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

Pain, Postoperative Clinical Trial

— AHRQPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881891
• Other study ID #: A131587
• Secondary ID: U18HS026135
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1525
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Pain, Postoperative
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
United States	Willamette Dental Group & Skourtes Institute	Hillsboro	Oregon
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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