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Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PICCOPD+)

M

Michael Garron Hospital

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease
Multiple Comorbidity

Treatments

Behavioral: Smoking cessation
Behavioral: Priority access
Behavioral: Tele-home monitoring
Behavioral: Individualized action plan
Behavioral: Web based self management materials
Behavioral: in-hospital rehabilitation/self-management program
Behavioral: Individualized care plan
Behavioral: Standardized reinforcement/motivational interviewing and action plan teach-back sessions
Behavioral: Coordinated and improved communication
Behavioral: Action plan Respirologist
Behavioral: 40 minute standardized education session
Behavioral: Dictated patient summary

Study type

Interventional

Funder types

Other

Identifiers

NCT01648621
TEGH001 PIC COPD

Details and patient eligibility

About

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.

Enrollment

470 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

470 participants in 2 patient groups

Case Management
Experimental group
Description:
In addition to usual care, the intervention group will receive case management that includes: 40 minute standardized education session, an individualized action plan, an individualized care plan for management of COPD and comorbidities, standardized reinforcement/motivational interviewing and action plan teach-back sessions and assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions), tele-home monitoring, coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and CCAC facilitated by the case manager, priority access to ambulatory clinics.
Treatment:
Behavioral: Priority access
Behavioral: 40 minute standardized education session
Behavioral: Dictated patient summary
Behavioral: Individualized action plan
Behavioral: Standardized reinforcement/motivational interviewing and action plan teach-back sessions
Behavioral: Smoking cessation
Behavioral: in-hospital rehabilitation/self-management program
Behavioral: Individualized care plan
Behavioral: Coordinated and improved communication
Behavioral: Tele-home monitoring
Usual care
Active Comparator group
Description:
Usual care for these patients comprises: Dictated patient summary, referral to an 8 week in-hospital rehabilitation and self-management education program, referral to a smoking cessation program (as applicable), individualized action plan developed with treating respirologist at the discretion of the attending respirologist, Referral to web based educational materials and resources.
Treatment:
Behavioral: Action plan Respirologist
Behavioral: Dictated patient summary
Behavioral: Web based self management materials
Behavioral: Smoking cessation
Behavioral: in-hospital rehabilitation/self-management program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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