NCT03067220

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

February 22, 2017

Last Update Submit

June 8, 2017

Conditions

Keywords

outpatientsgeneral surgeryvirtual clinicpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Secondary outcomes included a "did not respond" (DNR) or did not attend (DNA) rate

    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.

    At each patients review appointment approximately 6 weeks after discharge.

  • Patient satisfaction and opinions regarding their follow up arrangements

    6-8 weeks after their review appointment

Study Arms (2)

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

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.

Other: Virtual outpatient clinic appointment

Interventions

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.

Virtual out patient 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

Standard outpatient clinic appointment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connolly Hospital

Dublin, Ireland

Location

Related Publications (8)

  • 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.

    PMID: 18206461BACKGROUND
  • 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.

    PMID: 15870714BACKGROUND
  • 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.

    PMID: 21116423BACKGROUND
  • 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.

    PMID: 10864107BACKGROUND
  • 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.

    PMID: 24309978BACKGROUND
  • 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.

    PMID: 10749018BACKGROUND
  • 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.

    PMID: 15550362BACKGROUND
  • 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.

    PMID: 20649914BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Thomas Walsh, MD MCh FCRSI

    Department of General Surgery, Connolly Hospital and Royal College of Surgeons in Ireland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Registrar

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 1, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations