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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RD000376-01A1 | Other Grant/Funding Number | ORD |
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Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.
The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPACT | Experimental | Data from Veteran participants randomized to digital intervention (IMPACT) |
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| ETAU | Placebo Comparator | Data from Veteran participants randomized to ETAU (no access to IMPACT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) | Behavioral | The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference 6b | T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference). | 3-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference 6b | T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less pain interference). | 6- and 9-months post randomization |
| Veterans Rand 12-Item Health Survey (VR-12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R. Ross MacLean, PhD | Contact | (203) 932-5711 | 7423 | robert.maclean@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| R. Ross MacLean, PhD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States |
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The present study is a hybrid type 1 effectiveness-implementation trial of IMPACT versus ETAU to improve functioning and quality of life in Veterans with chronic pain and OUD.
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| Enhanced Treatment as Usual (ETAU) | Behavioral | ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility. |
|
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to better quality of life). |
| 3-months post-randomization |
| Activity Measure for Post-Acute Care (AM-PAC) | Measure has two scales: Basic Mobility (range: 0-24) and Daily Activity (range: 0-24); on both scales higher scores corresponds to better performance. | 3-months post-randomization |
| PROMIS Sleep Disturbance 6a and Duration | T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less sleep disturbance). | 3-months post randomization |
| Buprenorphine retention | retention is defined as both continuous and verified enrollment in MOUD in the 30 days prior to the specified timepoint. Continuous will be defined as having a continuously active buprenorphine prescription with a record of dispensing that includes the prior 30 days verified by Electronic Health Record. Retention will be a binary outcome with 1 = retained (conditions met) and 0 = not retained | 3-months post randomization |
| Buprenorphine adherence | Timeline Follow-back will collect days of use for buprenorphine since last time point. During treatment period, weekly Timeline Follow-back adherence to buprenorphine will be compared to daily surveys and active buprenorphine prescription will be verified in Electronic Health Record (EHR). If a participant does not complete Timeline Follow-Back and/or has missing data in daily surveys or did not pick up buprenorphine as prescribed in EHR, the week will be considered non-adherent. Injectable buprenorphine will be verified in EHR and, if participant received injection as scheduled, they will be considered adherent. Mean adherent weeks will be calculated in each group; higher number corresponds to greater adherence. | 3-months post randomization |
| Non-prescribed opiate use | Timeline Follow-back will collect days of non-prescribed opiate use since last time point. Weekly Timeline Follow-back non-prescribed opiate use will be collected during treatment period. Mean days of non-prescribed opiate use in a week will be calculated in each group; higher number corresponds to greater non-prescribed opiate use. | 3-months post randomization |
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States |
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| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
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| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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