TelemedicineNCT06841081
Super-Supporters - Virtual Care Technology Navigators
A study testing Super Supporter Support in people with Telemedicine, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The Super-Supporter Program is designed to provide pre-visit support to patients who are at risk of not being able to participate in Virtual Care modalities (specifically, Clinical Video Visits). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Super Supporter Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to 21 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for a video visit with a provider at Atrium Health (all locations)
- Identified as at risk of a failed video visit using criteria (1) a failed prior video visit (a discrete data field noting a prior visit was unsuccessful or converted to telephone-only visit), or 2) no prior access to the Electronic Health Record-connected patient portal
Who cannot join
- Patient plans to change visit to in-person or telephone only
- Patient declines assistance from the Super-Supporter program.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atrium Health
Charlotte, North Carolina, 28203
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Super-Supporters - Specially Trained Staff to Facilitate Virtual Care for Vulnerable Patients and Family Caregivers: A Real-world Implementation and Evaluation Across North and South Carolina
The Super-Supporter Program is designed to provide pre-visit support to patients who are at risk of not being able to participate in Virtual Care modalities (specifically, Clinical Video Visits). Patient technology navigators (Super-Supporters) will reach out before video visits and help the patient connect more easily and successfully with their providers in Virtual Care appointments.
Read the detailed description
The Super Supporter Technology Navigator Program was designed to support patients, across the health system, to connect more easily and successfully with their providers in Virtual Care appointments. Super Supporters call patients in advance of Virtual Care appointments to remind them of their appointment, ensure that they have a device on which to conduct the appointment, set up the device for a successful Virtual Care appointment, help them set up and log into their patient portal account, and practice connecting with their provider using a practice virtual video visit. This research study is designed to determine differences in connection rate, patient reported health, patient access and responses to a healthcare climate questionnaire by comparing those helped by a Super Supporter and those supported by an Enhanced Usual Care program.
- Conditions
- Telemedicine
- Being tested
- Enhanced Usual Care, Super Supporter Support
- Keywords
- virtual health, virtual telehealth, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual CareOther
Offer written instructions to the patient and refer the patient to their clinical team if they have unresolved issues.
Super Supporter SupportOther
Assist and troubleshoot with the patient including a practice video visit.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | At the beginning of the call for patients randomized to Enhanced Usual Care, the Super Supporter will identify themselves, verify they are speaking with the patient, confirm the patient has an upcoming video visit, and ask if they are prepared to log into the video visit. If they are not, the Super Supporter will offer to send written instructions to the patient and refer the patient to their clinical team if they have unresolved issues. Then, they will tell the patient about the research the team is conducting and ask if they would like to participate. If so, the Super Supporter will follow the same protocol for Super Supporter intervention in telling them about the study. If they are interested, as with the other randomized group, REDCap will send the survey by email link with the info sheet included at the beginning. Receives: Other: Enhanced Usual Care |
| Super Supporter Support | Experimental | At the beginning of the call for patients randomized to Super Supporter support, the Super Supporter will identify themselves, verify they are speaking with the patient, confirm the patient has an upcoming video visit, and ask if they would like assistance connecting with their upcoming visit. Once the Super Supporter has assisted and trouble shot with the patient and conducted a practice video visit, they will tell the patient about the opportunity to participate in the research study and ask if they would like to participate . If so, the Super Supporter will select yes that they are interested in REDCap and REDCap will automatically send the initial survey with the verbal consent included as the face page to the survey. Receives: Other: Super Supporter Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Video Visits
Data will be collected from electronic health record review
Measured: Up to Week 3
Secondary outcomes (1)
Health Care Climate Questionnaire (HCCQ)
This 15-item scale assesses participants' perceptions of the degree of autonomy support versus controllingness of relevant healthcare providers. Total score range is 15-105 with higher scores indicating a more positive perception of healthcare communication.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Nov 2021
- Primary completion7 Jun 2024
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a randomized implementation of the quality improvement program, the "Super-Supporter" program, with post-implementation evaluation using patient assessments (24 hour survey and six month survey). Investigators will use a randomization protocol especially suited to comparison of a best standard compared with an enhanced intervention: the Zelen protocol. In this protocol, randomization occurs prior to calling patients and enrolling them in the evaluation. A cluster-randomized design will be used with 1-week intervals as the randomization cluster. All patients called within a given week will be randomized to the same group. Allocation of weeks to group will be determined by a block-randomization table establish prior to trial initiation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Houston, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841081
- Sponsor's protocol ID
- IRB00078662
- Status last verified
- May 2024
- First submitted
- 14 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This project by a specific endowment and thus does not have a sharing requirement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-Supporters - Specially Trained Staff to Facilitate Virtual Care for Vulnerable Patients and Family Caregivers: A Real-world Implementation and Evaluation Across North and South Carolina
- ClinicalTrials.gov ID
- NCT06841081
- Acronym / sponsor ID
- IRB00078662
- Conditions
- Telemedicine
- Keywords
- virtual health, virtual telehealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 24 Feb 2025 (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.
