A Study Comparing Three Methods of Outpatient Follow up After Surgical Admission; Text Message, Phone Call and In-person Appointment (ISOTOPE)

An Open Label Randomised Control Trial Comparing Three Methods of Outpatient Follow up After Surgical Admission in Connolly Hospital Blanchardstown; Text Message, Phone Call and In-person Appointment

This study compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Data will be collected to identify complications identified in each arm along with the rate of non-response to the follow up methods and the level of satisfaction with the method. Willingness to use a telemedicine app in the future will also be evaluated through satisfaction survey.

Study Overview

• Status: Completed
• Conditions: General Surgery; Outpatients; Virtual Clinic; Text Messaging
• Intervention / Treatment: Other: Text message follow up; Other: Telephone follow up; Other: In person follow up

Detailed Description

This is a non-blinded, single centre open randomised control trial of the outpatient follow up method following surgical admission to Connolly Hospital Blanchardstown.

All eligible patients will be randomised into three arms, text message, telephone or in-person follow up. The follow up will be carried out at 6-8 weeks following discharge. The rate of complications, the non-response rate and the level of satisfaction will be compared between the three groups.

Willingness to use a telemedicine app in the future in place of an in-person follow up will also be measured by patient satisfaction questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Dublin
    • Dublin 15, Co. Dublin, Ireland, D07 A59E
      • Connolly Hospital Blanchardstown

Participation Criteria

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:

• Surgical patients admitted either as an emergency or for an elective procedure
• 16 years or older

Exclusion Criteria:

• Did not consent or cannot give consent
• Age less than 16
• No smartphone
• Further follow up required for treatment of further investigation
• Diagnosis or suspected diagnosis of malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Text Message; Patients will be followed up with a series of text messages at 6-8 weeks	Other: Text message follow up; A text message will be sent to the patient 6-8 weeks following discharge
Active Comparator: Telephone; Patients will be followed with a telephone conversation at 6-8 weeks	Other: Telephone follow up; The patient will be followed up at 6-8 weeks following discharge with a telephone call
Active Comparator: In person; Patients will be followed in person in the Outpatient department at 6-8 weeks	Other: In person follow up; The patient will be followed up at 6-8 weeks following discharge in person in the outpatient department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications that require further follow up	Complications are identified by patient record and follow up method selected	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction in follow up	A questionnaire will assess how happy based on a survey patients were with their follow up method. The CSQ 8 score will be used along with a previously published questionnaire from this institiution. In the CSQ-8 questionnaire a higher score indicates more satisfaction.	8-10 weeks
Willingness to use a virtual clinic app in the future	A questionnaire will assess patients preference in further follow up, specifically are patients happy to use a telemedicine based app. (answer no definitely not, no not really, yes generally, yes definitely.	8-10 weeks
Follow up preference	Preferred follow up method will be identified by above patient questionnaire (text, phone or OPD)	8-10 weeks
Lost to follow up	number of patients that are lost to follow up per follow up method	6-8 weeks
Further procedures arranged	number of patients who have an additional procedure arranged which will be identified in the medical record	8-10 weeks

Collaborators and Investigators

• Sponsor: Connolly Hospital Blanchardstown
• Investigators: Principal Investigator: Paul M Cromwell, BM BS BA MRCS, Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15; Study Chair: Thomas N Walsh, MD MCh FRCSI, Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): June 21, 2020
• Study Completion (Actual): June 21, 2020

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Satisfaction; Outpatients; General surgery; Text messaging; Virtual clinic; Randomised control trial
• Other Study ID Numbers: ISOTOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All data will be shared with other researchers if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No