NCT04441567

Right-Size Clinic Visits Using Memora Platform for PROMIS

Patient Reported Outcomes Measures Pilot Grant for Orthopedic Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Developing novel methods of patient communication is crucial in providing value-based care to orthopedic patients. Healthcare technology platforms have been developed to improve patient communication methods particularly for the administration of patient-reported outcome measures (PROMs). However, the majority of these interventions rely on web-based platforms that require patients to have computer access. Among American households earning less than $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband internet at home compared to mobile phone penetration which is estimated at 95% of which 93% regularly use text messages. The use of phone messaging may be the most effective means to have patients complete PROMs. The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded, clinically validated method of tracking patient-reported outcomes to efficiently assess patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive testing (CAT) to improve measurement precision and decrease survey time as compared to traditional PROMs. The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to right-size clinic visits (Phase 2).

Detailed description

Phase 1 will be a prospective evaluation of patients with the conditions listed. After consent, participants will complete PROMIS CAT questionnaires on their mobile phones to assess health status. During enrollment, participants will choose a method of completing the surveys throughout the duration of the study. The participants will either 1) receive a short message service(SMS) with a secure weblink to complete these PROMIS CAT questionnaires on a secure website, or 2) engage in two-way SMS communication by answering the survey questions individually by texting back their answers. The investigators will explain that the desired method of participation is by weblink due to privacy issues associated with two-way texting. The frequency at which the questionnaires will be sent is condition-specific. All patients will be seen in clinic at standard follow up time-points and will be asked to complete PROMIS questionnaires during each clinic visit, identical to the delivery of surveys while at home. The PROMIS measures collected over a 1-year period will be used to develop patient-based recovery curves. Phase 2 will begin at the end of Phase 1 and compare each participant's recovery (based on the PROMs) against the established recovery curve that was generated in Phase 1 for their orthopedic condition. The investigators will right-size in-person clinic visits based on individual recovery as compared with expected recovery. Earlier clinic appointments will be given to participants at risk for a poor outcome (defined as any PROMIS score ≥1 standard deviation below the mean). All other participants will receive a phone call to make sure that participants feel they are doing well and to have any issues addressed. If it is felt that a visit is warranted, it will be recommended, and if a subject wishes to have a visit it will be scheduled. If the subject is happy with their progress, then that in-person clinic visit will be deferred until the next standard follow-up visit and the same process will occur. Some in-person visits will be mandatory when a physical exam or x-ray is required for optimal care. These are condition specific. For all participants, a final in-person follow-up visit will occur unless the subject is happy and does not want to be seen in person.

Conditions

• Orthopedic Disorders

Interventions

Type	Name	Description
OTHER	Right-size clinic visits	The curve created in Phase 1 will be used to guide the number of clinic visits based on PROMs reported by the participants in Phase 2.

Timeline

• Start date: 2021-05-10
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2020-06-22
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States