Can A Virtual Clinic Review Replace A Surgical Clinic Visit After Discharge?

June 8, 2017 updated by: Paul Healy, Connolly Hospital Blanchardstown
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.

Study Overview

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

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dublin, Ireland
        • Connolly Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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