A Mixed-methods Randomised Feasibility Trial Comparing a Collaborative Care Model With Standard Care in People With Musculoskeletal and Co-existing Mental Health Conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Number of participants
研究概览
简要总结
This study aims to implement a feasibility Randomised Controlled Trial to support patients with musculoskeletal problems and a co-existing mental condition, which the intervention will be the implementation of a Collaborative Care Model.
In England, one in six adults suffers from a mental health condition, such as anxiety or depression. Despite these high numbers, mental health conditions are often unrecognised in physical healthcare settings, including patients with musculoskeletal (MSK) conditions. Patients with both a physical and mental health diagnosis are likely more difficult to treat in comparison to those with just a physical health condition.
The Collaborative Care Model offers an alternative way of improving musculoskeletal rehabilitation as it takes into consideration both physical and mental health needs. This model involves physical and mental healthcare professionals working together to better identify and manage people with both conditions. Patients are then further supported by a Case Manager who coordinates access to relevant professionals/services following an assessment of both physical and mental health needs.
The investigators propose a feasibility study to assess whether the collaborative care model is beneficial to orthopaedic patients in addressing both physical and mental health needs.
Patients over 18 years old, with an MSK condition attending therapy services at the Royal National Orthopaedic Hospital with a moderate to severe anxiety or depression score, may be eligible. Following informed consent, they will be randomly allocated to either treatment as usual or the intervention group (the collaborative care model with input from a Case Manager). All participants will participate for 6 months with a follow-up on months 3 and 6.
详细描述
Methodology:
The investigators will perform a single-center, mixed methods two-arm parallel-group Randomized Control trial (RCT), comparing the collaborative care intervention in patients with musculoskeletal (MSK) and co-existing mental conditions with usual care.
The study will be carried out at the Therapies Rehabilitation Outpatient setting, at the Royal National Orthopaedic Hospital NHS Trust, Stanmore, London. The duration of the study will be 12 months and the patient's participation will be for 6 months.
Patients will be approached by their attending physician in their routine outpatient clinic appointment regarding whether they would be interested in taking part in this study. As per routine care, this patient group complete PHQ-ADS in their outpatient appointment.
If the patient is interested in taking part and has a PHQ-ADS score of >20, they will be referred to the research team to further discuss participation. The study team will be introduced and available to discuss the study with potential participants. A written patient information sheet (PIS) will be provided. Patients will be given time to process the information should they be interested (a minimum of 24 hours), and consent will be obtained at their next routine appointment, once patients have read and understood the PIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants/ patients
- •Inclusion Criteria:
- •Patients over 18 years old, with an MSK condition requiring a therapy outpatient appointment.
- •Scoring ≥ 20 on the PHQ-ADS.
- •Able to provide written informed consent and willing to participate
- •Able and willing to complete questionnaires and study assessments
排除标准
- •Patients who are already receiving treatment for a psychiatric condition from a specialist mental health service.
- •Scoring < 20 on the PHQ-ADS.
- •Lacking capacity to consent
- •Unable or unwilling to complete questionnaires and study assessments
- •Participating in other trials
- •Participants/ staff
- •Clinical staff involved in the treatment of the participants allocated to the intervention group
结局指标
主要结局
Number of participants
时间窗: 6 months
Number of participants consented as a proportion of the number of patients eligible and invited.
Retention
时间窗: 6 months
Number of participants ending the trial as a proportion of the number of patients recruited.
Protocol adherence
时间窗: 6 months
Percentage of appointments attended as a proportion of booked appointments (%)
次要结局
- Pain Disability Index (PDI) to assess pain(pre-intervention, 3 months and 6 months)
- Global rating of change assessment validated questionnaire (GROC)(pre-intervention, 3 months and 6 months)
- Quality of life validated Questionnaire EQ-5D(pre-intervention, 3 months and 6 months)
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)(pre-intervention, 3 months and 6 months)
- Resourcing(month 6)
- NPRS(pre-intervention, 3 months and 6 months)
- Physical health quality assessment validated questionnaire (MSK-HQ)(pre-intervention, 3 months and 6 months)
研究者
Iva Hauptmannova
Head of Research Innovation Centre
Royal National Orthopaedic Hospital NHS Trust