HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
HOPE
A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis
10 other identifiers
interventional
643
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedStudy Start
First participant enrolled
January 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedResults Posted
Study results publicly available
January 13, 2025
CompletedJanuary 13, 2025
June 1, 2024
3 years
September 15, 2020
November 22, 2024
January 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Interference
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.
The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
Secondary Outcomes (25)
Pain Intensity
Weeks 12, 24, and 36
Pain Catastrophizing
Weeks 12, 24, and 36
Opioid Use
Weeks 12, 24, and 36
Number of Falls
Throughout the 36-week follow-up
Rate of Falls
Though Week 36 follow-up
- +20 more secondary outcomes
Study Arms (2)
Pain Coping Skills Training
ACTIVE COMPARATORThe 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.
Usual Care
OTHERParticipants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)lead
- Hennepin Health Carecollaborator
- New York Universitycollaborator
- Massachusetts General Hospitalcollaborator
- University of Illinois at Chicagocollaborator
- University of Pittsburghcollaborator
- University of Washingtoncollaborator
- University of New Mexicocollaborator
- Rogosin Institutecollaborator
- Vanderbilt University Medical Centercollaborator
- West Virginia Universitycollaborator
- Yale Universitycollaborator
- Durham VA Health Care Systemcollaborator
- VA Portland Healthcare Systemcollaborator
- West Haven VA Medical Centercollaborator
- University of Pennsylvaniacollaborator
- Dallas VA Medical Centercollaborator
- VA New York Harbor Healthcare Systemcollaborator
Study Sites (16)
West Haven VA Healthcare System
West Haven, Connecticut, 06516, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
New York University
New York, New York, 10010, United States
VA NY Harbor Healthcare System
New York, New York, 10010, United States
Rogosin Institute
New York, New York, 10021, United States
Durham VA Healthcare System
Durham, North Carolina, 27705, United States
VA Portland Healthcare System
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
University of Washington
Seattle, Washington, 98104, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (3)
Dember LM, Hsu JY, Mehrotra R, Cavanaugh KL, Kalim S, Charytan DM, Fischer MJ, Jhamb M, Johansen KL, Becker WC, Pellegrino B, Eneanya ND, Schrauben SJ, Pun PH, Unruh ML, Morasco BJ, Mehta M, Miyawaki N, Penfield J, Bernardo L, Brintz CE, Cheatle MD, Doorenbos AZ, Heapy AA, Keefe FJ, Krebs EE, Kuzla N, Nigwekar SU, Schmidt RJ, Steel JL, Wetmore JB, White DM, Kimmel PL, Cukor D; HOPE Consortium. Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140.
PMID: 39786400DERIVEDSteel JL, Brintz CE, Heapy AA, Keefe F, Cheatle MD, Jhamb M, McNeil DW, Shallcross AJ, Kimmel PL, Dember LM, White DM, Williams J, Cukor D. Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease. J Behav Med. 2025 Apr;48(2):298-307. doi: 10.1007/s10865-024-00534-x. Epub 2024 Dec 3.
PMID: 39627496DERIVEDDember LM, Hsu JY, Bernardo L, Cavanaugh KL, Charytan DM, Crowley ST, Cukor D, Doorenbos AZ, Edwards DA, Esserman D, Fischer MJ, Jhamb M, Joffe S, Johansen KL, Kalim S, Keefe FJ, Kimmel PL, Krebs EE, Kuzla N, Mehrotra R, Mishra P, Pellegrino B, Steel JL, Unruh ML, White DM, Yabes JG, Becker WC; HOPE Consortium. The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis. Contemp Clin Trials. 2024 Jan;136:107409. doi: 10.1016/j.cct.2023.107409. Epub 2023 Dec 10.
PMID: 38086444DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Natalie Kuzla
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Dember, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2020
First Posted
October 1, 2020
Study Start
January 3, 2021
Primary Completion
December 21, 2023
Study Completion
May 31, 2024
Last Updated
January 13, 2025
Results First Posted
January 13, 2025
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
De-identified participant-level data will be transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK) Central Repository after the trial has been completed.