Adolescent Surgery Roadmap Feasibility and Acceptability Study

Adolescent Surgery Roadmap Feasibility and Acceptability Study

The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. The main questions it aims to answer are:

• Can adolescent surgery patients and their caregivers be successfully enrolled in the study, with at least 40% of those invited choosing to participate?
• Will participants actively use the mobile app, completing at least two activities per week for at least half of the study period, either individually and/or as a caregiver-adolescent pair?

Participants will:

• Use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing
• Use the app either individually or together as a caregiver-adolescent pair.
• Complete surveys regarding risk factors for adverse postsurgical pain outcomes and physical and psychological symptoms experienced postoperatively
• Some participants will complete a semi-structured interview in which experiences with the study and intervention activities will be elicited

Inclusion Criteria (Adolescent Patient):

• Patient is aged 12-17 years on the date of surgery
• Surgery is a scheduled surgery (non-emergency)
• Surgery is occurring within the University of Michigan hospital system (University Hospital, C.S. Mott Children's Hospital, Brighton Ambulatory Surgery Center, East Ann Arbor Ambulatory Surgery Center)
• Participants are able to enroll within 1-2 weeks of surgery
• Patient and caregiver must be willing to participate
• Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app
• Eligible patient is able to sign/assent form
• Adolescent-caregiver dyad has at least one risk factor for adverse post-operative pain outcomes based on pre-enrollment screening (e.g., worries about managing pain, return to normal activities, limitations in doing desired activities, trouble with sleep)

Inclusion Criteria (Caregiver):

• Patient and caregiver must be willing to participate
• Caregiver must be providing at least 50% of the patient's postsurgical caregiving
• Caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance with institutional guidelines
• Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app

Exclusion Criteria (Adolescent Patient):

• Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English
• Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions
• Foster children or wards of the state are not eligible for inclusion
• Hardware removal or debridement surgery (not considered as painful as other orthopedic surgeries)
• Scoliosis surgery (due to extended longitudinal relationship with surgeon)
• Concurrent participation in another behavioral/self-management intervention trial
• Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate

Exclusion Criteria (Caregiver):

• Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions
• Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English
• Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate