Foot & AnkleNCT03854955
Device-Based Scribe Service (iScribes) on Patient Satisfaction
A study testing iScribes in people with Foot & Ankle, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot & Ankle
- What is being tested?
- iScribes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 26 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 18 years of age
- Written informed consent is obtained
- New patient visit
Who cannot join
- Patient refuses
- Patient is lacking decisional capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Randomized Controlled Trial of a Device-Based Scribe Service (iScribes) on Patient Satisfaction
This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).
Read the detailed description
This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. Device based scribing services record the patient-physician encounter and securely transmit data to an off-site facility where trained professionals transcribe the dictations. The information is then sent back to the physician and stored in the providing institutions electronic medical records. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).
- Conditions
- Foot & Ankle
- Being tested
- iScribes
- Keywords
- iScribes, patient satisfaction, device based scribe
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iScribesOther
Device-based scribing service.
| Study group | Role | What they receive |
|---|---|---|
| iScribes | Experimental | Device-based scribing service used for dictation and documentation. Receives: Other: iScribes |
| Traditional Dictation | No intervention | Standard dictation and documentation methods used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physician time spent on the encounter but not with the patient.
The total physician time spent on the encounter, including medical documentation, but not including time spent directly interacting with the patient.
Measured: Duration of patient visit (up to 1 day).
Secondary outcomes (1)
Patient satisfaction.
How satisfied the patient is with their care as rated on a scale of 0 to 10 post-visit questionnaire adapted from the Consumer Assessment of Healthcare Providers and Systems survey where 0 is poor and 10 is excellent.
Measured: Duration of patient visit (up to 1 day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start20 Aug 2018
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Foot & AnkleStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamran Hamid, Rush University Medical Center
- Investigators
- Kamran Hamid, MD,MPH, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854955
- Sponsor's protocol ID
- 18041305-IRB01
- Status last verified
- Feb 2019
- First submitted
- 20 Aug 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waters S, Edmondston SJ, Yates PJ, Gucciardi DF. Identification of factors influencing patient satisfaction with orthopaedic outpatient clinic consultation: A qualitative study. Man Ther. 2016 Sep;25:48-55. doi: 10.1016/j.math.2016.05.334. Epub 2016 Jun 4.
PubMed 27422597Teunis T, Thornton ER, Jayakumar P, Ring D. Time Seeing a Hand Surgeon Is Not Associated With Patient Satisfaction. Clin Orthop Relat Res. 2015 Jul;473(7):2362-8. doi: 10.1007/s11999-014-4090-z. Epub 2014 Dec 5.
PubMed 25475717Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PubMed 25057539Patterson BM, Eskildsen SM, Clement RC, Lin FC, Olcott CW, Del Gaizo DJ, Tennant JN. Patient Satisfaction Is Associated With Time With Provider But Not Clinic Wait Time Among Orthopedic Patients. Orthopedics. 2017 Jan 1;40(1):43-48. doi: 10.3928/01477447-20161013-05. Epub 2016 Oct 18.
PubMed 27755644Sinsky C, Colligan L, Li L, Prgomet M, Reynolds S, Goeders L, Westbrook J, Tutty M, Blike G. Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties. Ann Intern Med. 2016 Dec 6;165(11):753-760. doi: 10.7326/M16-0961. Epub 2016 Sep 6.
PubMed 27595430Wenger N, Mean M, Castioni J, Marques-Vidal P, Waeber G, Garnier A. Allocation of Internal Medicine Resident Time in a Swiss Hospital: A Time and Motion Study of Day and Evening Shifts. Ann Intern Med. 2017 Apr 18;166(8):579-586. doi: 10.7326/M16-2238. Epub 2017 Jan 31.
PubMed 28135724Bank AJ, Gage RM. Annual impact of scribes on physician productivity and revenue in a cardiology clinic. Clinicoecon Outcomes Res. 2015 Sep 30;7:489-95. doi: 10.2147/CEOR.S89329. eCollection 2015.
PubMed 26457055Koshy S, Feustel PJ, Hong M, Kogan BA. Scribes in an ambulatory urology practice: patient and physician satisfaction. J Urol. 2010 Jul;184(1):258-62. doi: 10.1016/j.juro.2010.03.040. Epub 2010 May 16.
PubMed 20483153Bastani A, Shaqiri B, Palomba K, Bananno D, Anderson W. An ED scribe program is able to improve throughput time and patient satisfaction. Am J Emerg Med. 2014 May;32(5):399-402. doi: 10.1016/j.ajem.2013.03.040. Epub 2014 Mar 15.
PubMed 24637134Misra-Hebert AD, Rabovsky A, Yan C, Hu B, Rothberg MB. A Team-based Model of Primary Care Delivery and Physician-patient Interaction. Am J Med. 2015 Sep;128(9):1025-8. doi: 10.1016/j.amjmed.2015.03.035. Epub 2015 Apr 23.
PubMed 25912207Heaton HA, Nestler DM, Jones DD, Varghese RS, Lohse CM, Williamson ES, Sadosty AT. Impact of Scribes on Billed Relative Value Units in an Academic Emergency Department. J Emerg Med. 2017 Mar;52(3):370-376. doi: 10.1016/j.jemermed.2016.11.017. Epub 2016 Dec 14.
PubMed 27988262Heaton HA, Castaneda-Guarderas A, Trotter ER, Erwin PJ, Bellolio MF. Effect of scribes on patient throughput, revenue, and patient and provider satisfaction: a systematic review and meta-analysis. Am J Emerg Med. 2016 Oct;34(10):2018-2028. doi: 10.1016/j.ajem.2016.07.056. Epub 2016 Jul 28.
PubMed 27534432Shultz CG, Holmstrom HL. Response: Re: The Use of Medical Scribes in Health Care Settings: A Systematic Review and Future Directions. J Am Board Fam Med. 2016 May-Jun;29(3):423-4. doi: 10.3122/jabfm.2016.03.160043. No abstract available.
PubMed 27170804Reuben DB, Knudsen J, Senelick W, Glazier E, Koretz BK. The effect of a physician partner program on physician efficiency and patient satisfaction. JAMA Intern Med. 2014 Jul;174(7):1190-3. doi: 10.1001/jamainternmed.2014.1315. No abstract available.
PubMed 24819399
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Device-Based Scribe Service (iScribes) on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT03854955
- Acronym / sponsor ID
- 18041305-IRB01
- Conditions
- Foot & Ankle
- Keywords
- iScribes, patient satisfaction, device based scribe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 26 Feb 2019 (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.
This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).
Detailed description
This project involves the implementation of a device-based scribe service (iScribes) for patient encounters. Device based scribing services record the patient-physician encounter and securely transmit data to an off-site facility where trained professionals transcribe the dictations. The information is then sent back to the physician and stored in the providing institutions electronic medical records. The objective of the proposed study is to track and compare the allocation of physician time and associated quality metrics with and without the use of iScribes. We anticipate that the use of iScribes will reduce the amount of physician time spent away from the patient (e.g., charting, dictating).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iScribes | Experimental | Other: iScribesDevice-based scribing service used for dictation and documentation. |
| Traditional Dictation | No intervention | –Standard dictation and documentation methods used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Written informed consent is obtained
- New patient visit
Key exclusion criteria (2 listed)
- Patient refuses
- Patient is lacking decisional capability
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 |
|---|---|---|
| iScribesDevice-based scribing service. | Other | iScribes |
Primary outcome
Total physician time spent on the encounter but not with the patient.
Time frame: Duration of patient visit (up to 1 day).
The total physician time spent on the encounter, including medical documentation, but not including time spent directly interacting with the patient.
1 secondary outcome
Patient satisfaction.
Time frame: Duration of patient visit (up to 1 day).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 27422597Waters S, Edmondston SJ, Yates PJ, Gucciardi DF. Identification of factors influencing patient satisfaction with orthopaedic outpatient clinic consultation: A qualitative study. Man Ther. 2016 Sep;25:48-55. doi: 10.1016/j.math.2016.05.334. Epub 2016 Jun 4.
- Background: PubMed 25475717Teunis T, Thornton ER, Jayakumar P, Ring D. Time Seeing a Hand Surgeon Is Not Associated With Patient Satisfaction. Clin Orthop Relat Res. 2015 Jul;473(7):2362-8. doi: 10.1007/s11999-014-4090-z. Epub 2014 Dec 5.
- Background: PubMed 25057539Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
- Background: PubMed 27755644Patterson BM, Eskildsen SM, Clement RC, Lin FC, Olcott CW, Del Gaizo DJ, Tennant JN. Patient Satisfaction Is Associated With Time With Provider But Not Clinic Wait Time Among Orthopedic Patients. Orthopedics. 2017 Jan 1;40(1):43-48. doi: 10.3928/01477447-20161013-05. Epub 2016 Oct 18.
- Background: PubMed 27595430Sinsky C, Colligan L, Li L, Prgomet M, Reynolds S, Goeders L, Westbrook J, Tutty M, Blike G. Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties. Ann Intern Med. 2016 Dec 6;165(11):753-760. doi: 10.7326/M16-0961. Epub 2016 Sep 6.
- Background: PubMed 28135724Wenger N, Mean M, Castioni J, Marques-Vidal P, Waeber G, Garnier A. Allocation of Internal Medicine Resident Time in a Swiss Hospital: A Time and Motion Study of Day and Evening Shifts. Ann Intern Med. 2017 Apr 18;166(8):579-586. doi: 10.7326/M16-2238. Epub 2017 Jan 31.
- Background: PubMed 26457055Bank AJ, Gage RM. Annual impact of scribes on physician productivity and revenue in a cardiology clinic. Clinicoecon Outcomes Res. 2015 Sep 30;7:489-95. doi: 10.2147/CEOR.S89329. eCollection 2015.
- Background: PubMed 20483153Koshy S, Feustel PJ, Hong M, Kogan BA. Scribes in an ambulatory urology practice: patient and physician satisfaction. J Urol. 2010 Jul;184(1):258-62. doi: 10.1016/j.juro.2010.03.040. Epub 2010 May 16.
- Background: PubMed 24637134Bastani A, Shaqiri B, Palomba K, Bananno D, Anderson W. An ED scribe program is able to improve throughput time and patient satisfaction. Am J Emerg Med. 2014 May;32(5):399-402. doi: 10.1016/j.ajem.2013.03.040. Epub 2014 Mar 15.
- Background: PubMed 25912207Misra-Hebert AD, Rabovsky A, Yan C, Hu B, Rothberg MB. A Team-based Model of Primary Care Delivery and Physician-patient Interaction. Am J Med. 2015 Sep;128(9):1025-8. doi: 10.1016/j.amjmed.2015.03.035. Epub 2015 Apr 23.
- Background: PubMed 27988262Heaton HA, Nestler DM, Jones DD, Varghese RS, Lohse CM, Williamson ES, Sadosty AT. Impact of Scribes on Billed Relative Value Units in an Academic Emergency Department. J Emerg Med. 2017 Mar;52(3):370-376. doi: 10.1016/j.jemermed.2016.11.017. Epub 2016 Dec 14.
- Background: PubMed 27534432Heaton HA, Castaneda-Guarderas A, Trotter ER, Erwin PJ, Bellolio MF. Effect of scribes on patient throughput, revenue, and patient and provider satisfaction: a systematic review and meta-analysis. Am J Emerg Med. 2016 Oct;34(10):2018-2028. doi: 10.1016/j.ajem.2016.07.056. Epub 2016 Jul 28.
- 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. This study is not recruiting at the moment.
Kamran Hamid, MD,MPH principal investigator
Rush University 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 iScribes in people with Foot & Ankle, run by Rush University 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 3 inclusion and 2 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 26 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total physician time spent on the encounter but not with the patient. (time frame: Duration of patient visit (up to 1 day).). 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 NCT03854955, which also lists 14 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 26 Feb 2019.