M2VA Pain Care Pathway for Pain

(M2VAPCP Trial)

Overseen By Christina Lazar, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Incapacity, Incarceration, No phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new support strategy, called Implementation Facilitation, can help case managers more effectively use a specific pain care plan, the M2VA Pain Care Pathway (M2VAPCP), for veterans who have recently left the military. The research aims to determine if this approach improves pain care delivery and leads to better health outcomes, such as reduced pain and decreased risky substance use. The trial compares regular training to enhanced training with additional support. Eligible veterans are those who have left military service within the past year, have a claim for a musculoskeletal disorder (such as back or knee issues), and live near a participating site. As an unphased trial, this study offers veterans the chance to contribute to innovative strategies that could enhance pain management and improve health outcomes for fellow veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this implementation facilitation strategy is safe for Veterans?

Research shows that the M2VA Pain Care Pathway and Implementation Facilitation are under study to assess their impact on pain management in Veterans. The trial aims to improve care and outcomes, with no direct mention of negative effects from the treatment itself.

The trial is in a phase called "Not Applicable," which typically focuses on implementing these methods rather than testing drug safety, a common focus in early trials. This suggests that the methods being tested, such as training and support for healthcare providers, are generally low-risk and well-tolerated.

In summary, the available data shows no direct evidence of safety concerns, indicating that the approach is likely safe. However, discussing any concerns with the trial team or a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the M2VA Pain Care Pathway (M2VAPCP) because it offers a structured approach to pain management through a unique combination of Motivational Interviewing and implementation facilitation. Unlike traditional pain management options, which may rely heavily on medication, this pathway focuses on empowering case managers with advanced communication techniques and ongoing support to improve patient outcomes. By integrating these elements, the method aims to personalize care and enhance the effectiveness of pain management strategies, potentially leading to more sustainable results for patients.

What evidence suggests that this trial's treatments could be effective for pain?

This trial will compare two approaches for supporting case managers in implementing the M2VA Pain Care Pathway. One group will receive Training-As-Usual, which includes an initial 8-hour virtual workshop on Motivational Interviewing and the M2VA Pain Care Pathway. Another group will receive Implementation Facilitation in addition to Training-As-Usual. Studies have shown that extra support and guidance, known as implementation facilitation, can help case managers follow the M2VA Pain Care Pathway more effectively. This approach provides additional help for those managing the treatment, potentially leading to better patient outcomes. Research suggests that this method can improve pain management and reduce risky substance use among veterans. With this extra layer of support, patients are more likely to use non-drug pain treatments. Overall, this combination might lead to better care and results for those involved. ^{1 2 3 4 6}

Who Is on the Research Team?

Marc Rosen, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for veterans dealing with pain and at risk of or currently facing substance use issues, specifically opioid abuse. It's designed to help case managers better adopt a special care pathway to improve these veterans' quality of life.

Inclusion Criteria

Study enrollment is within one year of ending military service

Lives within the catchment area of a participating site

I have filed a claim for a service-connected musculoskeletal disorder.

Exclusion Criteria

Does not have a landline or cell phone to complete study assessments

Still on active duty

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

M2VA case managers receive an initial 8-hour virtual didactic and experiential workshop on Motivational Interviewing and M2VAPCP protocol

1 day

1 virtual workshop

Implementation Facilitation

Implementation facilitation strategy to support the use of M2VAPCP, including external facilitation team and multifaceted activities

21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on pain and substance use outcomes

36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Facilitation
• M2VA Pain Care Pathway (M2VAPCP)

Trial Overview The study tests if adding extra support (implementation facilitation) helps case managers more effectively use the M2VA Pain Care Pathway compared to just standard training. The goal is to see if this leads to better care and outcomes for veterans.

How Is the Trial Designed?

Group I: Implementation Facilitation + Training-As-Usual Experimental Treatment 2 Interventions

M2VA case managers at sites randomized to IF+TAU will receive the M2VAPCP training workshop described above and IF delivered virtually for 21 months after receiving the M2VAPCP training workshop. IF for this trial will be organized around three major components: 1) an external facilitation team consisting of clinical and implementation experts who will work with internal facilitators at each site; 2) multifaceted activities to support the use of M2VAPCP; and 3) ongoing formative evaluation.

Group II: Training-As-Usual Active Control 1 Intervention

M2VA case managers at sites randomized to TAU will receive an initial 8-hour virtual didactic and experiential workshop conducted by an experienced Motivational Interviewing and M2VAPCP trainer, Dr. Martino, who is a longstanding member of the Motivational Interviewing Network of Trainers. The first four hours of the workshop will focus on principles and practices of Motivational Interviewing. The last four hours will be a review the M2VAPCP protocol, with demonstration and practice of its elements. Following the workshop, case managers will have up to seven opportunities to practice M2VAPCP with simulated patients over a 21-month period

Implementation Facilitation is already approved in United States for the following indications:

Approved in United States as Implementation Facilitation for:

• Improving pain care pathways
• Enhancing non-pharmacological pain treatments
• Reducing risky substance use

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

VA Connecticut Healthcare System

Collaborator

Trials

86

Recruited

8,800+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of a patient-centered Primary Care-Integrated Pain Support (PIPS) program in the Veterans Health Administration, focusing on reducing high-dose opioid prescriptions and risky opioid-benzodiazepine combinations.

By using implementation facilitation strategies, the study seeks to improve the adoption and sustainability of PIPS, which could lead to safer pain management practices and better access to complementary health treatments for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing implementation facilitation of a primary care-based collaborative care clinical program using a hybrid type III interrupted time series design: a study protocol. Midboe, AM., Martino, S., Krein, SL., et al.[2021]

Nine healthcare systems in the U.S. implemented various pain management strategies targeting patients, clinicians, and communities to address the opioid epidemic and improve chronic pain management.

Effective interventions included educational tools for patients, multidisciplinary teams for clinicians, and system-level measures like tracking metrics and safe opioid disposal methods, emphasizing the importance of community acceptance for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current interventions to promote safe and appropriate pain management. Jones, LK., Lussier, ME., Brar, J., et al.[2020]

A cluster randomized controlled trial will evaluate the effectiveness of an innovative Short Message Service with Interactive Voice Response (SMS-IVR) strategy to improve pain reporting and management in cancer patients across six oncology outpatient clinics in the Netherlands.

The intervention aims to enhance patient involvement and self-management in pain control, potentially leading to better adherence to clinical guidelines and reduced pain intensity for patients with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design, and implementation protocol of the Dutch clinical practice guideline pain in patients with cancer: a cluster randomised controlled trial with Short Message Service (SMS) and Interactive Voice Response (IVR). te Boveldt, N., Engels, Y., Besse, K., et al.[2021]

Engaging a diverse group of 25 participants, including clinicians and patients, led to significant improvements in the design of two care pathways for low back pain, enhancing patient experience and usability.

Key changes included shifting from telephone-based to flexible telehealth delivery, refining pain management activities, and modifying care models to better meet patient needs, highlighting the importance of patient-centered design in pragmatic clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Ballengee, LA., King, HA., Simon, C., et al.[2023]

The study utilized implementation mapping to identify barriers and facilitators for implementing an Integrative Medical Group Visit (IMGV) intervention in an outpatient clinic focused on chronic pain, involving insights from 15 key stakeholders.

Key strategies for successful implementation included training champions, ongoing education, and enhancing communication among staff, demonstrating that a structured approach can effectively translate integrative health interventions into practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementation Mapping for Integrative Medical Group Visits. Roth, IJ., Tiedt, MK., Barnhill, JL., et al.[2022]

The COVID-19 pandemic led to significant modifications in 11 pragmatic clinical trials (PCTs) focused on pain management within the Department of Veterans Affairs and Department of Defense, with each trial making between two and six adjustments to their protocols.

Key modifications aimed to enhance treatment feasibility and reduce patient exposure to COVID-19, including transitioning to virtual delivery methods and adding safety elements to interventions, while maintaining the core components of the treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 pandemic on nonpharmacological pain management trials in military and veteran healthcare settings: an evaluation informed by implementation science. Midboe, AM., Javier, SJ., Salsbury, SA., et al.[2023]

Long-term opioid therapy for chronic pain presents significant challenges, including potential safety issues like overdose and inadequate pain relief, highlighting the need for careful management.

The authors propose a research agenda focused on improving opioid prescribing practices, which includes developing patient-reported measures for safety and efficacy, creating evidence-based treatment algorithms, and promoting multi-modal treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A research agenda for enhancing appropriate opioid prescribing in primary care. Becker, WC., Fraenkel, L., Kerns, RD., et al.[2021]

A comprehensive care pathway for managing COPD exacerbations was developed, consisting of 38 evidence-based interventions and 39 indicators (24 process and 15 outcome), validated by nine multidisciplinary teams in Belgium.

The eight-step method used to create this care pathway can serve as a model for other healthcare teams to standardize clinical content for various patient populations, ensuring effective and evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. Lodewijckx, C., Decramer, M., Sermeus, W., et al.[2021]

A clinical pathways program was successfully developed and disseminated across a large academic healthcare system, resulting in 202 pathways created between February 2016 and April 2018, primarily in oncology, pulmonary/critical care, and cardiovascular medicine.

