Clinical trial NCT03653455: Patient Outcomes Collection: How Can we do Better?
Official title: Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder
Arthroscopy
sub-acromial decompression
distal clavicle resection
biceps tenodesis
rotator cuff repair
Patient reported outcomes
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: American Orthopaedic Society for Sports Medicine
First posted: 2018-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: 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?
timeFrame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Secondary outcomes:
measure: Effects of age on PRO compliance rate.
timeFrame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
measure: Effects of technological literacy on PRO compliance rate.
timeFrame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
measure: Effects of English proficiency on PRO compliance rate.
timeFrame: Change in PRO compliance rate between pre-surgery and 1-year post surgery
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Carla M. Edwards
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Nikhil Verma, MD
role: PRINCIPAL_INVESTIGATOR
References: