Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04885868 |
| Other study ID # |
RXQ |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2021 |
| Est. completion date |
July 31, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Ufonia |
| Contact |
Guy Mole, BSc MBBS MSc |
| Phone |
07760270520 |
| Email |
gm[@]ufonia.co |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients will have an automated call supervised by a human clinician to check how they are
after uncomplicated cataract surgery as part of their standard of care. The study aims to
evaluate the acceptability of this system through a net promoter score and for a subsection
of patients using a qualitative interview.
Description:
The study will be a qualitative cohort design. The target will be to recruit 1000 patients
who meet the inclusion criteria and provide consent following the process set out below. This
represents recruiting 75% of the total projected number of patients who will undergo cataract
surgery during the trial period.
Currently at Buckinghamshire Healthcare NHS Trust patients who have uncomplicated cataract
surgery are given post-op instructions and assessed for their suitability to undergo
telephone follow-up by the nursing team in the discharge lounge. If deemed suitable for a
telephone call (equivalent to the criteria for inclusion in this study, including the
capacity to consent) a date to expect a telephone follow-up call is given. During the study
these patients will also be given an information leaflet and information relating to the
study by the nursing team.
The post-op telephone call occurs three weeks later and at the start of this call patients
will be asked if they consent to take part as well as if they have any further questions. If
they agree to participate in the study their follow-up will be conducted by the autonomous
human supervised system as well as additional questions to determine the acceptability of the
system. If they decline to participate or are unable to consent (for example, the unlikely
event that their capacity has become impaired following surgery), they will have their
follow-up conducted by a human clinician as per the current standard of care.
For those patients who provide consent the autonomous human supervised system comprises
several conversational elements which occur in order:
1. Greeting and introduction
2. Identification of patient
3. Cataract follow-up symptom questions
4. Patient's queries and frequently asked questions
5. Acceptability questions
6. Closure of call
If all of the questions aren't asked by the autonomous system or the human supervisor feels
additional information is required they can ask these at the end of the call. The patient may
withdraw from the automated call at any point.
Up to 50 patients (5% of total recruited) who consent to participate will be invited to take
part in a subsequent structured telephone interview with a researcher to explore in greater
depth their experience of using the system. The interview will last no more that 30 minutes
and will be conducted within one week of the follow-up call.
Anonymised data from the patient ratings will undergo standard statistical analysis. The
qualitative responses to the reasons why they gave their score as well as the answers to the
in-depth interviews will undergo thematic analysis to understand patients' perceptions of
having the follow-up conducted by the autonomous human supervised system.
