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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05245773
Other study ID # 849348
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2022
Est. completion date February 3, 2023

Study information

Verified date February 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate a 30-day post-discharge intervention using an automated SMS platform to monitor patients and facilitate communication with their primary care practice. The population will be patients who receive care from participating practices and are discharged from an inpatient stay. In addition to the usual phone call from their practice, patients will be randomized to enrollment in the program, wherein they will receive automated SMS messages on a tapering schedule over 30 days.


Description:

Background: Current models of post-discharge care management are time and labor intensive, limited in scope, and inconvenient from the patient perspective, particularly when they have a need arise. Automation can significantly scale up patient touches while reserving staff time for concrete patient needs. Text messaging has been shown to enhance patient engagement (as compared to calls) in many settings, possibly due to greater convenience and the potential for asynchronous interaction. We believe using automated text messaging messaging as the foundation of a post-discharge, primary care based care management program can increase patient engagement, allow for earlier and more frequent identification of needs, and improve post-discharge outcomes. Objective: To evaluate the impact of a 30-day post-discharge intervention using an automated SMS platform in addition to usual care as compared to usual care alone in a multi-clinic, pragmatic randomized controlled trial on acute care utilization, post-discharge follow-up appointment scheduling and show-rates, overall patient engagement, and overall patient-clinic encounters. Description of Intervention: The intervention will consist of automated text messages on a tapering schedule over the course of 30 days post-discharge, with responses escalated back to the practice care management team. After enrollment, patients will receive an initial message asking them if they have a follow up appointment within the next 2 weeks. If they respond no, the practice will be notified to reach out and help them schedule an appointment. Beginning the day after this introductory message, patients will receive check-in messages on a tapering schedule over the course of 30 days. For the first week they will receive 3 total messages (Monday, Wednesday and Friday); the second week they will receive a total of 2 messages (Tuesday and Thursday). For the last 2 weeks they will receive weekly messages (on Tuesdays). If a patient need is identified, the request will be escalated to the practice (triaged by the care management RN) for a follow up phone call. Patients will be able to reach out at any time throughout the 30 days by sending a message to the same number, and they will be entered into the same pathway. For any escalated need, patients will receive a follow up phone call within 1 business day. Patients who do not respond to 3 consecutive messages will receive an additional check in message ensuring that they still want to be enrolled.


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date February 3, 2023
Est. primary completion date January 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The study subjects will be medium to high risk (UPHS risk score 4 and above; an internally developed and validated score assessing a patient's risk for readmission) adult (age = 18) patients of the Penn Primary Care Practices who are discharged home from acute inpatient care in the broad Philadelphia region as identified in HealthShare Exchange (HSX) reports Exclusion Criteria: - This study will exclude discharges who do not meet criteria for transitional care management. These criteria include discharges after 1) planned chemotherapy admissions; 2) certain scheduled surgeries, including spinal surgery, joint replacements, gastric bypass, transurethral resection of the prostate, gynecologic surgeries, and transplants; 3) obstetrics admissions. - We will exclude patients from re-enrollment during the study period (once they have been enrolled once, they will not be enrolled again). We will also exclude patients being discharged to home hospice.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Automated SMS program to support post-discharge transitions of care
The intervention will consist of automated text messages on a tapering schedule over the course of 30 days post-discharge, with responses escalated back to the practice care management team. After initial enrollment messages, patients will receive check-in messages on a tapering schedule over the course of 30 days. For the first week they will receive 3 total messages; the second week they will receive a total of 2 messages. For the last 2 weeks they will receive weekly messages. If a patient need is identified, the request will be escalated to the practice (triaged by the care management RN) for a follow up phone call. Patients will be able to reach out at any time by sending a message to the same number, and they will be entered into the same pathway. For any escalated need, patients will receive a follow up phone call from the practice staff.

Locations

Country Name City State
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-discharge acute care utilization A composite, binary measure indicating whether a patient visited the ED or was readmitted to inpatient care after discharge from the hospital. 30 days post-discharge
Secondary Post-discharge days in the hospital A continuous measure of total days spent in the hospital (in the ED or as an inpatient) after hospital discharge 30 days post-discharge
Secondary Post-discharge acute care utilization A composite, binary measure indicating whether a patient visited the ED or was readmitted to inpatient care after discharge from the hospital. 7 and 60 days post-discharge
Secondary Post-discharge ED visit A binary measure indicating whether a patient visited the ED after hospital discharge 7, 30, and 60 days post-discharge
Secondary Readmission A binary measure indicating whether a patient was readmitted after hospital discharge 7, 30, and 60 days post-discharge
Secondary Time from discharge to first acute care visit A continuous measure of the time from discharge to either first ED visit or readmission 30 days post-discharge
Secondary Post-discharge follow up visit A binary measure indicating scheduling and completion of a follow up visit with the primary care practice 14 days post-discharge
Secondary Number of patient-practice interactions A continuous measure of non-visit interactions between the patient and practice (which will include a) telephone encounters [which are the end point of any needs identified through the automated messaging program] and b) EMR portal messages) 30 days post-discharge
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