Optimizing Acute Post-Operative Dental Pain Management Using New Health Information Technology (AHRQPRO)

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Complication, Postoperative
• Intervention / Treatment: Behavioral: Follow-app intervention arm

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.

• Study Type: Interventional
• Enrollment (Actual): 1525
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Oregon
    • Hillsboro, Oregon, United States, 97124
      • Willamette Dental Group & Skourtes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Follow-app intervention arm; This arm will comprise of patients who are prompted to complete the PROMIS pain intensity scale through text/Short Message Service(SMS) or email mobile device notifications at pre-defined time intervals on Days 1, 3, 5 and 7 post-operatively.	Behavioral: Follow-app intervention arm; The intervention includes implementation and evaluation of the effectiveness of a mobile phone-based text messaging system (FollowApp.Care) to collect patients' assessments of their post-op symptoms (pain intensity) and to use that data to improve their quality of care (pain experience) in the dental office setting
No Intervention: Standard care arm; This arm will comprise of patients who receive the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument	Evaluate the pain intensity on Day 1 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.	On day 1 post procedure for each patient.
Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument	Evaluate the pain intensity on Day 3 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.	On day 3 post procedure for each patient.
Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument	Evaluate the pain intensity on Day 5 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.	On day 5 post procedure for each patient.
Pain intensity in the intervention arm, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v.1.0 survey instrument	Evaluate the pain intensity on Day 7 following completion of the specified dental procedures. Raw scores for the pain intensity construct are determined by summing each of the individual scores from the three questions for each participant. The raw scores are then standardized using a T-score, which ranges from 0 to 100 with a mean of 50 and standard deviation of 10. Scores closer to 100 indicate high pain intensities and scores closer to 0 indicate lower pain intensities.	On day 7 post procedure for each patient.
Pain experience in both arms, measured using the American Pain Society, the Patient Outcome Questionnaire (APS-POQ-R) questionnaire.	Assess patients' 7-day post-op pain experiences. The dependent variables for our analysis will be derived from the questions: "How often were you in severe pain in the first 7 days?" A score of zero signifies that the respondent was "never in severe pain" while a score of 100 means the patient was "always in severe pain"; and 2b) "How satisfied you are with the results of your pain treatment following your dental procedure?" The patient satisfaction outcome scale ranges from 0 to 10 with low scores representing low satisfaction and higher scores representing higher satisfaction.	The pain experience outcome will be measured 7 days post procedure.
Provider Acceptance of FollowApp.Care	The investigators will administer the 26-item Technology Acceptance Model (TAM2) Questionnaire to providers in the intervention group pre- and post-implementation, to assess their perceived usefulness and perceived ease of use of FollowApp.Care as predictors of their usage behavior. The control group will also be invited to complete the TAM2 questionnaire post-implementation only, to assess their acceptance of FollowApp.Care if it is made available to them.	2nd Quarter Year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unscheduled/emergency visits during the study period;	This measure will be compiled on a monthly basis through chart review. At the patient level, the distribution of emergency/unscheduled follow-up visits (frequency and mean) will be collected.	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Elsbeth Kalenderian, DDS, PhD, University of California, San Francisco; Principal Investigator: Muhammad F Walji, PhD, UT Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: A131587; U18HS026135 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No