- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03067220
Can A Virtual Clinic Review Replace A Surgical Clinic Visit After Discharge?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dublin, Ireland
- Connolly Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard outpatient clinic appointment
Patients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital
|
Patients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital
|
Experimental: Virtual out patient clinic appointment
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At each patients review appointment approximately 6 weeks after discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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.
|
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
|
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
|
Questionnaire that allows participants to provide free text responses about their experience.
|
6-8 weeks after their review appointment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas Walsh, MD MCh FCRSI, Department of General Surgery, Connolly Hospital and Royal College of Surgeons in Ireland
Publications and helpful links
General 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.
- Allgar 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.
- Gray 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.
- Rosbe 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.
- Ryan 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.
- Sardell 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.
- Booker 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.
- Beaver 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ConnollyHB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Outpatients General Surgery Virtual Clinic
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
Germans Trias i Pujol HospitalCompletedTelemedicine | General Surgery | OutpatientsSpain
-
Odense University HospitalUniversity of Southern DenmarkCompletedOphthalmological Virtual Surgery Training
-
Gazi UniversityCompletedDrug Effect | Anesthesia | General Surgery | Outpatients | Anorectal Disorder
-
Kırıkkale UniversityThe Scientific and Technological Research Council of TurkeyRecruitingColorectal Surgery | Virtual Reality | Education | Nursing Care | Nursing StudentTurkey
-
Cairo UniversityUnknownEvaluation of the Accuracy of Transferring the Virtual Planning to the Surgery
-
dr. Muhammad Abdelhafez Mahmoud, MDCompletedCovid19 | Telemedicine | Pandemic | Virtual ClinicSaudi Arabia
-
Gümüşhane UniversıtyRecruitingQuality of Life | Surgery | Virtual Reality | Symptom ManagementTurkey
-
Bucak State HospitalCompletedVirtual Reality | Total Knee Replacement SurgeryTurkey
-
Kutahya Health Sciences UniversityCompletedDental Anxiety | Virtual Reality | Oral SurgeryTurkey
Clinical Trials on Standard outpatient clinic appointment
-
Shaukat Khanum Memorial Cancer Hospital & Research...Enrolling by invitationSatisfaction, Patient | SatisfactionPakistan
-
St Vincent's Hospital MelbourneCompletedFunctional Dyspepsia | Irritable Bowel Syndrome | Constipation - Functional | Faecal Incontinence | Functional Abdominal Pain Syndrome | Other Rome IV Functional Gastrointestinal DisordersAustralia
-
University Hospital of North NorwayHelse NordCompleted
-
University of PennsylvaniaAurum Institute; University of Witwatersrand, South AfricaCompleted
-
Leiden University Medical CenterNot yet recruitingSystemic Sclerosis
-
Maastricht Radiation OncologyCompletedBreast CancerNetherlands
-
Case Comprehensive Cancer CenterTerminated
-
Assistance Publique - Hôpitaux de ParisRecruitingFibrosis | Post-traumatic Stress Disorder | Post-COVID Syndrome | SequelaeFrance
-
University Hospital, Gentofte, CopenhagenCompleted
-
Baylor College of MedicineCompletedMetabolic Syndrome X | Heart Failure, CongestiveUnited States