Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE)

University of Illinois

Status and phase: Active, not recruiting; Phase 2

Conditions: Sickle Cell Disease

Treatments: Other: Acupuncture; Behavioral: Guided Relaxation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04906447

1UG3AT011265-01 (U.S. NIH Grant/Contract)

2021-0124

Details and patient eligibility

About

The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while observing and gathering information on implementation in three health systems: University of Illinois Hospital & Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. During the UH3 Implementation Phase, the 3-arm, 3-site randomized controlled trial will follow a quantitative modified SMART design, a pragmatic trial that evaluates adaptive interventions where the guided relaxation and acupuncture interventions respond to patients' characteristics and evolving pain status. The investigators rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative health (CIH) therapies by those with SCD to reduce pain and opioid use, to help enable them to better cope with their pain, is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will.

Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis: At 6-weeks, SCD patients randomized to either CIH intervention will have a greater decrease in pain, opioid use, sleep, anxiety, depressive symptoms, and pain catastrophizing compared to SCD patients randomized to usual care.

Aim 2: Identify the best adaptive intervention for improved outcomes by documenting outcomes among adaptive intervention sequences: (1) initiate guided relaxation and switch to acupuncture for non-responders at midpoint; (2) initiate guided relaxation and continue with guided relaxation for non-responders at midpoint; (3) initiate acupuncture and switch to guided relaxation for non-responders at midpoint or (4) initiate acupuncture and continue with acupuncture for non-responders at midpoint.

Aim 3: Explore differences in response to the adaptive interventions by age and sex.

Aim 4: Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of CIH therapies into the 3 health systems by conducting individual interviews with participants in the intervention group who responded to the intervention and those who did not. The investigators will also conduct focus groups with hospital personnel at 4 timepoints.

Enrollment: 379 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of sickle cell disease based on hemoglobin electrophoresis
• Provision of signed and dated informed consent form
• Able to speak and understand English
• Chronic pain, defined as a response of "Some days," "Most days" or "Every day" to the question, "In the past 3 months, how often have you had pain?" (Answer options: Never, Some days, Most days, Every day)
• Current pain interference using the general activity question from PEG, score ≥3 on 0-10 scale

Exclusion criteria

• Has had a stem cell transplant for sickle cell disease
• Current incarceration
• Any other condition that the investigator considers precludes participation in the clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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379 participants in 3 patient groups

Control arm

No Intervention group

Description:

Participants randomized to the control arm will receive usual care

Acupuncture

Experimental group

Description:

Acupuncture treatments twice a week for five weeks

Treatment:

Other: Acupuncture

Guided Relaxation

Experimental group

Description:

Daily use of a guided relaxation app for 6 weeks

Treatment:

Behavioral: Guided Relaxation