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Better Service Design for Clinical Trial Screening 

Clinical Research Coordinator 

Dana Farber Cancer Institute 

Skills: Service Design/Workflow Design 

Independent Initiative 

Project Duration: 2 months (2019)

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Improving the workflow of clinical trial screening and enrollment to design better experiences for patients. 

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Problem Space

Metastatic breast cancer patients spend months to years jumping from one clinical trial to another because they are often the only treatment option available. The screening process required to enroll on a protocol can be exhausting to patients due to the lengthy series of assessments and emotional battles that accompany the disease. The goal of this project was to identify opportunities to improve the workflow of screening procedures to improve the patient's enrollment experience.

Design Strategy & Research Process

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Empathize 

Define

Create

Test

Implement

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Meet Mary  

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  • Stage IV metastatic breast cancer patient

  • 62 years old

  • Participated in 2 previous clinical trials 

  • Developed a trusting relationship with her care team 

  • Has a husband, dog, and two adult children 

  • Lives 40 miles outside of the city where DFCI is located

  • Owns a small business, but planning to retire soon 

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Patient Journey

As a clinical research coordinator, I was responsible for facilitating the completion of screening assessments. From direct work experience, observations, and conversations with providers, nurses, and patients, I took a look at the typical patient journey for someone enrolling on a new clinical trial. The journey map helped me understand where I could impact process inefficiencies to improve the patient experience. 

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Breast Cancer Patient Journey.PNG

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There is an opportunity to intervene and redesign the workflow surrounding "screening blood draws" to directly improve the experience of a patient enrolling on a new clinical trial.

 

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After reviewing the patient journey, I outlined the care team journey and asked myself, "As a clinical research coordinator, where can I directly make an impact?". I was able to identify the specific touchpoint that presented an opportunity directly related to my role.  I noticed the coordinator plays a prevalent role during the lowest emotional state on the patient journey: the initiation of screening procedures starting with blood work.  Overall, screening appointments are quite demanding on patients depending on the complexity of the clinical trial. 

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By redesigning the process of initiating a blood draw, there is an opportunity to speed up the initiation of screening procedures and decrease the time a patient spends waiting. Since blood work is often the first step in screening and an activity that is likely to repeat on a metastatic patient journey, there is a large opportunity for impact. Executing an efficient process is critical in helping a patient feel like they are not wasting time in the waiting room, progressing through their required screening assessments, and ultimately verifying eligibility for treatment efficiently. 

Current Blood Draw Workflow​​ 

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Time (min)

Patient

Nurse

Coordinator

Materials Manager

T = 0 

T = 5 

T = 25 

T = 55

T = 60

T = 65

T = 80

T = 100 

T = 110

T = 120 

Patient signs consent for new clinical trial and is directed to the phlebotomy waiting room

Nurse emails coordinator (CRC) patient's consent form for new clinical trial

Nurse pages CRC if no response within 20 minutes 

CRC reprioritizes current task to assist or is delayed due to current task (ex: occupied at biopsy lasting 30 min)

CRC emails scheduling team to book a same day blood draw for patient & prints paperwork

CRC emails materials manager to pull specific research kit containing blood draw tubes and to print patient labels 

If no response within 15 minutes, CRC walks to materials storage and attempts to find materials manager in person

CRC and materials manager locate specific research screening kit and print patient labels 

CRC combines kit, labels, and paperwork and delivers kit to phlebotomy floor in building across the street

Phlebotomists calls patient in waiting room to have screening blood work

Analysis of Inefficiencies 

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In a worst case scenario, it can take up to two hours from the time a patient signs consent to the time of a screening blood draw for the clinical trial. In the best case scenario, executing this workflow would take approximately 1 hour. The following events were determined to contribute the most time to the current workflow. 

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waiting to confirm next step via email communication - consent and materials 

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contacting the coordinator while they are preoccupied with a different task that they must complete

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obtaining required materials ( blood draw tubes + patient labels) from materials storage

Solution Creation 

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The following interventions were proposed to decrease time consuming events illustrated in the screening blood draw workflow.

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Remove email from the chain of communication - rely on pagers for immediate notice 

The nature of email communication is slow and should be eliminated from urgent, patient centered tasks​

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Designate a point coordinator that can be paged if assigned coordinator is occupied with another task 

Coordinators are not always able to respond quickly when paged - nurses should have a backup to reach out to ​

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Allow screening visit materials to be stored at CRC desk for quick access

Due to frequency of screening blood draws being scheduled on the same day, CRCs should have direct access to required supplies

Time (min)

Patient

Nurse

Coordinator

Materials Manager

New Blood Draw Workflow​​ 

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T = 0 

T = 5 

T = 10 

T = 20

T = 25

T = 35

T = 45

Patient signs consent for new clinical trial and is directed to the phlebotomy waiting room

Nurse emails and pages CRC patient's consent - waits 5 minutes before paging backup CRC

CRC reprioritizes current task or backup coordinator takes over process

CRC emails scheduling team to book a same day blood draw for patient 

CRC grabs screening kit & pre-printed paperwork. CRC prints patient labels

CRC combines kit, labels, and paperwork and delivers kit to phlebotomy floor in building across the street

Phlebotomists calls patient in waiting room to have screening blood work

Test & Implement

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Mapping the new workflow with the proposed interventions and their estimated time attributes a maximum of 45 minutes from the time the patient signs consent for a new clinical trial to the time they have a screening blood draw. I executed these interventions in practice across my portfolio of clinical trials for two weeks, and found the process simple and effective.  On average, patients were often waiting approximately 30 minutes to have blood work completed due to the improved efficiencies of the coordinator tasks. Time spent waiting was able to be tracked by timestamps in the EMR between patient check in at the phlebotomy counter and time of blood collection. 

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Solution Delivery

  • Trained staff of 15 CRCs and 6 research nurses at monthly department meeting on new screening blood draw workflow.

  • Developed spreadsheet to integrate with materials management system to track inventory of screening blood draw kits and create a system for CRCs to check out kits to store at their desk. Managing inventory was one of the primary barriers to initial adoption.

  • Created quick reference contact sheet listing clinical trial, coordinator pager, and backup coordinator to hang in each exam room.

  • This system was scaled within the Breast Oncology Center across all metastatic clinical trials. 

 

Finding ways to improve workflows that directly impact the patient are essential to provide excellent healthcare and improve experiences. 

 

Part 2: Clinical User Research

Problem Space

Pharmaceutical companies collect immense amounts of data throughout the clinical trial process in order to validate that a regimen is safe and effective.  Information obtained throughout the process can be beneficial to not only inform drug toxicity, but also to understand how a treatment process is impacting a patient's experience. 

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This case examines how a phase 1 clinical trial treatment system could be redesigned to improve a patient experience. 

Data collected during this stage of the clinical trial process helped inform how we could improve the patient experience

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Treatment Delivery Process

  • Patient signs 40 page consent form & has conversation with research nurse about medications 

  • Patient will report to clinic for infusion weekly & take home medication for self injection daily 

  • Patient receives paper with numbered instructions about how to administer self injection 

  • Patient picks up medication kit from pharmacy and transports it in cooler to home (kit includes medication and various tools)

  • Patient goes through drug administration process daily 

    • Take body weight ​

    • Calculate appropriate dose

    • Cleanse injection area

    • Use needle to draw up medication from vial 

    • Self-inject syringe 

  • Patient returns to clinic 1x week to meet with research nurse 

Research Insights

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Patient Diaries

Patients documented their experience self administering drug in the home setting. 

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Quality of Life Surveys

Surveys provided insight into the mental and emotional state of each patient

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Patient Interviews

Conversations illuminated specific pain points about the treatment process

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After 3 initial patients were enrolled and participating in the trial for 4 weeks, data from diaries, surveys, and nurse interviews was analyzed.  Recurring trends across the data informed the following recommendations.​

dfci trend.PNG

Clinical data collected during a research protocol can be beneficial to understand patient experiences. There is an opportunity to use these insights to inform future protocol improvements. In this case, designing a seamless user experience will not only benefit the patient participating in the clinical trial, but will aid in consistent drug administration, leading to more accurate clinical data. 

© 2023 Lindsey Milisits

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