Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs

NCT ID: NCT02287883

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

Diabetes; Cardiovascular Disease

Keywords

Patient activation and engagement; Patient reported outcomes; Accountable Care Organizations; Chronic illness; Vulnerable population; Comparison of approaches

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients at high PAE clinic

Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at clinics with high implementation of patient activation and engagement activities.

Observational: Patient Activation and Engagement (PAE)

Observational: Patient Activation and Engagement (PAE)

Intervention Type: OTHER

Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.

Patients at low PAE clinic

Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at clinics with low implementation of patient activation and engagement activities.

Observational: Patient Activation and Engagement (PAE)

Observational: Patient Activation and Engagement (PAE)

Intervention Type: OTHER

Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.

Interventions

Observational: Patient Activation and Engagement (PAE)

Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

HealthCare Partners Institute for Applied Research and Education

UNKNOWN

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen M Shortell, PhD,MPH,MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

University of California, Berkeley

Berkeley, California, United States

HealthCare Partners Insitute for Applied Research and Education

Torrance, California, United States

Advocate Health Care

Chicago, Illinois, United States

Dartmouth Colelge

Hanover, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IHS-1310-06821

Identifier Type: -

Identifier Source: org_study_id