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Implementing a Pragmatic Trial of Physical Activity Coaching in COPD

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"Lessons Learned with Implementing a Pragmatic Trial of Physical Activity Coaching in COPD"
Huong Q. Nguyen, PhD, RN
Research Scientist, Kaiser Permanente
Affiliate Associate Professor, University of Washington

A presentation of the Southern California Regional Dissemination, Implementation and Improvement Science Webinar Series.

Provided by the UCLA CTSI

Published in: Education
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Implementing a Pragmatic Trial of Physical Activity Coaching in COPD

  1. 1. Lessons Learned with Implementing a Pragmatic Trial of Physical Activity Coaching in COPD Southern California Regional Dissemination, Implementation and Improvement Science Webinar Series April 5, 2017 Huong Q. Nguyen, PhD, RN Research Scientist, Kaiser Permanente Southern California Affiliate Associate Professor, University of Washington Kaiser Permanente Research
  2. 2. Agenda  COPD Care in the Current Health Policy Landscape  Gaps in the Evidence Base for COPD Self- Management  Lessons Learned in Generating Real-World Evidence via a Pragmatic Trial of Physical Activity Coaching 2 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  3. 3. External Health Policy Pressures 3 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 CMS Readmissions Reduction (2015) HEDIS Hospitalization for Potentially Preventable Complications (2017) (Ambulatory Care Sensitive Conditions, ACSC) Chronic ACSC: COPD, asthma, diabetes, HTN, HF Acute ACSC: pneumonia, UTI, cellulitis, pressure ulcer
  4. 4. Chronic Care Model System Design 5.Decision Support 6. Clinical Information - Management Support 2. Health System Resources and Policies 1. Community Organization of Health Care Informed, Activated Patient Productive Interactions Prepared, Productive Interactions Informed, Activated Patient Prepared, Proactive Practice Team Self- Management Support Decision Support Clinical Information Systems Resources and Policies Community Health System Organization of Health Care Delivery System Design Assess Advise AgreeAssist Arrange Functional and Clinical Outcomes http://www.improvingchroniccare.org/
  5. 5. Self-Management Support “the systematic provision of education and supportive interventions by health care staff to: increase patients’ skills and confidence in managing their health problems, including regular assessment of progress and problems, goal setting, and problem-solving support.” ~ Institute of Medicine, 2004, Quality Chasm Summit
  6. 6. Multi-morbidity in COPD (+4) Vanfleteren et al (2013) AJRCCM 187(7):728
  7. 7. Convergence >> Inactivity-Deconditioning Substantial loss in lung function Anxiety Social isolation/ Depression
  8. 8. Pulmonary Rehabilitation is the Gold Standard Best “Medicine” for COPD 8 Uptake remains suboptimal System Provider Patient • Space • Staffing • Capacity • Reimbursement • Knowledge • Attitude • Referrals • Transportation • Distance • Scheduling • Motivation Johnston et al. (2013). Prim Care Respir J. & Physiother Can 62(4): 368-373
  9. 9. Agenda  COPD Care in the Current Health Policy Landscape  Gaps in the Current Evidence Base for COPD Self- Management  Lessons Learned in Generating Real-World Evidence via a Pragmatic Trial of Physical Activity Coaching 9 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  10. 10. Physical inactivity is associated with worse outcomes 10 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Annals of ATS, 2014 ERJ Open Research 2016
  11. 11. Physical Activity Associated with Lower Risk of 30-Day Readmission EVS RR, 95%CI P value 0 mins/wk 1.0 - 1-149mins/wk 0.67 (0.55, 0.81) <.001 >150mins/wk 0.66 (0.51, 0.87) <.001 11 Adjusted for age, gender, marital status, race/ethnicity, insurance status, BMI, smoking status, flu & pneumonia vaccination, use of inhaler medications, comorbidities, previous hospitalizations, length of stay, discharge disposition, ED/Obs. Stay, and receipt of inpatient palliative care consultation n=4,596 patients admitted for a COPD exacerbation with 5,862 index admissions from Jan 1, 2011 – Dec 31, 2012 Any PA → ↓ 34% readmission risk Nguyen et al. Annals of ATS (2014)
  12. 12. Conceptual Model for  Physical Activity 12 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Outcomes ↓Hospitalizations ↓ED visits/Ob stays ↓COPD exacerbations ↓Death ↑ Physical Activity Physical ↓Ventilatory requirements ↓Dyspnea/fatigue ↓BMI, BP, A1C, lipids ↓Systemic inflammation Psychological ↑Self-efficacy for self-care ↓Depression/anxiety ↑ Quality of life Antecedents/Moderators -Demographics, e.g. older age -Clinical, e.g. disease burden, chronic pain -Level of activation, e.g. depression, anxiety, cognition
  13. 13. Alternatives to clinic-based “rehab” 13 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  14. 14. Pedometers & Coaching in COPD PR vs. PR + Pedometer/Coaching (2-6 months) (n>5) Pedometer/Coaching vs. Usual Care (1-12 months) (n>5) Physical activity Uncertain added benefit ++ Exercise capacity Uncertain added benefit + Symptoms Worse? ++ HRQL Worse? ++ AECOPD ? + Acute care utilization ? ? Survival ? ? BOTTOM LINE Questionable added value Promising alternative 14 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 e.g. Nolan (2017) AJRCCM Burtin (2015) PLOS Altenburg (2015) Resp Med deBlock (2006) Pt Ed Couns e.g. Moy (2015) Chest Demeyer (2017) Thorax Nguyen (2013) JPSM Altenburg (2015) Resp Med
  15. 15. Pedometers (PR alternative) vs. Usual Care  Step goal increments/progression differed across studies but most emphasize accrual of steps throughout day  For every +1,000 steps/day @ low intensity -> COPD hospitalization risk  20% (Donaire-Gonzalez, 2015 ERJ) – High intensity PA did not have an impact on hospitalizations  Limitations of current evidence: mild to moderate COPD, younger, men  Short-medium term follow up,  PA plateaus at ~3 to 6 months 15 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Automated Step Goals Clinic/home Counseling Semi-automated Blended Telecoaching Moy 2015 Chest Tabak 2014 Clin Rehab Mendoza 2015 ERJ Hospes 2009 Pt Ed Couns Nguyen 2015 JPSM Demeyer 2017 Thorax Altenburg 2015 Resp Med $ $$$
  16. 16. Real-World Evidence to Inform Practice & Policy 16 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 (Valid/Generalizable)
  17. 17. 17 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Mark Cziraky, NAM 2016 Mtg Inform decision making
  18. 18. The RCT-PCT Continuum  No clinical trial is completely explanatory or pragmatic  Tradeoffs with decisions to be more explanatory or pragmatic 18 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Explanatory Trial Can an intervention work under ideal conditions? Pragmatic Trial Can an intervention work under usual conditions?
  19. 19. Agenda  COPD Care in the Current Health Policy Landscape  Gaps in the Current Evidence Base for COPD Self- Management  Lessons Learned in Generating Real-World Evidence via a Pragmatic Trial of Physical Activity Coaching 19 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  20. 20. Kaiser Permanente <-> National Health Care Landscape 20 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Kaiser Program Kaiser Regions (n=8) Medical Service Areas within Regions Medical Offices/Clinics Northern CA Southern CA Northwest WashingtonMid-Atlantic Georgia Colorado Hawaii Southern CA >4 Million Members ~50,000 with COPD 209 Medical Offices 14 Hospitals 6,035 Physicians 20,393 Nurses 61,897 Employees  Pre-paid, capitated health plan  Independent medical group  Integrated delivery system  “Mini national health system” accountable for total health of a population  Structure: Federal > State >County >City
  21. 21. Health System Care Structures & Processes  Mature population management & QI/PI infrastructure – Proactive preventive care – Wellness coaching and health education classes – Disease-based care management – Case management for higher risk patients  Care transition bundle for medium to high risk patients – Post discharge phone call 48-72 hours – Medication review – Scheduled follow up clinic visit within 5-7 days post discharge – Palliative care consult as appropriate – Complex case conferences 21 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  22. 22. Health System Structures to Facilitate PCTs  Single IRB for 6 participating sites (could expand up to 12 sites if needed)  Leverage existing workforce from pulmonary rehabilitation or care management structure at most of the sites  Comprehensive (almost) EMR facilitates – Population-based screening for eligibility – Passive outcome assessment 22 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  23. 23. Research Question  P: Patients with a history of a severe COPD exacerbation in previous 12 months  I: 12-month physical activity coaching (Walk On!)  C: Standard care  O: All-cause acute care utilization and survival 23 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  24. 24. “Real-World” PCT 24 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Patients w/a COPD-related hospitalization/ED/Obs encounter in the previous 12 months (n=2,700) ( from n=1,650) Randomization Standard Care (n=1,350)Standard Care + Physical Activity Coaching (n=1,350) -Baseline functional assessment to individualize walking exercise program; training in use of pedometer -Intensive phone coaching (wks 1-4) -Pro-active follow-up & support using panel management tools (wks 5-52) -Optional monthly group peer support visits-skills training & problem solving Primary Outcome: All-cause hospitalizations, ED/Ob stays & death over12 months Secondary Outcomes: COPD-related hospitalizations and ED/Ob stays, COPD exacerbations, physical activity, and cardio- metabolic markers (BMI, BP, HbA1c, & lipids), perception of support, symptoms, quality of life and satisfaction Nguyen et al. Contemporary Clinical Trials (2016) 46:18–29
  25. 25. 25 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  26. 26. Inclusion Criteria  Any COPD hospitalization, ED or Ob Stays in the previous 12 months – Principal discharge diagnoses of COPD (J44.1, J44.0, J41.8, J42, J43.1, J43.2, J43.8, J43.9, J44.9, J44.0, or J44.1) or principal diagnosis of respiratory failure (J96.00, J96.01, J96.02, J96.90, J96.91, J96.92, J80, J96.20, J96.21, J96.22, or R09.2) and a secondary diagnosis of acute exacerbation of COPD (J44.1 or J44.0)  age >40 years  on at least one bronchodilator or steroid inhaler prior to the index admission or if not on an inhaler, had a previous COPD diagnosis  Continuous health plan membership in the 12 months prior to the index admission. 26 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 *Centers for Medicare and Medicaid Services (CMS) and National Quality Forum (NQF) proposed criteria for the Hospital Readmission Reduction Program
  27. 27. Exclusion Criteria  FEV1/FVC ratio >0.70 for those with spirometry data in previous year  Discharged to hospice, SNF, long term-care or another acute care hospital during index admission  Bed bound at admission or discharge during the index admission  Has Alzheimers disease, dementia or metastatic cancer  Morbidly obese (BMI >40)  Completed pulmonary rehabilitation in the last 6 months 27 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  28. 28. Traditional RCT vs. Pragmatic RCT 28 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 COPD Population Patients who meet eligibility criteria (Pre-consent Randomization)  Generalizability  Uptake/Participation  Effectiveness COPD Population Patients who meet eligibility criteria Patients who consent to being randomized  Internal validity  Efficacy
  29. 29. Study Design Essentials for this PCT  A waiver of written consent for – Individual-level randomization – Primary outcome obtained on all eligible-randomized patients  Outcome data are already captured as part of routine clinical care  Primary analysis is intent-to-treat  Advantages: “real world” uptake and effectiveness since not dependent on motivated volunteers  Disadvantage: diluted treatment effects if low uptake 29 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  30. 30. Pragmatic-Explanatory Continuum (PRECIS-2) 30 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 (-) Not at point of care (-) Managed care- integrated system with robust EMR (-) Use of existing PR staff, some additional training (-) PROs at 6 & 12 months (-) General intervention guidance Who’s perspective? Loudon (2015) BMJ; Thorpe (2009) CMAJ
  31. 31. Walk On! Program 31 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Pre-Visit Tracking & Surveys Targeted Coaching Dashboard Baseline Intake Visit Step Goal Progression & Self-Tracking Peer Support
  32. 32. 32 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 Automated Data Upload (Validic, Open mHealth) Data Integration, Processing, and Visual Display for Patient- (kp.org) and Population-Level Management (Health Connect) Manual Data Entry Phone IVR or Texting Bluetooth/Internet-enabled devices $ $$$$ Targeted Coaching Dashboard
  33. 33. Walk On! Uptake & Top 3 Reasons for Declining 33 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 ~32% agreed to participate Not interested (22%) Unable to reach (19%) Too frail/ill (14%) ~24% completed baseline visit n=938 Outreached re: Walk On! Age: 77 vs. 72 Charlson: 4.8 vs. 3.5 FEV1%pred: 60% vs. 58% O2 use: 52% vs. 38% Age: 68 vs. 72 Charlson: 3.3 vs. 3.5 FEV1%pred: 63% vs. 58% Smoking: 29% vs. 11%
  34. 34. Enrollment by Site 34 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 n=85, 76% n=134, 86% n=78, 80% n=118, 80% n=130, 83% n=168, 62% n=716, 76% n=27, 24% n=21, 14% n=19, 20% n=29, 20% n=27, 17% n=102, 38% n=222, 24% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Bellflower (n=112) Fontana (n=155) LAMC (n=97) OC (n=147) Riverside (n=157) SD (n=270) Total (n=938) Declined Enrolled (n=938, up to wave #9 of 12)
  35. 35. Site Characteristics Sites 1 2 3 4 5 6 COPD care management program + + + Pulmonary rehabilitation program + + + + Dual role of coach and rehabilitation coordinator + + + Dual role of coach and care manager + Allocation of 0.5+ FTE on project + + + Highly engaged physician champion + + + + Coach feels “supported” in “proactive” culture + + Ease of access to clinic - - - Total “Enabling” Score 1 2 4 4 4 5 Average Walk On! Uptake (Waves 1-10) 14% 17% 19% 24% 20% 37% 35 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  36. 36. Baseline Sample Characteristics (up to wave #9 of 12) Total (n=1,878) Standard Care (n=940) Walk On! (n=938) Total (n=938) Participants (n=212) Non-P (n=736) Age 72 (10) 72 (10) 72 (10) 72 (9) 72 (11) Female 1022 (54%) 520 (55%) 502 (54%) 117 (55%) 385 (53%) FEV1/FVC* 54.8 (14.5) 54.4 (14.9) 55.2 (14.1) 52.9 (14.8) 56.0 (13.8) FEV1% Predicted 60.3 (21.2) 59.7 (21.3) 61.0 (21.2) 57.6 (22.8) 62.1 (20.6) Oxygen use 727 (39%) 385 (41%) 342 (36%) 80 (38%) 262 (36%) Heart failure 565 (30%) 290 (31%) 275 (29%) 53 (25%) 222 (31%) Depression 527 (28%) 258 (27%) 269 (29%) 55 (26%) 214 (29%) Anxiety 537 (29%) 275 (29%) 262 (28%) 57 (27%) 205 (28%) Chronic pain 379 (20%) 193 (21%) 186 (20%) 42 (20%) 144 (20%) Charlson co-morbidity index 3.7 (2.3) 3.8 (2.2) 3.7 (2.3) 3.5 (2.2) 3.7 (2.4) Hospitalizations 1065 (57%) 548 (58%) 517 (55%) 124 (58%) 393 (54%) ED visits 1527 (81%) 771 (82%) 756 (81%) 159 (75%) 597 (82%) Observational stays 523 (28%) 267 (28%) 256 (27%) 49 (23%) 207 (29%) Primary care visits 6.2 (5.6) 6.2 (5.5) 6.3 (5.7) 6.6 (5.2) 6.1 (5.9) Specialty care visits 9.4 (10.2) 9.7 (10.6) 9.0 (9.7) 10.3 (9.9) 8.6 (9.6) 36 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 *60% patients have spirometry results
  37. 37. Lessons Learned Patients  Timing of outreach may not synchronize with patient’s readiness for change  Activation with coach’s outreach call w/o “enrolling”  Individualized tailoring according to patient needs & preferences  Engaging family caregivers Engagement Data/Other  EMR data quality & timeliness  Unable to integrate study tools within EMR  Technology challenges  Evolving COPD care practices at study sites  Multi-stakeholder engagement in all aspects of the study  Executive sponsorship  Partnership with 7- member Patient Advisory Board (PAB)  Providers’ eagerness to provide program to more patients  IRB engaged during grant proposal & study start up
  38. 38. Partnership with Patient Advisory Board (PAB)  Deep commitment to help fellow members and patients  Recruitment/outreach scripting – Input and insights on how best to “motivate” peers  Test out study processes e.g. baseline visit, activity sensors  Strategies to improve uptake and retention  Human subjects research training  Co-lead monthly group visits with coaches 38 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017
  39. 39. Executive Sponsors Patient Advisors Research Staff Software/IT & Database Teams Physical Activity Coaches Pulmonary Chiefs & DAs
  40. 40. Lessons Learned: Use of Existing Clinical Staff (Respiratory Therapists) Training  No previous research training or experience  Variable experience working in outpatient setting with population management lens  Learning community for best practices – Motivational interviewing skills – Peer-to-peer mentoring Continuous QC“Culture”  Study FTEs: 30-100%  Clinical patient care priorities trump research study responsibilities  Labor regulations & different job class codes disallowed home visits  Motivate and empower – Cross-coverage  Turnover with 6 new coaches at 3 sites  Balancing pragmatism and quality control by research staff  Study management tools & weekly reports to ensure timely completion of study tasks  Cognitive overload with many new processes & disparate IT systems
  41. 41. Patient Feedback 41 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 I was in the hospital for 20 days. I had to learn to re-walk again. It was quite a bit to overcome. Walk On! gave me courage every day. I did my exercises. I totally enjoyed that. I had my little counter, I saw I walked 200, sometimes not even that 50. When they [coaches] checked on you every week. They checked on you if you needed anything. They’d help get your meds, call the doctor. It was wonderful. You had someone right there at your hand if you needed them. It’s neat. You wait for the call, ‘oh boy I did good,’ or ‘I didn’t do good.’ I don’t know who came up with the program but the way it’s set up, you’re not intimidated at all. You name your hour and what you want to do unlike the other program that I participated in before (rehab) where the meetings and exercise were set on specific days.
  42. 42. Patients have competing demands “Patients have the power in chronic disease. Patients decide what to eat, whether to exercise, and how often to take their medications. If people don’t want to do something, they won’t do it” Bodenheimer (2007) Motivating Change
  43. 43. Walk On! Estimated Per Patient Costs 43 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 # of Patients Estimated Cost Per Patient (-25%) for Research Activities Patients Outreached n=1,350 $1000/patient $750/patient Patients Enrolled Overall (~25%) n=350 $3700/patient $2700/patient Patients Enrolled Overall (~40%) n=540 $2400/patient $1800/patient Patients Enrolled Overall (~50%) n=700 $1850/patient $1350/patient Assumptions: $45/hr (Respiratory therapist) x 1.56 benefits x 2080 hrs/year x 3.0 FTEs (1SD, .5RV, .5DO, .3OC, .35LA, .3FO)= $440K/year x 3 years= $1.3 mil Note: Pulmonary rehab x 6 weeks ~$2500 (Medicare reimbursements)
  44. 44. What if results in Q3 2018 are… 44 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017 PA utilization or death PA  utilization or death SPREAD(Internal) -Funding -Implementation structure/refine -Other applications, e.g. PR maintenance WHY? -Who benefits? -Who doesn’t -Are there other improvements? -Additional studies needed? WHY? -Weak intervention? -Inadequate uptake? -Who benefits? -Who doesn’t? Would improvements in QoL or functioning be enough to justify spread?
  45. 45. Click to edit Master title style Population-based proactive, collaborative technology-enabled, cost-effective, scalable, care management
  46. 46. 46 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2017

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