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Contemp Clin Trials. Author manuscript; available in PMC 2022 Oct 1.
Published in final edited form as:
Contemp Clin Trials. 2021 Oct; 109: 106545.
Published online 2021 Aug 27. doi:10.1016/j.cct.2021.106545
PMCID: PMC8691659
NIHMSID: NIHMS1738188
PMID: 34455111
Carol M. Greco, PhD,a Susan A. Gaylord, PhD,b Kim Faurot, PhD,b Janice M. Weinberg, ScD,c Paula Gardiner, MD, MPH,d Isabel Roth, DrPH,b Jessica L. Barnhill, MD, MPH,b Holly N. Thomas, MD, MS,e Sayali C. Dhamne, MPH,f Christine Lathren, MD, MSPH,b Jose E. Baez, MD,g Suzanne Lawrence, MA,h Tuhina Neogi, MD, PhD,i Karen E. Lasser, MD, MPH,j Maria Gabriela Castro, MD,k Anna Marie White, MD,e Sandra Jean Simmons, MD,l Cleopatra Ferrao, NP,g Dhanesh D. Binda, BS,m Nandie Elhadidy, BS,b Kelly M. Eason, BS,b Kathleen M. McTigue, MD, MPH, MS,e and Natalia E. Morone, MD, MSj,*
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The publisher's final edited version of this article is available at Contemp Clin Trials
Abstract
Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV+MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients.
Keywords: Mindfulness meditation, online intervention, medical group visits, chronic low back pain, quadruple aim
1. Introduction
Chronic pain is one of the most common conditions treated in the primary care setting, with chronic low back pain (cLBP) costing over 30 billion dollars a year; yet treatment remains unsatisfactory for many patients.1 Prescribing opioids to treat cLBP has many unintended consequences such as addiction, overdose, and diversion.2 Compounding the problem, Primary Care Providers (PCP) have very little time during a 15–20 minute office visit to address the complex psychosocial and functional needs of the person with cLBP.3 The opioid crisis has underscored the urgency of alleviating patients’ cLBP with effective therapies, including evidence-based nonpharmacologic approaches that also address biopsychosocial needs.
Mindfulness is effective for the treatment of cLBP yet remains underutilized as it has not been regularly woven into the outpatient clinical setting, and is not reimbursed by health insurance companies.4,5 Mindfulness-based Stress Reduction (MBSR) is now part of the evidence-based guidelines of the American College of Physicians for initial treatment of cLBP and a Best Practice recommendation of the U.S. Department of Health and Human Services.6,7 The next necessary step is to conduct a pragmatic clinical trial (PCT) with the goal of informing clinicians, patients, administrators and policy-makers how a mindfulness-based program can work in a real-life clinical setting, can impact outcomes and increase access to non-opioid treatments, and be reimbursable. To accomplish this step, we are conducting an embedded superiority PCT of this program in primary care clinics, entitled “OPTIMUM” (Optimizing Pain Treatment In Medical settings Using Mindfulness).
Common chronic diseases seen in a PCP’s office such as hypertension, diabetes, obesity, and cLBP all require extensive patient education. Yet the time constraint of a typical office visit only allows the PCP to provide cursory advice. PCPs need more nonpharmacologic treatment options for their cLBP patients instead of falling back on medications (acetaminophen and nonsteroidal anti-inflammatory drugs [NSAIDs]) and referring out for treatment or prescribing opiate medications. The current model of caring for chronic pain patients does not allow sufficient time and attention for PCPs to adequately address the complex needs of their patients. Medical group visits (MGV), take place in the primary care setting with patients who have a chronic disease and are an efficient and effective way to communicate and provide support, advice and education.8–10 For example, Cleveland Clinic, Kaiser, and Harvard Vanguard health systems all offer MGVs. Offering a clinically-based group mindfulness pain management program modeled upon the evidence-based MBSR course is an ideal opportunity to provide a program that teaches patients skills to learn to cope with and improve their pain and function without the use of opioids. The medical group visit model increases patient education, social support, access to a clinician, and a sustainable way to bill for the treatment.
Our primary goal for the PCT is to determine the impact of this intervention under outpatient usual primary care circ*mstances. While both PCT and Randomized Controlled Trial (RCT) both create generalizable knowledge, a PCT is conducted under usual care conditions and under the highly controlled conditions of an RCT. The comparator in a PCT is what is done in real-world conditions-thus usual care. A PCT looks at the comparative benefits and burdens of delivering the PCT vs. an RCT that frequently has a mechanistic hypothesis.11 The rationale for this project is to inform key decision-makers how this effective nonpharmacologic treatment can be integrated into routine care and the impact of this integration on key outcomes of pain, function, and healthcare resource use.
2. Study Aims and Hypotheses
Aim 1:
To integrate and test a mindfulness clinical pain management program, OPTIMUM, for patients with cLBP in the primary care setting.
Primary Hypothesis:
Patients in OPTIMUM will have significantly improved pain intensity and interference as measured by the Pain, Enjoyment, General Activity (PEG) composite score at completion of the online 8-week program and 6-months (primary end point) and 12-months later, as compared to PCP usual care.12
Hypothesis 2:
Patients in OPTIMUM will have significantly improved psychological function as measured by the PROMIS-29+2 Mental Health Summary Scale at completion of the program and 6-and 12-months later, as compared to PCP usual care.
Hypothesis 3:
Patients in OPTIMUM will be less likely to start and more likely to reduce or stop an opioid prescription for cLBP as compared to those in PCP usual care.
Aim 2:
To evaluate use of healthcare resources by patients as documented in the Electronic Health Record.
Hypothesis:
Patients in OPTIMUM will have fewer emergency department visits, fewer hospitalizations, fewer imaging procedures (CT/MRI), and fewer other procedures (injections, surgery) than PCP usual care at the 6- and 12-month follow-ups.
Aim 3:
To evaluate PCP and practice site use of, satisfaction with, and integration of OPTIMUM.
Both intervention and control groups will receive their usual primary care.
3.0. Materials and Methods
3.1. Overview
The study is a multi-site PCT of a 8-week group mindfulness clinical pain management program (OPTIMUM) modeled on MBSR and delivered in the context of an online medical group visit, in primary care settings. Our three health care system (HCS) sites are unique for their diversity (safety net hospital, federally qualified health centers, large academic health system), which enhances the success of dissemination since we will demonstrate integration into these diverse systems. We will randomize 450 patients with cLBP to either OPTIMUM + PCP usual care or to PCP usual care, see Figure 1. The OPTIMUM program is mindfulness pain management program modeled on MBSR which is delivered in the context of 8-weekly 90-minute medical group visits within a clinical setting. The OPTIMUM MBSR program is based on a similar 8-week, 90-minute instructor-led format used by Morone and colleagues in a randomized controlled trial of 282 older adults who had cLBP. The program resulted in significant and clinically meaningful reductions in pain intensity and increased physical function.4 Due to the COVID-19 pandemic, the group program will now be delivered online through a telehealth group medical visit.
Figure 1.
Study Flow
Prior to or after the OPTIMUM program (first or last 30 minutes), patients meet one on one (approximately 5–10 minutes) with the clinician for a routine medical telehealth visit focused on their chronic pain. Billing for the telemedicine medical care visit is occurring at one site.
Measures to determine the impact of OPTIMUM in the real-world setting will be obtained at baseline (T1), program completion (T2) and six and 12 months after program completion (T3 and T4). Monthly assessment of pain medication use and healthcare system utilization will occur between T1-T4. The main outcome timepoint will be at six months (T3), which allows time for durability of effects to be determined. The PEG at six months will be the main outcome measure (obtained through online self-report surveys in REDCap). Secondary outcomes of physical and psychological function will also be self-report and obtained online, or if the patient prefers, by telephone. Health care system utilization will be obtained through the EHR as well as monthly surveys to participants and includes opioid prescriptions, imaging, ED visits, and hospitalizations. We will also measure patient, clinic staff, and PCP satisfaction with OPTIMUM.
3.2. Inclusion and exclusion criteria
Age ≥ 18
Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
A score > 3 on the PEG
Willing and able to provide telephone informed consent
Able to speak and read English as all materials and measures are in English
Exclusion Criteria
Do not meet the above inclusion criteria
Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
Pregnancy
Metastatic cancer
3.3. Recruitment
A multi-pronged approach to recruitment at all three sites will be used. This includes informing patients of the program by a letter from their PCP or clinic administrator (e.g., Medical Director, healthcare system administrator) who will also invite them to participate. Flyers and rack cards describing the program will be placed throughout the clinics at each site. Referral at the point of care may occur by creating an order in the electronic health record (EHR) that will refer patients to OPTIMUM. Direct in-person recruitment from the clinic by a research assistant before or after their appointment with the PCP may occur. All three HCSs use an EHR. A study website will inform potential participants about the study.
3.4. Screening
Screening will be conducted by telephone with the above inclusion and exclusion criteria reviewed. Potential participants will be informed about their eligibility during the screening procedure. After the COVID-19 pandemic ends, in-person screening procedures may occur since potential participants can be identified before their visit through medical record review.
Because the intervention is delivered in cohorts, if there has been more than an 8-week delay between baseline measures and the start of the cohort, then the participant will be rescreened for eligibility with the PEG. If the score is ≤ 3, they will be ineligible.
3.5. Randomization
To ensure balance between groups, we used permuted block randomization with block size of 4, in a 1:1 ratio, stratified by clinic and gender. The OPTIMUM data collection system is built in REDCap, which includes a built-in randomization module. The assignment table (created by the project biostatistician, JW) was loaded into the project and became locked once the project was moved to production. The randomization table is hidden and cannot be downloaded from REDCap; unallocated assignments are not viewable by any users. Randomization sequence was determined before the start of the trial by the study biostatistician (JW). Randomization of participants will be carried out by the unblinded Project Coordinator. Participants will be randomized after completion of baseline measures.
3.6. Study Intervention: adapted MBSR program
The study intervention is an adapted 90-minute, instructor-led, 8-session Mindfulness-Based Stress Reduction (MBSR) program. Additionally, just prior to the MBSR session each week as the participants gather online, or after the session, each participant will have a brief telehealth visit with a primary care provider. For the MBSR component, we are following the protocol used in our large clinical trial of MBSR for cLBP.4 This program generally followed the Mindfulness-Based Stress Reduction Authorized Curriculum Guide with some important modifications. The length of sessions was 90 minutes rather than 2.5 hours, chair yoga and standing mindful stretches replaced the lying yoga activity, and we did not include the all-day session. Modifications regarding pain included review of the biopsychosocial model of pain processing and its relationship to mindfulness, and pain-focused meditations, particularly the body scan. Both this trial and our previous work used similar formats. Both of these trials were included in the evidence-base recommendations of MBSR for cLBP by the American College of Physicians.4,6,13 An additional adaptation to MBSR for this trial is that all OPTIMUM sessions will take place online, via HIPAA-compliant Zoom, rather than in person, due to COVID-19-related concerns. The adapted MBSR will be taught by trained, experienced MBSR instructors at each site who are certified or qualified by the UMass Center for Mindfulness or the Center for Mindfulness at Brown University, with number of years of MBSR teaching ranging from 12 years to 15 years, and number years of personal meditation practice 27–41 years. The OPTIMUM teachers have experience teaching mindfulness to diverse populations includingthose who are economically challenged and underserved minorities as well as those with chronic pain.
The general structure of each OPTIMUM session includes mindfulness meditation practice, review and support regarding home practice, experiential exercises, and discussion of the theme for the session. Downloadable audio-recordings of guided mindfulness meditations are provided to all participants which they can access online.
Home practice assignments are recommended at the end of each session. All participants receive a participant manual.
Table 1 reviews the themes for each session and Table 2 reviews the different forms of mindfulness meditation that are taught in the 8-session program.
Table 1
Themes.
| Session | Theme |
|---|---|
| 1 | Mindfulness Introduction |
| 2 | Perception |
| 3 | Pleasure and power in the present moment |
| 4 | Conditioning and perception-shaping experience |
| 5 | Responding vs. Reacting, being stuck, recognizing patterns, automatic responding and choices |
| 6 | Communication |
| 7 | Integrating mindfulness into daily life |
| 8 | Strategies for maintaining practice and skills, keeping up the momentum |
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Table 2
Mindfulness Meditations.
| Body Scan |
| Awareness of Breathing |
| Mindful Eating |
| Walking Meditation |
| Mindful Movement |
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Medical Group Visit: Also called a shared medical appointment, an MGV involves multiple patients seeing the provider in a group for follow-up and/or management of chronic conditions such as chronic pain. The MGV also includes individual services provided to each patient. The individual service consists of a brief e-visit with the primary care provider, generally prior before the start of the MBSR session. This is potentially a billable visit when documentation supports evaluation and management codes. Prior to the start of the MBSR session, for approximately 30 minutes, the primary care provider meets briefly and privately with each participant through a telehealth visit (in a breakout room in the HIPAA compliant Zoom platform) to review medical aspects of treatment, focused specifically on the person’s back pain. At the first OPTIMUM session, the telehealth visits take place following the MBSR session due to the need to orient participants to the entire program at the initial session.
The primary care provider is an active participant in the MBSR portion of the session, providing valuable insight and comments during discussions. This allows the provider the opportunity to document both the individual services provided but also the services provided to the whole group. Whole group services include the components of the mindfulness program reviewed at each session.
The primary care providers in OPTIMUM participated in meetings over several months prior to initiating the program, and they will have weekly contact with the mindfulness instructor to review session content during and plan together.
3.7. Comparison
PCP usual care was chosen as the comparator as it is currently the most commonly used treatment option for patients with cLBP. Usual care or standard of care for cLBP includes non-pharmacologic approaches such as exercise, physical therapy, acupuncture, and MBSR, that are recommended as first-line therapies by organizations such as the American College of Physicians.14 All participants will participate in PCP usual care visits as needed, via telemedicine or in-person at their Primary Care clinic.
3.8. Adherence and retention
3.8.1. Strategies to promote adherence and retention
Adherence-promoting strategies for both study arms include reimbursem*nt for time completing patient-reported outcomes, and provision of a smart phone or tablet for the duration of the study for those participants without the equipment. A stand for the smart phone or tablet will be provided if needed as well as a headphone or earbuds for privacy. All participants will be offered a Zoom orientation session to facilitate their being able to use the platform with ease. The monthly phone calls by study staff will foster a relationship with the participant that will help maintain retention in the study. For the OPTIMUM arm, additional strategies include providing guided meditation recordings and a program manual. Group sessions will stress the importance of home practice and group participation, and discussion will include problem-solving around barriers to the meditation practice and coping with pain. Any protocol deviations will be documented as will adverse events.
3.8.2. Treatment fidelity
The mindfulness instructors met weekly for several months during the planning phase of the study, to refine and agree upon MBSR content, and following a pilot intervention at all three sites, the manual was further refined prior to recruiting the first cohort. Mindfulness instructors and study investigators will meet weekly during the first six months of the second year of the trial along with study investigators (NEM, SG, PG) to discuss the delivery of the program in primary care through an online format, review the structure and format of the sessions, and troubleshoot barriers as they arise. After the first six months, meetings will be biweekly and starting in Year 2 will be monthly. More frequent or less frequent meetings will be at the discretion of the group. A checklist of key elements of the intervention will be completed by a trained research staff member to record fidelity to the program. The mindfulness instructors will also complete self-evaluations using a Mindfulness-Based Intervention-Teacher Assessment Criteria (MBI-TAC) summary of key domains of teaching that support reflection on instructor strengths and learning edges.15,16 We are also collecting important fidelity components such as engagement of participants that includes attendance, contribution to discussion, and obtaining participants perspectives on telehealth, as well as a post-course interview that includes satisfaction and feedback.17
3.9. Outcome measures
The PEG is our main outcome measure. The PEG consists of three questions concerning 1) pain intensity and pain’s interference with 2) enjoyment and 3) general activities over the previous week, with each question rated on a 0–10 scale and then averaged, for an overall range of 0–10. The PEG is aligned with the Center for Disease Control’s (CDC) guidelines for pain evaluation and treatment.12 The CDC guidelines include evaluating the multidimensional impact of chronic pain with validated scales that measure pain intensity, function (in its broader sense to include physical, emotional and social function or quality of life), mood and anxiety.18 Additionally, they reiterate that a 30% improvement in pain and function is clinically meaningful. Table 3 lists outcome measures and timeline. Additional outcome measures include the PROMIS 29+2 profile,19 the Cognitive and Affective Mindfulness Scale-Revised,20 the Pain Catastrophizing Scale-short form,21 as well as a single-item Patient Global Impression of Change (PGIC) rating. Participants’ treatment expectations22 regarding the pain program will be collected. Table 3 also lists measures required by the HEAL initiative https://heal.nih.gov/.
Table 3
Outcome measures.
| T1 Baseline | T2 8-wks | *T3 6-mo | T4 12-mo | |
|---|---|---|---|---|
| Patient-reported Measures | ||||
| **PEG | X | X | X | X |
| PROMIS-29 + 2 (Q.1–4 & 17–20 same as PROMIS Physical Function & PROMIS Sleep | X | X | X | X |
| Current Opioid Misuse Measure | X | X | X | X |
| CAMS-R (mindfulness) | X | X | X | X |
| Satisfaction, single item | X | X | X | |
| Ethics. single item | X | |||
| Patient Global Impression of Change (PGIC) | X | X | X | |
| Opioid use, single item | X | X | X | X |
| Pain Catastrophizing Scale Short Form | X | X | X | X |
| Demographics | X | |||
| Tobacco, Alcohol, Prescription medications, and other Substance (TAPS- part 1). | X | X | ||
| Screening questionnaire | X | |||
| Pain Medication This form will be asked monthly | X | X | X | X |
| Carbon Co-Morbidity Index | X | |||
| Health Care System Utilization (self-report). This form will be asked monthly | X | X | X | |
| HEAL-Treatment Expectancy | X | |||
| Telehealth Usability Questionnaire | X | X | ||
| EHR Outcomes | ||||
| Opioid prescriptions and other prescriptions for pain, CT/MRIs of lumbar-sacral spine. Injections of lumbar-sacral spine, ED/urgent care visits for LBP, Surgeries of lumbar spine, hospitalizations for LBP, PCP visits for LBP, physical therapy referrals for LBP | X | X | X | |
| Core HEAL Pain Data Measures | ||||
| PROMIS Physical Function | X | X | ||
| PROMIS Sleep | X | X | ||
| PROMIS Sleep Disturbance | X | X | ||
| Depression PHQ-2 | X | X | ||
| Anxiety GAD-2 | X | X |
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*Primary Timepoint
**Primary outcome.
Pain impact is defined as pain intensity, pain interference and functional status calculated from 9 items of the PROM1S-29 + 2. PROMIS: patient reported outcomes measurement information system.
Because administering these measures is not part of usual care, we will capture patient-reported outcomes directly from patients during the four key timepoints of the PCT. We will obtain health care resource utilization directly from the EHR. The EHR will evaluate opioid medication use according to prescriptions written; CT/MRIs performed; invasive procedures such as injections and surgeries; ED visits, and hospitalizations. To supplement the EHR data, research associates who are blind to group assignment will contact participants on a monthly basis to ask about pain medication changes and receipt of any additional services, including integrative medicine such as yoga.
All 450 participants who are included based upon the screening criteria outlined above will receive identical assessments. Participants will have the option of completing the measures online or over the telephone. If over the telephone, data will be collected by a trained research assistant who is blinded to group assignment. In our experience, almost all the individual measures can be done in 5 minutes or less. The total time for assessment is expected to be 20 minutes, with many people completing measures in less time. All outcomes will be assessed at program completion and at six and twelve months (eight weeks (T2), six months (T3), and twelve months (T4) from baseline, respectively), except for satisfaction with OPTIMUM and a question regarding ethics, which will be assessed at program completion only. The Tobacco, Alcohol, Prescription medications, and Substance use (TAPS) will be assessed at baseline and 12-month follow-up only.23 Because the program is offered online, which may be novel for participants, we will administer the Telehealth Usability Questionnaire (TUQ) at baseline and T2.24 Study participants will each be enrolled for up to 12 months. A Follow-up of twelve months was chosen to evaluate duration of the program’s effect on patients’ cLBP.
We will also conduct an online survey with all PCPs in the participating practices, to learn about their perspectives on how well the study procedures integrated with their workflow, overcame common barriers to chronic pain management, and were consistent with the practice’s typical referral and feedback protocols. This survey will also ask PCPs to report if/how many of their patients who were enrolled in the study raised safety concerns during the study and overall satisfaction with the program. The survey will include open-ended questions to solicit feedback for protocol improvement.
Additional Baseline Variables.
We will assess age, gender, race, ethnicity, socioeconomic status, involvement in workers’ compensation, work status, previous treatment including nonpharmacologic therapies, and marital and educational status. Biomedical factors will include: a) comorbidity information, which will be gathered using the Charlson Co-Morbidity Index at T1;25 b) pain medications (regularly scheduled and as-needed) at baseline and monthly thereafter. Regularly scheduled opioid analgesics will be converted to daily oral morphine equivalents.26
Coordinating Center.
The Boston University Biostatistics and Epidemiology Data Analytics Center (BEDAC) is the Coordinating Center for the study. They developed the paperless data-entry system using REDCap, a secure web application for building and managing online surveys and databases. They also created on-demand reports for all three sites to access for ongoing management of the study. For the EHR data they created a custom data repository that resides on virtual machines stored inside a premium secure environment. BEDAC also provides ongoing support for technical issues or other study-related needs as they arise.
3.9.1. PRECIS-2 Rating
We evaluated OPTIMUM with PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) which rates a trial on the pragmatic-explanatory continuum. We present our ratings of the PCT on this continuum in table format (vs. wheel) so we could describe our rationale.27 Many of the domains lie on the pragmatic end. See Table 4 below.
Table 4
PRECIS-2 Ratings and Rationale for OPTIMUM. Scores: 5 = fully pragmatic; 1 = fully explanatory.
