Hospital DischargeNCT04547803
Post-discharge Early Assessment With a Video-visit
A study testing Video Visit in people with Hospital Discharge, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if a video visit with an advanced practice provider (Nurse Practitioner or Physician Assistant) within 7 days of discharge from Hospital Internal Medicine services will increase patient compliance with medication, self-management and home supports after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Discharge
- What is being tested?
- Video Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,190 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 1 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years
- Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital
- Patients or their legally authorized representative provides consent to participate in the study
- Patients discharged home or to assisted living facility
Who cannot join
- Patients discharged from Hospital Service Meds 1-4 and Med 17
- Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility
- Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure)
- Patient/legally authorized representative is Non-English speaking
- Patient leaves the hospital Against Medical Advice (AMA)
- No access to mobile technology/laptop/computer for post-discharge follow-up
- Patient with an active diagnosis Covid-19 infection
- Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Post-discharge Early Assessment With Remote Video Link (PEARL) Initiative: A Randomized Controlled Trial
The purpose of this study is to determine if a video visit with an advanced practice provider (Nurse Practitioner or Physician Assistant) within 7 days of discharge from Hospital Internal Medicine services will increase patient compliance with medication, self-management and home supports after hospital discharge.
Read the detailed description
Prior to discharge, patients will be referred by Hospital Internal Medicine (HIM) teams to the PEARL team and screened for study eligibility. Eligible patients who provide oral consent to participate. Participants will be randomized 1:1 with comparisons between "Usual care" and "Usual care + Video-visit" arms. Participants randomized to the intervention arm will participate in a 15-20 minute Video visit (using Zoom®) with an advanced practice provider (APP; nurse practitioner or physician assistant in HIM) approximately 2-5 days after discharge. The telephone follow-up will occur 3-6 days after discharge. If a patient has a Video visit, the telephone follow-up will be scheduled for after the Video visit.
It is standard practice for HIM teams to make and coordinate outpatient appointments and activities including radiologic procedures for discharging patients. During this study, usual care will continue for patients in each arm. The intervention (Video-visit) is in addition to and not in place of the usual standard of care.
If issues/concerns beyond the scope of the video visit or telephone follow-up arise, then the PEARL APP will direct these to the discharging hospitalist team/supervising physician, or the participant's primary care provider (PCP) consistent with current standards of practice and management of post-discharge issues. Issues re-directed to the discharging hospitalist team or other providers will be documented in the Video-visit encounter. If the APP deems the clinical situation urgent or emergent, the APP will refer the patient to emergency services, or if needed ask the patient his/her location and contact 911. The APP will also immediately notify the study PI or co-PI who are both hospitalists and familiar with the practice. The APP will also notify the discharging hospitalist team.
- Conditions
- Hospital Discharge
- Being tested
- Standard of Care, Video Visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Outpatient appointments and activities including radiologic procedures for discharging patients as standard of practice
Video VisitOther
15-20 minute Video visit with an advanced practice provider (nurse practitioner or physician assistant) approximately 2-5 days after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Video Visit and Standard of Care | Experimental | Participants will participate in a video visit and standard of care Receives: Other: Standard of Care; Other: Video Visit |
| Standard of Care | Active comparator | Participants will participate in standard of care for discharged patients. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to post-discharge recommendations
Number of participants to adhere to post-discharge recommendation including medication compliance, self-management, and home supports post hospital discharge
Measured: Through study completion, approximately 30 days
Secondary outcomes (2)
7 day readmission rate
Number of participants with hospital emergency department visits and hospital readmission within 7 days of discharge
Measured: 7 days after hospital discharge
30 day readmission rate
Number of participants with hospital emergency department visits and hospital readmission within 30 days of discharge
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 Aug 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital DischargeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- None (open label)
- Enrolment
- 1,190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar Dugani, Mayo Clinic
- Investigators
- Chandrasagar (Sagar) Dugani, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547803
- Sponsor's protocol ID
- 20-004688
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dugani SB, Kiliaki SA, Nielsen ML, Fischer KM, Lunde M, Kesselring GM, Lawson DK, Coons TJ, Schenzel HA, Parikh RS, Pagali SR, Liwonjo A, Croghan IT, Schroeder DR, Burton MC. Postdischarge Video Visits for Adherence to Hospital Discharge Recommendations: A Randomized Clinical Trial. Mayo Clin Proc Digit Health. 2023 Sep;1(3):368-378. doi: 10.1016/j.mcpdig.2023.06.006. Epub 2023 Aug 4.
PubMed 37641718
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-discharge Early Assessment With Remote Video Link (PEARL) Initiative: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04547803
- Acronym / sponsor ID
- 20-004688
- Conditions
- Hospital Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,190 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Sep 2020 (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 purpose of this study is to determine if a video visit with an advanced practice provider (Nurse Practitioner or Physician Assistant) within 7 days of discharge from Hospital Internal Medicine services will increase patient compliance with medication, self-management and home supports after hospital discharge.
Detailed description
Prior to discharge, patients will be referred by Hospital Internal Medicine (HIM) teams to the PEARL team and screened for study eligibility. Eligible patients who provide oral consent to participate. Participants will be randomized 1:1 with comparisons between "Usual care" and "Usual care + Video-visit" arms. Participants randomized to the intervention arm will participate in a 15-20 minute Video visit (using Zoom®) with an advanced practice provider (APP; nurse practitioner or physician assistant in HIM) approximately 2-5 days after discharge. The telephone follow-up will occur 3-6 days after discharge. If a patient has a Video visit, the telephone follow-up will be scheduled for after the Video visit.
It is standard practice for HIM teams to make and coordinate outpatient appointments and activities including radiologic procedures for discharging patients. During this study, usual care will continue for patients in each arm. The intervention (Video-visit) is in addition to and not in place of the usual standard of care.
If issues/concerns beyond the scope of the video visit or telephone follow-up arise, then the PEARL APP will direct these to the discharging hospitalist team/supervising physician, or the participant's primary care provider (PCP) consistent with current standards of practice and management of post-discharge issues. Issues re-directed to the discharging hospitalist team or other providers will be documented in the Video-visit encounter. If the APP deems the clinical situation urgent or emergent, the APP will refer the patient to emergency services, or if needed ask the patient his/her location and contact 911. The APP will also immediately notify the study PI or co-PI who are both hospitalists and familiar with the practice. The APP will also notify the discharging hospitalist team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Visit and Standard of Care | Experimental | Other: Standard of Care, Other: Video VisitParticipants will participate in a video visit and standard of care |
| Standard of Care | Active comparator | Other: Standard of CareParticipants will participate in standard of care for discharged patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years
- Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital
- Patients or their legally authorized representative provides consent to participate in the study
- Patients discharged home or to assisted living facility
Key exclusion criteria (8 listed)
- Patients discharged from Hospital Service Meds 1-4 and Med 17
- Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility
- Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure)
- Patient/legally authorized representative is Non-English speaking
- Patient leaves the hospital Against Medical Advice (AMA)
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 of CareOutpatient appointments and activities including radiologic procedures for discharging patients as standard of practice | Other | Standard of Care, Video Visit and Standard of Care |
| Video Visit15-20 minute Video visit with an advanced practice provider (nurse practitioner or physician assistant) approximately 2-5 days after discharge. | Other | Video Visit and Standard of Care |
Primary outcome
Adherence to post-discharge recommendations
Time frame: Through study completion, approximately 30 days
Number of participants to adhere to post-discharge recommendation including medication compliance, self-management, and home supports post hospital discharge
2 secondary outcomes
7 day readmission rate
Time frame: 7 days after hospital discharge
30 day readmission rate
Time frame: 30 days after hospital discharge
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 10 Aug 2022.
- Derived from this study: PubMed 37641718Dugani SB, Kiliaki SA, Nielsen ML, Fischer KM, Lunde M, Kesselring GM, Lawson DK, Coons TJ, Schenzel HA, Parikh RS, Pagali SR, Liwonjo A, Croghan IT, Schroeder DR, Burton MC. Postdischarge Video Visits for Adherence to Hospital Discharge Recommendations: A Randomized Clinical Trial. Mayo Clin Proc Digit Health. 2023 Sep;1(3):368-378. doi: 10.1016/j.mcpdig.2023.06.006. Epub 2023 Aug 4.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Chandrasagar (Sagar) Dugani, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Visit in people with Hospital Discharge, run by Mayo Clinic 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 4 inclusion and 8 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 10 Aug 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?
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?
Adherence to post-discharge recommendations (time frame: Through study completion, approximately 30 days). 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 NCT04547803, 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 10 Aug 2022.