HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Phase 2

Completed

Conditions: Opioid Dependence
End Stage Renal Disease
Chronic Pain

Interventions: Behavioral: Pain Coping Skills Training (PCST)
Drug: Buprenorphine

Registration Number: NCT04571619

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 643

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pain Coping Skills Training	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.
Pain Coping Skills Training	Buprenorphine	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.
Usual Care	Buprenorphine	Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.

Primary Outcome Measures

Name	Time	Method
Pain Interference	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 Outcome Measures

Name	Time	Method
Buprenorphine Acceptability	Through Week 36	The proportion of participants who initiate buprenorphine from among those offered buprenorphine.
Pain Intensity	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.
Pain Catastrophizing	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.
Opioid Use	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
Number of Falls	Throughout the 36-week follow-up	Number of fall events per arm.
Rate of Falls	Though Week 36 follow-up	Event rate as calculated by number of falls/patient years
Number of Hospitalizations	Through 36-week follow-up	Number of hospitalizations per arm.
Rate of Hospitalizations	Through Week 36 follow-up	Event rate as calculated by number of hospitalizations/patient years
Number of Deaths	Through the 36-week follow-up	The number of deaths per arms.
Buprenorphine Tolerability	Through Week 36	The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance.
Overall Sense of Quality of Life	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.
Physical Functioning	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.
Depression	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.
Anxiety	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.
Coping	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.
Sleep Quality	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.
Fatigue	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.
Satisfaction With Treatment	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.
Social Support	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.
Family Intrusion	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.
Self-Efficacy	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.
Presence of Other Symptoms	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.
Severity of Other Symptoms	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.
Discrimination	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.
Rate of Deaths	Through Week 36 follow-up	Rate of deaths as calculated by number of events/patient years

Trial Locations

Locations (16): West Haven VA Healthcare System
🇺🇸
West Haven, Connecticut, United States
University of Illinois at Chicago
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Chicago, Illinois, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Hennepin County Medical Center
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Minneapolis, Minnesota, United States
University of New Mexico
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Albuquerque, New Mexico, United States
New York University
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New York, New York, United States
VA NY Harbor Healthcare System
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New York, New York, United States
Rogosin Institute
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New York, New York, United States
Durham VA Healthcare System
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Durham, North Carolina, United States
VA Portland Healthcare System
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Portland, Oregon, United States
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West Haven VA Healthcare System
🇺🇸West Haven, Connecticut, United States