Here are some recruitment strategies and challenges shared by some of our sites:
1. Early detection/contact
Early screening and tagging of potential participants by research nurses seemed to increase the chances of successful recruitment. If possible, presenting the trial before pregnancy allows ample time for the patient to review the trial with her health care professionals and her personal support group. Some sites have found that handing out brochures and personal contact cards to patients early on can go a long way in making them feel more comfortable with the trial by the time they are eligible. This may also reduce the chance that the patient will later change her mind and withdraw.
2. Investigator/Endocrinologist involvement
The involvement of the investigator/endocrinologist can go a long way in reassuring patients of any concerns they may have concerning joining the trial. As stated by one site:
“I would say the more involved the endocrinologist/investigators are with introducing the study and speaking with the patients, the more effective … Patients who have already seen one of the investigators prior to pregnancy for their diabetes care and built up a relationship/rapport with them are more likely to be comfortable/interested in any of the studies we recruit for.”
3. Team communication
Multiple sites have found that ongoing, open communication among all members of the patient’s health care team can be beneficial in identifying potential recruits. Discussing the trial at staff meetings is an effective way to raise awareness and to encourage all involved to keep actively screening for potential recruits. Team communication can also extend out into the community, by informing obstetricians outside of the site about the study, and encouraging them to refer potential recruits early in the pregnancy.
1. Resistance from the patient’s family and/or significant other
When approaching a potential recruit, it can be very helpful to consider the needs of her family/personal support group. Many sites have faced the challenge of having a willing patient with an unwilling partner. Some sites have found it helpful to meet the patient’s partner to explain the trial and to answer any questions. This can help to clarify common misconceptions. Also, some people are encouraged by the fact that their child will be followed up to 2 years of age.
2. Reluctance to start/stop metformin
Many patients are apprehensive when faced with the decision to start or stop a medication during their pregnancy. Since these patients are high-risk, they are reluctant to make any changes to their medications while pregnant, and do not want to change or complicate their care in any way. These are all common, valid concerns. However, it may be helpful to remind the patient that Health Canada has approved metformin for use in this study, and that metformin has been used in many studies of pregnant women, including women with type 2 diabetes, and no harm was shown. Metformin is also regularly used in women with polycystic ovary syndrome during pregnancy.
For patients who are reluctant to stop their metformin, it may help to remind them that by participating in this trial, we are one-step closer to answering this important question for future generations.