OutpatientsISOTOPENCT04245020
A Study Comparing Three Methods of Outpatient Follow up After Surgical Admission; Text Message, Phone Call and In-person Appointment
A study testing Text message follow up, Telephone follow up and In person follow up in people with Outpatients and Virtual Clinic, run by Connolly Hospital Blanchardstown at 1 site in Ireland.
Trial summary
This study compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Outpatients, Virtual Clinic, Text Messaging
- What is being tested?
- Text message follow up, Telephone follow up and In person follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIreland
- Study dates
- 16 Sep 2019to 21 Jun 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Surgical patients admitted either as an emergency or for an elective procedure
- 16 years or older
Who cannot join
- Did not consent or cannot give consent
- Age less than 16
- No smartphone
- Further follow up required for treatment of further investigation
- Diagnosis or suspected diagnosis of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Randomised Control Trial Comparing Three Methods of Outpatient Follow up After Surgical Admission in Connolly Hospital Blanchardstown; Text Message, Phone Call and In-person Appointment
This study compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Data will be collected to identify complications identified in each arm along with the rate of non-response to the follow up methods and the level of satisfaction with the method. Willingness to use a telemedicine app in the future will also be evaluated through satisfaction survey.
Read the detailed description
This is a non-blinded, single centre open randomised control trial of the outpatient follow up method following surgical admission to Connolly Hospital Blanchardstown.
All eligible patients will be randomised into three arms, text message, telephone or in-person follow up. The follow up will be carried out at 6-8 weeks following discharge. The rate of complications, the non-response rate and the level of satisfaction will be compared between the three groups.
Willingness to use a telemedicine app in the future in place of an in-person follow up will also be measured by patient satisfaction questionnaire.
- Conditions
- Outpatients, Virtual Clinic, Text Messaging, General Surgery
- Being tested
- Text message follow up, Telephone follow up, In person follow up
- Keywords
- Randomised control trial, Virtual clinic, Text messaging, General surgery, Outpatients, Satisfaction, Telemedicine
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message follow upOther
A text message will be sent to the patient 6-8 weeks following discharge
Telephone follow upOther
The patient will be followed up at 6-8 weeks following discharge with a telephone call
In person follow upOther
The patient will be followed up at 6-8 weeks following discharge in person in the outpatient department
| Study group | Role | What they receive |
|---|---|---|
| Text Message | Active comparator | Patients will be followed up with a series of text messages at 6-8 weeks Receives: Other: Text message follow up |
| Telephone | Active comparator | Patients will be followed with a telephone conversation at 6-8 weeks Receives: Other: Telephone follow up |
| In person | Active comparator | Patients will be followed in person in the Outpatient department at 6-8 weeks Receives: Other: In person follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications that require further follow up
Complications are identified by patient record and follow up method selected
Measured: 6-8 weeks
Secondary outcomes (5)
Satisfaction in follow up
A questionnaire will assess how happy based on a survey patients were with their follow up method. The CSQ 8 score will be used along with a previously published questionnaire from this institiution. In the CSQ-8 questionnaire a higher score indicates more satisfaction.
Measured: 8-10 weeks
Willingness to use a virtual clinic app in the future
A questionnaire will assess patients preference in further follow up, specifically are patients happy to use a telemedicine based app. (answer no definitely not, no not really, yes generally, yes definitely.
Measured: 8-10 weeks
Follow up preference
Preferred follow up method will be identified by above patient questionnaire (text, phone or OPD)
Measured: 8-10 weeks
Lost to follow up
number of patients that are lost to follow up per follow up method
Measured: 6-8 weeks
Further procedures arranged
number of patients who have an additional procedure arranged which will be identified in the medical record
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start16 Sep 2019
- Primary completion21 Jun 2020
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutpatientsStudies 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
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connolly Hospital Blanchardstown
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Cromwell, Connolly Hospital Blanchardstown
- Investigators
- Paul M Cromwell, BM BS BA MRCS, Principal investigator, Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15Thomas N Walsh, MD MCh FRCSI, Study chair, Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245020
- Sponsor's protocol ID
- ISOTOPE
- Acronym
- ISOTOPE
- Status last verified
- Apr 2021
- First submitted
- 15 Sep 2019
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be shared with other researchers if requested
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomised Control Trial Comparing Three Methods of Outpatient Follow up After Surgical Admission in Connolly Hospital Blanchardstown; Text Message, Phone Call and In-person Appointment
- ClinicalTrials.gov ID
- NCT04245020
- Acronym / sponsor ID
- ISOTOPE / ISOTOPE
- Conditions
- Outpatients, Virtual Clinic, Text Messaging, General Surgery
- Keywords
- Randomised control trial, Virtual clinic, Text messaging, General surgery, Outpatients, Satisfaction, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Connolly Hospital BlanchardstownUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 21 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 28 Jan 2020 (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 compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Data will be collected to identify complications identified in each arm along with the rate of non-response to the follow up methods and the level of satisfaction with the method. Willingness to use a telemedicine app in the future will also be evaluated through satisfaction survey.
Detailed description
This is a non-blinded, single centre open randomised control trial of the outpatient follow up method following surgical admission to Connolly Hospital Blanchardstown.
All eligible patients will be randomised into three arms, text message, telephone or in-person follow up. The follow up will be carried out at 6-8 weeks following discharge. The rate of complications, the non-response rate and the level of satisfaction will be compared between the three groups.
Willingness to use a telemedicine app in the future in place of an in-person follow up will also be measured by patient satisfaction questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Text Message | Active comparator | Other: Text message follow upPatients will be followed up with a series of text messages at 6-8 weeks |
| Telephone | Active comparator | Other: Telephone follow upPatients will be followed with a telephone conversation at 6-8 weeks |
| In person | Active comparator | Other: In person follow upPatients will be followed in person in the Outpatient department at 6-8 weeks |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical patients admitted either as an emergency or for an elective procedure
- 16 years or older
Key exclusion criteria (5 listed)
- Did not consent or cannot give consent
- Age less than 16
- No smartphone
- Further follow up required for treatment of further investigation
- Diagnosis or suspected diagnosis of malignancy
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 |
|---|---|---|
| Text message follow upA text message will be sent to the patient 6-8 weeks following discharge | Other | Text Message |
| Telephone follow upThe patient will be followed up at 6-8 weeks following discharge with a telephone call | Other | Telephone |
| In person follow upThe patient will be followed up at 6-8 weeks following discharge in person in the outpatient department | Other | In person |
Primary outcome
Complications that require further follow up
Time frame: 6-8 weeks
Complications are identified by patient record and follow up method selected
5 secondary outcomes
Satisfaction in follow up
Time frame: 8-10 weeks
Willingness to use a virtual clinic app in the future
Time frame: 8-10 weeks
Follow up preference
Time frame: 8-10 weeks
Lost to follow up
Time frame: 6-8 weeks
Further procedures arranged
Time frame: 8-10 weeks
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 Apr 2021.
- Individual participant dataSharing planned: Undecided. All data will be shared with other researchers if requested
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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.
Paul M Cromwell, BM BS BA MRCS principal investigator
Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15
Thomas N Walsh, MD MCh FRCSI study chair
Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message follow up, Telephone follow up and In person follow up in people with Outpatients and Virtual Clinic, run by Connolly Hospital Blanchardstown at 1 site in Ireland.
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 5 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 Apr 2021. 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 Ireland. 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?
Complications that require further follow up (time frame: 6-8 weeks). 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 26 Apr 2021.