Chronic Obstructive Pulmonary Disease, Multiple Comorbidity
Conditions
Keywords
COPD, case management
Brief summary
Many patients with chronic obstructive pulmonary disease (COPD) also have other diseases referred to as comorbidities. Often these patients require health care by a variety of health care professionals from services linked to hospitals and in the community. Unfortunately, sometimes it may be difficult for these patients to receive appropriate care in a timely manner resulting in a trip to the emergency department. As well, patients may benefit from education that enables them to recognize early signs indicating they are getting sicker and to self-manage their disease. Our study will examine a strategy that includes a case manager who will make weekly phone contact with COPD patients with comorbidity that present either to the emergency department or are admitted to hospital. Weekly contact will focus on teaching patients to recognize worsening symptoms and self-management strategies. The case manager will work with patients, caregivers, community health care providers and hospital specialists to promote communication and optimize care delivery. The investigators will examine the impact of our intervention on the need for emergency department visits and hospital admission. The investigators will also examine the impact on patients' health related quality of life, number of COPD exacerbations, and disease progression.
Interventions
BEHAVIORAL40 minute standardized education session
40 minute standardized education session based on the Living Well with COPD Patient's Education Tool on study enrolment to assess and improve understanding of disease and ability to monitor symptoms and recognize exacerbation
BEHAVIORALIndividualized care plan
Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
BEHAVIORALIndividualized action plan
Individualized action plan using the Living Well with COPD template with patient individualized modification to address management strategies for exacerbation of comorbidity developed during the initial 40 minute session with case manager.
BEHAVIORALStandardized reinforcement/motivational interviewing and action plan teach-back sessions
Standardized reinforcement/motivational interviewing and action plan teach-back sessions based on Living Well with COPD modules as well as assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions) (telephone script; NOTE: case managers will make up to 3 attempts to contact participants during each week of the 12 weeks of weekly phone calls before determining inability to contact the participant for that week.
BEHAVIORALTele-home monitoring
Tele-home monitoring of SpO2, weight, dyspnea, sputum quantity and characteristics, and general well-being for maximum of 6 months. Inclusion criteria for tele-home monitoring: a. compatible phone line b. patient consent c. patient or caregiver demonstrated ability to use monitoring equipment d. patient unable to attend outpatient/community appointments for assessment and monitoring because of environmental barriers to access (e.g. physician's office only accessible by stairs) e. severe dyspnea on activities of daily living (Medical Research Council Questionnaire for Assessing Severity of Breathlessness \[MRC\] Class 4 & 5 or modified MRC \[mMRC\] 3 & 4) f. frequent ED visits (\> 2) in last 12 months 5\. 12 weeks of clinical stability with no ED visits.
BEHAVIORALCoordinated and improved communication
Coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and Community Care Access Centres (CCACs) facilitated by the case manager. This will include phone contact by case manager to family physicians and CCAC case manager if applicable after initial enrollment, education session and development of action plan, then monthly to report general status as well as after subsequent ED presentations/hospital admissions
BEHAVIORALPriority access
Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
BEHAVIORALDictated patient summary
Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
BEHAVIORALin-hospital rehabilitation/self-management program
Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are: 1. have had a recent exacerbation, but are now clinically stable; 2. symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment; 3. have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and 4. have sufficient motivation to participate.
BEHAVIORALSmoking cessation
Referral to a smoking cessation program (as applicable)
BEHAVIORALAction plan Respirologist
Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
BEHAVIORALWeb based self management materials
Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)
Sponsors
Southlake Regional Health Centre
University of Toronto
Ontario Ministry of Health and Long Term Care
Michael Garron Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD defined as chronic irreversible airflow limitation with FEV1 \< lower limit of normal for age as % predicted and a FEV1/FVC ratio \< than lower limit of normal (usually 70%) \[5\] Plus ≥ 2 comorbidities commonly associated with COPD as identified in the Canadian Thoracic Society COPD guidelines\* 1. Cardiovascular disease 2. Osteopenia and osteoporosis 3. Glaucoma and cataracts 4. Cachexia and malnutrition 5. Peripheral muscle dysfunction 6. Lung cancer 7. Metabolic syndrome (diabetes mellitus) 8. Depression 9. Chronic kidney disease OR Other conditions as primary admitting/presenting diagnosis + COPD as significant comorbidity + ≥ 1 other comorbidity THAT 1. Get admitted to participating hospital; or 2. Present to participating hospital ED; or 3. Have first referral to Respiratory Centre/Respirology team AND HAVE 1. ≥ 1 ED presentation/hospital admission in previous 12 months 2. ≥ 50 years age
Exclusion criteria
1. No access to primary care physician 2. Primary diagnosis of asthma 3. Terminal diagnosis (metastatic disease with a life expectancy of ≤ 6 months) 4. Dementia and absence of family caregiver able to assist with activation of the action plan and feedback on ongoing status and care coordination 5. Uncontrolled psychiatric illness 6. Inability to understand, read, and write English 7. No access to a phone 8. Inability to attend follow up at one of the participating sites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of ED presentations | 1 year after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in COPD self-efficacy scale | baseline at 90 days, 6 months and 1 year | The COPD SES provides items with sufficient complexity in relation to the specific situation of managing with COPD. The CSES consists of Likert scale with 5 responses from very confident to not at all confident scoring 5 to 1 with 5 representing higher self-efficacy. |
| Patient satisfaction using the CSQ8 | 90 days, 6 months and 1 year | — |
| Caregiver impact (Caregiver Impact Scale) | at baseline, 6 months and 1 year | This questionnaire assesses the impact of caregiving on 14 different domains (health, employment, family relations), using a 7-point Likert scale. |
| Change in health-related quality of life | baseline at 90 days, 6 months and 1 year | Measured using the EQ5D, St George's Respiratory Questionnaire, Hospital Anxiety and Depression Scale (HADS) |
| Number of hospitalized days over 1 year | At one year after randomization | — |
| Time to death | During 12 months of intervention | — |
| COPD severity measured by the BODE index | at baseline, 6 months and 1 year | The BODE Index is a simple grading system for COPD comprising the Six Minute Walk Distance (6MWD), the Medical Research Council Dyspnea Scale (MMRC) and body mass index (BMI). |
| Hospital admission rates | 1 year after randomization | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to chronic disease management measures | at 1 year | smoking cessation status (if applicable), influenza and pneumonia vaccination, up-to-date documented action plan, electronic medication reconciliation |
Countries
Canada
Outcome results
None listed