Trial Outcomes & Findings for N-of-1 Trials Using mHealth in Chronic Pain (NCT NCT02116621)

NCT ID: NCT02116621

Last Updated: 2018-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 215 participants
• Primary outcome timeframe: baseline, 26 weeks
• Results posted on: 2018-05-25

Participant Flow

Participant milestones

Measure	Trialist Intervention 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. Trialist Intervention: 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. smartphone	Control-Usual Care Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Baseline STARTED	108	107
Baseline Completed Baseline Visit	108	103
Baseline Completed Intervention Period	95	103
Baseline COMPLETED	108	103
Baseline NOT COMPLETED	0	4
Three Month Follow-up STARTED	108	103
Three Month Follow-up COMPLETED	89	96
Three Month Follow-up NOT COMPLETED	19	7
Six Month Follow-up STARTED	103	100
Six Month Follow-up COMPLETED	99	97
Six Month Follow-up NOT COMPLETED	4	3
Twelve Month Follow-up STARTED	100	98
Twelve Month Follow-up COMPLETED	84	86
Twelve Month Follow-up NOT COMPLETED	16	12

Reasons for withdrawal

Measure	Trialist Intervention 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. Trialist Intervention: 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. smartphone	Control-Usual Care Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Baseline Withdrawal by Subject	0	4
Three Month Follow-up Death	1	1
Three Month Follow-up Withdrawal by Subject	4	1
Three Month Follow-up Lost to Follow-up	0	1
Three Month Follow-up Did not complete follow-up survey	14	4
Six Month Follow-up Withdrawal by Subject	1	1
Six Month Follow-up Lost to Follow-up	2	1
Six Month Follow-up Did not complete follow-up survey	1	1
Twelve Month Follow-up Withdrawal by Subject	1	0
Twelve Month Follow-up Lost to Follow-up	0	1
Twelve Month Follow-up Did not complete follow-up survey	1	3
Twelve Month Follow-up Enrolled within 12 months of study end	14	8

