Comparison · NCT04571619-deaths
Pain Coping Skills Training vs Usual Care: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pain Coping Skills Training vs Usual Care: deaths from any cause. Trial comparisons, record NCT04571619-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04571619-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.11 | 0.08 | 0.149 | wilson | |
| Risk in group 2 | 0.105 | 0.0761 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00478 | -0.0436 | 0.0533 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.669 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.638 | 1.73 | log | |
| Number needed to harm, for one more death from any cause on Pain Coping Skills Training than on Usual Care | 209 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pain Coping Skills Training | PCST: Participants in the PCST arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. The PCST intervention aims to reduce pain interference and improve self-management skills. During Weeks 1-12 the PCST will be delivered by coaches via weekly video- or tele-conferencing sessions. During Weeks 13-24, Interactive Voice Response (IVR) will be delivered via daily telephone interactions, each lasting approximately 5 minutes. The IVR content is intended to enhance and sustain the effects of the coach-led session. Both components of the intervention will be available in English and Spanish.~Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch will be provided with individualized buprenorphine treatment recommendations made by a study physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. | 35 | 319 | EG000 |
| Group 2 | Usual Care | Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.~Buprenorphine: At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes. | 34 | 324 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Adverse event data was collected over the course of 36 Weeks, beginning after consent.
Source ClinicalTrials.gov
Trial
- Title
- HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
- NCT number
- NCT04571619
- Phases
- PHASE2
- Conditions
- End Stage Renal Disease, Chronic Pain, Opioid Dependence
- Interventions
- Pain Coping Skills Training (PCST), Buprenorphine
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2025-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04571619?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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