SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes

NCT03161262 | Completed

• 1 other identifier: IRB00094000
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Text-message reminder; Post-operative medication; Behavioral Research; Social Research; Short Message Service (SMS)

Outcome Measures

Primary Outcomes (3)

• Medication adherence assessed with patient responses to medication reminders

  Overall patient response rates to SMS reminders will be used to assess medication compliance. Participants are asked to reply to the reminders when they have taken the dose of medication.

  Month 3

• Medication adherence assessed by Adherence to Refills and Medications Survey (ARMS)

  The Adherence to Refills and Medications Survey (ARMS-7) is a 7-item survey asking respondents about their medication-taking behavior and factors that contribute to medication compliance or non-compliance. Participants select a score for each question ranging from 1-4, where 1 represents 'None' and 4 represents 'All'. The scores are treated as a continuous measure, with total points being added up, with lower scores indicating high adherence and high scores indicating low adherence.

  Month 3

• Participant Satisfaction

  Patient satisfaction with the SMS tool will be assessed using a 7-item survey administered at the conclusion of the study. Participants will rate the message reminders on a scale from 1 (very poor) to 5 (very good): helpfulness, ease of use, ease of understanding, frequency of messages, quality of messages, likelihood of continuing to use message reminders, and willingness to recommend message reminders to a friend.

  Month 1 through Month 3

Secondary Outcomes (8)

• Early detection of surgical site infection (SSI)

  Month 3

• Early intervention of surgical site infection (SSI)

  Month 3

• Care Transitions Measure (CTM-15) Score

  Day 1, Month 3

• Number of visits with provider

  Day 1, Month 3

• Number of appointments for routine care

  Day 1, Month 3

Study Arms (2)

SMS-based reminders

EXPERIMENTAL

This group will receive 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. They will also receive a monthly questionnaire via SMS to assess patient satisfaction with the intervention and changes in medication adherence behaviors.

Behavioral: SMS-based reminders

Control group

NO INTERVENTION

The control group will not receive medication reminders or questions regarding their pain or surgical site. This group will receive a monthly questionnaire via SMS to assess patient satisfaction with the intervention and changes in medication adherence behaviors.

Interventions

SMS-based reminders BEHAVIORAL

The SMS-based reminders consist of sending messages to participants assigned to this study arm reminding them to take their medication and prompting participants to complete surveys. Medication reminders are sent as per the participant's prescribed frequency and weekly surveys allow participants to report their pain level as well as send an image of their surgical site. Beyond pre-determined reminders and surveys sent to patients, the Memora Health platform is interactive and allows patients to text in questions they may have regarding their medications, care, or condition. Participants will receive the messages for 3 months.

Also known as: Memora Health platform

SMS-based reminders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rondi B Gelbard, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: June 9, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (1)