General MedicineNCT03002311
Improving Follow-Up for Discharged Emergency Care Patients
A study testing Epharmix/CareSignal eHealth in people with General Medicine and Emergency Medicine, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study's purpose is to test the effects of an electronic health intervention platform developed by Epharmix (also known as CareSignal), which features two-way SMS text messages and phone calls intended to improve clinical outcomes compared to the standard of care. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- General Medicine, Emergency Medicine, Mobile Health
- What is being tested?
- Epharmix/CareSignal eHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 18 years or older,
- accessible short message service (SMS) capable mobile phone or residential landline,
- able to read English or have English-speaking family member to assist with phone communications,
- discharged directly from the Barnes Jewish hospital (St. Louis, MO) emergency department (ED), and
- given a clinical referral to make an outpatient follow-up appointment at time of discharge to a specific clinic or provider
Who cannot join
- unable or refused to provide consent,
- could not be contacted by a phone call or SMS,
- non-English speaking,
- were admitted to the hospital, and
- already had a follow-up appointment scheduled before being discharged from the ED
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages
This study's purpose is to test the effects of an electronic health intervention platform developed by Epharmix (also known as CareSignal), which features two-way SMS text messages and phone calls intended to improve clinical outcomes compared to the standard of care. This was a randomized open, blinded end-point (PROBE) trial of adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard of care written instructions to contact listed referral providers. The primary outcome was time to the follow-up appointment.
Read the detailed description
Telemedicine is a modern field of clinical medicine that strives to incorporate telecommunication and information technology for diagnosing and managing health care at a distance. Interventions range from telephone reminders to remote physician consultation by streamed by webcam. Simple technology such as telephone and SMS texting are becoming common forms of communication and may improve patient adherence and engagement. Automated telephone appointment reminders have improved adherence with follow-up appointments in some settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.
An electronic intervention platform has been developed by Epharmix (now HealthSignal), uses SMS text messaging for adherence tracking and data collection applications, to supplement clinical care. Specific messages include: proactively asking patients or a designated patient advocate if the patient has experienced a medical event; requesting specific care-related information; and providing health care education. Patients receiving the messages are also provided with key contact information for their designated health care provider to promote patient engagement, as well as prompt and appropriate medical follow-up care. The service will maintain both a dedicated SMS and phone line for recording events or adverse reactions. Events designated as critical prompt a phone call from nursing staff. Overall, this study aims to determine whether an electronic intervention system that sends SMS text messages will improve adherence to follow-up appointments after an ED visit.
Patients age 18 years or older at Barnes Jewish Hospital are included in this study. We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message using the Epharmix (now HealthSignal) platform that connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard-of-care written instructions to contact listed referral providers. The primary outcome was time to appointment. The secondary outcome was time to return visit to the ED.
- Conditions
- General Medicine, Emergency Medicine, Mobile Health
- Being tested
- Epharmix/CareSignal eHealth
- Keywords
- Bioinformatics, Electronic pharmacology, Mobile health, Electronic health, Adherence, Digital health, Health information technology, mHealth, eHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epharmix/CareSignal eHealthDevice
The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm if they attended.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receiving current standard of care as designated by emergency department (ED) standard operating practice. |
| Epharmix/CareSignal eHealth Intervention | Experimental | After randomization, participants receive text reminders to have a follow-up visit. The participant can respond to these messages via numerical or binary answers (Y/N). Receives: Device: Epharmix/CareSignal eHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Follow-up Appointment
The primary outcome was the effect of the intervention on time to follow-up appointment using an intention-to-treat analysis and plotting the cumulative incidence functions (CIFs). Follow-up adherence was defined as a recorded visit in the EMR to the referral primary or specialty care provider within 120 days after ED discharge to address a similar diagnosis (or complaint) at the index ED visit.
Measured: Up to 120 days
Secondary outcomes (1)
Revisits to the ED
The secondary outcome was revisits to the ED after discharge.
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start1 Jan 2016
- Primary completion18 Sep 2017
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for General MedicineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SMS text messaging to prompt adherence with follow-up appointment.
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Epharmix, Inc.
- Responsible party
- Sponsor
- Investigators
- Will R Ross, MD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002311
- Sponsor's protocol ID
- 201504079
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2016
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Whittier WL. Surveillance of hemodialysis vascular access. Semin Intervent Radiol. 2009 Jun;26(2):130-8. doi: 10.1055/s-0029-1222457.
PubMed 21326504Cummings KM, Becker MH, Kirscht JP, Levin NW. Intervention strategies to improve compliance with medical regimens by ambulatory hemodialysis patients. J Behav Med. 1981 Mar;4(1):111-27. doi: 10.1007/BF00844851.
PubMed 7288877Parikh A, Gupta K, Wilson AC, Fields K, Cosgrove NM, Kostis JB. The effectiveness of outpatient appointment reminder systems in reducing no-show rates. Am J Med. 2010 Jun;123(6):542-8. doi: 10.1016/j.amjmed.2009.11.022.
PubMed 20569761Junod Perron N, Dao MD, Righini NC, Humair JP, Broers B, Narring F, Haller DM, Gaspoz JM. Text-messaging versus telephone reminders to reduce missed appointments in an academic primary care clinic: a randomized controlled trial. BMC Health Serv Res. 2013 Apr 4;13:125. doi: 10.1186/1472-6963-13-125.
PubMed 23557331Bame SI, Petersen N, Wray NP. Variation in hemodialysis patient compliance according to demographic characteristics. Soc Sci Med. 1993 Oct;37(8):1035-43. doi: 10.1016/0277-9536(93)90438-a.
PubMed 8235736Lua PL, Neni WS. A randomised controlled trial of an SMS-based mobile epilepsy education system. J Telemed Telecare. 2013 Jan;19(1):23-8. doi: 10.1177/1357633X12473920. Epub 2013 Feb 6.
PubMed 23390210Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.
PubMed 23329469Dall TM, Storm MV, Chakrabarti R, Drogan O, Keran CM, Donofrio PD, Henderson VW, Kaminski HJ, Stevens JC, Vidic TR. Supply and demand analysis of the current and future US neurology workforce. Neurology. 2013 Jul 30;81(5):470-8. doi: 10.1212/WNL.0b013e318294b1cf. Epub 2013 Apr 17.
PubMed 23596071Lieberman DZ, Kelly TF, Douglas L, Goodwin FK. A randomized comparison of online and paper mood charts for people with bipolar disorder. J Affect Disord. 2010 Jul;124(1-2):85-9. doi: 10.1016/j.jad.2009.10.019. Epub 2009 Nov 6.
PubMed 19896202Sawan M, Salam MT, Le Lan J, Kassab A, Gelinas S, Vannasing P, Lesage F, Lassonde M, Nguyen DK. Wireless recording systems: from noninvasive EEG-NIRS to invasive EEG devices. IEEE Trans Biomed Circuits Syst. 2013 Apr;7(2):186-95. doi: 10.1109/TBCAS.2013.2255595.
PubMed 23853301Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
PubMed 21080835Bauer KL, Sogade OO, Gage BF, Ruoff B, Lewis L. Improving Follow-up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-schedule: A Randomized Controlled Trial. Acad Emerg Med. 2021 Feb;28(2):197-205. doi: 10.1111/acem.14080. Epub 2020 Aug 5.
PubMed 32654257Chen RY, Feltes JR, Tzeng WS, Lu ZY, Pan M, Zhao N, Talkin R, Javaherian K, Glowinski A, Ross W. Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism. JMIR Res Protoc. 2017 Jun 16;6(6):e114. doi: 10.2196/resprot.7245.
