"Consultation Liaison and Integrated Care for COPD Patients With Psychiatric Co-Morbidity"
"Consultation Liaison and Integrated Care for COPD Patients With Psychiatric Co-Morbidity"
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.
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
Inclusion Criteria:

 -  Inpatients and specialist outpatients from: NUHS, SGH, CGH, SLH and AH.

 -  Clinical diagnosis of chronic obstructive pulmonary disease (COPD) based on history,
 physical examination, spirometry, measurement of arterial blood gases, and chest
 radiographs, that meets the criteria for COPD as defined in the Global Initiative for
 Chronic Obstructive Lung Disease (GOLD).

 -  COPD patients include cases of all grades of severity, and co-morbidity, without
 restriction.

 -  Participants provide written informed consent.

 Exclusion Criteria:

 -  Known diagnosis of a psychiatric disorder that is under treatment.

 -  Terminally ill COPD patients who are unable to complete baseline assessments.