| Domain | Score | Rationale | |
|---|---|---|---|
| 1 | Eligibility Criteria | 4 | Standard definition of pain with few exclusions. |
| 2 | Recruitment Path | 3 | Provider and staff referrals, information about group program in clinic are part of usual care. Invitation letters may be usual care at some clinics and not others. |
| 3 | Setting | 5 | Telemedicine sessions are currently offered in primary care settings and are utilized in the MGV + Mindfulness program. |
| 4 | Organization intervention | 3 | Additional training given to clinic-based providers on how to run MGVs and on mindfulness. |
| 5 | Flexibility of experimental Intervention-Delivery | 4 | Great deal of flexibility but must attend group sessions. |
| 6 | Flexibility of experimental Intervention-Adherence | 5 | Usual automated reminder calls about upcoming appointments, no additional pressure outside of usual care to attend group visits. |
| 7 | Follow up | 2 | More extensive follow up and data collection than usual care. |
| 8 | Outcome | 4 | PEG very relevant to patients, commonly used in primary care, commonly available in the EHR. Function and mood and anxiety sporadically measured during usual care, sometimes questionnaires available in the EHR and also important to patients and providers. Other outcomes relevant to patients and providers but measured outside of usual care such as patient global impression of change. |
| 9 | Analysis | 5 | Intention.to-treat regardless of patient compliance |
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3.10. Data Safety Monitory Plan
A Data Safety Monitory Board (DSMB) was created because the proposed program of research will be performed in three distinct healthcare systems. The DSMB will act in an advisory capacity to monitor participant safety. The initial responsibility of the DSMB was to approve the initiation of this pragmatic clinical trial. After this approval and twice a year during the course of the trial, the DSMB responsibilities are to:
1. Review the research protocol, informed consent documents and plans for data and safety monitoring.
2. Evaluate the progress of the trial, including assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of the trial sites, and other factors that can affect study outcome. The DSMB will consider factors external to the study when relevant information becomes available, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the trial.
4. Review clinical center performance, make recommendations and assist in the resolution of problems reported by the Principal Investigator (PI) or site PIs.
5. Protect the safety of the study participants.
6. Report on the safety and progress of the trial.
7. Make recommendations to the National Center for Complementary and Integrative Health (NCCIH) and the PI concerning continuation, termination or other modifications of the trial based on the observed beneficial or adverse effects of the treatment under study.
8. Ensure the confidentiality of the trial data and the results of monitoring.
9. Assist NCCIH by commenting on any problems with study conduct, enrollment, sample size and/or data collection.
10. No interim analyses are planned unless requested by the DSMB.
The DSMB will include experts in back pain treatment, the MBSR program, pragmatic clinical trial research, and biostatistics. Members will consist of persons completely independent of the investigators who have no financial, scientific, or other conflict of interest with the trial. A safety officer was identified at the first meeting. This person will be the contact person for severe adverse event reporting. The DSMB will be asked to review the study to determine if the study should be modified and/or discontinued if six serious adverse events or unexpected problems possibly related to the study protocol occur.
3.11. Auditing Trial Conduct and Adverse Events
Auditing will occur throughout the duration of the trial. Several approaches to assure scientific rigor will include: 1. Routine training and recurring skill assessment of all staff. 2. Built-in safeguards in REDCap so that measures cannot be submitted with missing data. 3. Customized reports that will track trial recruitment, retention, and dropouts. 4. Weekly site meetings at each site, bimonthly PI and Coordinator meetings, and bimonthly all-team-members meetings to address any issues that arise real-time.
Adverse event reporting will follow standard Institutional Review Board (IRB) and were approved by the single IRB (University of Pittsburgh), NCCIH, and DSMB before trial start up. Adverse event reporting was built into REDCap to easily enter events and produce reports and record event management. All staff will be trained in adverse events, their definition, and reporting procedures, including when to report serious events immediately to the PI. This is a minimal risk study and study related adverse events will likely be low.
3.12. Ethics and Dissemination
OPTIMUM has a single IRB (sIRB), which is the University of Pittsburgh. All sites have been onboarded and recruitment for the trial commenced XXX and is ongoing. As OPTIMUM is part of the NIH Helping to End Addiction Long-Term initiative the trial data set is required to be made available publicly and we will follow their procedures for making it available.
3.13. Data Analysis
We will compare the distributions of baseline characteristics between the two arms to assess the effectiveness of the randomization. All analyses for treatment arm comparisons will use the original treatment assignment as randomized for each participant (intent-to-treat). We will adjust for any baseline variable that either statistically (based on a p-value cutoff of p<0.2) or clinically differs between the two arms. All analyses will be conducted in SAS version 9.4 with p<0.05 considered statistically significant unless otherwise specified.
To address Aim 1, we will compare the PEG (primary outcome) at T2 (eight weeks from baseline), T3, and T4 (six months and 12 months from T2) with PEG at T1 (baseline) included in the vector of repeated measures using a mixed effects model. The mixed-effect models will include the baseline values as part of the vector of repeated outcome measurements. We will include the intervention group indicator, time, and their interaction as fixed effects, with random effects for repeated measures on individuals over time and random cohort effects for group in the intervention arm. We are proposing to control for clustering effect within each cohort using a random effect because the response of participants in the same cohort might be correlated. Alternative covariance structures for the repeated measures over time will be compared using Akaike’s Information Criteria. This model will be used to test specific hypotheses using contrast statements and to compare temporal changes over time between the intervention and control arms. Variables with baseline imbalances can be incorporated as additional fixed effects. We will also examine a clinically meaningful 30% improvement in PEG from baseline as a binary outcome (yes or no) at each follow-up time point using a logistic mixed effects model incorporating a random effect for cohort clustering.
Hypothesis 2 states that patients in OPTIMUM will have significantly improved psychological function at completion of the program and 6- and 12-months from baseline, as compared to PCP usual care. Analyses will mirror those described above using a mixed effects model with random effects for the clustering effect of intervention sessions and repeated measures on individuals over time, with fixed effects for group, time and their interaction. Contrast statements will be used to compare changes from baseline to specific time points.
Hypothesis 3 states that patients in OPTIMUM will be less likely to start and more likely to reduce or stop an opioid prescription for cLBP as compared to those in PCP usual care. We will examine opioid prescription for cLBP in two ways. First, we will examine the dose of opioids as morphine dose equivalent (continuous outcome) for those subjects with an opioid prescription at baseline. The analytic approach will mirror the mixed models described for Hypothesis 1 to compare group doses over time and in relation to baseline. Next, we will use a binary outcome which is yes/no for opioid prescription (any) for each patient at each time point. Analytic methods will again mirror methods for Hypothesis 1 now using a logistic mixed effects model.
To address Aim 2, healthcare utilization over 12 months (prescriptions of opioids, injections, surgery, CT/MRI, ED visits, hospitalizations) are mostly in the form of counts. We will fit a series of GEE models with each outcome as the dependent variable, a negative binomial distribution to account for over dispersion, a log link, exposed time period as an offset, intervention arm (OPTIMUM/usual care) as the independent factor of interest, and an exchangeable correlation structure for clustering. Alternative correlation structures will be examined via the QIC statistic. Intervention arm incident rate ratios and their significance will constitute the test of the hypothesis.
To address Aim 3, PCP satisfaction with the pain program survey responses will be summarized using descriptive statistics and histograms. We will also investigate if these measures are different depending on the demographic characteristics of the PCPs, such as gender, age, race, ethnicity, clinic location, and years since training, or the outcome of the patients using t-test, chi-square test, Pearson or Spearman correlation tests. Number of eight session programs delivered at each clinic will also be summarized with descriptive statistics. Adoption of OPTIMUM after study completion will be described.
We anticipate 20% attrition at the eight-week time point. We chose a higher attrition rate than in our previous work as we expect more attrition in the PCT because patients will not have the “high touch” of participants in the previous RCTs.4,28,29 Our sample size analyses have accounted for this potential amount of missing data. We will compare baseline characteristics of patients with and without the assessment immediately following the 8-week program in order to assess potential bias in study completion. We will also try to obtain reasons for study drop out so that we can assess the missing data mechanism (missing completely at random (MCAR), missing at random (MAR), non-ignorable missingness). At a single timepoint, we will conduct sensitivity analyses assigning poor scores and good scores for missing values differentially by treatment assignment to evaluate the impact on our study results. The mixed models proposed for analysis are robust to missing data under MCAR and MAR missing data mechanisms. If the amount of missing data differs between treatment groups or appears to be non-ignorably missing, we will conduct sensitivity analyses with imputed data based on varying assumptions (ignorable vs. non-ignorable missingness).
3.14. Power analysis and Justification of sample size
We assume an ICC estimate of 0.05330 within patient clusters, α= 0.05, SD of change = 2.5 and 20% attrition. Attrition is a conservative estimate as in our previous work attrition at 6-months was 9%.4 With a total sample size of 450, with an average of 10 subjects per cluster, we have close to 90% power to detect a 1-unit difference in the PEG between arms for the primary endpoint at six months. The SD of 2.5 and a clinically important change of 1-unit came from the work of Krebs.12,31
4. Discussion
The Mindfulness intervention plus medical group visit represents an innovation that is built upon an evidence-based approach for cLBP (MBSR) and that integrates the primary care clinician with the mindfulness instructor as part of a medical + mind-body behavioral model. This is a pragmatic rather than an efficacy design since MBSR is recognized as an evidence-based treatment for cLBP.7,14 This program has high potential for feasibility and acceptability within the primary care setting. Additionally, the program is likely to be scalable given that it is delivered in an online or telemedicine format.
