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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547803
Other study ID # 20-004688
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2020
Est. completion date July 1, 2022

Study information

Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1190
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
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Recruiting NCT05719870 - A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults N/A
Recruiting NCT05988229 - Tools to Improve Discharge Equity (TIDE) Pilot RCT N/A
Recruiting NCT06036628 - Resistant Bacteria in Children in France

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