Baseline Characteristics

N-of-1 Trials Using mHealth in Chronic Pain

Baseline characteristics by cohort

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=107 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app	Total n=215 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 10.8 • n=93 Participants	55.6 years STANDARD_DEVIATION 11.5 • n=4 Participants	55.5 years STANDARD_DEVIATION 11.1 • n=27 Participants
Sex: Female, Male Female	50 Participants n=93 Participants	52 Participants n=4 Participants	102 Participants n=27 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	55 Participants n=4 Participants	113 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	8 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=93 Participants	95 Participants n=4 Participants	186 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Race (NIH/OMB) White	75 Participants n=93 Participants	80 Participants n=4 Participants	155 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=93 Participants	8 Participants n=4 Participants	21 Participants n=27 Participants
Region of Enrollment United States	108 Participants n=93 Participants	107 Participants n=4 Participants	215 Participants n=27 Participants
Pain interference	64.0 units on a scale STANDARD_DEVIATION 5.9 • n=93 Participants	64.7 units on a scale STANDARD_DEVIATION 5.8 • n=4 Participants	64.3 units on a scale STANDARD_DEVIATION 5.8 • n=27 Participants
Pain intensity	53.5 units on a scale STANDARD_DEVIATION 5.4 • n=93 Participants	53.8 units on a scale STANDARD_DEVIATION 5.1 • n=4 Participants	53.7 units on a scale STANDARD_DEVIATION 5.2 • n=27 Participants
Global physical health	42.5 units on a scale STANDARD_DEVIATION 6.8 • n=93 Participants	40.6 units on a scale STANDARD_DEVIATION 5.5 • n=4 Participants	41.6 units on a scale STANDARD_DEVIATION 6.2 • n=27 Participants
Global mental health	44.9 units on a scale STANDARD_DEVIATION 9.1 • n=93 Participants	43.2 units on a scale STANDARD_DEVIATION 7.9 • n=4 Participants	44.1 units on a scale STANDARD_DEVIATION 8.6 • n=27 Participants
Analgesic adherence (overuse)	90.2 units on a scale STANDARD_DEVIATION 12.4 • n=93 Participants	89.4 units on a scale STANDARD_DEVIATION 13.4 • n=4 Participants	89.8 units on a scale STANDARD_DEVIATION 12.9 • n=27 Participants
Analgesic adherence (underuse)	75.2 units on a scale STANDARD_DEVIATION 22.3 • n=93 Participants	75.6 units on a scale STANDARD_DEVIATION 24.6 • n=4 Participants	75.4 units on a scale STANDARD_DEVIATION 23.4 • n=27 Participants
Trust in clinician	76.8 units on a scale STANDARD_DEVIATION 15.8 • n=93 Participants	75.3 units on a scale STANDARD_DEVIATION 17.1 • n=4 Participants	76.1 units on a scale STANDARD_DEVIATION 16.4 • n=27 Participants
Satisfaction with pain information	50.5 units on a scale STANDARD_DEVIATION 38.8 • n=93 Participants	50.7 units on a scale STANDARD_DEVIATION 37.8 • n=4 Participants	50.6 units on a scale STANDARD_DEVIATION 38.2 • n=27 Participants
Satisfaction with medical care	84.7 units on a scale STANDARD_DEVIATION 15.7 • n=93 Participants	79.5 units on a scale STANDARD_DEVIATION 19.2 • n=4 Participants	82.2 units on a scale STANDARD_DEVIATION 17.7 • n=27 Participants
Satisfaction with pain medication	65.2 units on a scale STANDARD_DEVIATION 22.1 • n=93 Participants	63.4 units on a scale STANDARD_DEVIATION 23.6 • n=4 Participants	64.4 units on a scale STANDARD_DEVIATION 22.8 • n=27 Participants
Medication related shared decision making	74.3 units on a scale STANDARD_DEVIATION 23.8 • n=93 Participants	75.0 units on a scale STANDARD_DEVIATION 24.3 • n=4 Participants	74.6 units on a scale STANDARD_DEVIATION 23.9 • n=27 Participants

PRIMARY outcome

Timeframe: baseline, 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks	-3.22 units on a scale Interval -4.31 to -2.13	-1.85 units on a scale Interval -2.96 to -0.75

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 26 weeks	-3.22 units on a scale Interval -4.31 to -2.13	-1.85 units on a scale Interval -2.96 to -0.75
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 52 weeks	-2.67 units on a scale Interval -3.82 to -1.52	-2.83 units on a scale Interval -3.98 to -1.68
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 13 weeks	-2.70 units on a scale Interval -3.83 to -1.57	-1.91 units on a scale Interval -3.02 to -0.81

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 13 weeks	-1.60 units on a scale Interval -2.67 to -0.54	-1.92 units on a scale Interval -2.96 to -0.87
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 26 weeks	-2.86 units on a scale Interval -3.89 to -1.83	-1.46 units on a scale Interval -2.5 to -0.41
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Change from baseline to 52 weeks	-3.00 units on a scale Interval -4.08 to -1.91	-1.76 units on a scale Interval -2.85 to -0.67

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale Change from baseline to 52 weeks	0.36 units on a scale Interval -1.01 to 1.74	-0.39 units on a scale Interval -1.76 to 0.98
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale Change from baseline to 13 weeks	-0.35 units on a scale Interval -1.71 to 1.0	0.30 units on a scale Interval -1.02 to 1.63
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale Change from baseline to 26 weeks	0.21 units on a scale Interval -1.09 to 1.52	-0.72 units on a scale Interval -2.04 to 0.6

