Outpatients General Surgery Virtual ClinicNCT03067220
Can A Virtual Clinic Review Replace A Surgical Clinic Visit After Discharge?
A study testing Virtual outpatient clinic appointment and Standard outpatient clinic appointment in people with Outpatients General Surgery Virtual Clinic, run by Connolly Hospital Blanchardstown at 1 site in Ireland.
Trial summary
To assess if a virtual out patient clinic via a telephone review was an acceptable and safe alternative to a clinic attendance for a broad range of general surgical patients discharged following a hospital admission. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Outpatients General Surgery Virtual Clinic
- What is being tested?
- Virtual outpatient clinic appointment and Standard outpatient clinic appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteIreland
- Study dates
- 1 May 2016to 1 May 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 16 years old
- Could provide written consent
- Comprised one of four categories based on reason for admission
- Category 1 - minor surgery
- Category 2- elective or emergency surgery such as appendicectomy, hernia repair, thyroidectomy
- Category 3- admitted for investigation or management of conditions such as non specific abdominal pain, head injury, cellulitis
- Category 4- attended for surveillance endoscopy for conditions such as colonic polys or Barrett's oesophagus
Who cannot join
- Declined to participate
- Had a previous, new or suspected diagnosis of malignancy
- On-going issues requiring follow up such as wound healing problems
- Required further investigation such as endoscopy after admission with e.g. diverticulitis.
Trial locations and contacts
1 site in 1 country.
About this study
To assess if a virtual out patient clinic via a telephone review was an acceptable and safe alternative to a clinic attendance for a broad range of general surgical patients discharged following a hospital admission.
Read the detailed description
The surgical out patients is often the first point of contact between a surgeon and patient after being referred by their general practitioner (GP). Here new patients are assessed, investigations are requested and treatment plans devised. On completion of treatment it has been common practice to review all patients post operatively (1). However the routine review of patients following low risk procedures contribute to increasing healthcare costs without necessarily a significant benefit for the patient. It may indeed be a burden on patients and families, who may miss work or college, have to travel long distances and wait for prolonged periods to be seen. There is also a financial burden associated with travel to appointments and on-site parking fees. Unnecessary appointments also contribute to increased waiting times for new referrals to be seen. This has the potential to lead to delayed diagnosis of serious conditions (2) and further increase the workload of overburdened emergency departments.
Previous studies have demonstrated a safe and acceptable alternative to traditional outpatient appointments with telephone follow up in certain paediatric and adult surgical patients (1,3,4). Improved efficiency and high levels of patient satisfaction have also been demonstrated in an Irish setting with the establishment of a virtual outpatient department (VOPD) following endoscopy (5). In an oncology setting telephone follow up has also been identified as an effective means of delivering care (6,7). In particular nurse led follow up of lung, breast and colorectal cancer patients has been associated with a high level of patient satisfaction (8).
The aim of this study was to determine whether a virtual out patient clinic via a telephone review was an acceptable and safe alternative to a clinic attendance for a broad range of general surgical patients discharged following a hospital admission.
If eligible for inclusion the patient was approached prior to discharge and the study rationale, randomisation and methods of follow up were explained. If they agreed to participate written consent was obtained and an information leaflet about the study was provided. Randomisation was performed by selecting an unmarked white envelope which contained either a coloured card indicating a telephone call follow up within 6-8 weeks or a white card indicating follow up with an outpatient appointment at 6-8 weeks.
After randomisation the patient was provided with a letter detailing their specific follow up arrangements and a contact number was provided if they had any further questions after discharge. Patients' were sent a further letter by administration staff after discharge, with the specific date of either the clinic appointment or phone follow up.
- Being tested
- Virtual outpatient clinic appointment, Standard outpatient clinic appointment
- Keywords
- outpatients, general surgery, virtual clinic, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual outpatient clinic appointmentOther
Patients will be sent an appointment letter stating a specific day approximately 6 weeks after their discharge from hospital in which they will be contacted by telephone for a review by a junior doctor from the discharging team.
