- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05601765
The Effect of Digital Team-based Communication on Patient-initiated Telephone Contacts to Hospital After Discharge
The Effect of Digital Team-based Communication Between Orthopaedic Surgery Patients and Healthcare Professionals on Patient-initiated Telephone Contacts to Hospital After Discharge: a Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark, 9000
- Orthopaedic Surgery Department, Aalborg University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Patients are recruited from the following orthopaedic surgery sub-specialties at Aalborg University Hospital:
- Deformity surgery
- Trauma surgery, including fractures of the spine
Inclusion Criteria:
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)
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard communication pathways after discharge
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.).
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. |
Standard communication pathways after discharge
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Experimental: Digital team-based communication after discharge
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.
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Standard communication pathways plus digital team-based communication after discharge
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-initiated telephone contacts to hospital up to 8 weeks after discharge
Time Frame: 8 weeks
|
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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Other patient-initiated contacts to hospital or other healthcare facilities through email, video, SMS up to 8 weeks after discharge
Time Frame: 8 weeks
|
Questionnaire on patient-initiated contacts to hospital or other healthcare facilities after discharge through email, video, SMS distributed on once a week for 8 weeks after discharge.
The questionnaire is self-developed and not validated, but tested for wording and understanding in 12 orthopaedic surgery patients using qualitative interviewing.
|
8 weeks
|
|
Patient Continuity of Care
Time Frame: 4 weeks
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Validated questionnaire containing 41 items.
27 items belong to 'before discharge' and will be administered on the day of discharge and 14 items belong to 'after discharge' and will be administered 30 days after discharge.
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4 weeks
|
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Feeling safe and satisfied with access to healthcare professionals
Time Frame: 8 weeks
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Questionnaire to test if intervention provides feeling of safety and satisfaction with access to healthcare professionals after discharge.
The questionnaire is self-developed to fit the intervention.
It contains of 4 items for the control group and 7 items for the intervention group and will be distributed 8 weeks after discharge.
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8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ole Rahbek, PhD, MD, Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark
- Study Chair: 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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