跳至主要内容
临床试验/NCT03653455
NCT03653455进行中(未招募)不适用

Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
1
主要终点
Does patient engagement, through education or monetary incentivization, increase PRO compliance rate at 1 year after surgery, when compared to PRO compliance rate before surgery?

研究概览

简要总结

Patient reported outcomes (PROs) are widely used by clinical providers as important tools to help inform their clinical and research practice, and to improve quality of care for patients. In this study, the investigators aim to investigate ways by which patient PRO completion rates may be improved.

详细描述

Patient reported outcomes (PROs) are widely used by clinical providers as important tools to help inform their clinical and research practice, and to improve quality of care for patients. In addition, PROs are increasingly cited as a tool in measuring surgical performance and the value of health care services being delivered. The quality of data captured by PROs is, however, largely dependent on patients' response rates, both pre- and post-operatively. For pre-operative surveys, higher response rates may be achieved as patients may be reminded to complete their surveys at an office visit or prior to surgery. However, patient non-compliance presents a major challenge post-operatively, undermining PRO data integrity.

As clinical practices have moved to using PROs for all patients, rather than just a research tool, automated systems have been developed to deliver and collect PRO electronically. However, while automation has helped streamline PRO administration and data collection, this hasn't always translated into obtaining better PRO compliance rates. In an attempt to improve response rates, efforts have been made to reduce patient burden (by reducing the number of questions asked, for example), to regularly remind patients to complete their forms (either by email or telephone), or even offer patients monetary or non-monetary incentives.

Despite these measures' variable success, however, achieving high response rates remains a challenge. This, in part, is due to the fact these platforms depend heavily on patients receiving the request and their willingness to participate in the program, often long after their care is completed. As data are increasingly used to measure physician performance and quality, as well as to determine reimbursement, low patient compliance rates remain a significant impediment and affect the validity of the data.

In this study, the invetigators hypothesize that direct patient engagement can improve patient compliance with automated PRO capture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled to undergo shoulder arthroscopy for rotator cuff condition (sub-acromial decompression, distal clavicle resection, biceps tenodesis, partial or full thickness rotator cuff tear repair or debridement) will be eligible for enrollment in the appropriate cohort. There will be no restrictions to this enrollment apart from that presented in the exclusions below.

排除标准

  • •Minors or those over the age of 80
  • •Subjects lacking English proficiency to complete the PROs of interest.
  • •Past or current medical history that would preclude patients from undergoing surgery.

研究组 & 干预措施

Pre- and post-operative discussion group

Experimental

Patients will discuss with their care provider their health outcomes before and at 6-months after their surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.

干预措施: Email reminders (Behavioral)

Pre- and post-operative discussion group

Experimental

Patients will discuss with their care provider their health outcomes before and at 6-months after their surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.

干预措施: Pre- and Post-operative discussion (Behavioral)

Incentivised group

Experimental

Patients will receive up to $30 in amazon gift cards as an incentive if they complete their forms before surgery, as well as at 6-months and 1-year after surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.

干预措施: Email reminders (Behavioral)

Incentivised group

Experimental

Patients will receive up to $30 in amazon gift cards as an incentive if they complete their forms before surgery, as well as at 6-months and 1-year after surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.

干预措施: Incentive (Behavioral)

Control group

Experimental

Patients will only receive email reminders to complete their forms, if they haven't done so.

干预措施: Email reminders (Behavioral)

结局指标

主要结局

Does patient engagement, through education or monetary incentivization, increase PRO compliance rate at 1 year after surgery, when compared to PRO compliance rate before surgery?

时间窗: Change in PRO compliance rate between pre-surgery and 1-year post surgery

Patients will discuss the importance of PROs and how they can be used to predict their health outcome with their care provider. Alternatively, patients may receive amazon gift cards if they complete their PROs before surgery, as well as at 6-months and 1-yr after surgery. Three established PROs \[American Shoulder And Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and the Veteran Rand 12-Item and 12-Item Short Form Health Survey (VR/SF12)\] will be automatically emailed to patients using an electronic platform (OBERD). Rate at which these forms are completed (compliance rate) before surgery, as well 1-year post surgery will be monitored through OBERD.

次要结局

  • Effects of technological literacy on PRO compliance rate.(Change in PRO compliance rate between pre-surgery and 1-year post surgery)
  • Effects of age on PRO compliance rate.(Change in PRO compliance rate between pre-surgery and 1-year post surgery)
  • Effects of English proficiency on PRO compliance rate.(Change in PRO compliance rate between pre-surgery and 1-year post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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