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Collaborative care; Opioid use disorder; Mental health; Primary care; Randomized controlled trial

Introduction

Opioid use disorder (OUD) represents a major public health crisis, characterized by the compulsive use of opioids despite adverse consequences. The prevalence of OUD has escalated over the past two decades, driven by factors including prescription practices, illicit drug availability, and socioeconomic stressors. The epidemic is further complicated by a high rate of co-occurring mental health disorders such as depression, anxiety, and post-traumatic stress disorder (PTSD) [1]. These comorbid conditions often exacerbate the severity of OUD, complicating treatment and contributing to poorer outcomes. Traditional treatment approaches for OUD have typically focused on pharmacological interventions such as methadone or buprenorphine, which target the physiological aspects of addiction. However, effective management of OUD often requires addressing the complex interplay between substance use and mental health. This necessitates a holistic approach that integrates mental health treatment with substance use disorder care. Collaborative care models have emerged as a promising approach for managing chronic conditions by integrating behavioral health services within primary care settings. These models involve a coordinated team of healthcare professionals, including primary care physicians, mental health clinicians, and care managers, working together to provide comprehensive, patient-centered care. The collaborative care model emphasizes ongoing communication and coordination among team members, tailored treatment plans, and continuous monitoring and adjustment of interventions [2, 3].

Rationale

Research suggests that collaborative care models improve outcomes for patients with chronic conditions such as diabetes, cardiovascular diseases, and depression. These models facilitate better management of complex conditions by enhancing access to mental health services, improving treatment adherence, and fostering a more integrated approach to patient care. Given the high prevalence of co-occurring mental health disorders among individuals with OUD, there is a compelling rationale to apply collaborative care principles to this population. Despite the potential benefits, there is limited research specifically evaluating the effectiveness of collaborative care models for managing OUD alongside mental health issues within primary care settings. Most existing studies focus on mental health conditions in isolation or on substance use disorders without considering the synergistic impact of combining these treatments. The integration of mental health and substance use disorder care in a primary care setting could address gaps in current treatment approaches and offer a more cohesive strategy for managing these interrelated conditions [4].

Objectives

The primary objective of this study is to evaluate the efficacy of a collaborative care model in primary care settings for the treatment of OUD and co-occurring mental health disorders compared to usual care. The study aims to assess whether the collaborative care model leads to:

1. Improved Treatment Adherence: By providing integrated support and monitoring, collaborative care may enhance adherence to prescribed treatments and interventions for both OUD and mental health conditions.
2. Enhanced Mental Health Outcomes: Collaborative care is hypothesized to improve mental health outcomes as measured by standardized assessment tools, leading to reduced symptoms of depression, anxiety, and other co-occurring mental health issues.
3. Better Overall Functioning: The study will evaluate whether collaborative care contributes to improved overall functioning and quality of life, addressing both the physical and psychological dimensions of patient health.

Understanding the effectiveness of collaborative care in managing OUD and co-occurring mental health disorders has significant implications for healthcare practice and policy. If found to be effective, this model could offer a scalable and replicable approach to improving care for individuals with these challenging and interrelated conditions. The findings could inform the development of integrated care pathways, influence healthcare policies, and ultimately contribute to better health outcomes for a population that faces substantial barriers to effective treatment. This protocol outlines a randomized controlled trial designed to compare the outcomes of a collaborative care model with usual care for patients with OUD and mental health disorders. The study will be conducted across multiple primary care sites, with rigorous data collection and analysis to assess treatment adherence, mental health status, and overall functioning. Results from this study will provide valuable insights into the benefits and challenges of implementing collaborative care in primary care settings and may offer a pathway for improving management strategies for OUD and co-occurring mental health conditions [5, 6].

Methods

Study design

This study will be a multicenter, randomized controlled trial (RCT) with a parallel-group design. The trial will compare the efficacy of a collaborative care model to usual care in primary care settings for patients with opioid use disorder (OUD) and co-occurring mental health disorders. Participants will be randomly assigned to one of two groups: the collaborative care intervention or the usual care control group.

Study sites

The trial will be conducted across multiple primary care clinics to ensure generalizability of findings. Clinics will be selected based on their ability to implement the collaborative care model and their capacity to recruit and manage participants.

Diagnosed with OUD as defined by dsm-5 criteria: Presence of at least one co-occurring mental health disorder, such as major depressive disorder, generalized anxiety disorder, or PTSD [7].

Ability to provide informed consent and participate in the study.

Exclusion criteria: Severe uncontrolled medical conditions (e.g., terminal illness) that would interfere with study participation.

Current substance use disorders other than opioids (e.g., active stimulant use).

Severe cognitive impairment or significant psychiatric disorders that prevent participation in the study (e.g., acute psychosis).

Randomization

Participants will be randomly assigned to either the collaborative care intervention group or the usual care control group using a computer-generated randomization sequence. The randomization process will ensure an equal distribution of participants between the two groups and will be managed by an independent biostatistician to avoid bias.

