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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; End Stage Renal Disease; Opioid Dependence
• Intervention / Treatment: Behavioral: Pain Coping Skills Training (PCST); Drug: Buprenorphine

• Study Type: Interventional
• Enrollment (Actual): 643
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Natalie Kuzla, MA; Phone Number: 2155732935; Email: nkuzla@pennmedicine.upenn.edu
• Study Contact Backup: Name: Leah Bernardo; Phone Number: 2157464755; Email: lleah@pennmedicine.upenn.edu

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • West Haven VA Healthcare System
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • New York, New York, United States, 10010
      • New York University
    • New York, New York, United States, 10010
      • VA NY Harbor Healthcare System
    • New York, New York, United States, 10021
      • Rogosin Institute
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Healthcare System
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Healthcare System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Undergoing in-center maintenance hemodialysis for ≥90 days
3. English- or Spanish-speaking
4. 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
5. Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4
6. Willing to provide informed consent
7. Willing to allow research team to obtain opioid pharmacy refill data
8. Willing to allow research team to contact and work with their opioid prescriber

Exclusion Criteria:

1. Current opioid use disorder
2. Current use of heroin
3. Current non-opioid substance use disorder with the exception of tobacco use disorder
4. Current use of methadone, buprenorphine, or naltrexone for opioid use disorder
5. Current receipt of hospice care
6. Cognitive impairment that, in the judgement of the research team, precludes trial participation
7. Active suicidal intent
8. Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder
9. Life expectancy < 6 months
10. Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months
11. Current incarceration
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Active Comparator: Buprenorphine	Drug: 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.
Active Comparator: Pain Coping Skills Training	Behavioral: Pain Coping Skills Training (PCST); 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.
No Intervention: No Buprenorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse.	Weeks 12, 24, and 36
Pain catastrophizing	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.	Weeks 12, 24, and 36
Opioid use		Weeks 12, 24, and 36
Rate of falls	Event rate; # per patient year	Throughout the 36-week follow-up
Rate of hospitalizations	Event rate; # per patient year	Throughout the 36-week follow-up
Death		Throughout the 36-week follow-up
Buprenorphine acceptability	The proportion of participants who initiate buprenorphine from among those randomized to the Buprenorphine group.	Week 36
Buprenorphine tolerability	The proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.	Week 36
Overall Sense of Quality of Life	Quality of life will be measured using the Single-Item QOL Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome.	Weeks 12, 24, and 36
Physical Functioning	Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Lowest score - 6; Highest score - 30; Higher score equals better outcome.	Weeks 12, 24, and 36
Depression	Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome.	Weeks 12, 24, and 36
Anxiety	Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome.	Weeks 12, 24, and 36
Coping	Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome.	Weeks 12, 24, and 36
Sleep Quality	Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a and the Sleep Duration Question. PROMIS Sleep Disturbance SF 6a: Lowest score - 6; Highest score - 30; Lower score equals better outcome. Sleep Duration Question: Reported in hours and minutes of sleep; Higher number equals better outcome.	Weeks 12, 24, and 36
Fatigue	Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Lowest score - 6; Highest score - 30; Lower score equals better outcome.	Weeks 12, 24, and 36
Satisfaction with Treatment	Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome.	Weeks 12, 24, and 36
Social Support	Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 7; Highest score - 7; Higher score equals better outcome.	Weeks 12, 24, and 36
Family Intrusion	Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Lowest score - 8; Highest score - 40; Higher score equals better outcome.	Weeks 12, 24, and 36
Self-Efficacy	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. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome.	Weeks 12, 24, and 36
Other Symptoms	Other symptoms will be measured using the Dialysis Symptom Index (DSI). Lowest score - 0; Highest score - 150; Lower score equals better outcome.	Weeks 12, 24, and 36
Discrimination	Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome.	Week 36

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: Massachusetts General Hospital; University of Pennsylvania; Yale University; New York University; University of Pittsburgh; University of Illinois at Chicago; University of Washington; Vanderbilt University Medical Center; University of New Mexico; VA New York Harbor Healthcare System; West Virginia University; Dallas VA Medical Center; Durham VA Health Care System; Hennepin Health Care; Rogosin Institute; VA Portland Healthcare System; West Haven VA Medical Center
• Investigators: Principal Investigator: Laura Dember, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): December 21, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain; hemodialysis; opioids; pain coping skills
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Narcotic-Related Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Pain; Kidney Failure, Chronic; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: HOPE; U01DK123813 (U.S. NIH Grant/Contract); U01DK123786 (U.S. NIH Grant/Contract); U01DK123787 (U.S. NIH Grant/Contract); U01DK123812 (U.S. NIH Grant/Contract); U01DK123814 (U.S. NIH Grant/Contract); U01DK123816 (U.S. NIH Grant/Contract); U01DK123817 (U.S. NIH Grant/Contract); U01DK123818 (U.S. NIH Grant/Contract); U01DK123821 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No