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

Trial Summary

What is the purpose of this trial?

The goal of this 2-cohort, cluster randomized, type 2 hybrid trial is to test the effectiveness, cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway (M2VAPCP) intervention. The main questions it aims to answer are: Will adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone? Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone? Will implementation facilitation improve Veterans' clinical outcomes (pain, risky substance use) and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone?

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 data supports the effectiveness of the M2VA Pain Care Pathway treatment?

Research shows that clinical pathways, like the M2VA Pain Care Pathway, can improve patient care by integrating evidence-based practices and enhancing teamwork among healthcare providers. These pathways have been effective in other settings, such as hospitals and community teams, by standardizing care and improving outcomes. ^{1 2 3 4 5}

Is the M2VA Pain Care Pathway generally safe for humans?

The M2VA Pain Care Pathway, which involves strategies like Implementation Facilitation, has been used in various studies to support safe opioid prescribing and pain management. These studies have not reported any significant safety concerns, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the M2VA Pain Care Pathway treatment different from other pain management treatments?

The M2VA Pain Care Pathway is unique because it uses an implementation facilitation strategy, which involves interactive problem-solving and support to help healthcare providers implement a collaborative care program for pain management. This approach focuses on reducing high-dose opioid use and promoting safer, multi-modal pain care models, which is different from traditional pain management methods that may not emphasize provider support and collaborative care. ^{9 11 12 13 14}

Research Team

Marc Rosen, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The development and implementation of an integrated multidisciplinary clinical pathway. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Using a 10-step framework to support the implementation of an evidence-based clinical pathways programme. [2020]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Impact of Clinical Pharmacist Practitioner-Driven High Opioid Dose Reevaluation in Veterans with Chronic Non-Cancer Pain. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A research agenda for enhancing appropriate opioid prescribing in primary care. [2021]

9. England 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. [2021]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Improving cancer pain management through a system wide commitment. [2005]

12. England pubmed.ncbi.nlm.nih.gov

Current interventions to promote safe and appropriate pain management. [2020]

13. England 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). [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Implementation Mapping for Integrative Medical Group Visits. [2022]