Feasibility and Acceptability of Collaborative Care for People With Musculoskeletal and Mental Problems

NCT05018039 | Unknown

• 1 other identifier: 21.06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Disorder; Musculoskeletal Diseases

Keywords

Collaborative Care Model; Case Manager; RCT; Feasibility; Mixed Methods

Outcome Measures

Primary Outcomes (3)

• Number of participants

  Number of participants consented as a proportion of the number of patients eligible and invited.

  6 months

• Retention

  Number of participants ending the trial as a proportion of the number of patients recruited.

  6 months

• Protocol adherence

  Percentage of appointments attended as a proportion of booked appointments (%)

  6 months

Secondary Outcomes (7)

• 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

• Pain Disability Index (PDI) to assess pain

  pre-intervention, 3 months and 6 months

• Quality of life validated Questionnaire EQ-5D

  pre-intervention, 3 months and 6 months

Study Arms (2)

Collaborative care model

EXPERIMENTAL

Collaborative care involves three professionals: a physical health care provider (physiotherapist or occupational therapist), a mental health care provider (psychologist or psychiatrist) and a case manager. The case manager will work closely with the patient to identify the mental health support necessary. This may involve appointments with a psychologist or psychiatrist as part of their musculoskeletal treatment. The case manager will define a treatment plan and organise appointments with the patients and monitor their progress using validated questionnaires, adjusting their mental or physical care support when required. This professional will also monitor patients' attendance and support managing their appointments and routinely update the clinical team on patient progress, and relaying information back to the clinical team. This model of care will work in parallel to the regular musculoskeletal appointments with the physiotherapist and/or occupational therapist (usual care).

Other: Collaborarive Care Model

Usal Care

NO INTERVENTION

Current usual care within musculoskeletal outpatients involves an initial patient assessment by a physiotherapist or occupational therapist (or both) to determine the needs and goals of the patient in relation to their musculoskeletal condition. Clinicians also help to inform, educate, and empower patients to self-manage their rehabilitation where possible. Following this initial assessment, patients are provided with a plan of their therapy treatment. The therapist(s) progress patients exercise, as appropriate. Therapy is most often a 1:1 session but can also include group classes. Physical therapy involves exercise and education, while occupational therapy focuses on practical strategies to perform daily tasks. If the therapists feel that patients require additional support for their mental health problems, they can request this support via the General Practitioner or the hospital mental health services.

Interventions

Collaborarive Care Model OTHER

Collaborative care involves three professionals: a physical health care provider (physiotherapist or occupational therapist), a mental health care provider and a case manager. The case manager will work closely with the patient to identify the mental health support necessary. This may involve appointments with a psychologist or psychiatrist as part of their musculoskeletal treatment. The case manager will define a treatment plan and organise appointments with the patients and monitor their progress using validated questionnaires, adjusting their mental or physical care support when required. This professional will also monitor patients' attendance and support managing their appointments and routinely update the clinical team on patient progress, and relaying information back to the clinical team. This model of care will work in parallel to the regular musculoskeletal appointments (usual care).

Collaborative care model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal National Orthopaedic Hospital NHS Trust: lead

Study Sites (2)

Iva Hauptmannova

Stanmore, London, HA7 4LP, United Kingdom

NOT YET RECRUITING

Royal National Orthopaedic NHS Trust, Brockley Hill

Stanmore, UK, HA7 4LP, United Kingdom

RECRUITING

Related Publications (1)

• Teixeira MJC, Ahmed R, Tehrany R, Jaggi A, Ramanuj P. Collaborative care model versus usual care for the management of musculoskeletal and co-existing mental health conditions: a randomised feasibility mixed-methods study. BMJ Open. 2024 Feb 21;14(2):e079707. doi: 10.1136/bmjopen-2023-079707.

  PMID: 38387980 DERIVED

MeSH Terms

Conditions

Mental Disorders; Musculoskeletal Diseases

Study Officials

• Parashar Ramanuj, MBBS

  Royal National Orthopaedic Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iva Hauptmannova, MA

CONTACT

0208 909 5529; iva.hauptmannova@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Innovation Centre

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 24, 2021
• Study Start: January 30, 2022
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)