Orthopedic DisorderNCT03431259
Inpatient Enrollment of Patient Portal App
A study testing Patient Gateway in people with Orthopedic Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to determine if inpatient enrollment into a patient communication app improves clinic follow-up of orthopedic trauma patients and improves survey completion rates after orthopedic trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Patient Gateway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the hospital for an orthopedic condition with the need for outpatient follow-up
- able to consent for themselves
Who cannot join
- unable to consent for themselves
- inability to communicate in English
- no possession of a smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Does Inpatient Enrollment Into a Patient Communication App (Patient Gateway) Result in Improved Follow-up and Survey Completion Rates After Orthopaedic Trauma?
This study aims to determine if inpatient enrollment into a patient communication app improves clinic follow-up of orthopedic trauma patients and improves survey completion rates after orthopedic trauma.
Read the detailed description
Follow-up in trauma is historically poor. As a result, outcomes from trauma are difficult to collect via surveys and are often significantly influenced by selection bias. Patient interaction apps like Patient Gateway are thought to facilitate greater participant involvement and adherence to treatment regimens. The investigators will explore if inpatient enrollment into Patient Gateway would improve clinic follow-up rates. Increasing follow-up rates could improve the quality of care delivered.
In addition, self-administered survey questionnaires are an important data collection tool in clinical practice, public health research and epidemiology. However, survey completion rates are typically poor in orthopaedic trauma.
With the evaluation of modern technology, electronic applications are being increasingly used in both hospital and personal settings. In outpatient clinics, questionnaires to measure outcomes and monitor quality of care are administered by staff members using hospital owned tablet devices. Recently, applications to complete these surveys on personal devices have been developed.
In a recent Cochrane review on the comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods it was concluded that there are no data available on response rates. The investigators will attempt to address this question.
All Patient Gateway naïve patients aged 18 years or older able to consent for themselves and admitted to the hospital for an orthopedic condition with the need for outpatient follow-up will be invited to participate in this study. Exclusion criteria will be patients unable to consent for themselves, inability to communicate in English, and no possession of a smartphone.
- Conditions
- Orthopedic Disorder
- Being tested
- Patient Gateway
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient GatewayOther
Patients will be enrolled in the Patient Gateway app.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment group | Experimental | Not described Receives: Other: Patient Gateway |
| Information group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Clinic
The number of patients enrolled who return to clinic for a followup visit at 3 months postop. It will be a count and proportion of the occurrence of a patient returning to clinic for followup
Measured: 3 months postoperative
Use of Any the Patient Gateway Portal at 3 Months
The number of patients who used the patient gateway portal for any purpose at 3 months. This will be a count of participants.
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start5 Feb 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Heng, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431259
- Sponsor's protocol ID
- 2017P001594
- Status last verified
- Apr 2022
- First submitted
- 20 Jan 2018
- Last updated
- 18 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhashyam AR, Bansal M, McGovern MM, van der Vliet QMJ, Heng M. In-hospital Enrollment Into an Electronic Patient Portal Results in Improved Follow-up After Orthopedic Surgery: Cluster Randomized Controlled Trial. JMIR Perioper Med. 2022 Aug 11;5(1):e37148. doi: 10.2196/37148.
PubMed 35969452
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inpatient Enrollment Into a Patient Communication App (Patient Gateway) Result in Improved Follow-up and Survey Completion Rates After Orthopaedic Trauma?
- ClinicalTrials.gov ID
- NCT03431259
- Acronym / sponsor ID
- 2017P001594
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Posted 18 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if inpatient enrollment into a patient communication app improves clinic follow-up of orthopedic trauma patients and improves survey completion rates after orthopedic trauma.
Detailed description
Follow-up in trauma is historically poor. As a result, outcomes from trauma are difficult to collect via surveys and are often significantly influenced by selection bias. Patient interaction apps like Patient Gateway are thought to facilitate greater participant involvement and adherence to treatment regimens. The investigators will explore if inpatient enrollment into Patient Gateway would improve clinic follow-up rates. Increasing follow-up rates could improve the quality of care delivered.
In addition, self-administered survey questionnaires are an important data collection tool in clinical practice, public health research and epidemiology. However, survey completion rates are typically poor in orthopaedic trauma.
With the evaluation of modern technology, electronic applications are being increasingly used in both hospital and personal settings. In outpatient clinics, questionnaires to measure outcomes and monitor quality of care are administered by staff members using hospital owned tablet devices. Recently, applications to complete these surveys on personal devices have been developed.
In a recent Cochrane review on the comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods it was concluded that there are no data available on response rates. The investigators will attempt to address this question.
All Patient Gateway naïve patients aged 18 years or older able to consent for themselves and admitted to the hospital for an orthopedic condition with the need for outpatient follow-up will be invited to participate in this study. Exclusion criteria will be patients unable to consent for themselves, inability to communicate in English, and no possession of a smartphone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrollment group | Experimental | Other: Patient Gateway |
| Information group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- admitted to the hospital for an orthopedic condition with the need for outpatient follow-up
- able to consent for themselves
Key exclusion criteria (3 listed)
- unable to consent for themselves
- inability to communicate in English
- no possession of a smartphone
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 |
|---|---|---|
| Patient GatewayPatients will be enrolled in the Patient Gateway app. | Other | Enrollment group |
Primary outcome
Return to Clinic
Time frame: 3 months postoperative
The number of patients enrolled who return to clinic for a followup visit at 3 months postop. It will be a count and proportion of the occurrence of a patient returning to clinic for followup
Use of Any the Patient Gateway Portal at 3 Months
Time frame: 3 months postoperative
The number of patients who used the patient gateway portal for any purpose at 3 months. This will be a count of participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35969452Bhashyam AR, Bansal M, McGovern MM, van der Vliet QMJ, Heng M. In-hospital Enrollment Into an Electronic Patient Portal Results in Improved Follow-up After Orthopedic Surgery: Cluster Randomized Controlled Trial. JMIR Perioper Med. 2022 Aug 11;5(1):e37148. doi: 10.2196/37148.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Gateway in people with Orthopedic Disorder, run by Massachusetts General Hospital at 1 site in United States.
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 2 inclusion and 3 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 18 Nov 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Return to Clinic (time frame: 3 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431259, which also lists 1 linked publication.
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 18 Nov 2022.