Comprehensive Self-management Support for COPD Patients
Comprehensive Self-management Support for COPD Patients
The study team will adapt and expand an effective model of asthma self-management support for
 patients with chronic obstructive pulmonary disease (COPD). In this new model, community
 health workers will comprehensively screen for and address barriers to effective COPD
 self-management, including maladaptive coping behaviors, and guide patients through
 home-based pulmonary rehabilitation. Feasibility of the new model will be assessed in
 preparation for a fully powered, multisite randomized trial.
Phase II will focus on intervention implementation and evaluation (months 13-36).

 The research team will randomize 58 COPD patients (29 per arm) to the SaMBA-COPD intervention
 or an attention control and follow them for 9 months to assess health and self-management
 behavior (SMB) outcomes.

 Intervention:

 Step 1: Outreach and Engagement. The project manager will notify the City Health Works (CHW)
 supervisor when an eligible and consented patient is randomized to receive care the
 intervention and will provide the patient's name and contact information. The CHW will call
 the patient within 7 days of consent to schedule a home visit. The CHW will encourage
 caregivers to join all meetings.

 Step 2: Intake. The CHW will perform an intake interview that includes collection of basic
 information about the patient and their health and healthcare, including medications,
 intended to enable them to understand their health problems and provide them with chronic
 illness self-management support.

 Step 3: Symptom assessment, medication adherence, and inhaler technique. The CHW will assess
 the patients' symptoms, adherence to medications, and check inhaler technique following a
 standardized protocol, and correct errors in inhaler use if identified.

 Step 4: SMB barrier screening with the Screener. The CHWs will assess barriers to good SMB
 that lie within 4 domains: 1) social context, 2) physical health and functioning, 3)
 cognitive factors, and 4) psychological factors. To assess elements in each domain, the study
 team will use questions drawn from validated surveys used in the study team's research and in
 the SAMBA screening tool. Screening questions are a part of the study intervention, of which
 they consented to in the research consent. Examples of barriers follow:

 1. Social context. Factors include adequacy of social support, financial and access
 concerns (costs, insurance, pharmacy convenience), language and literacy skills, coping
 with illness, alcohol and drug use, and use of culturally-rooted therapies like herbals
 and spiritual remedies.

 2. Physical health and functioning. These include physical functioning and medication
 concerns (e.g., side effects, multiple medications).

 3. Cognition. The CHW will screen for cognitive impairment with the validated Quick mild
 cognitive impairment screen (QMCI) because cognitive impairment may challenge their
 ability to perform SMB.

 4. Psychology. Factors include depression and anxiety, and maladaptive beliefs about COPD
 and COPD medications.

 Step 5: Addressing identified barriers. Each identified barrier links to a menu of actions
 for the patient and CHW to employ to resolve or work around it. Other actions may be
 identified by patient or CHW and pursued if desired. Wherever appropriate, the CHW will
 engage the patient's physicians and or a social worker to enact some of the action steps.
 Examples of barriers follow:

 1. Social context barriers. Examples of actions include enrolling the patient in the New
 York State pharmaceutical assistance program to reduce drug costs or ask physicians to
 consider generic or formulary approved alternatives. If retrieving or renewing
 prescriptions is a problem, the CHW may pick up the medication or arrange delivery. The
 CHW can contact the physician to request a renewal if needed, and refer the patient to a
 social worker for assistance with home aid services, entitlements, insurance matters,
 and assistance when second hand smoke is a problem.

 2. Physical health and functioning barriers. Examples include asking the physician to
 consider reducing medicines if the patient finds the regimen too burdensome, requesting
 occupational or physical therapy to address physical limitations, or engaging the social
 worker to arrange transportation.

 3. Cognition barriers. The study team will specifically target memory but also use
 strategies to compensate based on type of impairment, including medication organization,
 slower-paced and explicit verbal instructions, use of tangible external aids, repetition
 and teach-back, use of plain language, and guided imagery to reduce cognitive load. Such
 strategies have been shown to improve SMB in low-literacy populations. The CHW may have
 more frequent encounters (in-person, phone) with memory impaired patients. Daily cell
 phone text reminders are another option that patients can select when memory problems
 impact regular medication use.

 4. Psychological barriers. The CHW will notify the PCP if a participant voluntarily
 divulges any feelings of depression or anxiety. The PCP may evaluate and treat or refer
 to a mental health specialist.

 COPD action plan and medication rescue pack. The study team will obtain consent from each
 patient's primary care provider to have a pharmacist counsel patients about rescue
 medications (oral steroids and antibiotics, "rescue pack") to be used in the event of an
 exacerbation of COPD. This consent will be obtained at the time of obtaining consent from the
 physician to recruit the patient for study participation. If the physician provides consent
 to recruit the patient but refuses consent to counsel the patient about the rescue pack, the
 patient will receive all intervention components with the exception of rescue pack counseling
 by a pharmacist.