Intervention

Collaborative care model

The collaborative care model will be implemented with the following components:

Care team: The team will include a primary care physician, a mental health clinician (psychologist or psychiatrist), and a care manager. The roles and responsibilities of each team member will be clearly defined to ensure effective collaboration and communication.

Care coordination: Regular team meetings will be held to discuss each patient's progress, adjust treatment plans, and address any issues that arise. The care manager will facilitate communication among team members and coordinate care activities.

Treatment components

Integrated care planning: The team will develop a comprehensive, individualized treatment plan that addresses both OUD and mental health disorders.

Pharmacotherapy: The primary care physician will manage opioid agonist therapy (e.g., methadone or buprenorphine) and adjust dosages based on clinical need. Medications for mental health disorders will also be prescribed and monitored.

Behavioral health interventions: The mental health clinician will provide evidence-based psychotherapy (e.g., cognitive-behavioral therapy) and counseling to address mental health issues and support recovery from OUD.

Patient education and support: The care manager will offer educational resources about OUD and mental health, facilitate access to community resources, and provide ongoing support to patients.

Monitoring and follow-up: Regular follow-up appointments will be scheduled to monitor progress, assess treatment adherence, and adjust the care plan as needed.

Usual care

Participants in the usual care group will receive standard primary care treatment for OUD and mental health issues based on current practices at their respective clinics. This may include pharmacotherapy and mental health services, but without the integrated and coordinated approach provided in the collaborative care model.

Outcomes

Primary Outcomes

Treatment Adherence: Measured by medication refill rates (using pharmacy records) and self-reported adherence (using a standardized adherence questionnaire).

Mental health status: Assessed using validated scales

Patient health questionnaire-9 (PHQ-9): For evaluating depressive symptoms.

Generalized Anxiety Disorder-7 (GAD-7): For assessing anxiety symptoms.

Secondary outcomes

Overall Functioning: Measured by the Sheehan Disability Scale (SDS), which assesses the impact of mental health and substance use disorders on work, social, and family functioning.

Quality of Life: Assessed using the EQ-5D scale, which measures overall health-related quality of life.

Substance use: Monitored through urine drug screenings and self-reported substance use to assess changes in opioid and other substance use.

Data collection and analysis

Data collection

Data will be collected at three time points: baseline (before randomization), 3 months, and 6 months. Data collection will include:

Clinical assessments: Conducted by trained research staff to ensure consistency and accuracy.

Self-report measures: Completed by participants to gather information on mental health status, treatment adherence, and substance use.

Pharmacy records: Used to track medication adherence.

Data analysis

Statistical Methods: The primary analysis will use intent-to-treat principles to include all randomized participants in their assigned groups. Mixed-effects models will be used to account for repeated measures and potential confounders.

Outcome Measures: Differences between the intervention and control groups will be analyzed using t-tests or Mann-Whitney U tests for continuous variables and chi-square tests for categorical variables. Adjustments will be made for potential confounders such as age, gender, and baseline severity of OUD and mental health disorders [8].

Sensitivity analysis: To assess the robustness of the results, sensitivity analyses will be conducted, including examining the impact of missing data and variations in implementation fidelity.

Ethical considerations

Informed consent: Participants will provide written informed consent before enrollment, which will include details about the study’s purpose, procedures, potential risks, and benefits. Participants will have the opportunity to ask questions and withdraw from the study at any time without penalty.

Confidentiality: Participant data will be kept confidential and stored securely in locked files or encrypted electronic systems. Access will be restricted to authorize research staff only. Identifiable information will be removed from datasets before analysis and reporting.

Safety monitoring: An independent Data Safety Monitoring Board (DSMB) will oversee the study to ensure participant safety and adherence to ethical standards. The DSMB will review adverse events, monitor data integrity, and make recommendations regarding the continuation of the study. 

Ethical Considerations

Informed Consent

Informed consent is a fundamental ethical requirement in clinical research, ensuring that participants are fully aware of the nature, purpose, risks, and benefits of the study before agreeing to participate. The informed consent process for this study will be conducted as follows:

Consent form: Participants will be provided with a detailed consent form outlining the study's objectives, procedures, potential risks, and benefits. The form will also describe how participant data will be handled and their right to withdraw from the study at any time without penalty.

Voluntary participation: Participation in the study will be entirely voluntary. Participants will be informed that they can refuse to participate or withdraw from the study at any time without affecting their current or future care.

Comprehension: The consent process will include a thorough explanation of the study procedures, and participants will be encouraged to ask questions to ensure they fully understand what participation entails. Consent will be obtained in a language and manner appropriate to the participant's level of understanding.

Documentation: Written informed consent will be obtained from all participants before enrollment. Signed consent forms will be stored securely and separately from study data to maintain confidentiality.

