Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-discharge Early Assessment With a Video-visit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547803
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Sagar Dugani, Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Hospital Discharge Other: Standard of Care Other: Video Visit Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Post-discharge Early Assessment With Remote Video Link (PEARL) Initiative: A Randomized Controlled Trial
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : March 10, 2022
Estimated Study Completion Date : March 10, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Video Visit and Standard of Care
Participants will participate in a video visit and standard of care
 Other: Standard of Care
Outpatient appointments and activities including radiologic procedures for discharging patients as standard of practice

Other: Video Visit
15-20 minute Video visit with an advanced practice provider (nurse practitioner or physician assistant) approximately 2-5 days after discharge.
Active Comparator: Standard of Care
Participants will participate in standard of care for discharged patients.
 Other: Standard of Care
Outpatient appointments and activities including radiologic procedures for discharging patients as standard of practice


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 7 day readmission rate [ Time Frame: 7 days after hospital discharge ]
    Number of participants with hospital emergency department visits and hospital readmission within 7 days of discharge

  2. 30 day readmission rate [ Time Frame: 30 days after hospital discharge ]
    Number of participants with hospital emergency department visits and hospital readmission within 30 days of discharge


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547803


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Chandrasagar Dugani, MD    507-255-5123    Dugani.Chandrasagar@mayo.edu   
Contact: Burton M Caroline, MD    507-255-5123    Burton.MCaroline@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Chandrasagar (Sagar) Dugani, MD, PhD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Sagar Dugani, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04547803    
Other Study ID Numbers: 20-004688
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No