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale Change from baseline to 13 weeks	0.73 units on a scale Interval -0.21 to 1.67	0.44 units on a scale Interval -0.48 to 1.35
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale Change from baseline to 26 weeks	0.13 units on a scale Interval -0.77 to 1.03	0.30 units on a scale Interval -0.61 to 1.21
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale Change from baseline to 52 weeks	0.16 units on a scale Interval -0.79 to 1.12	0.42 units on a scale Interval -0.53 to 1.37

SECONDARY outcome

Timeframe: Baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 13 weeks	1.40 units on a scale Interval -1.18 to 3.98	0.35 units on a scale Interval -2.15 to 2.85
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 26 weeks	1.77 units on a scale Interval -0.75 to 4.3	-0.13 units on a scale Interval -2.64 to 2.39
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 52 weeks	1.61 units on a scale Interval -1.02 to 4.24	1.53 units on a scale Interval -1.06 to 4.12

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 52 weeks	-3.53 units on a scale Interval -8.62 to 1.56	-1.62 units on a scale Interval -6.66 to 3.42
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 13 weeks	2.53 units on a scale Interval -2.46 to 7.52	-1.71 units on a scale Interval -6.56 to 3.15
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire Change from baseline to 26 weeks	1.88 units on a scale Interval -3.0 to 6.76	-2.76 units on a scale Interval -7.63 to 2.11

SECONDARY outcome

Timeframe: baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale Change from baseline to 13 weeks	-2.49 units on a scale Interval -5.44 to 0.46	-4.25 units on a scale Interval -7.13 to -1.36
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale Change from baseline to 26 weeks	-2.30 units on a scale Interval -5.14 to 0.54	-4.84 units on a scale Interval -7.73 to -1.96
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale Change from baseline to 52 weeks	-4.00 units on a scale Interval -7.0 to -0.99	-5.53 units on a scale Interval -8.52 to -2.54

SECONDARY outcome

Timeframe: Baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information Change from baseline to 13 weeks	4.41 units on a scale Interval -3.18 to 12.0	-3.36 units on a scale Interval -10.84 to 4.11
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information Change from baseline to 26 weeks	11.28 units on a scale Interval 3.95 to 18.61	3.99 units on a scale Interval -3.47 to 11.45
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information Change from baseline to 52 weeks	9.02 units on a scale Interval 1.28 to 16.76	4.89 units on a scale Interval -2.84 to 12.63

SECONDARY outcome

Timeframe: Baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care Change from baseline to 13 weeks	-4.00 units on a scale Interval -7.56 to -0.44	-6.15 units on a scale Interval -9.64 to -2.66
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care Change from baseline to 26 weeks	-2.26 units on a scale Interval -5.68 to 1.17	-5.57 units on a scale Interval -9.04 to -2.09
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care Change from baseline to 52 weeks	-4.52 units on a scale Interval -8.13 to -0.9	-5.51 units on a scale Interval -9.12 to -1.91

SECONDARY outcome

Timeframe: Baseline, 13 weeks, 26 weeks, 52 weeks

Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.

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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication Change from baseline to 26 weeks	-0.18 units on a scale Interval -4.44 to 4.08	1.39 units on a scale Interval -2.99 to 5.77
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication Change from baseline to 52 weeks	0.77 units on a scale Interval -3.72 to 5.25	-0.34 units on a scale Interval -4.87 to 4.19
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication Change from baseline to 13 weeks	1.46 units on a scale Interval -2.93 to 5.86	-0.34 units on a scale Interval -4.73 to 4.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks	-2.86 units on a scale Interval -3.89 to -1.83	-1.46 units on a scale Interval -2.5 to -0.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks	0.21 units on a scale Interval -1.09 to 1.52	-0.72 units on a scale Interval -2.04 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks	0.13 units on a scale Interval -0.77 to 1.03	0.30 units on a scale Interval -0.61 to 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks	1.77 units on a scale Interval -0.75 to 4.3	-0.13 units on a scale Interval -2.64 to 2.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks	1.88 units on a scale Interval -3.0 to 6.76	-2.76 units on a scale Interval -7.63 to 2.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks	-2.30 units on a scale Interval -5.14 to 0.54	-4.84 units on a scale Interval -7.73 to -1.96

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks	11.28 units on a scale Interval 3.95 to 18.61	3.99 units on a scale Interval -3.47 to 11.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks	-2.26 units on a scale Interval -5.68 to 1.17	-5.57 units on a scale Interval -9.04 to -2.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 26 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks	-0.18 units on a scale Interval -4.44 to 4.08	1.39 units on a scale Interval -2.99 to 5.77

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks

Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.

