Clinical trial NCT03881891: Optimizing Acute Post-Operative Dental Pain Management Using New Health Information Technology
Official title: Optimizing Acute Post-Operative Dental Pain Management Using New Health Information Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Complication, Postoperative
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-03-20
Enrollment: 1525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators seek to implement a dental patient reported outcomes system using mobile phone and text messaging to target the over-reliance on pre-emptively prescribed opioids by dental providers. If successful, this project will help dentists actively track and manage their patients' pain after hours and enhance the overall care experience.

Detailed description: Pain has been deemed the fifth vital sign and many describe it as an adverse event. The adequate management of pain is the bane of the dental profession and its continuous assessment is crucial to minimizing patients' pain experiences. Due to the duration of action of most commonly-used local anesthetic agents, dental patients are unable to predict their pain following dental procedures until many hours later, when the participants have already returned home and dental offices are closed. This has led to an over-reliance on pre-emptively prescribed opioids by dental providers because the participants have no means to actively track their patients' pain after hours. Innovative mobile applications and connected health technologies that allow real-time tracking of patients' symptoms, functional status and quality of life, provide healthcare professionals with data that were previously unavailable, and have fostered patient engagement, shared decision-making and adherence to treatment plans. The investigators propose an innovative solution to optimize the quality of dental pain monitoring and management by implementing mobile phone technology to monitor patients' pain during the critical acute post-operative phase. The hypothesis is that by actively tracking these symptoms using mobile phones, the investigators modify analgesic prescriptions), thereby eliminating needless suffering, reducing the occurrence and/or severity of post-op complications, and enhancing the overall care experience. The investigators' ultimate goal is to achieve the quadruple aim: improve patient experience, improve patient outcomes, improve physician experience and reduce per capita costs. The investigators will test this hypothesis using a cluster-randomized experimental study design with: (1) an intervention arm where patients receive push notifications through text messages on their mobile phones (FollowApp.Care) at designated time intervals on Days 1, 3, 5 and 7; and (2) a control arm where patients receive the usual care. This project will be conducted at two dental institutions: Willamette Dental Group (WDG) and University of California San Francisco (UCSF). In Aim 1 the investigators will customize the design features of the existing FollowApp.Care at two dental institutions (Willamette Dental Group and University of California San Francisco) and assess its capacity to accurately capture patient-reported outcomes. In Aim 2 the investigators evaluate the impact of using FollowApp.Care on patient post-op experiences and oral health outcomes. And in Aim 3, the investigators evaluate provider acceptance of FollowApp.Care and its impact on provider performance. By collecting patient reported outcomes in a timely and usable way, the investigators expect to help dentists enhance their practice performance and reduce the burden of unnecessary opioid prescriptions on society.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone periodontal procedures.
* Patients who have undergone endodontic procedures.
* Patients who have undergone oral surgery procedures.

Exclusion Criteria:

* 3rd year pre-doctoral students
* 4th year pre-doctoral students
* dental hygiene students

Primary outcomes:
measure: Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument
timeFrame: On day 1 post procedure for each patient.
measure: Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument
timeFrame: On day 3 post procedure for each patient.
measure: Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument
timeFrame: On day 5 post procedure for each patient.
measure: Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument
timeFrame: On day 7 post procedure for each patient.
measure: Pain experience in both arms, measured using the American Pain Society, the Patient Outcome Questionnaire (APS-POQ-R) questionnaire.
timeFrame: The pain experience outcome will be measured 7 days post procedure.
measure: Provider Acceptance of FollowApp.Care
timeFrame: 2nd Quarter Year 3
Secondary outcomes:
measure: Unscheduled/emergency visits during the study period;
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Hillsboro
country: United States
facility: Willamette Dental Group & Skourtes Institute
state: Oregon
Study officials:
affiliation: University of California, San Francisco
name: Elsbeth Kalenderian, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Houston
name: Muhammad F Walji, PhD
role: PRINCIPAL_INVESTIGATOR
References: