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Connected Health to Decrease Opioid Use in Patients With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regret lottery
Way to Health technology enhanced care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Corporal Michael Cresenz VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Participate in technology-enabled care without regret lottery

Participate in technology-enabled care with regret lottery

Outcomes

Primary Outcome Measures

Activity Participation
Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Increased Mobility
steps per day measured by wearable step tracker at 12 weeks

Secondary Outcome Measures

Daily Opioid Use
measured by opioid morphine mg equivalents used each day (MED)
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.
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.

Full Information

First Posted
July 2, 2019
Last Updated
October 25, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04013529
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participate in technology-enabled care without regret lottery
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Participate in technology-enabled care with regret lottery
Intervention Type
Behavioral
Intervention Name(s)
Regret lottery
Intervention Description
Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
Intervention Type
Behavioral
Intervention Name(s)
Way to Health technology enhanced care
Intervention Description
Subjects receive text reminders to reach activity goals.
Primary Outcome Measure Information:
Title
Activity Participation
Description
Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Time Frame
12 weeks
Title
Increased Mobility
Description
steps per day measured by wearable step tracker at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily Opioid Use
Description
measured by opioid morphine mg equivalents used each day (MED)
Time Frame
12 weeks
Title
Physical Function
Description
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.
Time Frame
12 weeks
Title
Pain Severity
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Corporal Michael Cresenz VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share IPD
Citations:
PubMed Identifier
34634064
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.
Results Reference
derived

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Connected Health to Decrease Opioid Use in Patients With Chronic Pain

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