Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools

Study Overview
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Brief Summary
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This study will evaluate a new approach for back pain care management using artificial intelligence and evidence-based cognitive behavioral therapy (AI-CBT) so that services automatically adapt to each Veteran's unique needs, achieving outcomes as good as standard care but with less clinician time.

Detailed Description
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Cognitive behavioral therapy (CBT) is one of the most effective treatments for chronic back pain. However, only half of Veterans have access to trained CBT therapists, and program expansion is costly. Moreover, VA CBT programs consist of 10 weekly hour-long sessions delivered using an approach that is out-of-sync with stepped-care models designed to ensure that scarce resources are used as effectively and efficiently as possible. Data from prior CBT trials have documented substantial variation in patients' needs for extended treatment, and the characteristics of effective programs vary significantly. Some patients improve after the first few sessions while others need more extensive contact. After initially establishing a behavioral plan, still other Veterans may be able to reach behavioral and symptom goals using a personalized combination of manuals, shorter follow-up contacts with a therapist, and automated telephone monitoring and self-care support calls. In partnership with the National Pain Management Program, the investigators propose to apply state-of-the-art principles from reinforcement learning (a field of artificial intelligence or AI used successfully in robotics and on-line consumer targeting) to develop an evidence-based, personalized CBT pain management service that automatically adapts to each Veteran's unique and changing needs (AI-CBT). AI-CBT will use feedback from patients about their progress in pain-related functioning measured daily via pedometer step-counts to automatically personalize the intensity and type of patient support; thereby ensuring that scarce therapist resources are used as efficiently as possible and potentially allowing programs with fixed budgets to serve many more Veterans. The specific aims of the study are to: (1) demonstrate that AI-CBT has non-inferior pain-related outcomes compared to standard telephone CBT; (2) document that AI-CBT achieves these outcomes with more efficient use of scarce clinician resources as evidenced by less overall therapist time and no increase in the use of other VA health services; and (3) demonstrate the intervention's impact on proximal outcomes associated with treatment response, including program engagement, pain management skill acquisition, satisfaction with care, and patients' likelihood of dropout. The investigators will use qualitative interviews with patients, clinicians, and VA operational partners to ensure that the service has features that maximize scalability, broad scale adoption, and impact. 278 patients with chronic back pain will be recruited from the VA Connecticut Healthcare System and the VA Ann Arbor Healthcare System, and randomized to standard 10-sessions of telephone CBT versus AI-CBT. All patients will begin with weekly hour-long telephone counseling, but for patients in the AI-CBT group, those who demonstrate a significant treatment response will be stepped down through less resource-intensive alternatives to hour-long contacts, including: (a) 15 minute contacts with a therapist, and (b) CBT clinician feedback provided via interactive voice response calls (IVR). The AI engine will learn what works best in terms of patients' personally-tailored treatment plan based on daily feedback via IVR about patients' pedometer-measured step counts as well as their CBT skill practice and physical functioning. The AI algorithm the investigators will use is designed to be as efficient as possible, so that the system can learn what works best for a given patient based on the collective experience of other similar patients as well as the individual's own history. The investigator's hypothesis is that AI-CBT will result in pain-related functional outcomes that are no worse (and possibly better) than the standard approach, but by scaling back the intensity of contact that is not resulting in marginal gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. Secondary hypotheses are that AI-CBT will result in greater patient engagement and patient satisfaction. Outcomes will be measured at three and six months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout.

Official Title
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Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools

Conditions
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Back Pain

Intervention / Treatment
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* Behavioral: Behavioral: AI-CBT
* Behavioral: Behavioral: Standard Telephone CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Back pain-related dx including back and spine conditions and nerve compression and a score of >=4 (indicating moderate pain) on the 0-10 Numerical Rating Scale on at least two separate outpatient encounters in the past year At least 1 outpatient visit in last 12 months At least moderate pain-related disability as determined by a score of 5+on the Roland Morris Disability Questionnaire At least moderate musculoskeletal pain as indicated by a pain score of >=4 on the Numeric Rating Scale Pain on at least half the days of the prior 6 months as reported on the Chronic Pain item Touch-tone cell or land line phone. Exclusion Criteria: COPD requiring oxygen Cancer requiring chemotherapy Currently receiving CBT Suicidality Receiving surgical tx related to back pain Active psychotic symptoms Severe depressive symptoms Can't speak English Sensory deficits that would impair participation in telephone calls Patient not planning to get care at study site PCP not affiliated with study site Limited life expectancy (COPD requiring oxygen or Cancer requiring chemotherapy Active psychotic symptoms, suicidality, severe depressive symptoms (Beck Depression Inventory (BDI) score or 30+) Substance use disorder or dependence, active manic episode, or poorly controlled bipolar disorder as identified by MMini International Neuropsychiatric Interview Severe depression identified by chart review of diagnoses and mental health treatment notes Cognitive impairment defined by a score of <=5 on the Six-Item screener Current CBT or surgical treatment related to back pain.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI CBT<br>AI CBT engine will make recommendations to step-down or step-up intensity of CBT FU based on what patient reports and what other similar patients report. Stepped care model. | Behavioral: Behavioral: AI-CBT<br>* AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.<br>|
| Active Comparator: Standard telephone CBT<br>Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook. | Behavioral: Behavioral: Standard Telephone CBT<br>* Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-related Disability | The Roland Morris Disability Questionnaire (RMDQ) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. | 3 and 6 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Pain Intensity | An 11-point Numeric Rating Scale (NRS) for pain severity, with 0 representing No pain and 10 representing the Worst pain imaginable. Patients were asked to rate their level of pain on average in the last week. | 3 and 6 months post enrollment | 
| Pain-Related Interference | Pain-related interference was measured using the Brief Pain Inventory - Short Form (BPI). Scores range from 0-10, with higher scores indicating more interference. | 3 and 6 months post enrollment | 
| Depression Symptom Severity | Depression symptom severity was assessed using the 9-item Patient Health Questionnaire (PHQ-9). Scores range from 0-27, with higher scores indicating more depression symptom severity. | 3 and 6 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, Mobile Health Technology, Patient Care Management