The Super-Supporter Program is designed to provide pre-visit support to patients who are at risk of not being able to participate in Virtual Care modalities (specifically, Clinical Video Visits). Patient technology navigators (Super-Supporters) will reach out before video visits and help the patient connect more easily and successfully with their providers in Virtual Care appointments.
Detailed description
The Super Supporter Technology Navigator Program was designed to support patients, across the health system, to connect more easily and successfully with their providers in Virtual Care appointments. Super Supporters call patients in advance of Virtual Care appointments to remind them of their appointment, ensure that they have a device on which to conduct the appointment, set up the device for a successful Virtual Care appointment, help them set up and log into their patient portal account, and practice connecting with their provider using a practice virtual video visit. This research study is designed to determine differences in connection rate, patient reported health, patient access and responses to a healthcare climate questionnaire by comparing those helped by a Super Supporter and those supported by an Enhanced Usual Care program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a randomized implementation of the quality improvement program, the "Super-Supporter" program, with post-implementation evaluation using patient assessments (24 hour survey and six month survey). Investigators will use a randomization protocol especially suited to comparison of a best standard compared with an enhanced intervention: the Zelen protocol. In this protocol, randomization occurs prior to calling patients and enrolling them in the evaluation. A cluster-randomized design will be used with 1-week intervals as the randomization cluster. All patients called within a given week will be randomized to the same group. Allocation of weeks to group will be determined by a block-randomization table establish prior to trial initiation.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareAt the beginning of the call for patients randomized to Enhanced Usual Care, the Super Supporter will identify themselves, verify they are speaking with the patient, confirm the patient has an upcoming video visit, and ask if they are prepared to log into the video visit. If they are not, the Super Supporter will offer to send written instructions to the patient and refer the patient to their clinical team if they have unresolved issues. Then, they will tell the patient about the research the team is conducting and ask if they would like to participate. If so, the Super Supporter will follow the same protocol for Super Supporter intervention in telling them about the study. If they are interested, as with the other randomized group, REDCap will send the survey by email link with the info sheet included at the beginning. |
| Super Supporter Support | Experimental | Other: Super Supporter SupportAt the beginning of the call for patients randomized to Super Supporter support, the Super Supporter will identify themselves, verify they are speaking with the patient, confirm the patient has an upcoming video visit, and ask if they would like assistance connecting with their upcoming visit. Once the Super Supporter has assisted and trouble shot with the patient and conducted a practice video visit, they will tell the patient about the opportunity to participate in the research study and ask if they would like to participate . If so, the Super Supporter will select yes that they are interested in REDCap and REDCap will automatically send the initial survey with the verbal consent included as the face page to the survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for a video visit with a provider at Atrium Health (all locations)
- Identified as at risk of a failed video visit using criteria (1) a failed prior video visit (a discrete data field noting a prior visit was unsuccessful or converted to telephone-only visit), or 2) no prior access to the Electronic Health Record-connected patient portal
Key exclusion criteria (2 listed)
- Patient plans to change visit to in-person or telephone only
- Patient declines assistance from the Super-Supporter program.
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 |
|---|---|---|
| Enhanced Usual CareOffer written instructions to the patient and refer the patient to their clinical team if they have unresolved issues. | Other | Enhanced Usual Care |
| Super Supporter SupportAssist and troubleshoot with the patient including a practice video visit. | Other | Super Supporter Support |
Primary outcome
Rate of Successful Video Visits
Time frame: Up to Week 3
Data will be collected from electronic health record review
1 secondary outcome
Health Care Climate Questionnaire (HCCQ)
Time frame: Month 6
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 3 Mar 2025.
- Individual participant dataSharing planned: No. This project by a specific endowment and thus does not have a sharing requirement.
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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.
Thomas Houston, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Supporter Support in people with Telemedicine, run by Wake Forest University Health Sciences at 2 sites 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 2 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of Successful Video Visits (time frame: Up to Week 3). 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 3 Mar 2025.