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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03067220
Other study ID # ConnollyHB
Secondary ID
Status Completed
Phase N/A
First received February 22, 2017
Last updated June 8, 2017
Start date May 1, 2016
Est. completion date May 1, 2017

Study information

Verified date June 2017
Source Connolly Hospital Blanchardstown
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Outpatients General Surgery Virtual Clinic

Intervention

Other:
Virtual outpatient 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.
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

Locations

Country Name City State
Ireland Connolly Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
Connolly Hospital Blanchardstown

Country where clinical trial is conducted

Ireland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At each patients review appointment approximately 6 weeks after discharge.
Secondary 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 At each patients review appointment approximately 6 weeks after discharge.
Secondary 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 At each patients review appointment approximately 6 weeks after discharge.
Secondary Patient satisfaction and opinions regarding their follow up arrangements Questionnaire that allows participants to provide free text responses about their experience. 6-8 weeks after their review appointment