HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

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

Sponsor

Lead Sponsor: University of Pennsylvania

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

Fonte University of Pennsylvania
Breve riassunto

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.

Stato generale Not yet recruiting
Data d'inizio November 2020
Data di completamento May 2024
Data di completamento principale December 2023
Fase Phase 2
Tipo di studio Interventional
Il risultato principale
Misurare Lasso di tempo
Pain interference The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
Esito secondario
Misurare Lasso di tempo
Pain intensity Weeks 12, 24, and 36
Pain catastrophizing Weeks 12, 24, and 36
Opioid use Weeks 12, 24, and 36
Rate of falls Throughout the 36-week follow-up
Rate of hospitalizations Throughout the 36-week follow-up
Death Throughout the 36-week follow-up
Buprenorphine acceptability Week 36
Buprenorphine tolerability Week 36
Overall Sense of Quality of Life Weeks 12, 24, and 36
Physical Functioning Weeks 12, 24, and 36
Depression Weeks 12, 24, and 36
Anxiety Weeks 12, 24, and 36
Coping Weeks 12, 24, and 36
Sleep Quality Weeks 12, 24, and 36
Fatigue Weeks 12, 24, and 36
Satisfaction with Treatment Weeks 12, 24, and 36
Social Support Weeks 12, 24, and 36
Family Intrusion Weeks 12, 24, and 36
Self-Efficacy Weeks 12, 24, and 36
Other Symptoms Weeks 12, 24, and 36
Discrimination Week 36
Iscrizione 640
Condizione
Intervento

Tipo di intervento: Behavioral

Nome intervento: Pain Coping Skills Training (PCST)

Descrizione: 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 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.

Etichetta del gruppo del braccio: Pain Coping Skills Training

Tipo di intervento: Drug

Nome intervento: Buprenorphine

Descrizione: 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.

Etichetta del gruppo del braccio: Buprenorphine

Eleggibilità

Criteri:

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 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.

Genere: All

Età minima: 18 Years

Età massima: N/A

Volontari sani: No

Ufficiale generale
Cognome Ruolo Affiliazione
Laura Dember, MD Principal Investigator University of Pennsylvania
Contatto generale

Cognome: Natalie Kuzla, MA

Telefono: 2155732935

E-mail: [email protected]

Posizione
Servizio, struttura: Contatto: Investigatore:
West Haven VA Healthcare System | West Haven, Connecticut, 06516, United States Svetlana Vassilieva [email protected] William Becker, MD Principal Investigator
University of Illinois at Chicago | Chicago, Illinois, 60612, United States Cheryl Gilmartin [email protected] Michael Fischer, MD, MSPH Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Shananssa Percy [email protected] Sahir Kalim, MD,MMSc Principal Investigator
Hennepin County Medical Center | Minneapolis, Minnesota, 55415, United States Ursula Munet [email protected] Kirsten Johansen, MD, FASN Principal Investigator
University of New Mexico | Albuquerque, New Mexico, 87131, United States Tammy Seaman [email protected] Mark Unruh, MD Principal Investigator
New York University | New York, New York, 10010, United States Sobaata Chaudry [email protected] David Charytan, MD Principal Investigator
Rogosin Institute | New York, New York, 10021, United States Ines Chicos [email protected] Daniel Cukor, PhD Principal Investigator
Durham VA Healthcare System | Durham, North Carolina, 27705, United States Jeanette Rutledge [email protected] Wissam Kourany, MD Principal Investigator
VA Portland Healthcare System | Portland, Oregon, 97239, United States Melissa Adams Benjamin Morasco, PhD Principal Investigator
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Taylor Stallings [email protected] Nwamaka Eneanya, MD, MPH Principal Investigator
University of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States Melissa Weimer [email protected] Manisha Jhamb, MD Principal Investigator
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Sonya Williams [email protected] Kerri Cavanaugh, MD Principal Investigator
University of Washington | Seattle, Washington, 98104, United States Lori Linke [email protected] Rajnish Mehrotra, MD, MS Principal Investigator
West Virginia University | Morgantown, West Virginia, 26506, United States Cheryl Dalton [email protected] Bethany Pellegrino, MD Principal Investigator
Paesi di posizione

United States

Data di verifica

September 2020

Parte responsabile

Genere: Sponsor

parole
Ha accesso esteso No
Condizione Sfoglia
Numero di armi 4
Braccio di gruppo

Etichetta: Pain Coping Skills Training

Genere: Active Comparator

Etichetta: Usual Care

Genere: No Intervention

Etichetta: Buprenorphine

Genere: Active Comparator

Etichetta: No Buprenorphine

Genere: No Intervention

Acronimo HOPE
Dati del paziente Yes
Informazioni sul design dello studio

Assegnazione: Randomized

Modello di intervento: Parallel Assignment

Descrizione del modello di intervento: Sequential, multiple-assignment randomization

Scopo principale: Treatment

Mascheramento: None (Open Label)

Fonte: ClinicalTrials.gov