Orthopedic DisordersNCT04441567
Right-Size Clinic Visits Using Memora Platform for PROMIS
A study testing Right-size clinic visits in people with Orthopedic Disorders, run by Boston Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorders
- What is being tested?
- Right-size clinic visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 16Show fewer
- 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
- Speak either English or English as a primary language:
Who cannot join
- Limited and non-readers
- Vulnerable populations - incarcerated patients
- Patients with no cell phone to use for scoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Paul Tornetta III, MD, 617-414-5757, Paul.Tornetta@bmc.org
Karen McCartney, 617-414-5757, Karen.McCartney@bmc.org
About this study
Official title: Patient Reported Outcomes Measures Pilot Grant for Orthopedic Patients
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).
Read the 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
- Being tested
- Right-size clinic visits
- Keywords
- PROM, PROMIS, Memora Health Text messaging platform, SMS (Short Message Service), Orthopedic conditions, Recovery curves, Right-size clinic visits, CAT, SMS
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right-size clinic visitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Right-size clinic visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
Average number of PROMs collected through SMS and weblink
The number of PROMs collected through SMS and weblink will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.
Measured: 1 year
Average number of PROMs collected during clinic visits
The number of PROMs collected during clinic visits will be assessed. PROMs are standardized, validated questionnaires completed by patients to measure their perception of their functional well-being and health status.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start10 May 2021
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Tornetta III, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441567
- Sponsor's protocol ID
- H-38859
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Measures Pilot Grant for Orthopedic Patients
- ClinicalTrials.gov ID
- NCT04441567
- Acronym / sponsor ID
- H-38859
- Conditions
- Orthopedic Disorders
- Keywords
- PROM, PROMIS, Memora Health Text messaging platform, SMS (Short Message Service), Orthopedic conditions, Recovery curves, Right-size clinic visits, CAT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Right-size clinic visitsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (3 listed)
- Limited and non-readers
- Vulnerable populations - incarcerated patients
- Patients with no cell phone to use for scoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right-size clinic visitsThe 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. | Other | Phase 2 |
Primary outcome
Right-size clinic visits for specific orthopedic conditions
Time frame: 2 years
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.
Patient-based recovery curves for specific orthopedic conditions
Time frame: 1 year
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.
2 secondary outcomes
Average number of PROMs collected through SMS and weblink
Time frame: 1 year
Average number of PROMs collected during clinic visits
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Tornetta III, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right-size clinic visits in people with Orthopedic Disorders, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Tornetta III, MD (617 414 5757, Paul.Tornetta@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right-size clinic visits for specific orthopedic conditions (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.