HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)643 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

643

Conditions

End Stage Renal Disease Chronic Pain Opioid Dependence

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.

BuprenorphineDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

West Haven VA Healthcare System

West Haven, Connecticut, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of New Mexico

Albuquerque, New Mexico, United States

New York University

New York, New York, United States

VA NY Harbor Healthcare System

New York, New York, United States

Rogosin Institute

New York, New York, United States

Durham VA Healthcare System

Durham, North Carolina, United States

VA Portland Healthcare System

Portland, Oregon, United States

...and 6 more locations

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: Weeks 12, 24, and 36

Opioid Use

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

Time frame: Weeks 12, 24, and 36

Number of Falls

Number of fall events per arm.

Time frame: Throughout the 36-week follow-up

Rate of Falls

Event rate as calculated by number of falls/patient years

Time frame: Though Week 36 follow-up

Number of Hospitalizations

Number of hospitalizations per arm.

Time frame: Through 36-week follow-up

Rate of Hospitalizations

Event rate as calculated by number of hospitalizations/patient years

Time frame: Through Week 36 follow-up

Number of Deaths

The number of deaths per arms.

Time frame: Through the 36-week follow-up

Rate of Deaths

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

Time frame: Through Week 36 follow-up

Buprenorphine Acceptability

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

Time frame: Through Week 36

Buprenorphine Tolerability

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

Time frame: Through Week 36

Overall Sense of Quality of Life

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.

Time frame: 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. 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 12, 24, and 36

Sleep Quality

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.

Time frame: Weeks 12, 24, and 36

Fatigue

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.

Time frame: 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.

Time frame: Weeks 12, 24, and 36

Social Support

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.

Time frame: Weeks 12, 24, and 36

Family Intrusion

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.

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

Time frame: Weeks 12, 24, and 36

Presence of Other Symptoms

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.

Time frame: Weeks 12, 24, and 36

Severity of Other Symptoms

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.

Time frame: Week 12, 24, 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.

Time frame: Baseline, Week 36