HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Chronic Pain Clinical Trial

— HOPE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04571619
• Other study ID #: HOPE
• Secondary ID: U01DK123813U01DK
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 3, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 643
• Est. completion date: May 31, 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• End Stage Renal Disease
• Kidney Failure, Chronic
• Opioid Dependence
• Opioid-Related Disorders

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Dallas VA Medical Center	Dallas	Texas
United States	Durham VA Healthcare System	Durham	North Carolina
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York University	New York	New York
United States	Rogosin Institute	New York	New York
United States	VA NY Harbor Healthcare System	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	VA Portland Healthcare System	Portland	Oregon
United States	University of Washington	Seattle	Washington
United States	West Haven VA Healthcare System	West Haven	Connecticut

Sponsors (18)

Lead Sponsor

Collaborator

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

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Opioid use		Weeks 12, 24, and 36
Secondary	Rate of falls	Event rate; # per patient year	Throughout the 36-week follow-up
Secondary	Rate of hospitalizations	Event rate; # per patient year	Throughout the 36-week follow-up
Secondary	Death		Throughout the 36-week follow-up
Secondary	Buprenorphine acceptability	The proportion of participants who initiate buprenorphine from among those randomized to the Buprenorphine group.	Week 36
Secondary	Buprenorphine tolerability	The proportion of patients who do not discontinue buprenorphine due to adverse effects or intolerance.	Week 36
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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