Clinical trial NCT02116621: N-of-1 Trials Using mHealth in Chronic Pain
Official title: N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Pain
Keywords: Musculoskeletal pain
Chronic pain
Patient centered outcomes research
Physician patient relationship
Mobile applications
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-04-17
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
timeFrame: baseline, 26 weeks
Secondary outcomes:
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire
timeFrame: Baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale
timeFrame: baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information
timeFrame: Baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care
timeFrame: Baseline, 13 weeks, 26 weeks, 52 weeks
measure: Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication
timeFrame: Baseline, 13 weeks, 26 weeks, 52 weeks
Other outcomes:
measure: Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks
timeFrame: 26 weeks
measure: Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks
timeFrame: Baseline, 13 weeks
measure: Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks
timeFrame: Baseline, 52 weeks
measure: Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks
timeFrame: Baseline, 52 weeks
Locations:
city: Mather
country: United States
facility: Veteran's Administration-Northern California Health Care System
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Richard L Kravitz, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barr C, Marois M, Sim I, Schmid CH, Wilsey B, Ward D, Duan N, Hays RD, Selsky J, Servadio J, Schwartz M, Dsouza C, Dhammi N, Holt Z, Baquero V, MacDonald S, Jerant A, Sprinkle R, Kravitz RL. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial. Trials. 2015 Feb 27;16:67. doi: 10.1186/s13063-015-0590-8.
citation: Kravitz RL, Marois M, Sim I, Ward D, Kanekar SS, Yu A, Dounias P, Yang J, Wang Y, Schmid CH. Chronic pain treatment preferences change following participation in N-of-1 trials, but not always in the expected direction. J Clin Epidemiol. 2021 Nov;139:167-176. doi: 10.1016/j.jclinepi.2021.08.007. Epub 2021 Aug 14.
citation: Odineal DD, Marois MT, Ward D, Schmid CH, Cabrera R, Sim I, Wang Y, Wilsey B, Duan N, Henry SG, Kravitz RL. Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain: Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):102-111. doi: 10.1007/s11606-019-05303-0. Epub 2019 Aug 28.
citation: Kravitz RL, Schmid CH, Marois M, Wilsey B, Ward D, Hays RD, Duan N, Wang Y, MacDonald S, Jerant A, Servadio JL, Haddad D, Sim I. Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1368-1377. doi: 10.1001/jamainternmed.2018.3981.