Surgical Site InfectionNCT03161262
SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes
A study testing SMS-based reminders in people with Surgical Site Infection, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- SMS-based reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- SMS-based reminders
- Keywords
- Text-message reminder, Post-operative medication, Behavioral Research, Social Research, Short Message Service (SMS)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS-based remindersBehavioural
Also called Memora Health platform
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 1 through Month 3
Secondary outcomes (8)
Early detection of surgical site infection (SSI)
Participants will be allowed to intermittently provide pain scores and pictures of their surgical sites to help increase early detection of surgical site infection (SSI) post-discharge. The value of these images in early detection of SSIs will be measured through physician reporting of SSIs.
Measured: Month 3
Early intervention of surgical site infection (SSI)
Participants will be allowed to intermittently provide pain scores and pictures of their surgical sites to help increase early detection of surgical site infection (SSI) post-discharge. The number of incidents of early intervention for SSIs will be determined as a method of measuring early detection of SSIs.
Measured: Month 3
Care Transitions Measure (CTM-15) Score
Care Transitions Measure (CTM-15) is a 15-item survey asking respondents to indicate their degree of agreement with statements relating to the quality of care transition from being hospitalized to being discharged. Respondents select from: 1=Strongly Disagree, 2=Disagree, 3=Agree, 4=Strongly Agree. Missing responses and selections of "Don't Know/Don't Remember/Not Applicable" do not contribute to the total score. A mean score is obtained and higher scores indicate a better transition during hospital discharge.
Measured: Day 1, Month 3
Number of visits with provider
Responses to the question "In the last 3 months, how many times did you visit this provider to get care for yourself?" will be compared between study groups.
Measured: Day 1, Month 3
Number of appointments for routine care
Responses to the question "In the last 3 months, did you make any appointments for a check-up or routine care with this provider? (1 = yes, 2 = no)" will be compared between study groups.
Measured: Day 1, Month 3
Satisfaction with time spent by provider on care
Responses to the question "In the last 3 months, did the provider spend enough time on your care?" will be compared between study groups. Participants rate their satisfaction with the amount of time their provider spent on their care on a 5-point scale where 1 = strongly agree and 5 = strongly disagree.
Measured: Day 1, Month 3
Overall rating of provider
Responses to the question "Using any number from 0 to 10, where 0 is the worst provider possible and 10 is the best provider possible, what number would you use to rate this provider?" will be compared between study groups.
Measured: Day 1, Month 3
30-Day Readmission
Readmission to the hospital within 30 days of hospital discharge will be obtained through Electronic Health Records. Any hospital admissions will be analyzed to determine if they are related to the recent procedure.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start9 Jun 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rondi Gelbard, Emory University
- Investigators
- Rondi B Gelbard, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161262
- Sponsor's protocol ID
- IRB00094000
- Status last verified
- May 2019
- First submitted
- 18 May 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS-Based Follow-Ups to Improve Post-Discharge Surgical Outcomes
- ClinicalTrials.gov ID
- NCT03161262
- Acronym / sponsor ID
- IRB00094000
- Conditions
- Surgical Site Infection
- Keywords
- Text-message reminder, Post-operative medication, Behavioral Research, Social Research, Short Message Service (SMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SMS-based reminders | Experimental | Behavioral: SMS-based remindersThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS-based remindersAlso: Memora Health platformThe 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. | Behavioural | SMS-based reminders |
Primary outcome
Medication adherence assessed with patient responses to medication reminders
Time frame: Month 3
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.
Medication adherence assessed by Adherence to Refills and Medications Survey (ARMS)
Time frame: Month 3
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.
Participant Satisfaction
Time frame: Month 1 through Month 3
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.
8 secondary outcomes
Early detection of surgical site infection (SSI)
Time frame: Month 3
Early intervention of surgical site infection (SSI)
Time frame: Month 3
Care Transitions Measure (CTM-15) Score
Time frame: Day 1, Month 3
Number of visits with provider
Time frame: Day 1, Month 3
Number of appointments for routine care
Time frame: Day 1, Month 3
Satisfaction with time spent by provider on care
Time frame: Day 1, Month 3
Overall rating of provider
Time frame: Day 1, Month 3
30-Day Readmission
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rondi B Gelbard, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS-based reminders in people with Surgical Site Infection, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence assessed with patient responses to medication reminders (time frame: Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.