Pelvic Organ ProlapseNCT04138810
Postoperative Virtual Clinical Encounters
A study testing VCE and Survey in people with Pelvic Organ Prolapse, run by University of Pennsylvania at 1 site in United States.
Trial summary
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- VCE and Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 1 Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing surgery for pelvic organ prolapse
- Age greater than 18
- Access to a smartphone
- Access to high speed internet access (via 4G or 3G on their smartphone or high speed Wi-Fi)
- Signed up for MyPennMedicine web portal
- Ability to download MyChart mobile application
- Pennsylvania Hospital Subject: NJ or PA resident, HUP \& Presbyterian Hospital Subject: PA resident
Who cannot join
- Pregnancy
- Inability to read, speak or understand English
- Isolated midurethral sling procedure
- Extraperitoneal vaginal colpopexy with Uphold mesh
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Assessment of Video-conference Technology for Post-operative Follow up in a Urogynecologic Population
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women undergoing pelvic reconstructive surgery through a randomized controlled trial.
Read the detailed description
This will be a prospective randomized control study comparing postoperative virtual clinical encounters versus traditional in-office postoperative visits in women undergoing pelvic reconstructive surgery. The postoperative experiences of both groups will be assessed via surveys. Virtual Clinical Encounter Group: - Receive video-conference call from office nurse 48-72 hours post discharge from hospital - Receive video-conference call from fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit Traditional Office Group: - Receive telephone call from office nurse 48-72 hours post discharge from hospital - Have in-office postoperative visit with fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit
- Conditions
- Pelvic Organ Prolapse
- Being tested
- VCE, Survey
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCEOther
Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
SurveyOther
Measure of satisfaction regarding post-op visit.
| Study group | Role | What they receive |
|---|---|---|
| post-op VCE | Experimental | As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery. Receives: Other: VCE; Other: Survey |
| Office post-operative visits | Active comparator | As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18
PSQ-18 is a validated eighteen item patient satisfaction questionnaire that has been utilized across diverse healthcare settings. It measures satisfaction across the following domains: general satisfaction, technical quality of care, interpersonal manner of healthcare provider, communication, financial aspects of care, time spent with healthcare provider and accessibility/convenience of care. Total scores range from 18 to 90, with higher scores indicating higher patient satisfaction.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start17 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lee, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138810
- Sponsor's protocol ID
- 830273
- Status last verified
- Aug 2020
- First submitted
- 23 Oct 2019
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee DD, Arya LA, Andy UU, Harvie HS. Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):432-438. doi: 10.1097/SPV.0000000000000909.
PubMed 32604202
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Video-conference Technology for Post-operative Follow up in a Urogynecologic Population
- ClinicalTrials.gov ID
- NCT04138810
- Acronym / sponsor ID
- 830273
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women undergoing pelvic reconstructive surgery through a randomized controlled trial.
Detailed description
This will be a prospective randomized control study comparing postoperative virtual clinical encounters versus traditional in-office postoperative visits in women undergoing pelvic reconstructive surgery. The postoperative experiences of both groups will be assessed via surveys. Virtual Clinical Encounter Group: - Receive video-conference call from office nurse 48-72 hours post discharge from hospital - Receive video-conference call from fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit Traditional Office Group: - Receive telephone call from office nurse 48-72 hours post discharge from hospital - Have in-office postoperative visit with fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-op VCE | Experimental | Other: VCE, Other: SurveyAs per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery. |
| Office post-operative visits | Active comparator | Other: SurveyAs per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Undergoing surgery for pelvic organ prolapse
- Age greater than 18
- Access to a smartphone
- Access to high speed internet access (via 4G or 3G on their smartphone or high speed Wi-Fi)
- Signed up for MyPennMedicine web portal
Key exclusion criteria (4 listed)
- Pregnancy
- Inability to read, speak or understand English
- Isolated midurethral sling procedure
- Extraperitoneal vaginal colpopexy with Uphold mesh
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 |
|---|---|---|
| VCEVideoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well. | Other | post-op VCE |
| SurveyMeasure of satisfaction regarding post-op visit. | Other | Office post-operative visits, post-op VCE |
Primary outcome
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18
Time frame: 30 days
PSQ-18 is a validated eighteen item patient satisfaction questionnaire that has been utilized across diverse healthcare settings. It measures satisfaction across the following domains: general satisfaction, technical quality of care, interpersonal manner of healthcare provider, communication, financial aspects of care, time spent with healthcare provider and accessibility/convenience of care. Total scores range from 18 to 90, with higher scores indicating higher patient satisfaction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32604202Lee DD, Arya LA, Andy UU, Harvie HS. Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):432-438. doi: 10.1097/SPV.0000000000000909.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse
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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 VCE and Survey in people with Pelvic Organ Prolapse, run by University of Pennsylvania 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 7 inclusion and 4 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 Aug 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 Aug 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?
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18 (time frame: 30 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 NCT04138810, which also lists 1 linked publication.
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 Aug 2020.