Standard outpatient clinic appointmentOther
Patients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Standard outpatient clinic appointment | Other | Patients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital Receives: Other: Standard outpatient clinic appointment |
| Virtual out patient clinic appointment | Experimental | Patients will be sent an appointment letter stating a specific day approximately 6 weeks after their discharge from hospital in which they will be contacted by telephone for a review by a junior doctor from the discharging team. Receives: Other: Virtual outpatient clinic appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the rate of complications or on going issues requiring further assessment in either group.
Any unexpected outcome reported by the patient if contacted by telephone or reported and assessed by a doctor on their review at a standard clinic appointment. This would be expected to be an issue resulting in a deviation from a normal and expected post discharge recovery.
Measured: At each patients review appointment approximately 6 weeks after discharge.
Secondary outcomes (3)
Secondary outcomes included a "did not respond" (DNR) or did not attend (DNA) rate
If an attempt to contact the patient by telephone to conduct their review appointment is unsuccessful this will be recorded as a did not respond. A DNA will be recorded if a patient fails to attend for their scheduled review appointment
Measured: At each patients review appointment approximately 6 weeks after discharge.
The number of patients listed for further procedures, investigation or referral to other specialities based on their review.
If the patient is not discharged from follow up by the hospital service to the care of their general practitioner, these are the anticipated outcomes of the follow up review for each patient not discharged
Measured: At each patients review appointment approximately 6 weeks after discharge.
Patient satisfaction and opinions regarding their follow up arrangements
Questionnaire that allows participants to provide free text responses about their experience.
Measured: 6-8 weeks after their review appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 May 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Outpatients General Surgery Virtual ClinicStudies 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
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connolly Hospital Blanchardstown
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Healy, Connolly Hospital Blanchardstown
- Investigators
- Thomas Walsh, MD MCh FCRSI, Study chair, Department of General Surgery, Connolly Hospital and Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067220
- Sponsor's protocol ID
- ConnollyHB
- Status last verified
- Jun 2017
- First submitted
- 22 Feb 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McVay MR, Kelley KR, Mathews DL, Jackson RJ, Kokoska ER, Smith SD. Postoperative follow-up: is a phone call enough? J Pediatr Surg. 2008 Jan;43(1):83-6. doi: 10.1016/j.jpedsurg.2007.09.025.
PubMed 18206461Allgar VL, Neal RD. Delays in the diagnosis of six cancers: analysis of data from the National Survey of NHS Patients: Cancer. Br J Cancer. 2005 Jun 6;92(11):1959-70. doi: 10.1038/sj.bjc.6602587.
PubMed 15870714Gray RT, Sut MK, Badger SA, Harvey CF. Post-operative telephone review is cost-effective and acceptable to patients. Ulster Med J. 2010 May;79(2):76-9.
PubMed 21116423Rosbe KW, Jones D, Jalisi S, Bray MA. Efficacy of postoperative follow-up telephone calls for patients who underwent adenotonsillectomy. Arch Otolaryngol Head Neck Surg. 2000 Jun;126(6):718-21; discussion 722. doi: 10.1001/archotol.126.6.718.
PubMed 10864107Ryan EM, Rogers AC, Hanly AM, McCawley N, Deasy J, McNamara DA. A virtual outpatient department provides a satisfactory patient experience following endoscopy. Int J Colorectal Dis. 2014 Mar;29(3):359-64. doi: 10.1007/s00384-013-1801-y. Epub 2013 Dec 6.
PubMed 24309978Sardell S, Sharpe G, Ashley S, Guerrero D, Brada M. Evaluation of a nurse-led telephone clinic in the follow-up of patients with malignant glioma. Clin Oncol (R Coll Radiol). 2000;12(1):36-41. doi: 10.1053/clon.2000.9108.
PubMed 10749018Booker J, Eardley A, Cowan R, Logue J, Wylie J, Caress AL. Telephone first post-intervention follow-up for men who have had radical radiotherapy to the prostate: evaluation of a novel service delivery approach. Eur J Oncol Nurs. 2004 Dec;8(4):325-33. doi: 10.1016/j.ejon.2004.01.003.
