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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067220
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Healy, Connolly Hospital Blanchardstown

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.

Condition or disease Intervention/treatment Phase
Outpatients General Surgery Virtual Clinic Other: Virtual outpatient clinic appointment Other: Standard outpatient clinic appointment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Can A Virtual Clinic Review Replace A Surgical Clinic Visit After Discharge?
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067220


Locations
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Ireland
Connolly Hospital
Dublin, Ireland
Sponsors and Collaborators
Connolly Hospital Blanchardstown
Investigators
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Study Chair: Thomas Walsh, MD MCh FCRSI Department of General Surgery, Connolly Hospital and Royal College of Surgeons in Ireland
Publications:

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Responsible Party: Paul Healy, Surgical Registrar, Connolly Hospital Blanchardstown
ClinicalTrials.gov Identifier: NCT03067220    
Other Study ID Numbers: ConnollyHB
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Healy, Connolly Hospital Blanchardstown:
outpatients
general surgery
virtual clinic
patient satisfaction