HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT04571619

Collaborator

Hennepin Health Care (Other), New York University (Other), Massachusetts General Hospital (Other), University of Illinois at Chicago (Other), University of Pittsburgh (Other), University of Washington (Other), University of New Mexico (Other), Rogosin Institute (Other), Vanderbilt University Medical Center (Other), West Virginia University (Other), Yale University (Other), Durham VA Health Care System (U.S. Fed), VA Portland Healthcare System (Other), West Haven VA Medical Center (Other), University of Pennsylvania (Other), Dallas VA Medical Center (U.S. Fed), VA New York Harbor Healthcare System 630 (Other)

640

Enrollment

Locations

Arms

39.9

Anticipated Duration (Months)

45.7

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Chronic Pain Opioid Dependence	Behavioral: Pain Coping Skills Training (PCST) Drug: Buprenorphine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

640 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Sequential, multiple-assignment randomizationSequential, multiple-assignment randomization

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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: Usual Care
Active Comparator: Buprenorphine	Drug: Buprenorphine At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be randomly assigned, with equal likelihood, to Buprenorphine or No Buprenorphine. Participants randomized to Buprenorphine will be provided with individualized buprenorphine treatment recommendations and encouraged to switch from their full agonist opioid medication to buprenorphine. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants randomized to No Buprenorphine will continue to be followed without a pharmacologic study intervention.
No Intervention: No Buprenorphine

Outcome Measures

Primary Outcome Measures

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

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]
Rate of falls [Throughout the 36-week follow-up]
Event rate; # per patient year
Rate of hospitalizations [Throughout the 36-week follow-up]
Event rate; # per patient year
Death [Throughout the 36-week follow-up]
Buprenorphine acceptability [Week 36]
The proportion of participants who initiate buprenorphine from among those randomized to the Buprenorphine group.
Buprenorphine tolerability [Week 36]
The proportion of patients who do 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 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. Lowest score - 6; Highest score - 30; Higher score equals 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 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.
Fatigue [Weeks 12, 24, and 36]
Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Lowest score - 6; Highest score - 30; Lower score equals 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 - 7; Highest score - 7; Higher score equals better outcome.
Family Intrusion [Weeks 12, 24, and 36]
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.
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. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome.
Other Symptoms [Weeks 12, 24, and 36]
Other symptoms will be measured using the Dialysis Symptom Index (DSI). Lowest score - 0; Highest score - 150; Lower score equals better outcome.
Discrimination [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Haven VA Healthcare System	West Haven	Connecticut	United States	06516
2	University of Illinois at Chicago	Chicago	Illinois	United States	60612
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
5	University of New Mexico	Albuquerque	New Mexico	United States	87131
6	New York University	New York	New York	United States	10010
7	Rogosin Institute	New York	New York	United States	10021
8	Durham VA Healthcare System	Durham	North Carolina	United States	27705
9	VA Portland Healthcare System	Portland	Oregon	United States	97239
10	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
11	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
12	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
13	University of Washington	Seattle	Washington	United States	98104
14	West Virginia University	Morgantown	West Virginia	United States	26506