Confidentiality

Maintaining the confidentiality of participant information is critical to uphold their privacy and protect sensitive data. The measures to ensure confidentiality include:

Data protection: All participant data will be anonymized or de-identified before analysis. Personal identifiers will be removed from datasets, and data will be stored in encrypted electronic systems or locked physical storage.

Access control: Access to participant data will be restricted to authorized research personnel who need the information for the conduct of the study. Data will only be shared with individuals who have signed confidentiality agreements.

Reporting: When reporting study results, aggregated data will be presented to avoid revealing individual participants' identities. Specific details that could identify participants will not be included in any publications or presentations.

Safety monitoring

The safety and well-being of participants are paramount in clinical research. To ensure ongoing safety and address any concerns, the study will include:

Data safety monitoring board (DSMB): An independent DSMB will be established to monitor the study's progress, review safety data, and oversee adherence to ethical standards. The DSMB will be composed of experts in clinical research, ethics, and relevant medical fields.

Adverse event reporting: Any adverse events or serious adverse events occurring during the study will be reported to the DSMB and regulatory authorities as required. A standardized adverse event reporting form will be used to document and assess the severity of any incidents.

Risk management: The study will include provisions for managing and mitigating risks associated with participation. Participants will be informed of the potential risks and given appropriate support if adverse events occur.

Privacy and data security

Protecting the privacy of participants and the security of their data is crucial

Data Security Measures: Electronic data will be stored in password-protected, encrypted files, and access will be restricted to authorized study personnel only. Physical records will be kept in locked cabinets in secure locations.

Data Sharing: Data sharing will be conducted in accordance with institutional policies and applicable regulations. Researchers will obtain appropriate approvals before sharing data with external parties or for secondary research purposes.

Compliance: The study will comply with all relevant regulations and guidelines concerning data protection and privacy, including the Health Insurance Portability and Accountability Act (HIPAA) in the United States or similar regulations in other jurisdictions.

Results

Participant Recruitment and Enrollment

• Screened for eligibility: 250 individuals
• Enrolled in study: 120 participants
• Collaborative care group: 60 participants
• Usual care group: 60 participants
• Retention rates:
• At 3 Months: Collaborative Care Group: 90% (54/60), Usual Care Group: 85% (51/60)
• At 6 Months: Collaborative Care Group: 85% (51/60), Usual Care Group: 80% (48/60)

Baseline characteristics

Baseline characteristics of participants are summarized in the table below (Table 1-3).

Table 1. Baseline Characteristics of Participants.

Table 2. Primary Outcomes Collaborative Care Group.

Table 3. Secondary Outcomes Collaborative Care Group.

Adverse events

• Adverse events reported: Collaborative Care Group: 5 events (8.3%), Usual Care Group: 8 events (13.3%)
• Nature of Adverse Events: Common adverse events included mild gastrointestinal issues and transient headaches. All events were managed effectively.

Sensitivity analysis

• Missing data handling: Results adjusted for missing data using multiple imputations; analysis showed consistent trends.
• Implementation fidelity: Variations in the implementation of the collaborative care model were noted but did not significantly affect the overall outcomes.

Discussion

The results of this study suggest that the collaborative care model significantly improves treatment outcomes for individuals with opioid use disorder (OUD) and co-occurring mental health issues compared to usual care. Participants in the collaborative care group demonstrated higher treatment adherence, significant reductions in depressive and anxiety symptoms, and better overall functioning. These findings are consistent with previous research indicating that integrated care models can enhance treatment outcomes for complex conditions by addressing multiple needs simultaneously. Higher treatment adherence in the collaborative care group (85%) compared to the usual care group (75%) highlights the benefits of a structured, team-based approach. The collaborative care model’s emphasis on regular follow-ups, coordinated care plans, and close monitoring likely contributed to improved adherence. This is crucial, as adherence to prescribed treatments is a key factor in managing OUD and mental health disorders. The significant reduction in depressive (PHQ-9) and anxiety (GAD-7) scores in the collaborative care group aligns with the integrated care approach’s focus on comprehensive management. Improved mental health outcomes are likely attributable to the combined efforts of mental health professionals and primary care providers working together to address both OUD and co-occurring mental health conditions. Enhanced overall functioning and quality of life in the collaborative care group (measured by SDS and EQ-5D) underscore the model’s effectiveness in improving daily life activities and general well-being. These improvements reflect the holistic approach of the collaborative [9, 10].

Conclusion

The collaborative care model significantly improves outcomes for opioid use disorder (OUD) and co-occurring mental health conditions in primary care settings. It leads to higher treatment adherence, better mental health outcomes, improved overall functioning, and enhanced quality of life. Additionally, it is associated with a more significant reduction in opioid use and has a comparable safety profile to usual care. These findings support the effectiveness and feasibility of collaborative care as an integrated approach to managing complex patient needs.

Acknowledgement

None

Conflict of Interest

None

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