Orthopaedic SurgeryNCT05601765
The Effect of Digital Team-based Communication on Patient-initiated Telephone Contacts to Hospital After Discharge
A study testing Standard communication pathways after discharge and Digital team-based communication after discharge in people with Orthopaedic Surgery, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopaedic Surgery
- What is being tested?
- Standard communication pathways after discharge and Digital team-based communication after discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2022to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Surgery Department, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: 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
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.
Read the detailed description
Transition of care from hospital to home following orthopaedic surgery pose a significant risk to patient safety. After discharge, patients or primary care providers may need to communicate with the specialized healthcare team at the hospital about symptoms, postoperative complications, rehabilitation, wounds and medication, but are hampered by a fragmented healthcare system with slow communication pathways. Communication through phone often involves several intermediaries and waiting time for both patients and healthcare professionals. The fact that patients and healthcare professionals must be present at the same time is inflexible and disruptive to work processes. However, cross-sectoral communication and collaboration with patients after hospital discharge are prerequisites to achieve high-quality care and good patient outcomes. Review of the literature show that few studies have explored the effects of digital team-based communication with the patient and across sectors to facilitate collaboration and knowledge sharing after discharge. On the basis of findings from a preliminary pilot study suggesting asynchronous digital team-based communication between orthopaedic surgery patients and healthcare professionals across sectors (eDialogue) may be a solution to the existing problems in communication pathways, we initiated this trial.
- Conditions
- Orthopaedic Surgery
- Being tested
- Standard communication pathways after discharge, Digital team-based communication after discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard communication pathways after dischargeOther
Standard communication pathways after discharge
Digital team-based communication after dischargeOther
Standard communication pathways plus digital team-based communication after discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Digital team-based communication after discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 8 weeks
Patient Continuity of Care
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.
Measured: 4 weeks
Feeling safe and satisfied with access to healthcare professionals
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start31 Oct 2022
- Primary completion1 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Ole Rahbek, Aalborg University Hospital
- Investigators
- Ole Rahbek, PhD, MD, Principal investigator, Interdisciplinary Orthopaedics, Aalborg University Hospital, DenmarkLili WH Jensen, MSc, Study chair, Interdisciplinary Orthopaedics, Aalborg University Hospital, DenmarkBirthe I Dinesen, PhD, MSc, Study chair, Aalborg UniversitySøren Kold, PhD, MD, Study chair, Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601765
- Sponsor's protocol ID
- 2021-219
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05601765
- Acronym / sponsor ID
- 2021-219
- Conditions
- Orthopaedic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Transition of care from hospital to home following orthopaedic surgery pose a significant risk to patient safety. After discharge, patients or primary care providers may need to communicate with the specialized healthcare team at the hospital about symptoms, postoperative complications, rehabilitation, wounds and medication, but are hampered by a fragmented healthcare system with slow communication pathways. Communication through phone often involves several intermediaries and waiting time for both patients and healthcare professionals. The fact that patients and healthcare professionals must be present at the same time is inflexible and disruptive to work processes. However, cross-sectoral communication and collaboration with patients after hospital discharge are prerequisites to achieve high-quality care and good patient outcomes. Review of the literature show that few studies have explored the effects of digital team-based communication with the patient and across sectors to facilitate collaboration and knowledge sharing after discharge. On the basis of findings from a preliminary pilot study suggesting asynchronous digital team-based communication between orthopaedic surgery patients and healthcare professionals across sectors (eDialogue) may be a solution to the existing problems in communication pathways, we initiated this trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard communication pathways after discharge | Active comparator | Other: Standard communication pathways after dischargePatients 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. |
| Digital team-based communication after discharge | Experimental | Other: Digital team-based communication after dischargePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- if patient is < 15 years old, the parent(s) will be included in the study as user(s) of LetDialog.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard communication pathways after dischargeStandard communication pathways after discharge | Other | Standard communication pathways after discharge |
| Digital team-based communication after dischargeStandard communication pathways plus digital team-based communication after discharge | Other | Digital team-based communication after discharge |
Primary outcome
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.
3 secondary outcomes
Other patient-initiated contacts to hospital or other healthcare facilities through email, video, SMS up to 8 weeks after discharge
Time frame: 8 weeks
Patient Continuity of Care
Time frame: 4 weeks
Feeling safe and satisfied with access to healthcare professionals
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Rahbek, PhD, MD principal investigator
Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark
Lili WH Jensen, MSc study chair
Interdisciplinary Orthopaedics, Aalborg University Hospital, Denmark
Birthe I Dinesen, PhD, MSc study chair
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard communication pathways after discharge and Digital team-based communication after discharge in people with Orthopaedic Surgery, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-initiated telephone contacts to hospital up to 8 weeks after discharge (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.