NCT05601765

Brief Summary

The aim of this study is to investigate the effects of eDialogue versus standard communication pathways on patient-initiated telephone contacts to the hospital following discharge. Secondary aims are to explore the effect on other patient-initiated contacts after hospital discharge (mail, video, SMS, personal attendance) and, if digital team-based communication can positively affect patients experience of continuity of care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

October 28, 2022

Last Update Submit

November 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient-initiated telephone contacts to hospital up to 8 weeks after discharge

    Questionnaire on patient-initiated telephone contacts to hospital after discharge distributed once a week for 8 weeks after discharge. The questionnaire is short, self-developed and not validated, but tested for wording and understanding in 12 orthopaedic surgery patients using qualitative interviewing.

    8 weeks

Secondary Outcomes (3)

  • Other patient-initiated contacts to hospital or other healthcare facilities through email, video, SMS up to 8 weeks after discharge

    8 weeks

  • Patient Continuity of Care

    4 weeks

  • Feeling safe and satisfied with access to healthcare professionals

    8 weeks

Study Arms (2)

Standard communication pathways after discharge

ACTIVE COMPARATOR

Patients who need contact within 72 hours of discharge are advised to call the bed section, from where they were discharged. Telephone counseling can be provided by the nurses available at the time of calling (e.g., questions for medical treatment, precautions after surgery etc.). * If deemed relevant, the patient may be asked to appear in person at the ward (e.g., for the examination of wounds). * If more serious conditions are suspected, a doctor or emergency department will be contacted by the nurse for assessment, triage and possibly readmission. Patients who need contact after 72 hours of discharge are advised to call the outpatient clinic, if they have planned attendances here, or alternatively their own general practitioner or home care nurse. Standard communication pathways between healthcare professionals across sectors are electronic correspondences and telephone inquiries.

Other: Standard communication pathways after discharge

Digital team-based communication after discharge

EXPERIMENTAL

Patients will be given access to digital communication with their healthcare team across sectors who are involved in their treatment and care after hospital discharge (eDialogue). They will be set up in a messenger-like tool on the day of discharge, and relevant healthcare professionals will be connected. Individually, the patients will define who they would like to involve, and consent is given digitally. The minimum participants for each patient will be the patient and/or their closest relative, the orthopaedic surgeon, a nurse from the outpatient clinic and a secretary. Patients will have access to eDialogue for 60 days after discharge, and the response rate is set to be 24 hours on weekdays. On weekends and public holidays, patients are informed that they cannot expect a response. If the primary healthcare professional is registered to be on vacation or other absence, "substitutes" within the respective health professional groups will be included.

Other: Digital team-based communication after discharge

Interventions

Standard communication pathways after discharge

Standard communication pathways after discharge

Standard communication pathways plus digital team-based communication after discharge

Digital team-based communication after discharge

Eligibility Criteria

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

You may qualify if:

  • Patients admitted and operated at Aalborg University Hospital, who;
  • have complex care needs involving cross disciplinary and cross sectoral care after hospital discharge
  • will be discharged to their home
  • will need follow-up in the outpatient clinic after discharge
  • Patients at all ages, but:
  • if patient is \< 15 years old, the parent(s) will be included in the study as user(s) of LetDialog.
  • if patient is 15-18 years old, the patient will be the user in LetDialog and answer the questionnaires to comply with existing Danish legislation Health Act § 17. If the patient wishes, parent(s) can be included as user(s) in LetDialog as well.
  • Have access to and ability to use a smartphone Have access to NemID (needed to create a GDPR-safe user profile in LetDialog)

You may not qualify if:

  • Patients, who:
  • have previously participated in the eDialogue pilot study
  • are discharged to a rehabilitation center, nursing home or similar
  • do not speak/read Danish or English well enough to understand participant information and use digital communication in Danish or English through LetDialog
  • are included in other ongoing randomized controlled trials or prospective follow-up studies in the Orthopaedic Surgery Department at Aalborg University Hospital, where participation could possibly affect the results of these studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Surgery Department, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Study Officials

  • Ole Rahbek, PhD, MD

    Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR
  • Lili WH Jensen, MSc

    Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark

    STUDY CHAIR
  • Birthe I Dinesen, PhD, MSc

    Aalborg University

    STUDY CHAIR
  • Søren Kold, PhD, MD

    Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 1, 2022

Study Start

October 31, 2022

Primary Completion

June 1, 2023

Study Completion

July 10, 2023

Last Updated

November 3, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After 1 year from study start
Access Criteria
Researchers that provide a methodologically sound plan

Locations