Patient/Family Interaction Training in the Fall 2011
by Brianna McSorley
BACKGROUND. The Center for Rare and Neglected Diseases (CRND) spring semester course BIOS 40450 appealed to many students because of the clinical research aspect of the class that was different from any other science class Notre Dame Students have taken. In this course, we went through nine Niemann Pick Disease Type C (NP-C) patient’s clinical records and quantified their disease progression using the Yanjanin et al 2010 paper developed by the NIH. These findings were published in the online PLoS One Journal with the title of “Defining Natural History: Assessment of the Ability of College Students to Aid in Characterizing Clinical Progression of Niemann-Pick Disease, Type C.” In addition to formulating disease scores, we also developed clinical summaries for the patients’ records. A clinical summary is a condensed document outlining the chronology of the most vital aspects of the patient’s entire medical file, which includes symptom onset, major surgeries and illnesses, disease progression, a complete list of physicians with contact information, and all drug and supplement history. These clinical summaries are vital for patients with rare diseases since they see many different clinicians and may see new clinicians more frequently as well. A long with sifting through the records developed by the NIH, we met and spoke with the leading clinicians and researchers in the NP-C community. This spring class focused mostly on the science aspect of the disease and all of the students became experts in this rare disease.
BIOS 60565: NEW MEDICAL RECORDS FROM PATIENTS. Because the CRND spring course intrigued many students, six students were interested in taking their knowledge of NP-C to the next level. This course was geared towards establishing a system of outreach to patients and patient service organizations, creating a system for obtaining and organizing new medical records, and continuing to learn about rare diseases and the rare disease community. Students were paired up and were assigned to a family to contact and interact with throughout the semester, ultimately obtaining their medical records. In return, students would provide the family with a complete electronic medical record and a clinical summary of the patient’s record, following the same guidelines used for the spring class. In addition, a narrative summary with the significant medical history was added to the end of the document for those who prefer reading narratives to charts.
Because it is crucial to maintain the patient’s privacy and rights, all of the students and professors involved with the patients had to strictly follow the IRB and HIPAA protocols. In order to ensure that privacy was kept, students first had to receive a consent form from the patient before receiving the medical record. Also, every phone conversation was recorded and conducted in a secure and private room. Both the emails and phone calls were monitored by Dr. Haldar to make sure that the students were following IRB and HIPAA protocols. When the electronic record was made, it was put in a password-protected PDF format. Every step of the process was secure and every student was thoroughly trained and carried out privacy codes in order to maintain the rights of the patient.
We developed a standardized method for patient contact and continuing communication that was effective in obtaining medical records, securely digitizing them, and ultimately generating a concise clinical summary for the patients to use in further clinical visits. Before the students began contacting patients, the students were trained to contact patients. Yes, most of us have volunteered in hospitals before and had some type of patient contact; however, we were never the link to contacting patients, maintaining a professional and personal relationship with them, and obtaining their medical records.
In the first part of the training, there was a series of mock phone conversations and emails. Each mock interview brought new issues into play of how to approach sensitive topics and develop personal and professional relationships with the patients and their families. This practice of writing and talking to classmates developed solid templates and scripts to help prepare the students for conversations with patient families. In addition, the work of program coordinator Marisa Truong, Michael Clark, and Dr. Kasturi Haldar over the summer had established relationships with several patient families through the NNPDF family conference. Each student pair was given background information about the families by Dr. Haldar, and the students were able to see previous email contacts between CRND and the patient families. This helped prepare the students to learn more about the families and gauge what would be necessary to discuss with the families and what would be repetitive. Though Dr. Haldar had previous contact with the families, it was the leap from professor to student that presented the first challenge as the Center for Rare and Neglected Diseases approached the issue of collecting patient files.
After the training and receiving the background information of the patient families, students were ready to contact their assigned patient families. Each pair then contacted their families via an introductory e-mail, explaining our role as students in BIOS 60565 and the structure of the class. We also included information about our prior experience working with NP-C including a summary of the PLoS One publication on our spring 2011 class outcomes. Also included in the email was a presentation by Dr. Haldar on the new concept of a patient medical file repository. In addition to the technicalities and information about the class, this introductory email stressed the importance of the patient’s privacy and explained that everyone who will be dealing with the records and the families will be following IRB and HIPAA protocols. We also sent the consent form in the email, stressing the importance of the patient’s consent before we begin the process of obtaining the records. In the final part of the email, we set up a time where we could call the patient families, informed them that all of the phone calls would be recorded, and that the phone calls would be conducted in a secure, private room. The students made sure that the patient families understood that at every step of the process all scripts, emails, and phone calls were approved and documented by Dr. Haldar.
After the introductory email, the students were more than ready to establish phone contact with the patient families. The initial phone conversation was based off of a script that was written by student partners and edited heavily by Dr. Haldar. This first phone conversation was a way for the patient families and students to learn more about each other, establish a relationship more on a personal level, and discuss the technicalities of obtaining the medical records. Most families already began contacting their doctors and the doctors were in the process of collecting all of the records for the families. Variations occurred from families as to how long it took for the records to be obtained from the patient’s doctors. Some families sent the records after two weeks, and other families sent part of the records at first, and didn’t receive the whole record until about six- seven weeks after initial contact.
The first two phone calls were essential for questions and technicalities that went along with obtaining the records, and they were a great way for the students to get to know their families. Beyond the first two calls, the rest of the phone and email contact with the patient’s family could be classified as follow up. The phone conversations were brief and mostly updates on the progress and clarifications of unclear details in the medical files. Contacting the patient families on a weekly basis helped keep the students on task and helped them work towards the end goal of completing the clinical summary within 30 days.
Many variations between families occurred, including variations in the way of contact, level of sharing personal information, and personalities of families themselves. Students need to understand that every patient family has been through a similar situation; however, they will not all be the same in how they share information and to what extent they will share personal information. One family was very open and shared almost everything about the patient and his family and even sent in videos and pictures of the patient throughout his life. They also were eager to keep in touch via phone contact and were very open to help out with the class and with CRND itself. Another family was more reserved and did not share too much personal information, especially over the phone. They were also less eager to keep in phone contact, so with this family, email contact was preferred after the first two phone calls. It is okay to have different types of communication with the families. Students need to gauge this from the family’s personality and vibe they give off, and students need to be adaptable and respectful of whatever the family wishes to share, to not share, and in what way they will share information. Another family was very eager to help and had many different blogs and stories about their children. This family had two children succumb to the horrible disease of NP-C, so the students assigned to this family were much more sensitive and relaxed in their interactions with this family. They were very cooperative and sent in both of the children’s records right away, but once the record was received, less contact was made with the family. Every family is different, and as long as all of the students are respectful and sensitive to their assigned families, the contact and process of obtaining their patient’s record will run smoothly.
It was a special moment to meet a family. One student’s experience at NNPDF conference showed him that many families are interested in doing anything to help their child and other children who suffer from NP-C. Many families were eager to give us records; however, some families did not follow through for whatever reason. Though they may want to follow through with connecting with CRND, the families are dealing with a child with a rare disease and that is an enormous burden in itself, not to mention it is very time consuming and an emotional and sensitive issue. Before contacting patients, the students need to understand that the families are changing their daily schedules to help CRND obtain patient medical records, and we need to understand that not all families can do this. Students need to respect the families that do not want to participate and do not push the issue. Some families’ children may be more severe in disease progression than the others, and when dealing with these families, no pressure should be put on them to obtain their child’s medical record. Every person who works through CRND needs to show compassion for families that suffer from a rare disease and try to understand the daily burdens that they are going through.
Meeting a patient was a great honor and a unique experience. After studying this horrible disease (NP-C) for so long and studying it so in depth, it was truly meaningful to meet someone who suffers from this disease. Though the child suffers from such a rare disease, he was very normal and did not let his disease stop him. His mother was also very attentive to him and it was obvious how much she cared about him. It was a special moment to see this love and to meet such strong people who are burdened with this horrible disease in their family. It definitely was more special to actually meet the family because it gave a new perspective on the whole outreach portion of the class. Talking on the phone, seeing pictures and videos, and sending emails is a great opportunity to interact with patients and their families; however, meeting them in person and spending time with them gives students a new perspective on the disease itself and the rare disease community in general. Meeting the patient and their family gave their symptoms a context and instead of seeing them as a medical record, we got to see them as real people.
The idea for obtaining patient’s medical records was to define as many natural histories as possible. Records were long and detailed, but they are fine to go through if students know what to look for such as major and minor domains and other prevalent symptoms of NP-C. The spring class helped us with this a lot because we were trained on how to go through records and though we didn’t score these records, we knew what we were looking for to include in the clinical summary. Having this background training was essential to establish an efficient method in going through the long, strenuous medical record.
After obtaining and organizing the records, the next step was to formulate a clinical summary for the patient families. It involves sifting through a large degree of information, often in a jumbled timeline, assimilating this data into a coherent “story,” and determining which data is essential to the patient’s disease progression. They are meant to be a concise, yet technical summary of the patient’s disease progression that a clinician could glance at and obtain knowledge of his or her patient’s unique medical history. The clinical summaries included information about the history and progression of symptoms, complete history of procedures, complete history of medications and supplements, and complete lists of physicians. After the student pairs formulated the clinical summaries, Dr. Haldar looked through the summaries and gave advice to the students on what should be changed.
After the final clinical summaries were formed, each student pair sent the clinical summaries to the patient families along with the electronic form of the medical record and closing remarks and gratitude for the generosity of the patient families to take the time to obtain the records and send them to us. Each student pair formed a personal, yet professional, relationship with the patient families, and all of the students appreciated getting to know a different side of NP-C from what we knew before. In addition to knowing all of the science and technicalities of the disease, we now gained insight about the patients and their families who are burdened by this rare disease. The process of getting to know the patient and his/ her family offered new insight in the medical history and the disease itself. Listening and communicating with the family was more than a tool for obtaining information about a set of medical files, it was a cathartic process for both the family and the students.
This fall 2011 course has proved that trained undergraduates can provide services useful for both families and the continuation of the large scale Clinical Research on Rare and Neglected Diseases. Providing support and tools to the families of the rare disease community is a valuable asset for the continuation of the program. With proper guidance, this research initiative will continue to flourish in the hands of undergraduate pre-medical students. Through both of the CRND classes, the students have gained the knowledge of the importance of becoming an advocate for the rare disease community, and they plan to continue with their efforts to help this community not only in the rest of their undergraduate career, but after they graduate, especially in medical school and when they are clinicians themselves.