An mHealth Self-Management Program to Decrease Postoperative Symptom Distress

The purposes of the single-blind randomized, controlled comparative effectiveness trial are
to determine if use of the Postoperative Care at Home (PoCAH) tailored self-management
program delivered via mobile technology after discharge to home will result in: 1) fewer
and/or less intense patient symptoms (pain, nausea and vomiting, fatigue, sore throat,
constipation, sleep dysfunction); 2) enhanced patient satisfaction, perceived self-efficacy,
and quality of life; 3) lower healthcare resource use (patient to healthcare provider calls;
unscheduled patient appointments with healthcare providers; and hospital readmission and
emergency department use). A secondary objective is to assess the utility and effectiveness
of the mHealth app after orthopaedic ambulatory surgery. This is a single-blind, two-group
randomized, controlled comparative effectiveness trial stratified by knee and shoulder
surgical procedures (N = 40; 20 per procedure, with half in each procedure group randomized
to each treatment group) to compare the effectiveness of treatment as usual to treatment as
usual combined with PoCAH. PoCAH is a theory based, patient-centered, and tailored
self-management program delivered via mHealth technology to orthopaedic ambulatory surgery
patients. Patients in the treatment as usual group will receive standard discharge and care
instructions provided on an iPad mini. Patients in the intervention group (treatment as usual
combined with PoCAH) will have access to the PoCAH app, in addition to the standard discharge
and care instructions. The PoCAH app will provide the patient with additional information
regarding self-management of symptoms and other consequences of surgery. Orthopaedic patients
who undergo knee and shoulder ambulatory surgery will be recruited because these patients
typically report more postoperative symptom distress than patients undergoing other surgical
procedures. The sample will consist of 40 adults recruited from the University of Kentucky
Orthopaedic Surgery and Sports Medicine Clinic in Lexington, Kentucky. After consent is
obtained, all patients, regardless of grouping, will complete assessments (a Patient Diary)
at enrollment (i.e., baseline), which will query/assess demographic information, health
literacy, quality of life, quality of recovery and perceived self-efficacy of symptom
management. Health literacy will be acquired preoperatively in the event literacy is a
confounding factor in use of the app. These materials will be collected by the researcher at
that time. During surgery, patients will undergo anesthesia as determined by the anesthesia
provider and receive usual surgical care preoperatively and postoperatively. Medical chart
data regarding the surgery will be abstracted and will include length of surgery, length of
stay in the Post Anesthesia Care Unit (PACU), medications/anesthetics administered, and
information regarding pain and nausea in the PACU and Phase 2 Recovery (Step-Down Unit).
After surgery, data will be collected daily for 5 days from all participants (Day 1 through
Day 5) via a Patient Diary. The Patient Diary will contain previously validated
questionnaires that will assess Quality of Life, Quality of Recovery, and postoperative
symptoms. The Patient Diary will be completed in the patients' homes while they recover. The
investigators will call the patients at home on Day 2 to facilitate data collection. At the
conclusion of the study (Day 5), participants in the intervention group will evaluate the
utility and effectiveness of the PoCAH app. The iPad minis and Patient Diaries will be
returned to the research staff when the patient attends the physician's office on the first
office visit at 5 days post-surgery. Because the course of post discharge symptoms extends
past 5 days, phone interviews at 2 weeks and 4 weeks are included to better describe the
recovery trajectory and outcomes for operative patients.

Inclusion Criteria:

1. individuals of either gender and any ethnicity;

2. general and regional anesthesia for a shoulder or knee procedure;

3. surgery scheduled at the UK Center for Advanced Surgery (CAS);

4. age greater than or equal to 18

Exclusion Criteria:

1. chronic pain or nausea unrelated to surgery;

2. inability to speak or read English;

3. diagnosed cognitive dysfunction;

4. disabilities that limit the capability to manipulate the mHealth device (iPad mini);

5. visual impairment;

6. unscheduled admission after surgery.