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

NCT02287883 | Completed Results

• 1 other identifier: IHS-1310-06821
• Study Type: observational
• Target: 2,176
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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)

Other: Observational: Patient Activation and Engagement (PAE)

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)

Other: Observational: Patient Activation and Engagement (PAE)

Interventions

Observational: Patient Activation and Engagement (PAE) OTHER

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

Patients at high PAE clinic; Patients at low PAE clinic

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Berkeley: lead
• Dartmouth College: collaborator
• Wake Forest University Health Sciences: collaborator
• HealthCare Partners Institute for Applied Research and Education: collaborator

Study Sites (4)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

HealthCare Partners Insitute for Applied Research and Education

Torrance, California, 90502, United States

Location

Advocate Health Care

Chicago, Illinois, 60515, United States

Location

Dartmouth Colelge

Hanover, New Hampshire, 03755, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Patient Participation; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patricia Ramsay, Project Drector
• Organization: University of California, Berkeley

pramsay@berkeley.edu

(510)643-8063

Study Officials

• Stephen M Shortell, PhD,MPH,MBA

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: September 30, 2017
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)