Recruitment Strategies for Clinical Trials in Radiology:

Active vs. Passive Patient Recruitment

J Hollada

S G Ruehm

A Tognolini

W Speier

L Ristow

W Marfori

Rationale

• Patient recruitment for research studies is challenging

• Radiological studies involving potentially harmful ionizing radiation, such as computed tomography (CT), often defer patients from voluntary study enrollment

• The analysis of effective recruitment strategies is therefore of high interest

Radiological Clinical Trials: Challenges

• Radiologists often have limited direct patient interaction

• Radiologists typically do not control patient referrals for imaging tests

• Radiological clinical trials are often highly dependent on other specialists to refer patients for enrollment

Importance of Effective and Efficient Patient Recruitment

• Compliance with grant proposals and regulatory requirements is essential

• Exceeding proposed time frames increases costs of trial execution

• Inadequate approaches to patient recruitment may lead to a poor representation of the population under investigation introducing bias

• General: Important for advancement of knowledge, technology and overall public health

Objective

To compare the impact of active and passive recruitment strategies on cardiac CT based

research studies

Study Population

• Analysis of patient recruitment data over a 12-month period

• Total of 641 subjects:

– 279 females and 362 males (mean age: 66 +/- 10) were invited to participate in one of three IRB and HIPPA compliant cardiac CT research trials

• Recruitment strategies included both passive and active measures

Active Recruitment Methods

• Research Staff– Research staff: Strategic review of medical records– Eligible subjects:

a) contact via letters/flyers by mail b) follow-up telephone calls to confirm receipt of letter/flyer

– Research staff explaining study to interested subjects who responded to the letters/flyers, or who expressed interest during the follow-up phone call

• Physician referrals of pre-qualified patients

Passive Recruitment Methods

• Flyer Pick Up• Posters• Brochures

• Internet Postings/Ads– All 3 studies were posted on the UCLA radiology research page

• Word of Mouth– Patients referred family members, friends and colleagues

Placed in 5 different patient waiting areas and replenished monthly

Results

• Of 767 potential study participants contacted, 108 (14.08%) were successfully enrolled in one of three imaging research studies (cardiac CT)

• Active Recruitment: Of 738 potential study participants, 92 (12.47%) patients were successfully enrolled

• Passive Recruitment: Of 26 potential study participants, 16 (61.54%) patients were successfully enrolled

- Please note: Percentages represent the known amount of patients who were passively recruited and qualified to participate. Number of patients who saw flyers/brochures/posters/internet ads and chose not to participate remains unknown

Active Recruitment Results

• 85% of patients were actively recruited (92/108 subjects)

• Active Recruitment Strategies:

- Research Staff: 73% (79/108 subjects) successfully recruited

- Physician Referrals: 12% (13/108 subjects) successfully recruited

Passive Recruitment Results

• 15% of subjects were passively recruited (16/108 subjects)

• Passive Recruitment Strategies:

– Word of Mouth: 56% (9/16 patients)

– Flyer Distribution: 44% (7/16 patients)

– Brochure Pick Up: 0% (0/16 patients)

– Internet Postings/Ads: 0% (0/16 patients)

– Posters: 0% (0/16 patients)

Recruitment Strategies

• Active recruitment > Passive recruitment- Active recruitment strategies: enrollment of significantly more patients

per month than passive recruitment strategies (p<0.00001)

• Direct Recruitment via Research Staff > Passive Recruitment- The most effective method of direct recruitment via research staff

enrolled significantly more patients per month than all passive recruitment strategies together (p<0.00001)

Patient Recruitment Summary Table

Conclusions

• Active recruitment via dedicated research staff is a more effective method for recruiting patients to cardiovascular imaging CT research studies- Active patient recruitment allowed the questions and concerns of

potential subjects to be addressed whether via research staff or referring physicians

• Direct patient recruitment via research stass has the added bonus of providing a greater pool of potential patients that qualified for various radiological clinical trials

Clinical Relevance

• Successful strategies for patient recruitment require research staff dedicated to active patient recruitment

• Continuous training of research staff involved in patient recruitment is expected to improve the efficiency of radiological trials

• Further analysis of patient recruitment data derived from large scale clinical radiological trials are warranted to further improve recruitment strategies

Future Directions

• Cost Analysis of Recruitment Methods– Compare the cost effectiveness of each recruitment method to

further analyze what methods of recruitment work best for research studies involving cardiac CT