PubMed 15550362Beaver K, Williamson S, Chalmers K. Telephone follow-up after treatment for breast cancer: views and experiences of patients and specialist breast care nurses. J Clin Nurs. 2010 Oct;19(19-20):2916-24. doi: 10.1111/j.1365-2702.2010.03197.x.
PubMed 20649914
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can A Virtual Clinic Review Replace A Surgical Clinic Visit After Discharge?
- ClinicalTrials.gov ID
- NCT03067220
- Acronym / sponsor ID
- ConnollyHB
- Keywords
- outpatients, general surgery, virtual clinic, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Connolly Hospital BlanchardstownUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 1 Mar 2017 (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.
To assess if a virtual out patient clinic via a telephone review was an acceptable and safe alternative to a clinic attendance for a broad range of general surgical patients discharged following a hospital admission.
Detailed description
The surgical out patients is often the first point of contact between a surgeon and patient after being referred by their general practitioner (GP). Here new patients are assessed, investigations are requested and treatment plans devised. On completion of treatment it has been common practice to review all patients post operatively (1). However the routine review of patients following low risk procedures contribute to increasing healthcare costs without necessarily a significant benefit for the patient. It may indeed be a burden on patients and families, who may miss work or college, have to travel long distances and wait for prolonged periods to be seen. There is also a financial burden associated with travel to appointments and on-site parking fees. Unnecessary appointments also contribute to increased waiting times for new referrals to be seen. This has the potential to lead to delayed diagnosis of serious conditions (2) and further increase the workload of overburdened emergency departments.
Previous studies have demonstrated a safe and acceptable alternative to traditional outpatient appointments with telephone follow up in certain paediatric and adult surgical patients (1,3,4). Improved efficiency and high levels of patient satisfaction have also been demonstrated in an Irish setting with the establishment of a virtual outpatient department (VOPD) following endoscopy (5). In an oncology setting telephone follow up has also been identified as an effective means of delivering care (6,7). In particular nurse led follow up of lung, breast and colorectal cancer patients has been associated with a high level of patient satisfaction (8).
The aim of this study was to determine whether a virtual out patient clinic via a telephone review was an acceptable and safe alternative to a clinic attendance for a broad range of general surgical patients discharged following a hospital admission.
If eligible for inclusion the patient was approached prior to discharge and the study rationale, randomisation and methods of follow up were explained. If they agreed to participate written consent was obtained and an information leaflet about the study was provided. Randomisation was performed by selecting an unmarked white envelope which contained either a coloured card indicating a telephone call follow up within 6-8 weeks or a white card indicating follow up with an outpatient appointment at 6-8 weeks.
After randomisation the patient was provided with a letter detailing their specific follow up arrangements and a contact number was provided if they had any further questions after discharge. Patients' were sent a further letter by administration staff after discharge, with the specific date of either the clinic appointment or phone follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard outpatient clinic appointment | Other | Other: Standard outpatient clinic appointmentPatients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital |
| Virtual out patient clinic appointment | Experimental | Other: Virtual outpatient clinic appointmentPatients will be sent an appointment letter stating a specific day approximately 6 weeks after their discharge from hospital in which they will be contacted by telephone for a review by a junior doctor from the discharging team. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Over 16 years old
- Could provide written consent
- Comprised one of four categories based on reason for admission
Key exclusion criteria (4 listed)
- Declined to participate
- Had a previous, new or suspected diagnosis of malignancy
- On-going issues requiring follow up such as wound healing problems
- Required further investigation such as endoscopy after admission with e.g. diverticulitis.
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 |
|---|---|---|
| Virtual outpatient clinic appointmentPatients will be sent an appointment letter stating a specific day approximately 6 weeks after their discharge from hospital in which they will be contacted by telephone for a review by a junior doctor from the discharging team. | Other | Virtual out patient clinic appointment |
| Standard outpatient clinic appointmentPatients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital | Other | Standard outpatient clinic appointment |
Primary outcome
The primary outcome was the rate of complications or on going issues requiring further assessment in either group.
