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临床试验/NCT03161262
NCT03161262已完成不适用

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

Emory University2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2017年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
235
试验地点
2
主要终点
Medication adherence assessed by Adherence to Refills and Medications Survey (ARMS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: SMS-based reminders (Behavioral)

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.

结局指标

主要结局

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

时间窗: 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.

Medication adherence assessed with patient responses to medication reminders

时间窗: 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.

Participant Satisfaction

时间窗: 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.

次要结局

  • Overall rating of provider(Day 1, Month 3)
  • Early detection 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)
  • Early intervention of surgical site infection (SSI)(Month 3)
  • Satisfaction with time spent by provider on care(Day 1, Month 3)
  • 30-Day Readmission(Day 30)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rondi Gelbard

Assistant Professor

Emory University

研究点 (2)

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