Right-Size Clinic Visits Using Memora Platform for PROMIS

NCT04441567 | Recruiting

• 1 other identifier: H-38859
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Orthopedic Disorders

Keywords

PROM; PROMIS; Memora Health Text messaging platform; SMS (Short Message Service); Orthopedic conditions; Recovery curves; Right-size clinic visits; CAT; SMS

Outcome Measures

Primary Outcomes (2)

• Right-size clinic visits for specific orthopedic conditions

  Right-size clinic visits for patients recovering at/better than expected while maintaining or improving overall patient-reported outcomes (PROMS) will be assessed by comparing to the mean condition-specific recovery curve from phase 1. Earlier clinic visits will be scheduled for those who are more than 1 standard deviation from the mean recovery at any time point and less frequent visits for all others to establish the right size clinic visits.

  2 years

• Patient-based recovery curves for specific orthopedic conditions

  Each participant's recovery (based on the patient-reported outcome measures- PROMs) for their orthopedic condition will be assessed against the established recovery curve that was generated in phase one of the research for their condition.

  1 year

Secondary Outcomes (2)

• Average number of PROMs collected through SMS and weblink

  1 year

• Average number of PROMs collected during clinic visits

  1 year

Study Arms (2)

Phase 1

NO INTERVENTION

Participants in phase 1 will be observed and data about their recovery time will be collected from which recovery curves will be calculated for Phase 2

Phase 2

EXPERIMENTAL

Participants in Phase 2 will have their clinic visits potentially revised based on the phase 1 recovery curves which may increase or decrease the number of clinic visits they receive based on the PROMs reported.

Other: Right-size clinic visits

Interventions

Right-size clinic visits OTHER

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.

Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that are classified by the Current Procedural Terminology/International Classification of Diseases (CPT/ICD)-10 Diagnosis Codes, having sustained the injury within 3 weeks of enrollment for non-operative treatment or will undergo surgery during the enrollment period:
• Ankle Fracture
• Distal Radius Fracture
• Tibial Plateau Open reduction internal fixation (ORIF)
• Spine Operative
• Anterior cervical discectomy with fusion (ACDF)
• Cervical Laminectomy
• Lumbar Fusion
• Lumbar Decompression
• Spine Non-operative
• Lumbar Stenosis
• Lumbar Degenerative Disc Disease
• Rotator Cuff Repair
• Anterior cruciate ligament (ACL) Reconstruction
• Have personal use of cellular phone with access to the internet

You may not qualify if:

• Limited and non-readers
• Vulnerable populations - incarcerated patients
• Patients with no cell phone to use for scoring

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Paul Tornetta III, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Tornetta III, MD

CONTACT

617 414 5757; Paul.Tornetta@bmc.org

Katarzyna Wegrzyn, MD

CONTACT

617-414-5757; Katarzyna.Wegrzyn@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-phase pilot study recruiting approximately 1500 subjects in each of the two phases. Phase 1 - No intervention, create recovery curves only. Phase 2 - Adjust clinic follow-up based on patient responses in relation to recovery curves generated from Phase 1.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: May 10, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)