Clinical trial NCT04013529: Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Official title: Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this pilot study to evaluate if behavioral incentives applied at the VA Medical Center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.

Detailed description: Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost productivity, and $261-300 billion in health care expenditures. To manage their chronic pain, 5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects.

Opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. Tapering opioids, however, requires replacing them with effective non-opioid strategies. Improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. Concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility.

Appreciating the gains in health outcomes that can be made with "connected health" approaches, we propose a novel pilot study designed to evaluate if technology enabled care (TEC) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic pain patients who receive TEC-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. Secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. The results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.

Eligibility criteria: Inclusion Criteria:

* Chronic non-malignant pain
* High dose opioid therapy
* Possession of activated cell phone with text messaging capabilities
* Willingness to comply with study requirements

Exclusion Criteria:

* Pain of malignant origin
* Sensory impairments precluding use of text messaging and activity tracker
* Physical disability precluding improvements in physical activity

Primary outcomes:
measure: Activity Participation
timeFrame: 12 weeks
measure: Increased Mobility
timeFrame: 12 weeks
Secondary outcomes:
measure: Daily Opioid Use
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Pain Severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael Cresenz VA Medical Center
state: Pennsylvania
Study officials:
References:
citation: Compton P, Chaiyachati KH, Dicks T, Medvedeva E, Chhabra M. A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain. PLoS One. 2021 Oct 11;16(10):e0257320. doi: 10.1371/journal.pone.0257320. eCollection 2021.