Post-discharge Early Assessment With a Video-visit

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.

Study Overview

• Status: Completed
• Conditions: Hospital Discharge
• Intervention / Treatment: Other: Standard of Care; Other: Video Visit

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 Type: Interventional
• Enrollment (Actual): 1190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, approximately 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7 day readmission rate	Number of participants with hospital emergency department visits and hospital readmission within 7 days of discharge	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	30 days after hospital discharge

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chandrasagar (Sagar) Dugani, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-004688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No