Clinical trial NCT03746678: Patient-Centred Perioperative Mobile Application
Official title: Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Delivery
Keywords: Cesarean delivery
Perioperative medicine
Mobile health
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective Cesarean delivery patients at the IWK Health Centre

Brief summary: With increasingly more complex surgical patients and the trend toward decreased hospital stay after operations, continuity of care and prompt management of symptoms and side effects perioperatively are ever more crucial. The investigators' goal is to improve perioperative care with a patient-centred mobile application, starting with a pilot in patients undergoing elective Cesarean delivery. The investigators have completed a research study where they created a prototype based on feedback from patients and anesthesiologists. In this study, the investigators would like to learn about how patients use our mobile application after delivery and how the mobile application can be integrated into daily practice.

Detailed description: The objective of this cohort study is to build the mobile application and evaluate its feasibility in providing patient education and reminders for self-monitoring for cesarean delivery patients. The investigators will measure the extent of patient engagement with our application through in-app usage data, as well as receive quantitative and qualitative feedback regarding feasibility. By understanding user behavior and needs through questionnaires and application usage data, the investigators could design more effective and tailored interventions for patients. Results of this study will help further development and implementation of an interdisciplinary mobile monitoring and communication platform for perioperative care.

This study is funded by the Dalhousie University Department of Anesthesia, Pain Management \& Perioperative Medicine.

Eligibility criteria: Inclusion Criteria:

Part 1 (screened by asking nurse)

* Patient scheduled for elective Cesarean delivery
* Age equal or greater than 18
* American Society of Anesthesiologists (ASA) Physical Status I-III (i.e. not in life-threatening situation)

Part 2 (screened in person)

* Possesses an iOS Smartphone with active data plan and access to WiFi, and self-reported use of it on a regular basis (at this stage in development, the mobile application prototype is only available on iOS)
* Self-reported proficiency with Smartphone and mobile applications
* Reported fluency in English

Exclusion Criteria:

Self-reported physical or psychiatric condition that may impair the ability to use the mobile application, answer questionnaires and surveys, and/or provide insights representative of the general population, such as blindness, under current influence of recreational drugs or alcohol.

Primary outcomes:
measure: Median number of information topics viewed per participant
timeFrame: 30 days
measure: Median number of self-monitoring questionnaires completed per participant
timeFrame: 30 days
measure: Median number of total visits to the mobile application per participant
timeFrame: 30 days
measure: Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)
timeFrame: 2 to 3 weeks
measure: Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery
timeFrame: 2 to 3 weeks
measure: Percentage of self-monitoring questionnaires completed (out of 5) per participant
timeFrame: 30 days
Secondary outcomes:
measure: Which topics were viewed the most (rank by topic name and by postoperative day)
timeFrame: 30 days
measure: Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
timeFrame: 30 days
measure: Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)
timeFrame: 30 days
measure: Time of the day patient visited site (scatter plot of Nova Scotia time vs. # visits) - one visit = at least one interaction within app, e.g. opening a topic, navigating within app
timeFrame: 30 days
measure: Time of the day patient filled out the questionnaire
timeFrame: 30 days
measure: Number of visits vs. postoperative day
timeFrame: 30 days
measure: Median duration (number of days starting from delivery date until the last day of visit) patient interacted with application.
timeFrame: 30 days
measure: % participant who responded "yes" to the question that C-Care App provided them with knowledge about Cesarean delivery and anesthesia
timeFrame: 2 to 3 weeks
measure: % participant who responded "yes" to the question that C-Care App provided them with knowledge about potential complications to monitor for
timeFrame: 2 to 3 weeks
measure: % participant who responded "yes" to the question that C-Care App provided them with knowledge about the recovery process after Cesarean delivery
timeFrame: 2 to 3 weeks
measure: Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?
timeFrame: 2 to 3 weeks
measure: If the patient did not use the mobile application, what were the reasons?
timeFrame: 2 to 3 weeks
measure: How could we make the mobile application more helpful for the patient?
timeFrame: 2 to 3 weeks
measure: What do patients think about the name of this App, "C-Care"? Do they have any other suggestions for our name/logo?
timeFrame: 2 to 3 weeks
measure: Any other comments and/or suggestions
timeFrame: 2 to 3 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Women's and Obstetric Anesthesia, IWK Health Centre
state: Nova Scotia
Study officials:
References:
citation: Ke JXC, George RB, Wozney L, Munro A. Perioperative mobile application for mothers undergoing Cesarean delivery: a prospective cohort study on patient engagement. Can J Anaesth. 2021 Apr;68(4):505-513. doi: 10.1007/s12630-020-01907-x. Epub 2021 Jan 9.