PubMed 28623183
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medical Care With Electronic Interventions Based on Automated Text and Phone Messages
- ClinicalTrials.gov ID
- NCT03002311
- Acronym / sponsor ID
- 201504079
- Conditions
- General Medicine, Emergency Medicine, Mobile Health
- Keywords
- Bioinformatics, Electronic pharmacology, Mobile health, Electronic health, Adherence, Digital health, Health information technology, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Epharmix, Inc.
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's purpose is to test the effects of an electronic health intervention platform developed by Epharmix (also known as CareSignal), which features two-way SMS text messages and phone calls intended to improve clinical outcomes compared to the standard of care. This was a randomized open, blinded end-point (PROBE) trial of adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message that automatically connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard of care written instructions to contact listed referral providers. The primary outcome was time to the follow-up appointment.
Detailed description
Telemedicine is a modern field of clinical medicine that strives to incorporate telecommunication and information technology for diagnosing and managing health care at a distance. Interventions range from telephone reminders to remote physician consultation by streamed by webcam. Simple technology such as telephone and SMS texting are becoming common forms of communication and may improve patient adherence and engagement. Automated telephone appointment reminders have improved adherence with follow-up appointments in some settings, but have mixed results in patients discharged from the emergency department (ED). Increasing adherence to follow-up care has been a priority in the ED to improve patient outcomes and reduce unnecessary future visits.
An electronic intervention platform has been developed by Epharmix (now HealthSignal), uses SMS text messaging for adherence tracking and data collection applications, to supplement clinical care. Specific messages include: proactively asking patients or a designated patient advocate if the patient has experienced a medical event; requesting specific care-related information; and providing health care education. Patients receiving the messages are also provided with key contact information for their designated health care provider to promote patient engagement, as well as prompt and appropriate medical follow-up care. The service will maintain both a dedicated SMS and phone line for recording events or adverse reactions. Events designated as critical prompt a phone call from nursing staff. Overall, this study aims to determine whether an electronic intervention system that sends SMS text messages will improve adherence to follow-up appointments after an ED visit.
Patients age 18 years or older at Barnes Jewish Hospital are included in this study. We conducted a prospective randomized open, blinded end-point (PROBE) trial of 278 adult patients discharged from the ED and referred to a provider for follow-up care. Participants in the intervention arm received a self-scheduling text or phone message using the Epharmix (now HealthSignal) platform that connected them to their referral provider to schedule a follow-up appointment and sent them appointment reminders. Those in the control arm received standard-of-care written instructions to contact listed referral providers. The primary outcome was time to appointment. The secondary outcome was time to return visit to the ED.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SMS text messaging to prompt adherence with follow-up appointment.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receiving current standard of care as designated by emergency department (ED) standard operating practice. |
| Epharmix/CareSignal eHealth Intervention | Experimental | Device: Epharmix/CareSignal eHealthAfter randomization, participants receive text reminders to have a follow-up visit. The participant can respond to these messages via numerical or binary answers (Y/N). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 years or older,
- accessible short message service (SMS) capable mobile phone or residential landline,
- able to read English or have English-speaking family member to assist with phone communications,
- discharged directly from the Barnes Jewish hospital (St. Louis, MO) emergency department (ED), and
- given a clinical referral to make an outpatient follow-up appointment at time of discharge to a specific clinic or provider
Key exclusion criteria (5 listed)
- unable or refused to provide consent,
- could not be contacted by a phone call or SMS,
- non-English speaking,
- were admitted to the hospital, and
- already had a follow-up appointment scheduled before being discharged from the ED
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 |
|---|---|---|
| Epharmix/CareSignal eHealthThe self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm if they attended. | Device | Epharmix/CareSignal eHealth Intervention |
Primary outcome
Adherence to Follow-up Appointment
Time frame: Up to 120 days
The primary outcome was the effect of the intervention on time to follow-up appointment using an intention-to-treat analysis and plotting the cumulative incidence functions (CIFs). Follow-up adherence was defined as a recorded visit in the EMR to the referral primary or specialty care provider within 120 days after ED discharge to address a similar diagnosis (or complaint) at the index ED visit.
1 secondary outcome
Revisits to the ED
Time frame: Up to 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21326504Whittier WL. Surveillance of hemodialysis vascular access. Semin Intervent Radiol. 2009 Jun;26(2):130-8. doi: 10.1055/s-0029-1222457.
- Background: PubMed 7288877Cummings KM, Becker MH, Kirscht JP, Levin NW. Intervention strategies to improve compliance with medical regimens by ambulatory hemodialysis patients. J Behav Med. 1981 Mar;4(1):111-27. doi: 10.1007/BF00844851.
- Background: PubMed 20569761Parikh A, Gupta K, Wilson AC, Fields K, Cosgrove NM, Kostis JB. The effectiveness of outpatient appointment reminder systems in reducing no-show rates. Am J Med. 2010 Jun;123(6):542-8. doi: 10.1016/j.amjmed.2009.11.022.
- Background: PubMed 23557331Junod Perron N, Dao MD, Righini NC, Humair JP, Broers B, Narring F, Haller DM, Gaspoz JM. Text-messaging versus telephone reminders to reduce missed appointments in an academic primary care clinic: a randomized controlled trial. BMC Health Serv Res. 2013 Apr 4;13:125. doi: 10.1186/1472-6963-13-125.
- Background: PubMed 8235736Bame SI, Petersen N, Wray NP. Variation in hemodialysis patient compliance according to demographic characteristics. Soc Sci Med. 1993 Oct;37(8):1035-43. doi: 10.1016/0277-9536(93)90438-a.
- Background: PubMed 23390210Lua PL, Neni WS. A randomised controlled trial of an SMS-based mobile epilepsy education system. J Telemed Telecare. 2013 Jan;19(1):23-8. doi: 10.1177/1357633X12473920. Epub 2013 Feb 6.
- Background: PubMed 23329469Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.
- Background: PubMed 23596071Dall TM, Storm MV, Chakrabarti R, Drogan O, Keran CM, Donofrio PD, Henderson VW, Kaminski HJ, Stevens JC, Vidic TR. Supply and demand analysis of the current and future US neurology workforce. Neurology. 2013 Jul 30;81(5):470-8. doi: 10.1212/WNL.0b013e318294b1cf. Epub 2013 Apr 17.
- Background: PubMed 19896202Lieberman DZ, Kelly TF, Douglas L, Goodwin FK. A randomized comparison of online and paper mood charts for people with bipolar disorder. J Affect Disord. 2010 Jul;124(1-2):85-9. doi: 10.1016/j.jad.2009.10.019. Epub 2009 Nov 6.
- Background: PubMed 23853301Sawan M, Salam MT, Le Lan J, Kassab A, Gelinas S, Vannasing P, Lesage F, Lassonde M, Nguyen DK. Wireless recording systems: from noninvasive EEG-NIRS to invasive EEG devices. IEEE Trans Biomed Circuits Syst. 2013 Apr;7(2):186-95. doi: 10.1109/TBCAS.2013.2255595.
- Background: PubMed 21080835Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
- Results publication: PubMed 32654257Bauer KL, Sogade OO, Gage BF, Ruoff B, Lewis L. Improving Follow-up Attendance for Discharged Emergency Care Patients Using Automated Phone System to Self-schedule: A Randomized Controlled Trial. Acad Emerg Med. 2021 Feb;28(2):197-205. doi: 10.1111/acem.14080. Epub 2020 Aug 5.
- Individual participant dataSharing planned: No
Related trials for General Medicine
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
RecruitingPhase 3
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer
Active, not recruitingPhase 3
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Will R Ross, MD, MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epharmix/CareSignal eHealth in people with General Medicine and Emergency Medicine, run by Washington University School of Medicine 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 24 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Follow-up Appointment (time frame: Up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002311, which also lists 13 linked publications.
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 24 Nov 2020.