Post-Op ComplicationNCT03922737
Telehealth Following Orthopaedic Procedures
A study testing In-person office visit and Teleheath visit in people with Post-Op Complication, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- In-person office visit and Teleheath visit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 1 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).
Who cannot join
- Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
- Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
- Subjects with workman's compensation or automotive claims or other ongoing litigation
- Subjects that are unable or unwilling to consent for enrollment
- Patients under the age of 18 years
- Pregnant or breastfeeding women
Show all 9Show fewer
- Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
- Patients without English-language proficiency
- Patients with unforeseen intra-operative or perioperative complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery
This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.
- Conditions
- Post-Op Complication
- Being tested
- In-person office visit, Teleheath visit
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person office visitProcedure or surgery
Post-operative visit to occur in-person with provider
Teleheath visitProcedure or surgery
Post-operative visit to occur via telehealth software platform with provider
| Study group | Role | What they receive |
|---|---|---|
| In-person office visit | Active comparator | Not described Receives: Procedure: In-person office visit |
| Telehealth visit with provider | Active comparator | Not described Receives: Procedure: Teleheath visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction: Likert Score
Likert Score self-reported patient satisfaction
Measured: 2 mont post-operative period following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start6 Oct 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922737
- Sponsor's protocol ID
- 2019Horneff
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Telehealth Follow-up Appointments Following Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT03922737
- Acronym / sponsor ID
- 2019Horneff
- Conditions
- Post-Op Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 22 Apr 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 study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person office visit | Active comparator | Procedure: In-person office visit |
| Telehealth visit with provider | Active comparator | Procedure: Teleheath visit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).
Key exclusion criteria (9 listed)
- Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
- Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
- Subjects with workman's compensation or automotive claims or other ongoing litigation
- Subjects that are unable or unwilling to consent for enrollment
- Patients under the age of 18 years
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 |
|---|---|---|
| In-person office visitPost-operative visit to occur in-person with provider | Procedure or surgery | In-person office visit |
| Teleheath visitPost-operative visit to occur via telehealth software platform with provider | Procedure or surgery | Telehealth visit with provider |
Primary outcome
Patient Satisfaction: Likert Score
Time frame: 2 mont post-operative period following surgery
Likert Score self-reported patient satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person office visit and Teleheath visit in people with Post-Op Complication, run by Rothman Institute Orthopaedics 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Apr 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?
Results are not available in the source record.
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?
Patient Satisfaction: Likert Score (time frame: 2 mont post-operative period following surgery). 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 22 Apr 2019.