Clinical trial NCT05018039: Feasibility and Acceptability of Collaborative Care for People With Musculoskeletal and Mental Problems
Official title: A Mixed-methods Randomised Feasibility Trial Comparing a Collaborative Care Model With Standard Care in People With Musculoskeletal and Co-existing Mental Health Conditions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder
Musculoskeletal Diseases
Keywords: Collaborative Care Model
Case Manager
RCT
Feasibility
Mixed Methods
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Randomised Control Trial:

Following written informed consent, participants will be randomized in a 1:1 ratio (usual care: intervention) which will be undertaken via an online randomization software.

Sample:

It is proposed to recruit 40 patients in total, 20 randomized to each arm of the study. As the study is a feasibility trial, all analyses will be descriptive, with no hypothesis testing. As such no formal sample size calculation has been conducted.

All potentially eligible participants will be recruited through the direct clinical care team. Over 4,000 new patients are attending the therapies appointments annually and they need to complete the PHQ-ADS as a routine of their care.

Data collection:

Data will be collected through questionnaires administrated in clinical, telephone, or video calls according to participant preference and availability. At the eligibility assessment, the PHQ-ADS is collected as a routine of the outpatients setting.

Baseline data will be collected from participants on both arms, including demographic data (age, ethnicity, marital status, highest qualification level, employment status, type of musculoskeletal and mental conditions known and treatment), medical history and current medication using a tailored questionnaire.

The participant will also be asked to complete other quantitative measures at the baseline visit (approx. 50 minutes). This will include self-reported measures of depression, anxiety, pain, and quality of life. These questionnaires will also be completed on month 3 and 6 follow-ups, including any update on the current medication. Participants will stay in the study for a total of 6 months.

Interviews and Focus Group:

Once participant involvement in the study is complete to assess the acceptability of this model of care, participants from the intervention group will be invited to interviews, and health care professionals will be invited for a focus group. The interviews and focus groups will be optional.

Patient interviews will last for approximately 1 hour with some guided topics. The interview is planned to happen face-to-face at the RNOH. Nevertheless, due to COVID restrictions or participant preference, video or telephone interviews will also be available options. Interviews will avoid breaches of confidential material regarding participants' mental health conditions.

The focus group for staff will occur at the end of the RCT. There will be an estimated 6 to 10 members of staff in the focus group, and it will last for approximately 90 minutes. It will take place in RNOH and will be scheduled to suit staff availability. The trial aims to hold face-to-face focus groups but due to COVID restrictions, these focus groups will also be offered on an online platform. It is not expected for staff to attend more than one session, but the staff is welcome to attend another session if they have further feedback to contribute.

This data will give us a chance to understand the experience of being involved in the intervention group. The investigators would like to know the views, thoughts, and experiences of the participants; for example, their opinions on working with a Case Manager, potential advantages, and challenges.

Quantitative data analysis:

The primary analysis will estimate the number of potentially eligible participants, consent and overall uptake. The retention and adherence rates will be calculated in relation to the number of participants recruited. Standard deviations and confidence intervals of clinical outcomes will be calculated and used to determine which outcomes are most sensitive to change which will inform the sample size calculation for a future multi-centre RCT. The staff costs for the intervention group will be calculated using the National Cost index for the NHS.

A statistical analysis plan will be developed by the study statistician supported by SPSS software version 27.

Qualitative data analysis:

Focus groups and interviews will be transcribed in full (ipsis verbis) by an external company, checked for accuracy by a Principal Investigator and then imported into NVIVO version12 qualitative data analysis software, to aid management and indexing of data.

The analysis will begin shortly after data collection starts and framework analysis with Normalization Process Theory (NPT) will be used by the Principal Investigator (Jo). This type of analysis explains processes by which complex interventions become routinely embedded in health care practice. Transcripts from the participants and health care professionals will be analyzed separately. A subset of transcripts will be independently double coded by the other member of the research team and compared. Discrepancies will be discussed and resolved to achieve a coding consensus.

It is aimed to obtain a deeper understanding of the acceptability of the intervention, resources needed, and disclose potential barriers and facilitators from the participants' and health care professionals' points of view.

Eligibility criteria: 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Protocol adherence
timeFrame: 6 months
Secondary outcomes:
measure: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
timeFrame: pre-intervention, 3 months and 6 months
measure: Resourcing
timeFrame: month 6
measure: NPRS
timeFrame: pre-intervention, 3 months and 6 months
measure: Pain Disability Index (PDI) to assess pain
timeFrame: pre-intervention, 3 months and 6 months
measure: Quality of life validated Questionnaire EQ-5D
timeFrame: pre-intervention, 3 months and 6 months
measure: Physical health quality assessment validated questionnaire (MSK-HQ)
timeFrame: pre-intervention, 3 months and 6 months
measure: Global rating of change assessment validated questionnaire (GROC)
timeFrame: pre-intervention, 3 months and 6 months
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Iva Hauptmannova
state: London
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic NHS Trust, Brockley Hill
state: UK
Study officials:
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Parashar Ramanuj, MBBS
role: PRINCIPAL_INVESTIGATOR
References: