Clinical trial NCT02610894: An mHealth Self-Management Program to Decrease Postoperative Symptom Distress
Official title: A mHealth Self-Management Program to Decrease Postoperative Symptom Distress in Orthopaedic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopaedic Surgery
Keywords: postoperative symptom management
symptom management
mHealth application
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purposes of this study are to determine if use of the Postoperative Care at Home (PoCAH) tailored self-management program delivered via mobile technology (a mobile app) 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 how easy the mobile app was to use after orthopaedic ambulatory surgery.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in perceived pain
timeFrame: baseline, day 1, day 2, day 3, day 4, day 5, day 14, day 28
Secondary outcomes:
measure: Change in perceived self efficacy
timeFrame: baseline, day 1, day 5, day 14, day 28
measure: Change in quality of life
timeFrame: baseline, day 1, day 5, day 14, day 28
measure: Change in postoperative heath status
timeFrame: preoperative assessment, Day 1, Day 5, day 14,and day 28.
measure: Change in postoperative health status
timeFrame: preoperative assessment, Day 1, Day 5, day 14,and day 28.
measure: Healthcare resource use
timeFrame: 28 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Orthopaedic Surgery and Sports Medicine Clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jan Odom Forren, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: