An mHealth Self-Management Program to Decrease Postoperative Symptom Distress

NCT ID: NCT02610894

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-07
• Study Completion Date: 2016-07-25

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.

Conditions

Orthopaedic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

mHealth application

Participants will be provided an iPad Mini tablet computer loaded with an mHealth application (PoCAH) to provide enhanced post-operative pain care management. The app will utilize algorithms tailored to the patient's needs and symptoms in an attempt to reduce poor outcomes related to post-operative pain management.

Group Type: EXPERIMENTAL

mHealth application (PoCAH)

Intervention Type: OTHER

Participants will have unlimited access to the mHealth app via iPad Mini for 5 days post-operatively to aid in pain management

Control Group

Participants will be provided an iPad Mini tablet computer loaded with a PDF of the As usual standard discharge and care instructions for post-operative pain care management.

Group Type: ACTIVE_COMPARATOR

As usual standard discharge and care instructions

Intervention Type: OTHER

As usual standard discharge and care instructions are provided via iPad mini to orthopaedic ambulatory surgery patients.

Interventions

mHealth application (PoCAH)

Participants will have unlimited access to the mHealth app via iPad Mini for 5 days post-operatively to aid in pain management

Intervention Type: OTHER

As usual standard discharge and care instructions

As usual standard discharge and care instructions are provided via iPad mini to orthopaedic ambulatory surgery patients.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jan Odom Forren

OTHER

Sponsor Role: lead

Responsible Party

Jan Odom Forren

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jan Odom Forren, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Orthopaedic Surgery and Sports Medicine Clinic

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

15-0340-P6H

Identifier Type: -

Identifier Source: org_study_id