The CCOPER trial - Version 2.0
Research type
Research Study
Full 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.
IRAS ID
301463
Contact name
Parashar Ramanuj
Contact email
Sponsor organisation
Royal National Orthopaedic Hospital NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Problems that affect the bones and muscles, called Musculoskeletal (MSK) problems, are the second most common cause of incapacity around the world. Mental health conditions, such as anxiety or depression affect one in six adults in England. Patients with both a physical and mental health diagnosis may be more difficult to treat in comparison to those with just a physical health condition. However, at present these patients do not typically have both conditions managed at the same time.This trial aims to evaluate if the Collaborative Care Model is a suitable and acceptable alternative to the usual care that patients with MSK and mental health conditions currently receive. The Collaborative Care Model is an alternative treatment to address physical and mental health needs and 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 will coordinate access to relevant professionals/services, manage appointments and monitor progress.
The current ‘usual care’ for these patients involves physical therapy and a referral to an internal psychiatric service if the therapist decides it is appropriate.
Patients who are or over 18 years old, with an MSK condition and with moderate to severe anxiety or depression; attending outpatients therapy services at the Royal National Orthopaedic Hospital, may be eligible. After patients give consent, they will be randomly allocated to receiving either usual care or collaborative care. All participants will take part for 6 months, with a follow-up at month 6. At the end of the study, there will be an optional interview for participants who are receiving collaborative care and a focus group for professionals who delivered the collaborative model. This is so that we can further explore the suitability of the collaborative care model.
Summary of Results
Summary
This document is the final report of a two-part study, to determine the practicality and acceptability of providing Collaborative Care for patients with musculoskeletal problems and moderate to severe levels of anxiety and depression in an outpatient setting at the Royal National Orthopaedic Hospital NHS Trust (RNOH).The first part of the study aimed to enrol RNOH outpatients with chronic musculoskeletal conditions with moderate or severe levels of anxiety and depression. Patients were t divided into two groups. One group was supported by a professional, called a case manager (20 participants). This professional assessed these patients' mental health, navigated them to some self-help resources and or referred them for appropriate professional psychology/psychiatry support, while the patients continued to receive physical therapy, also known as a Collaborative Care Model. The other group only received their physical therapy, called usual care (20 participants).
The second part of the study explored the opinions of both patients and professionals involved in the study about how the study was run and the collaborative care model intervention.2.1 Primary outcomes
Participation was defined as the number of patients who agreed to take part in the study, by providing written consent, out of the total number of eligible patients invited to take part.
The recruitment period occurred from 19th January 2022 to 19th May 2022. During this time, the Case Manager or Principal Investigator recruited participants on
1. Mondays, Wednesdays, and Thursdays (between 8 am to 5 pm)
2. Fridays (between 9 am to 1 pm)
This amounted to a total of 59.5 working days (around 438 hours).Results: Out of the 250 participants referred by clinicians and approached by the research team, 89 patients provided written consent (35.6%).
Recruitment - Our target was to recruit 40 patients who also had mental health symptoms (moderate or severe anxiety and depression levels).
Results: Out of the 89 patients who consented to the study, 40 (44.9%) participants were eligible and randomised. This means that they were separated by chance into two groups: 20 patients went under the collaborative care model and 20 under the usual care. This outcome, therefore, achieved the target.
Retention was defined as the number of participants who attended the 6-month follow-up assessments. It was expected to have 36 participants attending the six-month follow-up.
Results: 25 (62.5%) participants attended the 6-month follow-up. This included 12 (60%) participants under usual care and 13 (65%) participants under the collaborative care model.
37.5% of participants were withdrawn from the trial for several reasons such as stopping their participation in the trial or the research team was not able to contact them. The maximum withdrawal rate expected was 25%.Patient adherence to first and follow-up appointments was defined as the percentage of first and follow-up appointments attended out of the total number of booked appointments. The attendance at the monthly follow-ups with the case manager expected was (75%) has been recommended for successful trials.
Results: For participants receiving the collaborative care model (the intervention arm), participants attended 60 appointments of the 102 appointments booked. The overall adherence to appointments for participants receiving the collaborative care model was 58.82%. Three participants receiving the collaborative care model never attended any appointments.
Month 1 (n=12/17) - adherence rate 70.59% Month 2 (n=11/17) - adherence rate 64.70% Month 3 (n=10/17) - adherence rate 58.82% Month 4 (n=6/17) - adherence rate 35.29% Month 5 (n=9/17) - adherence rate 52.94% Month 6 (n=13/17) - adherence rate 76.47%Secondary outcomes
Completion of the clinical questionnaires There was a high completion rate of all clinical questionnaires at each follow-up appointment.
Results: 100% of forms were completed on the baseline and 6-month follow-up appointments for included participants.
During the interviews, 20 participants highlighted aspects relating to the form/questionnaires which could be improved in a future study:
1. Seven participants felt undecided about options.
2. Three participants had difficulty understanding some of the language used in the forms.
3. Four participants expressed that some forms were generic (creating a feeling of 'dehumanisation').
4. Two participants highlighted sensitive topics e.g., suicide, pain, and depression that can trigger negative emotions in patients.
5. Two participants suggested that future forms should have opened questions to give patients the opportunity to express their opinion and feelings.
6. One participant found the forms too long.Usage of additional healthcare resources This was defined as any unplanned service attendance related to their Musculoskeletal condition, including pain, or mental health conditions during the 6-month of the trial. This information was either self-reported by participants on the 6-month follow-up.
The 13 participants under collaborative care reported:
1. 29 appointments with their GP.
2. 15 appointments with a private physiotherapist.
3. 5 visits to A&E.
4. 1 appointment with an osteopath.
5. 1 appointment with a private psychologist.
The 12 participants under the usual care reported:
1. 21 appointments with their GP.
2. 10 appointments with a private physiotherapist.
3. 7 appointments with a chiropractor.
4. 6 sessions in a gym.
5. 4 visits to A&E.
6. 1 obstetric appointment (pregnancy during the trial).
7. 1 appointment with an NHS psychologist outside of the Trust.
8. 1 appointment with a private psychiatrist.Facilitators and barriers associated with the implementation of the collaborative care model There were several facilitators:
* The case manager's flexibility to make appointments outside of working hours.
* The case manager's personality was highlighted by all participants as a key to their adherence, mainly due to her ability to listen and not rush the appointments.
* The flexibility of providing these appointments in person or virtual (telephone or via Teams).
* Ability to book in-person appointments on the same day as visits to your therapists, avoiding extra visits.
* Possibility of receiving the forms/ questionnaires by email to fill out and return by free mail or deliver in person at the next face-to-face service.
* The option to use email to contact the case manager or principal investigator at any time.
* Support from all therapists during the recruitment process through their enthusiasm and belief in the benefits of the intervention.
* The suicidal ideation and risk of self-harm flowchart reassured participants that they would obtain support from a psychiatrist if they were at risk of suicide.
* The immediate reply of the psychiatric department when the risk of suicide was raised.The main barrier to the implementation of the Collaborative Care Model was the impossibility of booking the psychological appointments requested by the case manager, even after contacting the team of psychologists to prioritise study participants. Psychology appointments have several months of waiting lists. None of the participants had their first appointment during the trial, despite attempts by the case manager to chase these requests.
Acceptability of the collaborative care model and trial by patients Three of the 20 participants did not attend any appointment with the case manager. The other 17 participants under collaborative care stated that this type of intervention is essential. 25 participants accepted to participate in the interview: 13 participants under the collaborative care model and 12 under the usual care.
Benefits of participating in the trial shared during the interviews:
* Having someone to listen to them.
* The importance of emotional and mental health support (psychiatric support).
* Without the trial, two participants would commit suicide (one under usual care).
* The trial changed the participants' life for the better.
* The trial reduced loneliness and humanised care.
Disadvantages of participating in the trial:
* The need to use personal time to attend appointments with the case manager.
* The trial made a participant think about anger, which was uncomfortable for the participant.
The importance of the case manager's personality was key to maintaining engagement during the trial, as expressed by 16 of the interviewed participants. One participant was not satisfied with the trial. This is because the participant anticipated the case manager to track all participant's investigations and appointments and keep the participant updated, but that did not happen.Acceptability of the collaborative care model and trial by clinicians Eight out of 20 potential healthcare professionals participated in the focus groups. All participants agreed that the trial was essential, describing some reasons:
* To bring more evidence to something that everyone knows to be a problem: patients with musculoskeletal problems need more mental health support.
* To provide a service that permits the ability to see the person as a whole.
* To highlight the importance of the anxiety and depression risk levels to their practice.
* The usefulness of the suicide flowchart to understand the different referral paths.
* To make them think they need formal mental health training.
* To emphasise limited local mental health services.
* To think about better communication between all professionals involved in patient care.
Overall, all clinicians stated that the trial was a very positive experience for them.
However, none of the clinicians was aware of which patients has been allocated to the case manager (collaborative care model). Although these clinicians knew which patients had a risk of suicide, they received no further information about how the patient was progressing in their care plan or if any referral was sent to the mental health services. Clinicians, therefore, expressed they would have liked the case manager to share more about the patients under her care. They never had a formal meeting with the case manager.Assess staff cost needed to implement the collaborative care model We used the National Cost Index (NCI), a measurement of the relative cost difference between NHS providers, as well as the cost per hour of the Case Manager, as this role is not part of the NCI. Only 13 out of 20 participants were included, participants that attended the 6-month follow-up.
Case manager appointments costs
The Case Manager was paid £17.24 per hour. 62 appointments were delivered: face-to-face (30); via Teams (19) and by telephone (13). A total of 65 hours amounted to a cost of £1120.6. However, the time used to book or reschedule appointments was not included in this figure.
Physiotherapists costs
Participants had appointments with clinicians in different professional bands. The band determine the level of pay for a job role, with a range of salaries within each band. However, most of the clinicians were 'Band 6' and the intermediate step of £18.19 was used to calculate the costs. The time used to book or reschedule appointments was not included.
In total, 34 appointments were attended by the 13 participants under the collaborative care month by month 6. This included 13 first appointments lasting one hour each and 21 follow-ups of 30 minutes. This time amounted to a total of 23.5 hours = £427.46 Occupational therapist - This service was not used in the intervention arm.
Mental health specialist - psychiatric
Five face-to-face appointments were attended by participants receiving the collaborative care model, where each session lasted an average of one hour. The cost is £371.30 for a first appointment, therefore the total cost for the psychiatrist was £1856.5.
Mental health specialist - psychologist - 7 appointments requested. However, they were never booked.
The total cost of the collaborative care model (including all the staff/specialities mentioned above) was £ 3404.56 over 6 months (£43.65 per month per participant).2 Conclusions
This was the first trial to investigate the use of the Collaborative Care Model for people with musculoskeletal and co-existing moderate or severe levels of anxiety or depression. The results obtained provided important evidence that this novel model is feasible and worth further investigation in the future.
The main results show that patients want to take part in this type of study as they foresee these studies as beneficial to their mental health, even for individuals under the usual care. All participants (patients and clinicians) highlighted the benefits of the trial.
The recruitment rates are clear evidence of patients' adherence to the trial. Retention numbers were lower than expected. However, part-time roles made it difficult to approach all potential participants as well as working hours. Some potential participants were not approached as not all working days were covered. Moreover, it required working overtime, as some participants could only attend to follow-up after their working day. Nevertheless, it was clear that participants under collaborative care used more unplanned health services. An overview of the cost was calculated for the participants retained.
Limitations
Not booking psychological appointments was the main limitation of this feasibility study since the support of the key health professionals involved in the collaborative care model failed. Another limitation was the lack of communication between the case manager and the clinicians.3 Recommendations
Future trials must have allocated two full-time team members to perform recruitment and follow-ups. In addition, flexible working hours are required to recruit and follow-up to reassure that all patients have the same opportunity to participate in the trial.
Furthermore, a clear description of the case manager role is required, including frequency and type of strategy required with the clinical team to reassure transparent communication.
A formal and signed agreement must be in place to reassure that participants are prioritised by the psychology department. Alternatively employing a part-time psychologist to support a future trial may be required so that participants receive timely psychological support.
A better understanding of participants under the collaborative care model accessing more health care services should be explored. A more robust retention strategy which may include timely reminders, and financial incentives may need to be considered for a future trial.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0257
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion