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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Wake Forest University Health Sciences | OTHER |
| HealthCare Partners Institute for Applied Research and Education | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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4368 patients with diabetes or cardiovascular disease receiving care from selected clinics at two Accountable Care Organizations in Los Angeles, CA and Chicago, IL.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen M Shortell, PhD,MPH,MBA | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Berkeley | Berkeley | California | 94720 | United States | ||
| HealthCare Partners Insitute for Applied Research and Education |
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Sixteen primary care practices at two ACOs in the US (greater Los Angeles and Chicago), were selected based on their responses to a 39-item questionnaire of their patient activation and engagement activities. 4168 eligible patients from these sites were included in the baseline survey. 2176 of these patients responded and were included in the study
Adult patients with diabetes and/or cardiovascular disease from sixteen primary care practice sites at two Accountable Care Organizations (ACOs) in the US (greater Los Angeles and Chicago areas) were surveyed about their patient reported outcomes (PROs), patient assessment of chronic illness care (PACIC) and patient activation and engagement (PAM).
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients at High PAE Practices (n=8 Practices) | Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities (top quartile). |
| FG001 | Patients at Low PAE Practices (n=8 Practices) | Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities (bottom quartile). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients at High PAE Practices | Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities. |
| BG001 | Patients at Low PAE Practices |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Patients who completed surveys at both baseline (2015) and at one year follow-up (2016). | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
3 years (January 2014-December 2016)
We collected information annually on all-cause mortality occurring the prior calendar year. We did not collect other information about Serious Adverse Events or non-serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients at High PAE Practices | Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with high implementation of patient activation and engagement (PAE) activities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Ramsay, Project Drector | University of California, Berkeley | (510)643-8063 | pramsay@berkeley.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2014 | Oct 18, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2016 | Oct 18, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D010358 | Patient Participation |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Torrance |
| California |
| 90502 |
| United States |
| Advocate Health Care | Chicago | Illinois | 60515 | United States |
| Dartmouth Colelge | Hanover | New Hampshire | 03755 | United States |
| Non-response to survey |
|
Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Patient Activation Measure (PAM-13) | Unweighted average of responses to 13-item Patient Activation Measure (PAM-13) which assesses patient knowledge, skill, and confidence for self-management. Response categories for all items range from 1 (disagree strongly with statements of activation) -4 (agree strongly with statements of activation). | Mean | Standard Deviation | units on a scale |
|
| Patient Assessment of Chronic Illness Care (PACIC) | Unweighted average of responses to 11-item Patient Assessment of Chronic Illness Care (PACIC). PACIC measures patients' experience with care they received from their health care providers with for their chronic condition. The response scale for all items ranges from 1 (never experienced care management process) -4 (always experienced care management process). | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 8a | Patient Reported Social Functioning, scale 1 (never trouble or limited)-5 (always trouble or limited) | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 12a | Patient-Reported Physical Functioning, scale 1 (no difficulty) -5 (unable to do activity) | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire 4 (PHQ-4) | Patient Reported Emotional Functioning, scale 1 (not at all anxious or depressed) -5 (anxious or depressed nearly every day) | Mean | Standard Deviation | units on a scale |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Low density lipoprotein cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage |
|
Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities. |
|
|
|
| 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). | Patients completing a survey at both baseline (2015) and one-year follow-up (2016). | Posted | Mean | Standard Deviation | units on a scale | 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). | Patients who completed a survey at both baseline and at one-year follow-up. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
|
|
|
| 14 |
| 1,081 |
| 0 |
| 1,081 |
| 0 |
| 1,081 |
| EG001 | Patients at Low PAE Practices | Patients with diabetes or cardiovascular disease receiving care within two Accountable Care Organizations (ACOs) at practices with low implementation of patient activation and engagement (PAE) activities. | 14 | 1,095 | 0 | 1,095 | 0 | 1,095 |
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| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |