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出境医 / 临床实验 / Connected Health to Decrease Opioid Use in Patients With Chronic Pain

Connected Health to Decrease Opioid Use in Patients With Chronic Pain

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Regret lottery Behavioral: Way to Health technology enhanced care Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Actual Study Start Date : August 31, 2018
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : September 15, 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Control
Participate in technology-enabled care without regret lottery
Behavioral: Way to Health technology enhanced care
Subjects receive text reminders to reach activity goals.

Experimental: Experimental
Participate in technology-enabled care with regret lottery
Behavioral: Regret lottery
Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.

Behavioral: Way to Health technology enhanced care
Subjects receive text reminders to reach activity goals.

Outcome Measures
Primary Outcome Measures :
  1. Activity participation and increased mobility [ Time Frame: 12 weeks ]
    measured by the Stanford Exercise Questionnaire

  2. Increased mobility [ Time Frame: 12 weeks ]
    measured by wearable step tracker


Secondary Outcome Measures :
  1. Opioid use [ Time Frame: 12 weeks ]
    measured by medication adherence

  2. Opioid use [ Time Frame: 12 weeks ]
    measured by pill counts

  3. physical function [ Time Frame: 12 weeks ]
    measured by 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.

  4. pain severity [ Time Frame: 12 weeks ]
    measured by 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Pennsylvania
Corporal Michael Cresenz VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE August 31, 2018
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Activity participation and increased mobility [ Time Frame: 12 weeks ]
    measured by the Stanford Exercise Questionnaire
  • Increased mobility [ Time Frame: 12 weeks ]
    measured by wearable step tracker
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Opioid use [ Time Frame: 12 weeks ]
    measured by medication adherence
  • Opioid use [ Time Frame: 12 weeks ]
    measured by pill counts
  • physical function [ Time Frame: 12 weeks ]
    measured by 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 [ Time Frame: 12 weeks ]
    measured by 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Official Title  ICMJE Connected Health to Decrease Opioid Use in Patients With Chronic Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Behavioral: Regret lottery
    Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.
  • Behavioral: Way to Health technology enhanced care
    Subjects receive text reminders to reach activity goals.
Study Arms  ICMJE
  • Placebo Comparator: Control
    Participate in technology-enabled care without regret lottery
    Intervention: Behavioral: Way to Health technology enhanced care
  • Experimental: Experimental
    Participate in technology-enabled care with regret lottery
    Interventions:
    • Behavioral: Regret lottery
    • Behavioral: Way to Health technology enhanced care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2020
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013529
Other Study ID Numbers  ICMJE 01758
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share IPD
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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