NCT03653455

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Apr 2019Aug 2027

First Submitted

Initial submission to the registry

July 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7.7 years

First QC Date

July 24, 2018

Last Update Submit

April 9, 2026

Conditions

Shoulder Pain

Keywords

ShoulderArthroscopysub-acromial decompressiondistal clavicle resectionbiceps tenodesisrotator cuff repairPatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • 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?

    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.

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

Secondary Outcomes (3)

  • Effects of age on PRO compliance rate.

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

  • Effects of technological literacy 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

Study Arms (3)

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.

Behavioral: Email remindersBehavioral: Pre- and Post-operative discussion

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.

Behavioral: Email remindersBehavioral: Incentive

Control group

EXPERIMENTAL

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

Behavioral: Email reminders

Interventions

Email remindersBEHAVIORAL

Patients will receive email reminders until their PROs are completed.

Control groupIncentivised groupPre- and post-operative discussion group
Pre- and Post-operative discussionBEHAVIORAL

Patients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms.

Pre- and post-operative discussion group
IncentiveBEHAVIORAL

Patients will receive up to $30 in amazon gift cards upon the completion of their PROs.

Incentivised group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carla M. Edwards

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Lead

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Nikhil Verma, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 31, 2018

Study Start

April 30, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)