The program utilized a cloud-based technology platform to enhance accessibility and engagement, with 1279 registered users and an average of 2150 monthly views of the pathways, demonstrating effective integration of evidence-based practices into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a 10-step framework to support the implementation of an evidence-based clinical pathways programme. Flores, EJ., Mull, NK., Lavenberg, JG., et al.[2020]

The EQCP study will assess the impact of care pathways on interprofessional teamwork among 132 teams caring for patients with proximal femur fractures and COPD, comparing an intervention group implementing a structured care pathway to a control group providing usual care.

The study aims to identify effective components and strategies for implementing care pathways, with relational coordination as the main outcome measure, which will help improve teamwork in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European quality of care pathways (EQCP) study on the impact of care pathways on interprofessional teamwork in an acute hospital setting: study protocol: for a cluster randomised controlled trial and evaluation of implementation processes. Deneckere, S., Euwema, M., Lodewijckx, C., et al.[2021]

Integrated care pathways can facilitate teamwork in community-based settings, but their effectiveness is heavily influenced by the organizational dynamics present in each setting, as shown in a comparison of community mental health teams and rapid response teams across Scotland.

In community mental health teams, a rigid, management-driven pathway was resisted due to a lack of task sharing, while a flexible, team-driven pathway in rapid response teams was better received but suffered from poor management engagement, highlighting the need for alignment between management and team dynamics for successful integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of quality improvement tools: joint working in integrated community teams. Huby, G., Rees, G.[2019]

Implementing clinical pathways can improve the efficiency and cost-effectiveness of patient care, but translating these pathways from concept to practice is challenging due to various organizational and personal barriers.

Successful pathway development requires clear goals, stakeholder engagement, and strong institutional support, as demonstrated by experiences in implementing specific care pathways for cystectomy and pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and implementation of an integrated multidisciplinary clinical pathway. Ramos, MC., Ratliff, C.[2019]

Conventional educational methods have not significantly improved cancer pain management, highlighting the need for innovative institutional strategies that include quality assurance and quality improvement efforts.

The proposed pain management project emphasizes collaboration among healthcare teams and utilizes pharmacist prescriptive authority, aiming to enhance patient care and outcomes in cancer pain management through systematic evaluation and commitment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cancer pain management through a system wide commitment. Farber, S., Andersen, W., Branden, C., et al.[2005]

The implementation of a Pain Clinical Pharmacist Practitioner (CPP) at the West Palm Beach VA Healthcare System led to an average opioid dose reduction of 17.7 mg MEDD in 28% of Veterans evaluated, demonstrating effective management of high-dose opioid prescriptions.

Importantly, 83% of Veterans reported no change or improvement in pain levels after reevaluation, and there were no documented cases of opioid overdose or related crises, indicating that the CPP approach is both safe and effective in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Clinical Pharmacist Practitioner-Driven High Opioid Dose Reevaluation in Veterans with Chronic Non-Cancer Pain. Faley, B., Brooks, A., Vartan, CM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06526143

Study Details | NCT06526143 | M2VA Pain Care Pathway Aim 2: Determine if implementation facilitation of M2VAPCP improves participants' clinical outcomes. The primary clinical outcome is the PEG measure of pain.

2. ctv.veeva.com ctv.veeva.com/study/m2va-pain-care-pathway

M2VA Pain Care Pathway (M2VAPCP) - ClinicalTrials.Veeva Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training ...

3. academic.oup.com academic.oup.com/painmedicine/article/25/Supplement_1/S99/7887771

Screening, brief intervention, and referral to treatment for pain ... Implementation facilitation might help case managers use SBIRT-PM and engage veterans in services to improve outcomes. Design. This study is a 2 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06526143/m2va-pain-care-pathway

M2VA Pain Care Pathway | Clinical Research Trial Listing Investigators will conduct a type 2 hybrid cluster randomized trial to test the effectiveness, cost-effectiveness, and patient-level effects of ...

5. clinicaltrial.be clinicaltrial.be/en/details/444202?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

M2VA Pain Care Pathway Investigators will conduct a type 2 hybrid cluster randomized trial to test the effectiveness, cost-effectiveness, and patient-level effects ...

6. queri.research.va.gov queri.research.va.gov/tools/Facilitation-Manual.pdf

Using Implementation Facilitation to Improve Healthcare This is an Implementation Facilitation Training Manual, version 3.1, for using implementation facilitation to improve healthcare.