PCPs are in need of more nonpharmacologic treatment options for their cLBP patients instead of falling back on medications (acetaminophen and nonsteroidal anti-inflammatory drugs [NSAIDs]) and referring out for treatment or prescribing opiate medications. The current model of caring for chronic pain patients does not allow for the time and attention that PCPs need to adequately address the complex needs of their patients. The medical group model increases patient education, social support, access to a clinician, and a sustainable way to bill for the treatment. The MGV has the potential to meet the quadruple aim of improving patient experience, population health, provider experience, and reducing healthcare costs.32,33 MGVs may also improve provider well-being.34 Our proposed project addresses the need for nonpharmacologic treatments for cLBP since the mindfulness pain management program will be delivered in the primary care setting so that PCPs will have another evidence-based therapy to offer patients; the mindfulness pain management program provides the time and attention that is necessary to adequately educate patients about chronic pain; and the medical group model provides for a reimbursable model of care. The intervention, modeled on MBSR, provides ample opportunity for discussion, allowing time to clarify misconceptions around chronic pain. The intervention also provides group support for learning pain self-management and for integrating meditation and mindfulness practices into daily life
Another unique aspect of the program is that it is delivered through HIPAA compliant, secure telehealth and videoconferencing. The COVID-19 pandemic required us to pivot to an online intervention rather than in-person. As a result, future integration of this program into primary care will be facilitated by the digital approach as patients can participate in the convenience of their home without the necessity to travel or incur childcare or other added expenses. Additionally, there is more flexibility in scheduling since delivery of the program is not limited by availability of rooms in the clinic. Integrating into primary care may increase patient engagement as patients who otherwise might not participate in a mindfulness program may be more apt to try it out if it is embedded in the clinic.
We expect that at least 2/3 of our sample will be from an underserved population. Chronic pain is particularly impactful in low income and racially and ethnically diverse patients whose access to treatment is often limited.35 By offering this program through telehealth it can represent an accessible and effective pain management program that will not require the patient to travel to the provider’s office or rely on the provider for prescriptions.
It is estimated that 18 million Americans use meditation for health.36 An innovative and exciting aspect of this MGV + mindfulness program is that we will be able to address questions related to offering mindfulness interventions to low income and racially diverse patients in an online format.37,38 In our experience, patients have been enthusiastic about learning mindfulness meditation and mind-body methods. By providing a convenient, group mindfulness pain program in primary care, we propose to parlay that interest into improved access to the program, and thus, to improved health.
This pragmatic clinical trial integrated into primary care settings offers many potential advantages to stakeholders at many layers of the health care system, informing and benefiting patients, clinicians, administrators, and policy makers. Firstly, we will demonstrate how a medical group-based mindfulness pain program can be embedded into clinical practice. More specifically, we will demonstrate how the mindfulness pain management program can be embedded in a variety of Health Care Systems, such as a safety net hospital, a federally qualified health center, and a large academic health care system. This PCT will determine the impact of this intervention on patients under usual care circ*mstances. Unlike many efficacy RCTs, this PCT will demonstrate how the mindfulness pain program can be delivered to an underserved population. Addressing the needs of clinicians, the project will provide PCPs with an available non-opioid, nonpharmacologic and supportive therapy modeled on the MBSR program to treat their cLBP patients. This represents an additional option for their care of cLBP patients, which is currently limited to writing prescriptions for medications and referring out to other providers. Perhaps most importantly, if successful, this PCT will expand the access and availability of evidence-based treatments to patients with cLBP, who otherwise may not be able to participate in an integrative mindfulness pain program. The measures were are collecting will allow future cost-effectiveness analyses, which will provide valuable information for stakeholders.
Our program is unique because it places more non-opioid and nonpharmacologic resources into the hands of the PCP for treating their patients with cLBP and combines conventional and integrative/complementary medicine. According the NCCIH, “integrative health brings conventional and complementary approaches together in a coordinated way.”39 We are bringing integrative health into the clinic by coordinating with the processes of the primary care clinics including integration into the electronic health record, communication between the study PCP and the participants’ PCPs. Thus, our medical group-based mindfulness pain management program is a novel, patient-centered approach for patient self-management of cLBP. With the successful completion of this project, we will demonstrate how health care systems can embed an evidence-based mindfulness pain management program into medical settings and have a positive impact on outcomes.
Acknowledgements
This work was supported by the National Institutes of Health (NIH) through the NIH HEAL Initiative under award number UG3AT010621/UH3AT010621 from the National Center for Complementary and Integrative Health. This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative. The authors wish to acknowledge Marni Holder, MSN, RN, FNP-BC, Program Development Director, for her work in facilitating integration of the study into Piedmont Health Services.
Protocol:
Version 2, approved by the National Center For Complementary and Integrative Health (NCCIH) on 11/13/20. Version 1 approved 9/17/2020 by NCCIH. NCCIH had no role in the study design, data collection, management, analysis, or interpretation of data, and had no role in the writing of the manuscript.
Footnotes
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ClinicalTrials.gov: NCT04129450
The authors have no conflict of interest to declare.
Declaration of interests
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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