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Randomized Controlled Trial
. 2022 Sep 1;182(9):975-983.
doi: 10.1001/jamainternmed.2022.3178.

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial

John D Piette  1   2   3 , Sean Newman  1   2 , Sarah L Krein  1   3 , Nicolle Marinec  1   2 , Jenny Chen  1   2 , David A Williams  4 , Sara N Edmond  5   6 , Mary Driscoll  5   6 , Kathryn M LaChappelle  5 , Robert D Kerns  5   6   7   8 , Marianna Maly  1   2 , H Myra Kim  1   2 , Karen B Farris  9 , Diana M Higgins  10   11 , Eugenia Buta  12 , Alicia A Heapy  5   6
Affiliations
Randomized Controlled Trial

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial

John D Piette et al. JAMA Intern Med. .

Abstract

Importance: Cognitive behavioral therapy for chronic pain (CBT-CP) is a safe and effective alternative to opioid analgesics. Because CBT-CP requires multiple sessions and therapists are scarce, many patients have limited access or fail to complete treatment.

Objectives: To determine if a CBT-CP program that personalizes patient treatment using reinforcement learning, a field of artificial intelligence (AI), and interactive voice response (IVR) calls is noninferior to standard telephone CBT-CP and saves therapist time.

Design, setting, and participants: This was a randomized noninferiority, comparative effectiveness trial including 278 patients with chronic back pain from the Department of Veterans Affairs health system (recruitment and data collection from July 11, 2017-April 9, 2020). More patients were randomized to the AI-CBT-CP group than to the control (1.4:1) to maximize the system's ability to learn from patient interactions.

Interventions: All patients received 10 weeks of CBT-CP. For the AI-CBT-CP group, patient feedback via daily IVR calls was used by the AI engine to make weekly recommendations for either a 45-minute or 15-minute therapist-delivered telephone session or an individualized IVR-delivered therapist message. Patients in the comparison group were offered 10 therapist-delivered telephone CBT-CP sessions (45 minutes/session).

Main outcomes and measures: The primary outcome was the Roland Morris Disability Questionnaire (RMDQ; range 0-24), measured at 3 months (primary end point) and 6 months. Secondary outcomes included pain intensity and pain interference. Consensus guidelines were used to identify clinically meaningful improvements for responder analyses (eg, a 30% improvement in RMDQ scores and pain intensity). Data analyses were performed from April 2021 to May 2022.

Results: The study population included 278 patients (mean [SD] age, 63.9 [12.2] years; 248 [89.2%] men; 225 [81.8%] White individuals). The 3-month mean RMDQ score difference between AI-CBT-CP and standard CBT-CP was -0.72 points (95% CI, -2.06 to 0.62) and the 6-month difference was -1.24 (95% CI, -2.48 to 0); noninferiority criterion were met at both the 3- and 6-month end points (P < .001 for both). A greater proportion of patients receiving AI-CBT-CP had clinically meaningful improvements at 6 months as indicated by RMDQ (37% vs 19%; P = .01) and pain intensity scores (29% vs 17%; P = .03). There were no significant differences in secondary outcomes. Pain therapy using AI-CBT-CP required less than half of the therapist time as standard CBT-CP.

Conclusions and relevance: The findings of this randomized comparative effectiveness trial indicated that AI-CBT-CP was noninferior to therapist-delivered telephone CBT-CP and required substantially less therapist time. Interventions like AI-CBT-CP could allow many more patients to be served effectively by CBT-CP programs using the same number of therapists.

Trial registration: ClinicalTrials.gov Identifier: NCT02464449.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Krein reported grants from the Department of Veterans Affairs (VA; Nos. IIR 13-350, RCS 11-222) during the conduct of the study. Dr Williams reported personal fees from Swing Therapeutics and Community Health Focus outside the submitted work. Dr Farris reported grants from AstraZeneca outside the submitted work. Dr Higgins reported grants from VA Office of Research and Development during the conduct of the study. Dr Heapy reported grants from the VA Health Services Research 7 Development during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
Figure 2.
Figure 2.. Number of Completed Treatment Sessions, by Randomization Group
Abbreviations: AI, artificial intelligence; CBT-CP, cognitive behavioral therapy for chronic pain.
See this image and copyright information in PMC

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