Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04441567
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-06-18
Brief Title:
Right-Size Clinic Visits Using Memora Platform for PROMIS
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Patient Reported Outcomes Measures Pilot Grant for Orthopedic Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30000 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 Healths 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
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 Healths 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 serviceSMS 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 participants 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
Phase 2 will begin at the end of Phase 1 and compare each participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None