Clinical trial NCT02287883: Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs
Official title: The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Cardiovascular Disease
Keywords: Patient activation and engagement
Patient reported outcomes
Accountable Care Organizations
Chronic illness
Vulnerable population
Comparison of approaches
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Wake Forest University Health Sciences
name: HealthCare Partners Institute for Applied Research and Education
First posted: 2014-11-11
Enrollment: 2176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 4368 patients with diabetes or cardiovascular disease receiving care from selected clinics at two Accountable Care Organizations in Los Angeles, CA and Chicago, IL.

Brief summary: The investigators will study the delivery of care to patients with diabetes and cardiovascular diseases from 16 practices in health care organizations who receive incentives for improving the quality of patient care. Half of those will be far along in engaging patients in their care and half will not. The investigators will see whether patients with diabetes or cardiovascular diseases who receive care from practices that more fully involve their patients have better clinical outcomes and satisfaction with their care than those who do not. The investigators expect that these findings will help practices and patients to achieve better outcomes of care.

Detailed description: BACKGROUND Engaged patients have been referred to as "...the blockbuster drugs of the 21st century". Under the Affordable Care Act (ACA), Accountable Care Organizations (ACOs) are required to engage patients. The specific question we will address is: Do patients receiving care from ACO practices with highly developed patient activation and engagement (PA\&E) activities achieve better patient reported health outcomes, report better experiences of care, and have better selected clinical measures (blood pressure, hemoglobin levels, and LDL-C) compared to patients receiving care from ACO practices with less developed PA\&E initiatives? We plan to capitalize on the natural occurring variation in degree of implementing PA\&E activities.

OBJECTIVES

1) To collect information on the PA\&E activities in 16 practices of two ACOs at baseline and over three years - including initiatives focused on disease prevention and health promotion, care team-patient communication, shared decision-making, self-management support, advanced serious illness care, and patient involvement in the care redesign experience; 2) to assess the differences on patient-reported outcomes of care, patient experiences, and selected clinical measures between patients exposed to highly developed PA\&E initiatives versus those receiving care from practices with minimal PA\&E activities; and 3) examine practice-level variation in PA\&E implementation processes including culture, leadership, teamwork, and relational coordination.

METHODS We will take advantage of the naturally occurring variation in the implementation of PA\&E activities in 16 practices of two ACOs treating patients with diabetes and cardiovascular disease (CVD). A random sample of chronically-ill patients from each of the two ACOs will be sampled and will complete a patient-reported outcome instrument that includes select Patient-Reported Outcomes (PROMIS) measures and patient experience measures in early and late stages of the project. They will also complete the patient activation measure (PAM). We will examine changes over time in the outcome variables noted above. We will also survey ACO/ practice stakeholders regarding organizational culture, leadership, team effectiveness, and relational coordination using previously validated instruments supplemented by site visits. Multilevel analyses examine PA\&E effects and practice-level heterogeneity within ACOs, controlling for patient characteristics.

PATIENT OUTCOMES The proposed project's explicit focus on examining the PA\&E activities of ACO practices with highly developed PA\&E activities in comparison with those with very little and linking these to the outcomes measures noted above should be of great interest to patients, the Patient-Centered Outcomes Research Institute (PCORI), and the health care policy and practitioner community. The findings should help to guide PCORI's future research agenda in this area while providing all involved with knowledge to advance patient-centered care.

Eligibility criteria: Inclusion Criteria:

* adult, 18-82
* diagnosis of diabetes or cardiovascular disease
* receives primary care at one of 16 selected clinical sites from two Accountable Care Organizations

Exclusion Criteria:

* Incomplete mailing address available from Electronic Medical Record
* Patient language other than English or Spanish

Primary outcomes:
measure: PROMIS Short Form 8a
timeFrame: 1 year
measure: PROMIS Short Form 12a
timeFrame: 1 year
measure: PHQ-4
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
city: Torrance
country: United States
facility: HealthCare Partners Insitute for Applied Research and Education
state: California
city: Chicago
country: United States
facility: Advocate Health Care
state: Illinois
city: Hanover
country: United States
facility: Dartmouth Colelge
state: New Hampshire
Study officials:
affiliation: University of California, Berkeley
name: Stephen M Shortell, PhD,MPH,MBA
role: PRINCIPAL_INVESTIGATOR
References: