"Consultation Liaison and Integrated Care for COPD Patients With Psychiatric Co-Morbidity"
Condition: Chronic Obstructive Pulmonary Disease; Anxiety; Depression
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) stands out among chronic diseases with its high
      and rising prevalence and mortality, poor quality of life, high re-hospitalization rates and
      societal burden of care. Current therapeutic and management practices are generally met with
      limited success. Research in recent years have highlighted the high level of psychiatric
      co-morbidity in COPD patients, and the major prognostic significance of anxiety/depression in
      COPD outcomes such as re-hospitalization, smoking cessation, quality of life, and survival.
      This suggests that addressing psychiatric and psycho-social aspects of care prominent in COPD
      patients may have strongly positive impact on outcomes, but the available evidence of
      effectiveness is limited.

      The primary aim of the proposed research is to evaluate the effectiveness of a holistic
      disease management paradigm of psychiatric liaison consultation (CL) that integrates
      psychiatric and respiratory care to improve outcomes for COPD patients. This integrated
      psychiatric consultation liaison (IPCL) management paradigm includes the routine screening
      and structured collaborative care of anxiety and major depressive symptoms and
      depressive/anxiety disorder in COPD patients. We postulate that the IPCL care paradigm would
      reduce mood symptoms, increase smoking quit rates, reduce symptom burden and functional
      disability, and improve quality of life, while reducing rehospitalization, emergency
      department (ED) and unscheduled physician visits. A secondary aim is to evaluate its cost
      effectiveness by concurrently collecting resource utilization data.
    

Detailed description: 
      Specific Aims

      The aim of the proposed research is to evaluate the effectiveness of a holistic disease
      management paradigm of) that integrates psychiatric and respiratory care (Integrated
      Psychiatric Consultation Liaison, IPCL) that addresses the high level of psychiatric
      co-morbidity in COPD patients to improve COPD outcomes.

      Methods

      Patient population Inpatients and specialist outpatients with established clinical diagnosis
      of chronic obstructive pulmonary disease (COPD).

      Settings

      Hospital based specialist outpatient and inpatient acute care and step-down care facilities
      in four hospitals (NUHS, AH, SGH and CGH) and one community hospital (SLH).

      The site PIs from each hospital are Lim Tow Keang (NUHS),Loo Chian Min (SGH),K. Narendran
      (CGH), Gerald Chua (AH) and Tan Boon Yeow (SLH).

      Study design Parallel group, randomized, controlled trial.

      Eligible individuals are randomly assigned (1:1 ratio) to either:

        1. Integrated Psychiatric Consultation Liaison (IPCL) care (N=450);

        2. Usual care. Patients in this group will receive usual standard care (N=450).

      Baseline screening and assessment. Prior to randomization to either IPCL or UC arm, COPD
      patients are screened for anxiety /depression using the Hospital Anxiety and Depression Scale
      (HADS, see below for details).21.For patients with high HADS scores(≥8), a semi-structured
      diagnostic assessment will be immediately performed using Structured Clinical Interview for
      DSM-IV Axis I Disorders (SCID-I for DSM-IV22 by an advanced practice nurse (APN) and the
      provisional diagnosis of anxiety and/or major depressive disorder will be confirmed by a
      psychiatrist, Cases with significant anxiety or depressive symptomatology that do not meet
      DSM-IV threshold criteria are classified as subsyndromal cases.

      Randomization. After informed consent is signed and patient eligibility is confirmed, the
      patient will be randomized in a 1:1 ratio to either the intervention arm receiving IPCL care
      or the control arm receiving usual care. Stratification by center is used to ensure balance
      between the two arms across centers. Random permuted blocks are used to ensure balance over
      time. The block length is determined by the study statistician. The patient will be assigned
      an individual number upon randomization. This assigned randomized number will identify the
      patient and will be used for all documentation for this patient in this study. The list of
      randomizations will go through Singapore Clinical Research Institute (SCRI). Randomization
      may be done via the following options: (i) Direct web randomization: Authorized study center
      personnel will randomize the patient via a password-protected internet web site available 24
      hours a day; (ii) Envelope Randomization: In case of web downtime due to technical error,
      site personnel may randomize patients using the back-up envelopes that will be provided upon
      activation of the site.

      IPCL Care Group For patients who are randomly allocated to the IPCL arm,

        1. Routine active screening and diagnosis of psychiatric co-morbidity using HADS followed
           by appropriate SCID interview by a trained APN, and confirmation by a consultant
           psychiatrist, will be performed at 3 monthly intervals during unscheduled and scheduled
           outpatient consultation or follow up visits and at each hospital admission.

        2. The appropriate management of psychiatric and psycho-social problems will be performed
           by a multi-disciplinary care team that includes the respiratory physician, psychiatrist,
           advanced practice nurse and nurse clinicians

        3. The APN and nurse clinician perform critical roles as case manager and patient educator.
           Psychoeducation is a critical care process component that will aim to ensure that the
           majority (over 70%) of COPD patients in the IPCL group with psychological symptoms will
           accept psycho-social and psychiatric care, in contrast to a large majority of patients
           who will conventionally refuse care, particularly in the UC group.

        4. The treatment of cases will accord with recommended treatment guidelines for
           anxiety/depression, and individualized for each patient according to a treatment plan
           drawn up by the psychiatrist, with the agreement of the respiratory physician. Treatment
           and care management of mild depressive symptomatology, psycho-social problems, or severe
           major depression and/or anxiety disorder will include appropriate pharmacologic and/or
           non-pharmacologic therapies (such as cognitive and/or behavioural therapy) and
           psycho-social support.

        5. Where pharmacologic treatment is indicated, the preferred drugs are SSRI antidepressants
           prescribed according to local standard dosages. The recommended first line of treatment
           is Fluoxetine, a dose of 20 mg/day or Escitalopram (10 to 20 mg/day). Alternatively,
           patients who do not respond to Fluoxetine or Escitalopram after 4 weeks, or who have
           intolerable side effects may be prescribed Venlafaxine XR, 75/mg/day, increased to
           150-225 mg/day OR Mirtazapine (15mg/day, increased to 30-45 mg/day). If no response,
           mood stabilizer or electro convulsive therapy (ECT) or psychosocial intervention will be
           added on with the medication (Figure 2).

        6. Non-drug psychotherapy will be provided either by the psychiatrist or psychological
           counselor where appropriate (for most patients with only depressive or anxiety
           symptomatology).

        7. The case manager will liaise with medical social worker for financial and other
           community services support.

        8. The nurse educator will provide standard patient education and behavioural modification
           including information about disease and medications for both COPD and depression, and
           changing attitudes and behaviour particularly in regard to smoking cessation and
           medication adherence, and general psycho-social supportive counseling.

        9. Appropriate existing and redesigned treatment algorithms and management protocols will
           be put together and provide a sourcebook for drawing up individual care plans.

       10. Routine monitoring and outcomes assessments is integrated as part of IPCL care and
           performed at 3 or 6 monthly intervals as appropriate: these include perceived symptoms
           of breathlessness, exercise tolerance, spirometric measurement (12 month), smoking
           cessation, HADS, SGRQ quality of life, acute COPD exacerbations, rehospitalization(s),
           emergency department visits, and unscheduled physician visits etc.(see schedule).

       11. Ad hoc follow up visits are scheduled at any appropriate times for therapeutic
           monitoring and responses.

       12. The management of COPD will proceed as usual according to standard clinical practice for
           COPD.

      Usual Care Control Group. For patients who are randomly allocated to the UC Control Group,

        1. The presence of psychiatric co-morbidity will be identified under standard conditions by
           usual care team, with the appropriate psychiatric consultation-liaison referrals and
           treatment effected as deemed necessary.

        2. Treatment and care management of psychiatric and psycho-social problems will include
           appropriate pharmacologic and/or non-pharmacologic therapies and psycho-social support,
           in accordance with standard recommended guidelines and practices for both COPD and
           anxiety/depression.

        3. The assessment of trial outcomes performed at 3 or 6 monthly intervals as appropriate
           (perceived symptoms of breathlessness, exercise tolerance, spirometric measurement,
           smoking cessation, HADS, SGRQ quality of life, acute COPD exacerbations,
           rehospitalization(s), emergency department visits, and unscheduled physician visits
           etc.) is also performed, but is not an integral part of Usual Care.

        4. Ad hoc outpatient follow up visits are scheduled at any appropriate times for
           therapeutic and other care monitoring and responses.

        5. The management of COPD will proceed as usual according to standard clinical practice for
           COPD.

      To mimic prevailing conditions of healthcare financing and delivery, payments for referrals
      to hospital psychiatrists for treatment, drugs and psychotherapy, regardless of allocation to
      IPCL or UC group, will be borne by the patients using existing avenues of health service
      financing (Medisave, Medishield, and/or out-of-pockets) as appropriate.

      Trial related scheduled assessments of outcome measures All participants in both IPCL and UC
      control arms will be assessed at baseline, 3 months, 6 months, 9 months and 12 months for the
      following trial related outcomes. We define loss to follow-up (LTFU) as incomplete
      ascertainment of the primary outcome for subjects randomized in the trial. Operationally,
      LTFU is defined as absence from at least 2 consecutive assessments (>6 months).

      Statistical Analysis

      Primary effectiveness end-points

        -  HADS score

        -  Breathlessness (MRC Index)

        -  Six-minutes walking distance

        -  Borg's scale

        -  FEV1, FEV1/FVC, PEFR, SpO2

        -  BODE Index

        -  Smoking quit rates

        -  Functional health and quality of life (SGRQ scores, CAT score, quality-adjusted life
           years (QALY))

        -  Acute COPD exacerbations

        -  Emergency department visits

        -  Unscheduled physician visits

        -  Re-hospitalization(s)

      Secondary effectiveness end points:

        -  Resource use and direct costs of care:

        -  1. Resource use include inpatient service use (No. of times hospitalized and total days
           in hospital) , outpatient service use (physician visits consisting of GP visits and
           specialist visits,) and medication use( usage of any or specific drug classes)

        -  2. Direct costs of care include costs for outpatient medical and mental health care,
           inpatient medical and mental health services and medication.

        -  Mortality

        -  COPD medication adherence

        -  Psychiatric medication adherence
    

Intervention name(s): Integrated care; Usual control
Intervention type(s): Procedure; Procedure
Intervention description(s): Integrated care will be provided with management of multifaceted group including, nurse educators, doctors, case manager and psychologists.; Usual control group will be provided with usual standard procedures for management of COPD and psychiatric comorbidities.
Other intervention name(s): IPCL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: COPD; Integrated care; IPCL