- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02287883
Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs (ACTIVATE)
The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94720
- University of California, Berkeley
-
Torrance, California, United States, 90502
- HealthCare Partners Insitute for Applied Research and Education
-
-
Illinois
-
Chicago, Illinois, United States, 60515
- Advocate Health Care
-
-
New Hampshire
-
Hanover, New Hampshire, United States, 03755
- Dartmouth Colelge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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) |
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: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 year
|
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).
|
1 year
|
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).
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen M Shortell, PhD,MPH,MBA, University of California, Berkeley
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHS-1310-06821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
-
Penn State UniversityAlmond Board of California; The Hershey CompanyCompletedCardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentCompleted
-
Aziyo Biologics, Inc.CompletedCardiovascular DiseaseUnited States
-
Monash UniversityCompletedCardiovascular DiseaseAustralia
Clinical Trials on Observational: Patient Activation and Engagement (PAE)
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; Dana-Farber... and other collaboratorsCompleted
-
VA Office of Research and DevelopmentWithdrawn
-
Queen Mary University of LondonSocial Action for HealthRecruitingCOVID-19 | Influenza | Vaccination RefusalUnited Kingdom
-
Duke UniversityCompletedShoulder Pain | Rotator Cuff Injury | Rotator Cuff Impingement SyndromeUnited States
-
The University of Texas Health Science Center at...National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Department...CompletedUpper Gastrointestinal BleedingUnited States
-
Peter MinneciPatient-Centered Outcomes Research InstituteCompletedChildren | AppendicitisUnited States
-
Jewish General HospitalUniversity of Manitoba; McGill University Health Centre/Research Institute... and other collaboratorsRecruitingLow Anterior Resection Syndrome | Rectal Cancer | Surgery | Patient Activation | Low Anterior ResectionCanada, United States
-
Tufts UniversityMerck Sharp & Dohme LLCNot yet recruiting
-
VA Office of Research and DevelopmentWithdrawn