Use of a Smartphone App to Support Pre- and Post-Surgical Preparedness and to Improve Clinical Outcomes in Patients Undergoing Shoulder Arthroscopy

This study is testing whether a smartphone app can help patients better follow instructions before and after shoulder surgery, compared to the usual paper instructions.

People from all backgrounds sometimes have trouble understanding or remembering everything needed to prepare for surgery and recover safely - things like when to stop certain medications, how to shower with a special soap before surgery, or how to care for a wound afterward. Missing these steps can lead to surgery being delayed or canceled, or to problems during recovery. These difficulties can be greater for patients facing barriers such as limited health information, language differences, or lack of support at home.

This study includes adults having planned shoulder arthroscopy (a type of shoulder surgery) at Johns Hopkins. Participants will be randomly assigned to one of two groups: one will receive the standard printed instructions currently used in clinic, and the other will receive the same instructions through an app on the smartphone. The app also pulls basic information from the patient's electronic health record - surgery type, date, surgeon, and medications - so instructions can be tailored to each patient. Patients using the app confirm when each step is completed, such as taking a medication or showering before surgery, and also report on how the participant is doing after surgery, which is shared with the patient's care team.

The goal is to see whether the app helps patients follow instructions more closely, improves the patient's experience and recovery, and reduces the workload on nurses and clinic staff - particularly for patients who face more barriers to care.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Arthroscopy
• Intervention / Treatment: Behavioral: Written Patient Instructions; Behavioral: Smartphone App-based Digital Patient Instructions

Detailed Description

Disparities in surgical outcomes between marginalized and non-marginalized populations are well documented and are driven in part by systemic factors such as provider bias, limited health literacy, and inadequate patient support. These factors contribute to poor adherence to pre- and post-operative instructions, which in turn is associated with worse clinical outcomes, higher rates of day-of-surgery delay or cancellation, and increased healthcare costs, disproportionately affecting underserved patients. Patients with fewer resources often face additional difficulty navigating complex perioperative instructions without adequate guidance or support.

A smartphone application has been developed to improve patient adherence to complex medical instructions, with a particular focus on perioperative care. The application digitizes patient education materials that are otherwise delivered on paper, converting instructions into discrete, trackable tasks that patients acknowledge as completed. The application is linked, on a read-only basis, to the patient's electronic health record (EHR) to retrieve procedure type, procedure date, treating physician, and current medications, allowing instructions to be lightly personalized without requiring manual data entry by clinical staff. With the exception of medication information, the content delivered through the application is the same as that currently provided on paper. Prior non-research deployments of the application have suggested it may improve adherence and reduce administrative and clinical staff burden, though this has not been formally evaluated in a controlled study.

This is a proof-of-concept, randomized clinical trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of smartphone-based patient education compared to standard paper-based patient education in adults undergoing planned shoulder arthroscopy.

The primary objective is to assess the feasibility and acceptability of implementing the smartphone application in this clinical population, evaluated through study-tracked implementation metrics (e.g., enrollment, retention, app engagement) and participant self-report.

Secondary objectives are to: (1) evaluate whether the application, by delivering EHR-linked, updated patient instructions, improves patient adherence to pre- and post-operative instructions, assessed via application usage data and self-report; (2) evaluate whether the application improves patient experience and health outcomes, assessed via self-reported satisfaction and patient-reported outcome measures; and (3) evaluate whether the application reduces burden on nursing and office staff, assessed through post-study staff interviews.

Approximately 100 adults scheduled for planned shoulder arthroscopy will be recruited. Potentially eligible patients will be identified from the clinic schedule by the research team and contacted by email in advance of the scheduled clinic visit to describe the study and provide research team contact information for those interested in learning more. At the scheduled visit, the treating surgeon will confirm surgical candidacy as a clinical decision, separate from the decision of whether the patient wishes to participate in the research study. For patients expressing interest, the research team will describe the study in detail, answer questions, and the treating surgeon will obtain informed consent.

Enrolled participants will be randomized to one of two arms: (1) standard paper-based patient instructions, reflecting current clinical practice, or (2) the same instructional content delivered through a smartphone application. Participants randomized to the application arm will be provided a link to install the application on the participant's personal smartphone (Apple or Android operating system) and will register within the application to enable linkage to EHR, with assistance from a research coordinator as needed. These participants will be instructed to log into the application daily to review pre- and post-operative instructions and confirm completion of individual tasks (for example, pre-operative antiseptic showers, medication holds, fasting instructions, daily medications, and post-operative wound care), with prioritization given to actions associated with risk of day-of-surgery delay or cancellation and post-operative complications. The application will also collect patient-reported outcome measures, which will be shared with the treatment team through a separate portal. Participants will be instructed to contact the treating surgeon's office for clinical questions and the research team for study-related questions throughout study participation.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard L Skolasky, Sc.D.; Phone Number: 410-502-7975; Email: rskolas1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• scheduled for shoulder arthroscopy with participating surgeon

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Written Patient Instructions; Written patient instructions	Behavioral: Written Patient Instructions; Written Patient Instructions
Experimental: Smartphone App-based Digital Patient Instructions; Smartphone app-based digital patient instructions	Behavioral: Smartphone App-based Digital Patient Instructions; Smartphone App-based Digital Patient Instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Information Retention	Self-report of retention of patient instruction information. Participants will rate their retention of key information using a 6 item scale with a score range from 0 - 12 with higher numbers indicating greater retention.	6 weeks, 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Frontive
• Investigators: Principal Investigator: Richard Skolasky, Sc.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB00475783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No