Two Implementation Strategies for the Collection of Electronic Patient-Reported Outcomes Among Patients With Multiple Myeloma

Study Overview
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Brief Summary
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This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM typically receive continuous therapy from the time of diagnosis, which often comes with treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains such as physical and emotional well-being, social functioning, and financial burden. Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can generate information to help facilitate clinical decision making and follow up care. PROs are direct reports from patients about their health status. Compared with paper versions, electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their clinic visit, facilitate direct data collection through the electronic health record, and enable clinicians to track symptoms long-term. The use of ePROs is associated with improved patient health outcomes, including better quality of life, reduced emergency department usage, and prolonged overall survival. The increased use of electronic communication technologies to capture PRO data long-term has been implemented through various methods including web-based, social media, text messages, mobile applications, and electronic portals. Text messaging is an accessible, though under-explored, communication channel for promoting ePRO collection. Information gathered from this study may help researchers understand MM patients' preferences for reporting symptoms via text message compared to a patient portal system.

Detailed Description
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PRIMARY OBJECTIVES: I. To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, considering their demographic information. II. To evaluate each patient's adherence to the approach of his/her own choice by examining their utilization of the ePRO. SECONDARY OBJECTIVE: I. To examine the usability and satisfaction of the two implementation approaches of each patient's choice. EXPLORATORY OBJECTIVE: I. To explore and measure any differences in patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, as well as the number of completed of ePRO responses, in the course of 6 months, reported between race (African American versus [vs.] Caucasian) and approaches (Chatbot vs. MyChart/Patient Portal). OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients receive a text message notification and complete surveys through TXT-Chatbot once every two weeks (Q2W) for 6 months. GROUP II: Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 months. After completion of study intervention, patients are followed up for 30 days.

Official Title
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Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Planned Notification
* Other: Survey Administration
* Behavioral: Behavioral Intervention
* Other: Electronic Health Record Review
* Other: Interview
* Other: Survey Administration
* Other: Planned Notification
* Behavioral: Behavioral Intervention
* Other: Electronic Health Record Review
* Other: Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MM Able to use TXT or have Internet access Can read and understand English If patients are undergoing an autologous stem cell transplant, they will be enrolled after their transplant Exclusion Criteria: < 18 years of age Cognitive impairment documented in the electronic medical record (EMR)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (TXT-Chatbot )<br>Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months. | Other: Planned Notification<br>* Receive text notification<br>* Other names: PlannedNotification;Other: Survey Administration<br>* Complete surveys<br>Behavioral: Behavioral Intervention<br>* Participate in TXT-Chatbot<br>* Other names: Behavioral Treatments;Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Interview<br>* Ancillary studies<br>|
| Experimental: Group II (MyChart/Patient Portal)<br>Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks. | Other: Survey Administration<br>* Complete surveys<br>Other: Planned Notification<br>* Receive email notification<br>* Other names: PlannedNotification;Behavioral: Behavioral Intervention<br>* Participate in MyChart/Patient Portal<br>* Other names: Behavioral Treatments;Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Interview<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of TXT-Chatbot | The choice of implementation approaches will be summarized using percentages. Multivariable logistic regression analysis will be performed to explore the relationship between the choice of approaches and age, gender, etc. | Up to 6 months | 
| Number of completed electronic Patient-Reported Outcome (ePRO) responses | The number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American versus Caucasian) and implementation approaches. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Satisfaction Scores Using the Client Satisfaction Questionnaire (CSQ-8) | Participants will complete the Client Satisfaction Questionnaire (CSQ-8), a validated measure that elicits the client's perspective on the value of services received. The 8 items are rated on a 1-5 scale with higher scores indicating greater satisfaction. The overall satisfaction score will be summarized using means and standard deviations across the 8 items. The dichotomized satisfaction score (overall score ≥ 3.5) will be summarized using percentages . Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, and other measures. | At 6 months |