Chronic Pain
Conditions
Keywords
m-health
Brief summary
There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.
Detailed description
The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months. To ensure rigor and successful future implementation, the investigators will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.
Interventions
BEHAVIORALSUMMIT
multicomponent web-based application focused on pain self-management skills
BEHAVIORALcontrol
My Pain Diary app
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
We will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial. Eligible participants will be randomized to LIMIT versus a pain monitoring app. Outcome measures will be collected over 9 months. To ensure rigor and successful future implementation, we will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Summit App Use | 6 months | Total number of minutes of use of the Summit app over the 6 month intervention |
| Daily Morphine Milligram Equivalents (MME) | 9-months | Morphine milligram equivalents per day based on participant self report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior Intervention Rating Scale (BIRS) | six months | The BIRS is a 24-item validated measure of an intervention's acceptability and perceived effectiveness scored on 5-point agreement scales. The total score is divided by the total number of completed items and this ranges from 1 to 5. Higher mean item scores represent higher acceptability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SUMMIT Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
SUMMIT: multicomponent web-based application focused on pain self-management skills | 24 |
| Control Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
control: My Pain Diary app | 20 |
| Total | 44 |
Baseline characteristics
| Characteristic | SUMMIT | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 24 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 20 Participants | 8 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.9 | 65.4 years STANDARD_DEVIATION 9.5 | 68.8 years STANDARD_DEVIATION 9.3 |
| Prescribed Opioids Difficulties Scale - Opioid Control Concerns | 6.3 units on a scale STANDARD_DEVIATION 3.4 | 6.9 units on a scale STANDARD_DEVIATION 3.7 | 7.5 units on a scale STANDARD_DEVIATION 4.1 |
| Prescribed Opioids Difficulties Scale - Psychosocial Problems | 7.5 units on a scale STANDARD_DEVIATION 6.7 | 7.3 units on a scale STANDARD_DEVIATION 6.4 | 7.1 units on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 4 Participants |
| Region of Enrollment United States | 24 Participants | 44 Participants | 20 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 21 Participants | 37 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 20 |
| other Total, other adverse events | 0 / 24 | 0 / 20 |
| serious Total, serious adverse events | 0 / 24 | 0 / 20 |
Outcome results
Primary
Daily Morphine Milligram Equivalents (MME)
Morphine milligram equivalents per day based on participant self report.
Time frame: 9-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUMMIT | Daily Morphine Milligram Equivalents (MME) | 25.1 Morphine milligram equivalents per day | Standard Deviation 44.7 |
| Control | Daily Morphine Milligram Equivalents (MME) | 21.9 Morphine milligram equivalents per day | Standard Deviation 28.6 |
p-value: 0.91t-test, 2 sided
Primary
Minutes of Summit App Use
Total number of minutes of use of the Summit app over the 6 month intervention
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUMMIT | Minutes of Summit App Use | 20.9 Minutes of use | Standard Deviation 19.8 |
Comparison: descriptive statistic of system use
Secondary
Behavior Intervention Rating Scale (BIRS)
The BIRS is a 24-item validated measure of an intervention's acceptability and perceived effectiveness scored on 5-point agreement scales. The total score is divided by the total number of completed items and this ranges from 1 to 5. Higher mean item scores represent higher acceptability.
Time frame: six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SUMMIT | Behavior Intervention Rating Scale (BIRS) | 4.4 score on a scale | Standard Deviation 0.4 |
| Control | Behavior Intervention Rating Scale (BIRS) | 4.5 score on a scale | Standard Deviation 0.4 |
p-value: 0.5t-test, 2 sided