Time frame: At each patients review appointment approximately 6 weeks after discharge.
Any unexpected outcome reported by the patient if contacted by telephone or reported and assessed by a doctor on their review at a standard clinic appointment. This would be expected to be an issue resulting in a deviation from a normal and expected post discharge recovery.
3 secondary outcomes
Secondary outcomes included a "did not respond" (DNR) or did not attend (DNA) rate
Time frame: At each patients review appointment approximately 6 weeks after discharge.
The number of patients listed for further procedures, investigation or referral to other specialities based on their review.
Time frame: At each patients review appointment approximately 6 weeks after discharge.
Patient satisfaction and opinions regarding their follow up arrangements
Time frame: 6-8 weeks after their review appointment
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 9 Jun 2017.
- Background: PubMed 18206461McVay MR, Kelley KR, Mathews DL, Jackson RJ, Kokoska ER, Smith SD. Postoperative follow-up: is a phone call enough? J Pediatr Surg. 2008 Jan;43(1):83-6. doi: 10.1016/j.jpedsurg.2007.09.025.
- Background: PubMed 15870714Allgar VL, Neal RD. Delays in the diagnosis of six cancers: analysis of data from the National Survey of NHS Patients: Cancer. Br J Cancer. 2005 Jun 6;92(11):1959-70. doi: 10.1038/sj.bjc.6602587.
- Background: PubMed 21116423Gray RT, Sut MK, Badger SA, Harvey CF. Post-operative telephone review is cost-effective and acceptable to patients. Ulster Med J. 2010 May;79(2):76-9.
- Background: PubMed 10864107Rosbe KW, Jones D, Jalisi S, Bray MA. Efficacy of postoperative follow-up telephone calls for patients who underwent adenotonsillectomy. Arch Otolaryngol Head Neck Surg. 2000 Jun;126(6):718-21; discussion 722. doi: 10.1001/archotol.126.6.718.
- Background: PubMed 24309978Ryan EM, Rogers AC, Hanly AM, McCawley N, Deasy J, McNamara DA. A virtual outpatient department provides a satisfactory patient experience following endoscopy. Int J Colorectal Dis. 2014 Mar;29(3):359-64. doi: 10.1007/s00384-013-1801-y. Epub 2013 Dec 6.
- Background: PubMed 10749018Sardell S, Sharpe G, Ashley S, Guerrero D, Brada M. Evaluation of a nurse-led telephone clinic in the follow-up of patients with malignant glioma. Clin Oncol (R Coll Radiol). 2000;12(1):36-41. doi: 10.1053/clon.2000.9108.
- Background: PubMed 15550362Booker J, Eardley A, Cowan R, Logue J, Wylie J, Caress AL. Telephone first post-intervention follow-up for men who have had radical radiotherapy to the prostate: evaluation of a novel service delivery approach. Eur J Oncol Nurs. 2004 Dec;8(4):325-33. doi: 10.1016/j.ejon.2004.01.003.
- Background: PubMed 20649914Beaver K, Williamson S, Chalmers K. Telephone follow-up after treatment for breast cancer: views and experiences of patients and specialist breast care nurses. J Clin Nurs. 2010 Oct;19(19-20):2916-24. doi: 10.1111/j.1365-2702.2010.03197.x.
- Individual participant dataSharing planned: No
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 Walsh, MD MCh FCRSI study chair
Department of General Surgery, Connolly Hospital and Royal College of Surgeons in Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual outpatient clinic appointment and Standard outpatient clinic appointment in people with Outpatients General Surgery 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 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 9 Jun 2017. 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?
The primary outcome was the rate of complications or on going issues requiring further assessment in either group. (time frame: At each patients review appointment approximately 6 weeks after discharge.). 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 NCT03067220, which also lists 8 linked publications.
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 9 Jun 2017.