Clinical trial NCT02234284: Aides in Respiration Health Coaching for COPD
Official title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
Health Coaching
Health Disparities
Self-management
Chronic Disease Model
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-09-09
Enrollment: 192
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months

Detailed description: Health coaching is a promising model for improving evidence-based care for patients with COPD which had not been evaluated at the time the current study began in 2014. Health coaching by health workers or peers trained as coaches, has emerged as an effective model to improve these management domains for children with asthma and adults with diabetes, and hypertension receiving care in urban safety-net clinics. The role of the health coach includes many of the activities also provided by patient navigators, patient educators, and community health workers. Health coaching is a patient-centered model that recognizes that that people living with chronic disease are the primary decision-makers in their care; it is a tailored approach that builds on the strengths and expertise of patients and helps to ensure that they have the knowledge and skills to be active participants within the medical encounter and to effectively manage their conditions. Incorporating health coaches into care delivery fits well with the of integrated care model recommended by the American Thoracic Society which is based on the Chronic Care Mode. Health coaching can work on several components of the Chronic Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote patient goals. Health coaches provide decision support by helping execute customized care plans jointly developed by patients and providers. Coaches track care targets and conduct 'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the support they need by facilitating access to community, clinic, and specialist support, improving communication between patients and providers, working with patients to set goals and develop action plans to reach those goals. The goal of our study was to evaluate the effectiveness of a health coach model for improving outcomes for low-income urban patients with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual care (health coached arm) to usual care (usual care arm) alone for patients with moderate to severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of the study were:

Specific Aim 1. To compare disease specific quality of life for patients randomized to receive 9 months of health coaching plus usual care to those randomized to usual care alone. Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients in the health-coached arm when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the health coached arm to those in the usual care arm during the 9 month period starting at enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer exacerbations when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached arm to those in the usual care arm. Our hypothesis was that patients in the health-coached arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the health coached arm when tested against the null hypothesis of no difference in self-efficacy between health-coached and usual care patients.

Eligibility criteria: Inclusion Criteria:

* Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
* Age 40 and older
* Speaking English or Spanish
* Plan to continue to be seen at current clinic and to not leave the area for \>2 months anytime in the next 9 months or to be absent at 9 or 15 months
* COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) \<.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
* Willingness to attempt spirometry
* At least moderate COPD, defined as at least one of the following:

  * Ever Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted
  * 1 or more emergency department (ED) visit for COPD exacerbation in past 12 months
  * 1 or more hospital stays for COPD exacerbation in past 12 months
  * 1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12 months
  * Ever on home oxygen therapy
  * Ever outpatient percutaneous oxygen saturation of \</=88%
  * Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of \</=55mm Hg
  * At least 3 outpatient visits for COPD in past 12 months AND (a current COPD Assessment Test (CAT) score of \>/=10 OR an modified Medical Research Council (mMRC) score of \>/=2).
  * Currently using tiotropium inhaler or combination inhaled corticosteroid and long-acting beta agonist

Exclusion Criteria:

* Unable to participate in the study due to mental or physical impairment
* Severe or terminal illness that precludes focus on COPD
* No phone

Primary outcomes:
measure: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score
timeFrame: 9 months
measure: Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)
timeFrame: 9 months
Secondary outcomes:
measure: Rate of COPD Exacerbations Per Year
timeFrame: Over 9 month study period
measure: Exercise Capacity (6-minute Walk Test)
timeFrame: 9 months
measure: Self-efficacy to Manage Chronic Disease Scale
timeFrame: 9 months
Other outcomes:
measure: Short Version of the Patient Assessment of Quality of Care (PACIC)
timeFrame: 9 months
measure: COPD Assessment Test
timeFrame: 9 months
measure: Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)
timeFrame: 9 months
measure: Proportion (%) of Participants Reporting Current Cigarette Use
timeFrame: 9 months
measure: COPD-related Function (Bed Days Due to Respiratory Problems)
timeFrame: 9 months
measure: Proportion (%) of Participants Demonstrating Adequate Inhaler Use
timeFrame: 9 months
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 1
timeFrame: 9 months
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 2
timeFrame: 9 months
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 3
timeFrame: 9 months
measure: Proportion (%) of Participants With Correct Answer to Knowledge Question 4
timeFrame: 9 months
measure: Rate of Outpatient Visits
timeFrame: Over 9 month study period
measure: Rate of ED Visits for COPD
timeFrame: Over 9 month study period
measure: Rate of ED Visits Not for COPD
timeFrame: Over 9 month study period
measure: Rate of Hospitalization for COPD
timeFrame: Over 9 month study period
measure: Rate of Hospitalizations Not for COPD
timeFrame: Over 9 month study period
Locations:
city: San Francisco
country: United States
facility: San Francisco Departmen of Public Health Community Clinics
state: California
Study officials:
affiliation: University of California, San Francisco
name: David H Thom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3.
citation: Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y.
citation: Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
citation: Willard-Grace R, Chirinos C, Wolf J, DeVore D, Huang B, Hessler D, Tsao S, Su G, Thom DH. Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial. Ann Fam Med. 2020 Jan;18(1):5-14. doi: 10.1370/afm.2461.