N-of-1 Trials Using mHealth in Chronic Pain

Study Overview
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Brief Summary
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Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a trial and error fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment. The purpose of the PREEMPT Study is to test whether using a mobile phone application (Trialist app) that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.

Official Title
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N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)

Conditions
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Musculoskeletal Pain, Chronic Pain

Intervention / Treatment
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* Behavioral: Trialist Intervention
* Device: smartphone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale Age 18-75 years Own web-enabled Android or iOS phone with data plan In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments Ability to speak and read English Exclusion Criteria: Treated with surgery, radiation or chemotherapy for cancer in past 5 years Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety Pregnant or breastfeeding Dementia, bipolar disorder, schizophrenia, active suicidality Current alcohol or prescription drug abuse; history of disruptive behavior Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Trialist Intervention<br>Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician. | Behavioral: Trialist Intervention<br>* Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.<br>* Other names: mobile health;Device: smartphone<br> <br> |
| No Intervention: Control-Usual Care<br>Receive usual care from clinician for chronic pain, do not use Trialist smartphone app | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | baseline, 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. | Baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. | baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. | Baseline, 13 weeks, 26 weeks, 52 weeks | 
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. | Baseline, 13 weeks, 26 weeks, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal pain, Chronic pain, Patient centered outcomes research, Physician patient relationship, Mobile applications