They are basically an Ad that when clicked on links you to another web page

• In Clinical Trials, the ad allows the user to be directed to a page with

general information about the study

• From here potential participants can register their interest to

participate in the clinical trial

• They are then asked to complete an online and/or phone screening

questionnaire with main inclusion/exclusion criteria

STRATEGIES – Banner Advertising

• The questions asked have all been approved by a HREC

• The user can even self-select the most convenient location where

they may participate

• The results for advertisement campaigns are monitored real-time,

therefore all registrations are actioned promptly

• The recruiting site contacts the applicant directly (they will have the

persons contact details via a secure online account for that study)

Online Advertising

Study information

Questionnaire –Incl./ exclusion

Choice of nearby Investigator site

Sign up to volunteer for trial

Site access user’s data

STRATEGIES

• Perseverance, thinking outside the box…….

3. SUCCESSFUL IMPLEMENTATION

IMPLEMENTATION - Approaching participants

• Principal Investigator/ Sub-Investigator – Where possible first line approach

• When PI not available to call – explain that the Principal Investigator has delegated this task to you

• Friendly Phone Manner – Fundamental

• Find a balance – ‘Inform without overwhelming’

• Encourage face to face consultation with the doctor with no obligation or commitment

IMPLEMENTING – Provide RelevantInformation

• Purpose of the study

• Size of the study

• Your sites involvement

• Information about the Study Medication

• Potential benefits

• Potential risks

• What their commitment will be (visits/bloods etc.)

• Duration of study

• What happens at the end of the study

IMPLEMENTING – Participant Confidence

• Develop rapport – You must have confidence in the study

• Be transparent • Reiterate that its voluntary, don’t have to participate • Encourage discussion with their family• Explain Placebo – potential to receive, %• Let them know how you got their number

(telemarketers)

IMPLEMENTING- In Summary

• Make it EASY – Accommodate the participant, be flexible

with appointments, phone calls etc.

• BE PATIENT – Incremental information, may require

several visits/calls before participation

• FOLLOW-UP - If you tell a participant you are going to call

them back at a specified time DO IT!!

4. EVALUATING RECRUITMENT

SUCCESS

EVALUATE – What works, what doesn’t?

It’s important to monitor Recruitment Success / Failure Closely

• Number of participants pre-screened

• Number of participants eligible/ called

• Number of consents sent?

• Reasons for refusals both pre/post consent being sent

• Screen Fails

• Reasons for Screen fails

EVALUATE - and Improve

• Its simple…adapt your methods of recruitment accordingly so that you see improvement

• Use the data gained during the evaluation period for future feasibilities…. Don’t make the same mistakes

5. RECRUITMENTTROUBLESHOOTING

TROUBLESHOOTING

• Don’t overcommit to studies that are difficult to recruit for

• Keep the GP’s abreast of your research, pre-empt their

concerns with education sessions/information flyers/ GP

send outs

• Complex studies create complex problems – be wary

• Nobody likes a long consent – reduce the length of the

document where possible.

• Increasing demands on study coordinator’s is resulting

in reduced time for recruiting patients!!!!

TROUBLESHOOTING – More time for what matters…. RECRUITMENT

EXCESSIVE TRAINING – Expectations have become unrealistic and non-sustainable at a site level.

• Recognition of prior learning• TransCelerate – Needs to be adopted by all sponsor’s nationally• Sites must be selective, how many people really need this training?• Mandatory funding for all training performed

SPONSOR’s /CRO’s REQUESTS – Need to consider how they can best help sites, implement initiatives which reduce the sites workload.

• Simplifing processes• Print documents and post them don’t ask SC to do this. • Provide pre-addressed, reply paid envelopes for ease of returning docs

Don’t make assumptions about computer literacy – Varying degrees of PC skills, provide guidance and support to save wasted time

TROUBLESHOOTING - More time for recruitment!

SLOW ELECTRONIC CASE REPORT FORMS/ PORTALS / IVRS/IXRSSponsors need to consider the cheapest option is not always the best option. More time should be spent determining which is the most proficient systems for your study.

• How long does it take to turn a page?

• Can a single visit be on one page so no

page turning is required?

TROUBLESHOOTING - ECRF Considerations to give time back to recruiting!

• 24/24 accessibility - Can upgrades be performed without

blocking user access?

• Can user ID’s/passwords be sent with clearly defined study

name and protocol number. (why do we need to change

passwords so regularly?)

• Can SAE’s be performed in paper format when system is down

or primary coordinator away?

• Help lines that are Toll free, Speak English and are able to

Help!

TROUBLESHOOTING - ECRF Considerations to give time back to recruiting!

http://www.samanage.com/blog/2013/05/the-10-funniest-it-memes/

6. THE KEY TO SUCCESSFUL

RECRUITMENT?

The Key??

Planning, implementing and evaluating recruitment

strategies that work

• Remember to get back to basics

• Do your homework

• Utilise resources and technology available

• Make time for recruitment

• Most importantly…………….. You will need

A DEDICATED TEAM!