 For patients for whom the study team have consent from the PCP to provide counseling about
 the rescue pack, the CHW will suggest to the patient that they meet with the pharmacist. The
 meeting will be voluntary. For patients who agree, a referral will be made to the pharmacist
 and a visit scheduled, to take place in a clinical setting. The pharmacist will counsel the
 patient on the use of the rescue pack. If the patient agrees to receive a rescue pack, the
 pharmacist will place an order in the Epic electronic health record for the rescue pack
 medications, then pend and route the order to the patient's PCP. The PCP can choose to sign
 the order, cancel or delete it. The pharmacist will check to determine whether the
 prescription order was signed by the PCP. If it was not, the pharmacist will assume that the
 physician does not wish to provide the patient a rescue pack prescription. If the
 prescription order was signed by the physician, the pharmacist will contact the patient 7-10
 days later to determine whether the patient picked up the medication and to ensure that the
 patient understands when and how to use the medications appropriately, and will notify the
 CHW that the patient received the medications. The CHW will discuss the use of the rescue
 pack medications with the patient at subsequent encounters to ensure that they continue to
 understand how to use them appropriately. Should the patient use the medications, the CHW,
 pharmacist, and or patient will notify the PCP, who will be encouraged to follow up with the
 patient.

 Step 6: Home-Based Pulmonary Rehabilitation Protocol (HBPR). HBPR will be available to all
 patients who are able to ambulate with or without an assistive device (cane or walker),
 regardless of supplemental oxygen use. If the patient expresses interest in HBPR, the CHW
 will schedule the appointment and accompany the patient and caregiver (if available) to a
 clinical practice at the Mount Sinai Hospital. The patient will undergo a standard evaluation
 by a licensed respiratory therapist employed by Mount Sinai Hospital to develop the HBPR
 prescription. The evaluation will have two components, assessment of aerobic capacity using
 the 6-minute walk test (6MWT), and an assessment of muscular strength using elastic
 resistance bands. Target exercise intensity for HBPR will be set at 60-80% of the maximum
 work rate achieved during the 6MWT, a conservative goal intended to achieve benefit while
 minimizing risk of fatigue and shortness of breath. The therapist will select an appropriate
 band for home use for strength training exercises. During the evaluation, the respiratory
 therapist will monitor the patient's oxygen saturation, blood pressure, heart rate, and
 respiratory rate.

 During the home visit that follows, the CHW will provide a timer, a pedometer to measure
 steps, an elastic resistance band, and an exercise diary. They may also provide the patient
 with an ergo cycle to enable them to conduct the aerobic exercises sitting down if walking is
 too burdensome or the patient is considered to be at high fall risk. The CHW and patient will
 consider the space available for exercise, such as a hallway, common space in the building
 (e.g., lobby, gathering room, etc.), outdoors during favorable weather, and local facilities
 like senior centers or churches. Once the area for exercise is selected, the CHW will
 demonstrate the walking and resistance training routines and observe the patient perform them
 on his/her own. The two will set a schedule for exercising and post the schedule and
 instructions prominently in the home.

 Resistance training will consist of a simple routine of upper extremity extension and
 abduction movements with the elastic band. Each movement will be performed in 3 sets of 10
 repetitions (15 minutes). The walking routine will last 20-40 minutes and the patient's pace
 will be guided by an audible click from the timer that is set by the CHW. The patient will be
 asked to perform the complete exercise routine 6 days a week. The CHW will directly supervise
 the patient multiple times over the 6-month intervention period. She will call periodically
 to support the patient when she is unable to visit.

 The respiratory therapist will oversee the HBPR work of the CHW. This will include reviewing
 all cases in person or by phone every 7-14 days. Patients will be asked to reduce the
 intensity of exercise or rest for 5-10 minutes if they develop an uncomfortable level of
 shortness of breath or fatigue, and to stop exercising if they have symptoms that cause
 distress or discomfort and do not resolve after rest. Low literacy education methods will be
 used to ensure their understanding and retention of these instructions. The CHW will maintain
 communication with the therapist by HIPAA compliant secure email and telephone to report
 patient performance, trouble shoot problems, and to receive continuing education.

 Step 7: Follow-up and Maintenance. The CHW will recommend that in-person meetings occur 1, 4,
 8, and 12 weeks after intake and telephone follow-ups weekly through week 8 and monthly
 thereafter until month 6 when the intervention ends. Calls may be made more often to
 cognitively impaired patients to enhance information retention. Importantly, the patient and
 CHW will have the flexibility to tailor the number and frequency of encounters as they see
 fit. During follow up the CHW will assess patients' progress with SMB, their goals, and their
 symptoms.

 Step 8: Graduation. SaMBA-COPD patients will receive a certificate upon program completion.
Inclusion Criteria:

 -  Age >40 years

 -  Chart-document severe or very severe COPD (FEV1<50% predicted) or COPD-related
 ED/hospitalization ≥ 1 visit within the past 12 months

 -  Prescribed any daily medication for COPD, English or Spanish speaking, Smoking history
 ≥ 10 pack-years

 Exclusion Criteria:

 -  Diagnosis in the clinical record of dementia, because the study focuses on patients
 with capacity to independently perform self-management tasks.