Clinical trial NCT03161262: SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes
Official title: SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Text-message reminder
Post-operative medication
Behavioral Research
Social Research
Short Message Service (SMS)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either the intervention group or control group. The test group constitutes receiving consistent medication reminders, as per the patient's prescribed frequency, and weekly surveys prompting them to report their pain level and an image of their surgical site for the duration of the full 3 months. The control group will not receive medication reminders or questions regarding their pain or surgical site. Both control and test groups will receive a monthly questionnaire via SMS to assess patient satisfaction with the intervention and changes in medication adherence behaviors.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether low-cost Short Message Service (SMS)-based follow-up medication reminders and surveys for surgical site infection (SSI) reporting can improve outcomes by increasing medication adherence and earlier detection and care of SSI. This will be a prospective study involving enrollment of patients onto the Memora Health platform, a web application developed for automating SMS content to patients. Post-operative patients will be identified by providers and enrolled prior to discharge, after which they will be followed for 3 months.

Primary endpoints include medication adherence and patient satisfaction with the text messaging tool. Secondary endpoints include early detection of SSIs, patient satisfaction with overall post-discharge care and health-related quality of life, and pertinent 30-day readmissions.

Detailed description: Post-operative follow up with patients is critical to providing high quality and cost effective care. In the current standard of care, patients receive verbal instructions from their physician along with discharge paperwork that outlines best practices for self-care. Unfortunately, difficult instructions can be miscommunicated or be overwhelming, and patients often leave confused, resulting in poor patient care post-discharge and high 30-day readmission rates. Medication adherence represents a crucial area for follow-up, as it is a major determinant of high-quality outcomes for post-operative care. Specifically, over 50% of patients in the U.S. either forget to or don't correctly take their prescription medications. Non-adherence causes nearly 10% of all hospital admissions in the U.S. and 125,000 annual deaths.

In a survey of 10,000 patients, the most common reported reason for missing medications was forgetfulness (24%), followed by perceived side effects (20%), high drug costs (17%), and perception that a prescribed medication would have little effect on their disease (14%). The majority of the factors contributing to non-adherence could therefore be resolved by longitudinally addressing forgetfulness and misconceptions about medication effectiveness, options for treatment, and side effects.

An SMS patient engagement case-management platform (Memora Health, Boston, MA) has been created that enables providers to input a new medication regimen into a web-based, HIPAA compliant app that then sends text message reminders to the patient to take their medication. Communication is two-way, therefore not only helping to improve adherence and self-management for the patient, but also providing care staff with more data on the post-discharge behavior and care satisfaction of their patients. While the value of SMS-based interventions on health outcomes is abundant in the literature, there is a paucity of data evaluating the impact of SMS follow-up on improving surgical outcomes through improved medication adherence and early detection of SSI. The purpose of this study is to utilize Memora Health, a platform that leverages mobile messaging as a medium for advancing preventive care, to improve the quality of post-operative care delivered to patients, and thereby improve patient satisfaction as well as reducing readmissions.

Eligibility criteria: Inclusion Criteria:

* Patient has a working cell phone that can send and receive SMS/Multimedia Messaging Service (MMS) over the next three months
* Patient has a working cell phone with a camera
* Being able to read and write fluently in English
* All patients identified in the Electronic Medical Record (EMR) with International Classification of Diseases (ICD)-10 codes for patients who underwent procedures with external wounds and can be at risk of surgical site infection (SSI). Only patients falling under the categories of 'Major Diagnostic' and 'Major Therapeutic' will be considered.

Exclusion Criteria:

* Patient deceased prior to discharge
* Patient transferred to another hospital
* Patient has a terminal illness with less than 3-month expected survival
* Vulnerable populations including patients who are in the middle of a pregnancy or prisoners

Primary outcomes:
measure: Medication adherence assessed with patient responses to medication reminders
timeFrame: Month 3
measure: Medication adherence assessed by Adherence to Refills and Medications Survey (ARMS)
timeFrame: Month 3
measure: Participant Satisfaction
timeFrame: Month 1 through Month 3
Secondary outcomes:
measure: Early detection of surgical site infection (SSI)
timeFrame: Month 3
measure: Early intervention of surgical site infection (SSI)
timeFrame: Month 3
measure: Care Transitions Measure (CTM-15) Score
timeFrame: Day 1, Month 3
measure: Number of visits with provider
timeFrame: Day 1, Month 3
measure: Number of appointments for routine care
timeFrame: Day 1, Month 3
measure: Satisfaction with time spent by provider on care
timeFrame: Day 1, Month 3
measure: Overall rating of provider
timeFrame: Day 1, Month 3
measure: 30-Day Readmission
timeFrame: Day 30
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Rondi B Gelbard, MD
role: PRINCIPAL_INVESTIGATOR
References: