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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Participate in technology-enabled care without regret lottery |
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| Experimental | Experimental | Participate in technology-enabled care with regret lottery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regret lottery | Behavioral | Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100. |
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| Measure | Description | Time Frame |
|---|---|---|
| Activity Participation | Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome | 12 weeks |
| Increased Mobility | steps per day measured by wearable step tracker at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Use | measured by opioid morphine mg equivalents used each day (MED) | 12 weeks |
| Physical Function | measured by interference with walking on PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporal Michael Cresenz VA Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34634064 | Derived | 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. |
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no plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. |
| FG001 | Experimental | Participate in technology-enabled care with regret lottery Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100. Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. |
| BG001 | Experimental |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Activity Participation | Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
12 weeks
Although considered a minimal risk study, all participants were monitored for adverse events on a weekly basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. |
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Although subjects were blinded to group assignment, it is possible that those in the intervention arm communicated their potential to receive payment to those in the control arm who did not have the same benefit, which may have served as a disincentive for controls to engage in physical activity. Also, subjects in both groups received large numbers of text messages over the study period and may have found the messaging burdensome and thus stopped reading or responding to them as anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manik Chhabra | Corporal Michael J. Crescenz VA Medical Center | (215) 823-5800 | manik.chhabra@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2019 | Sep 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Way to Health technology enhanced care | Behavioral | Subjects receive text reminders to reach activity goals. |
|
| 12 weeks |
| Pain Severity | measured by pain severity on PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain. | 12 weeks |
Participate in technology-enabled care with regret lottery
Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Increased Mobility | steps per day measured by wearable step tracker at 12 weeks | Posted | Mean | Standard Deviation | steps per day | 12 weeks |
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| Secondary | Daily Opioid Use | measured by opioid morphine mg equivalents used each day (MED) | Posted | Mean | Standard Deviation | morphine mg equivalents per day (MED) | 12 weeks |
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| Secondary | Physical Function | measured by interference with walking on PROMIS (Patient-reported Outcomes Measurement Information System) pain interference tool, which is a 6-item self-report survey; each item is scored from 1 (not at all) to 5 (very much), thus scores ranged from 6 to 30, with higher score indicating more pain interference. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Secondary | Pain Severity | measured by pain severity on PROMIS (Patient-reported Outcomes Measurement Information System) pain severity tool, which is a 3-item self-report survey; each item is scored from 1 (no pain at all) to 5 (very severity), thus scores ranged from 3 to 15, with higher score indicating more severe pain. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Experimental | Participate in technology-enabled care with regret lottery Regret lottery: Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100. Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals. | 0 | 19 | 0 | 19 | 0 | 19 |
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