Connected Health to Decrease Opioid Use in Patients With Chronic Pain

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04013529
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.5
• Patients Per Site Per Month: 1.6

Study Details

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	N/A

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

• Study Type: Interventional
• 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: Aug 31, 2018
• Actual Primary Completion Date: Sep 15, 2020
• Actual Study Completion Date: Sep 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 [12 weeks]

   Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome

2. Increased Mobility [12 weeks]

   steps per day measured by wearable step tracker at 12 weeks

Secondary Outcome Measures

1. Daily Opioid Use [12 weeks]

   measured by opioid morphine mg equivalents used each day (MED)

2. Physical Function [12 weeks]

   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.

3. Pain Severity [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Corporal Michael Cresenz VA Medical Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 30, 2019

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04013529
• Other Study ID Numbers: 01758
• First Posted: Jul 9, 2019
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	19
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Control	Experimental	Total
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (11.0)	59.6 (13.5)	57.4 (12.3)
Sex: Female, Male (Count of Participants)
Female	1 5%	2 10%	3 7.5%
Male	19 95%	18 90%	37 92.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 15%	2 10%	5 12.5%
Not Hispanic or Latino	17 85%	18 90%	35 87.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 40%	7 35%	15 37.5%
White	10 50%	12 60%	22 55%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 10%	1 5%	3 7.5%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Activity Participation
Description	Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	156.0 (116.8)	135.8 (123.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Experimental
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.90
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Increased Mobility
Description	steps per day measured by wearable step tracker at 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Measure Participants	19	19
Mean (Standard Deviation) [steps per day]	4313 (4231)	4075 (5598)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Experimental
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	= 0.88
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Daily Opioid Use
Description	measured by opioid morphine mg equivalents used each day (MED)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Measure Participants	19	19
Mean (Standard Deviation) [morphine mg equivalents per day (MED)]	167.2 (244.4)	31.9 (35.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Experimental
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.17
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	25.4 (10.94)	24.2 (12.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Experimental
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	ANCOVA
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.	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.
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	6.7 (1.63)	6.8 (1.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Experimental
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	= 0.81
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	Although considered a minimal risk study, all participants were monitored for adverse events on a weekly basis.
Arm/Group Title	Control		Experimental
Arm/Group Description	Participate in technology-enabled care without regret lottery Way to Health technology enhanced care: Subjects receive text reminders to reach activity goals.		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.
All Cause Mortality
	Control		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Control		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Control		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.