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

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ClinicalTrials.gov Identifier: NCT02287883
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Dartmouth College
Advocate Health Care
HealthCare Partners Institute for Applied Research and Education
Information provided by (Responsible Party):
University of California, Berkeley

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.

Condition or disease Intervention/treatment
Diabetes Cardiovascular Disease Other: Observational: Patient Activation and Engagement (PAE)

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.

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Study Type : Observational
Actual Enrollment : 2176 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations
Study Start Date : April 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 30, 2017

Group/Cohort Intervention/treatment
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)
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)

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.




Primary Outcome Measures :
  1. PROMIS Short Form 8a [ Time Frame: 1 year ]
    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).

  2. PROMIS Short Form 12a [ Time Frame: 1 year ]
    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).

  3. PHQ-4 [ Time Frame: 1 year ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287883


Locations
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United States, California
University of California, Berkeley
Berkeley, California, United States, 94720
HealthCare Partners Insitute for Applied Research and Education
Torrance, California, United States, 90502
United States, Illinois
Advocate Health Care
Chicago, Illinois, United States, 60515
United States, New Hampshire
Dartmouth Colelge
Hanover, New Hampshire, United States, 03755
Sponsors and Collaborators
University of California, Berkeley
Dartmouth College
Advocate Health Care
HealthCare Partners Institute for Applied Research and Education
Investigators
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Principal Investigator: Stephen M Shortell, PhD,MPH,MBA University of California, Berkeley
  Study Documents (Full-Text)

Documents provided by University of California, Berkeley:
Informed Consent Form  [PDF] April 6, 2016


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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02287883    
Other Study ID Numbers: IHS-1310-06821
First Posted: November 11, 2014    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Berkeley:
Patient activation and engagement
Patient reported outcomes
Accountable Care Organizations
Chronic illness
Vulnerable population
Comparison of approaches
Additional relevant MeSH terms:
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Cardiovascular Diseases