Trial · NCT03026790
Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
NCT03026790, Phase 2, Completed, University of Minnesota; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study. Trials, record NCT03026790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03026790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
- NCT number
- NCT03026790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 820 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Chronic Pain
- Interventions
- Medication management, Non-pharmacological pain management, Buprenorphine-Naloxone
- First posted
- 2017-01-20
- Last updated
- 2023-06-05
- Results first posted
- 2023-06-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Response | 12 months | Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline |
| Secondary | 50% Reduction in Opioid Daily Dose | 12 months | Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline |
| Secondary | Composite Response | 12 months | Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline. |
| Secondary | Brief Pain Inventory (BPI) Total Score | 12 months | Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse) |
| Other | VR-12 Physical Component Score | 12 months | Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better) |
| Other | Symptom Checklist | 12 months | Medication-related adverse symptoms count (0-19; higher is worse) |
| Other | PODS Problems | 12 months | Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse) |
| Other | PHQ-8 | 12 months | Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse) |
| Other | GAD-7 | 12 months | General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse) |
| Other | PROMIS Sleep Disturbance | 12 months | Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Response | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 50% Reduction in Opioid Daily Dose | 12 months | All participants who were alive at 12 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite Response | 12 months | All participants who completed the measure at 12 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Brief Pain Inventory (BPI) Total Score | 12 months | All participants who completed the measure at 12 months | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | VR-12 Physical Component Score | 12 months | All participants who completed the measure at 12 months | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Symptom Checklist | 12 months | All participants who completed the measure at 12 months | symptom count | MEAN |
| OTHER_PRE_SPECIFIED | PODS Problems | 12 months | All participants who completed the measure at 12 months | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | PHQ-8 | 12 months | All participants who completed the measure at 12 months | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | GAD-7 | 12 months | All participants who completed the measure at 12 months | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | PROMIS Sleep Disturbance | 12 months | All participants who completed the measure at 12 months | T-score | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Response | Active Comparator: Telecare Collaborative Management (TCM) | 58 | Participants | ||
| Pain Response | Active Comparator: Integrated Pain Team (IPT) | 54 | Participants | ||
| 50% Reduction in Opioid Daily Dose | Active Comparator: Telecare Collaborative Management (TCM) | 102 | Participants | ||
| 50% Reduction in Opioid Daily Dose | Active Comparator: Integrated Pain Team (IPT) | 98 | Participants | ||
| Composite Response | Active Comparator: Telecare Collaborative Management (TCM) | 17 | Participants | ||
| Composite Response | Active Comparator: Integrated Pain Team (IPT) | 17 | Participants | ||
| Brief Pain Inventory (BPI) Total Score | Active Comparator: Telecare Collaborative Management (TCM) | 6.07 | Standard Deviation 1.81 | units on a scale | |
| Brief Pain Inventory (BPI) Total Score | Active Comparator: Integrated Pain Team (IPT) | 6.01 | Standard Deviation 1.91 | units on a scale | |
| VR-12 Physical Component Score | Active Comparator: Telecare Collaborative Management (TCM) | 41.9 | Standard Deviation 12.9 | units on a scale | |
| VR-12 Physical Component Score | Active Comparator: Integrated Pain Team (IPT) | 42.5 | Standard Deviation 13.2 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Comparator: Telecare Collaborative Management (TCM) | 411 | |
| Overall Study | STARTED | Active Comparator: Integrated Pain Team (IPT) | 409 | |
| Overall Study | COMPLETED | Active Comparator: Telecare Collaborative Management (TCM) | 358 | |
| Overall Study | COMPLETED | Active Comparator: Integrated Pain Team (IPT) | 363 | |
| Overall Study | NOT COMPLETED | Active Comparator: Telecare Collaborative Management (TCM) | 53 | |
| Overall Study | NOT COMPLETED | Active Comparator: Integrated Pain Team (IPT) | 46 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Emergency department visit | General disorders | Active Comparator: Telecare Collaborative Management (TCM) | 207 | 358 | |
| other | Emergency department visit | General disorders | Active Comparator: Integrated Pain Team (IPT) | 178 | 363 | |
| serious | Hospitalization | General disorders | Active Comparator: Telecare Collaborative Management (TCM) | 109 | 358 | |
| serious | Hospitalization | General disorders | Active Comparator: Integrated Pain Team (IPT) | 109 | 363 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Comparator: Telecare Collaborative Management (TCM) | 7 | 358 |
| Total, all-cause mortality | Active Comparator: Integrated Pain Team (IPT) | 9 | 363 |
| Total, other adverse events | Active Comparator: Telecare Collaborative Management (TCM) | 207 | 358 |
| Total, other adverse events | Active Comparator: Integrated Pain Team (IPT) | 178 | 363 |
| Total, serious adverse events | Active Comparator: Telecare Collaborative Management (TCM) | 109 | 358 |
| Total, serious adverse events | Active Comparator: Integrated Pain Team (IPT) | 109 | 363 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Comparator: Telecare Collaborative Management (TCM) vs Active Comparator: Integrated Pain Team (IPT): Pain Response | Trial comparisons |
| Active Comparator: Telecare Collaborative Management (TCM) vs Active Comparator: Integrated Pain Team (IPT): Composite Response | Trial comparisons |
| Active Comparator: Telecare Collaborative Management (TCM) vs Active Comparator: Integrated Pain Team (IPT): deaths from any cause | Trial comparisons |
| Active Comparator: Telecare Collaborative Management (TCM) vs Active Comparator: Integrated Pain Team (IPT): 50% Reduction in Opioid Daily Dose | Trial comparisons |
| Active Comparator: Telecare Collaborative Management (TCM) vs Active Comparator: Integrated Pain Team (IPT): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03026790
GET https://conductscience.org/api/trials/v1/NCT03026790/results?page=2