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Completed

NCT Number: NCT04571619

HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

HOPE is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. The hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.

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Key information

Conditions

End Stage Renal Disease Chemically-Induced Disorders Chronic Disease Chronic Pain Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Dependence Opioid-Related Disorders Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Substance-Related Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West Haven VA Healthcare System, West Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Undergoing in-center maintenance hemodialysis for ≥90 days
  • English- or Spanish-speaking
  • Chronic pain defined as a response of "Most days" or "Every day" to the following question: "In the past 3 months, how often have you had pain?" Answer options: Never, Some days, Most days, Every day
  • Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4
  • Willing to provide informed consent
  • Willing to allow research team to obtain opioid pharmacy refill data
  • Willing to allow research team to contact and work with their opioid prescriber

Exclusion criteria

  • Current opioid use disorder
  • Current use of heroin
  • Current non-opioid substance use disorder with the exception of tobacco use disorder
  • Current use of methadone, buprenorphine, or naltrexone for opioid use disorder
  • Current receipt of hospice care
  • Cognitive impairment that, in the judgement of the research team, precludes trial participation
  • Active suicidal intent
  • Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder
  • Life expectancy < 6 months
  • Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months
  • Current incarceration
  • Any other condition that the investigator considers precludes participation in the clinical trial

Subgroup with Current or Recent Opioid Use During eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. The trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. The number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. If the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.

Treatment and study plan

Pain Coping Skills Training (PCST)

Behavioral

The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.

buprenorphine

Drug

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.

Primary outcomes

  1. Pain Interference

    Time frame: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.

    Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse.

Secondary outcomes

  1. Pain Intensity

    Time frame: Weeks 12, 24, and 36

    Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse.

  2. Pain Catastrophizing

    Time frame: Weeks 12, 24, and 36

    Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse.

  3. Opioid Use

    Time frame: Weeks 12, 24, and 36

    Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A

  4. Number of Falls

    Time frame: Throughout the 36-week follow-up

    Number of fall events per arm.

  5. Rate of Falls

    Time frame: Though Week 36 follow-up

    Event rate as calculated by number of falls/patient years

  6. Number of Hospitalizations

    Time frame: Through 36-week follow-up

    Number of hospitalizations per arm.

  7. Rate of Hospitalizations

    Time frame: Through Week 36 follow-up

    Event rate as calculated by number of hospitalizations/patient years

  8. Number of Deaths

    Time frame: Through the 36-week follow-up

    The number of deaths per arms.

  9. Rate of Deaths

    Time frame: Through Week 36 follow-up

    Rate of deaths as calculated by number of events/patient years

  10. Buprenorphine Acceptability

    Time frame: Through Week 36

    The proportion of participants who initiate buprenorphine from among those offered buprenorphine.

  11. Buprenorphine Tolerability

    Time frame: Through Week 36

    The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance.

  12. Overall Sense of Quality of Life

    Time frame: Weeks 12, 24, and 36

    Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome.

  13. Physical Functioning

    Time frame: Weeks 12, 24, and 36

    Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.

  14. Depression

    Time frame: Weeks 12, 24, and 36

    Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome.

  15. Anxiety

    Time frame: Weeks 12, 24, and 36

    Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome.

  16. Coping

    Time frame: Weeks 12, 24, and 36

    Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome.

  17. Sleep Quality

    Time frame: Weeks 12, 24, and 36

    Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a.

    Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.

  18. Fatigue

    Time frame: Weeks 12, 24, and 36

    Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.

  19. Satisfaction With Treatment

    Time frame: Weeks 12, 24, and 36

    Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome.

  20. Social Support

    Time frame: Weeks 12, 24, and 36

    Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported.

  21. Family Intrusion

    Time frame: Weeks 12, 24, and 36

    Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.

  22. Self-Efficacy

    Time frame: Weeks 12, 24, and 36

    Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain.

    PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome.

    Normalized score reported.

    Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome.

  23. Presence of Other Symptoms

    Time frame: Weeks 12, 24, and 36

    Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome.

  24. Severity of Other Symptoms

    Time frame: Week 12, 24, 36

    Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome.

  25. Discrimination

    Time frame: Baseline, Week 36

    Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome.

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • Dallas VA Medical Center
  • Durham VA Health Care System
  • Hennepin Health Care
  • Massachusetts General Hospital
  • New York University
  • Rogosin Institute
  • University of Illinois at Chicago
  • University of New Mexico
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Washington
  • VA New York Harbor Healthcare System
  • VA Portland Healthcare System
  • Vanderbilt University Medical Center
  • West Haven VA Medical Center
  • West Virginia University
  • Yale University

Registry information

Official study title

A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis

Acronym: HOPE

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 1, 2020
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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