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

Diabetes Clinical Trial

— ACTIVATE  

Official title:

The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287883
• Other study ID #: IHS-1310-06821
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: October 18, 2017
• Start date: April 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2176
• Est. completion date: September 30, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes

Intervention

Other:
• Observational: Patient Activation and Engagement (PAE)
Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California
United States	Advocate Health Care	Chicago	Illinois
United States	Dartmouth Colelge	Hanover	New Hampshire
United States	HealthCare Partners Insitute for Applied Research and Education	Torrance	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	Advocate Health Care, Dartmouth College, HealthCare Partners Institute for Applied Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Short Form 8a	Patient Reported Social Functioning, scale 1 (always trouble or limited)-5 (never trouble or limited). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).	1 year
Primary	PROMIS Short Form 12a	Patient-Reported Physical Functioning, scale 1 (unable to do activity) -5 (no difficulty). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).	1 year
Primary	PHQ-4	Patient Reported Emotional Functioning, scale 1 (anxious or depressed nearly every day) -5 (not at all anxious or depressed). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).	1 year