Outcome measures

Measure	Trialist Intervention n=62 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=45 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks	79.6 units on a scale Interval 74.9 to 84.3	67.7 units on a scale Interval 58.7 to 76.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks	-2.70 units on a scale Interval -3.83 to -1.57	-1.91 units on a scale Interval -3.02 to -0.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks	-1.60 units on a scale Interval -2.67 to -0.54	-1.92 units on a scale Interval -2.96 to -0.87

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks	0.73 units on a scale Interval -0.21 to 1.67	0.44 units on a scale Interval -0.48 to 1.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks	-0.35 units on a scale Interval -1.71 to 1.0	0.30 units on a scale Interval -1.02 to 1.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks	1.40 units on a scale Interval -1.18 to 3.98	0.35 units on a scale Interval -2.15 to 2.85

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks	2.53 units on a scale Interval -2.46 to 7.52	-1.71 units on a scale Interval -6.56 to 3.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks	-2.49 units on a scale Interval -5.44 to 0.46	-4.25 units on a scale Interval -7.13 to -1.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks	4.41 units on a scale Interval -3.18 to 12.0	-3.36 units on a scale Interval -10.84 to 4.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks	-4.00 units on a scale Interval -7.56 to -0.44	-6.15 units on a scale Interval -9.64 to -2.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 13 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks	1.46 units on a scale Interval -2.93 to 5.86	-0.34 units on a scale Interval -4.73 to 4.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks	-2.67 units on a scale Interval -3.82 to -1.52	-2.83 units on a scale Interval -3.98 to -1.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks	-3.00 units on a scale Interval -4.08 to -1.91	-1.76 units on a scale Interval -2.85 to -0.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks	0.16 units on a scale Interval -0.79 to 1.12	0.42 units on a scale Interval -0.53 to 1.37

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks	0.36 units on a scale Interval -1.01 to 1.74	-0.39 units on a scale Interval -1.76 to 0.98

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks	1.61 units on a scale Interval -1.02 to 4.24	1.53 units on a scale Interval -1.06 to 4.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks	-3.53 units on a scale Interval -8.62 to 1.56	-1.62 units on a scale Interval -6.66 to 3.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Patient trust in physician measured with 11-item Trust in Physician Scale at baseline 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks	-4.00 units on a scale Interval -7.0 to -0.99	-5.53 units on a scale Interval -8.52 to -2.54

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks	9.02 units on a scale Interval 1.28 to 16.76	4.89 units on a scale Interval -2.84 to 12.63

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks	-4.52 units on a scale Interval -8.13 to -0.9	-5.51 units on a scale Interval -9.12 to -1.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 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.

Outcome measures

Measure	Trialist Intervention n=108 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=103 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks	0.77 units on a scale Interval -3.72 to 5.25	-0.34 units on a scale Interval -4.87 to 4.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 52 weeks

Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.

Outcome measures

Measure	Trialist Intervention n=48 Participants 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. Trialist Intervention: 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. smartphone	Control-Usual Care n=51 Participants Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks	74.8 units on a scale Interval 69.0 to 80.6	65.4 units on a scale Interval 57.7 to 73.0

Adverse Events

Trialist Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control-Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Kravitz, MD, MSPH

University of California, Davis

Phone: 916-734-1248

Email: rlkravitz@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place