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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02287883
Acronym
ACTIVATE
Enrollment
2176
Registered
2014-11-11
Start date
2015-04-30
Completion date
2017-09-30
Last updated
2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes

Keywords

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

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.

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.

Interventions

OTHERObservational: Patient Activation and Engagement (PAE)

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

Sponsors

Dartmouth College
CollaboratorOTHER
Wake Forest University Health Sciences
CollaboratorOTHER
HealthCare Partners Institute for Applied Research and Education
CollaboratorUNKNOWN
University of California, Berkeley
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PROMIS Short Form 8a1 yearPatient 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).
PROMIS Short Form 12a1 yearPatient-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).
PHQ-41 yearPatient 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).

Countries

United States

Participant flow

Recruitment details

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).

Pre-assignment details

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

Participants by arm

ArmCount
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.
1,081
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.
1,095
Total2,176

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath87
Overall StudyNo longer eligible222182
Overall StudyNon-response to survey229237

Baseline characteristics

CharacteristicPatients at High PAE PracticesPatients at Low PAE PracticesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
590 Participants582 Participants1172 Participants
Age, Categorical
Between 18 and 65 years
491 Participants513 Participants1004 Participants
Diastolic Blood Pressure76.14 mmHg
STANDARD_DEVIATION 8.65
75.47 mmHg
STANDARD_DEVIATION 8.1
75.80 mmHg
STANDARD_DEVIATION 8.39
Ethnicity (NIH/OMB)
Hispanic or Latino
371 Participants358 Participants729 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
668 Participants699 Participants1367 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
42 Participants38 Participants80 Participants
Hemoglobin A1c (HbA1c)7.33 percentage
STANDARD_DEVIATION 1.63
7.20 percentage
STANDARD_DEVIATION 1.49
7.27 percentage
STANDARD_DEVIATION 1.57
Low density lipoprotein cholesterol (LDL-C)91.82 mg/dL
STANDARD_DEVIATION 32.27
90.58 mg/dL
STANDARD_DEVIATION 31.5
91.22 mg/dL
STANDARD_DEVIATION 31.89
Patient Activation Measure (PAM-13)3.27 units on a scale
STANDARD_DEVIATION 0.45
3.27 units on a scale
STANDARD_DEVIATION 0.44
3.27 units on a scale
STANDARD_DEVIATION 0.45
Patient Assessment of Chronic Illness Care (PACIC)2.72 units on a scale
STANDARD_DEVIATION 0.83
2.65 units on a scale
STANDARD_DEVIATION 0.84
2.68 units on a scale
STANDARD_DEVIATION 0.83
Patient Health Questionnaire 4 (PHQ-4)1.55 units on a scale
STANDARD_DEVIATION 0.75
1.51 units on a scale
STANDARD_DEVIATION 0.72
1.53 units on a scale
STANDARD_DEVIATION 0.74
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 12a2.01 units on a scale
STANDARD_DEVIATION 0.89
1.99 units on a scale
STANDARD_DEVIATION 0.88
2.00 units on a scale
STANDARD_DEVIATION 0.88
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 8a2.37 units on a scale
STANDARD_DEVIATION 1.03
2.34 units on a scale
STANDARD_DEVIATION 1.06
2.35 units on a scale
STANDARD_DEVIATION 1.05
Race (NIH/OMB)
American Indian or Alaska Native
8 Participants5 Participants13 Participants
Race (NIH/OMB)
Asian
89 Participants107 Participants196 Participants
Race (NIH/OMB)
Black or African American
230 Participants35 Participants265 Participants
Race (NIH/OMB)
More than one race
22 Participants27 Participants49 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants5 Participants9 Participants
Race (NIH/OMB)
Unknown or Not Reported
316 Participants315 Participants631 Participants
Race (NIH/OMB)
White
412 Participants601 Participants1013 Participants
Sex: Female, Male
Female
599 Participants592 Participants1191 Participants
Sex: Female, Male
Male
482 Participants503 Participants985 Participants
Systolic Blood Pressure133.11 mmHg
STANDARD_DEVIATION 14.99
130.31 mmHg
STANDARD_DEVIATION 13.19
131.70 mmHg
STANDARD_DEVIATION 14.18

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
14 / 1,08114 / 1,095
other
Total, other adverse events
0 / 1,0810 / 1,095
serious
Total, serious adverse events
0 / 1,0810 / 1,095

Outcome results

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).

Time frame: 1 year

Population: Patients who completed a survey at both baseline and at one-year follow-up.

ArmMeasureValue (MEAN)Dispersion
Patients at High PAE PracticesPHQ-40.03 units on a scaleStandard Deviation 0.62
Patients at Low PAE PracticesPHQ-4-0.04 units on a scaleStandard Deviation 0.57
p-value: 0.05t-test, 2 sided
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).

Time frame: 1 year

Population: Patients completing a survey at both baseline (2015) and one-year follow-up (2016).

ArmMeasureValue (MEAN)Dispersion
Patients at High PAE PracticesPROMIS Short Form 12a-0.07 units on a scaleStandard Deviation 0.51
Patients at Low PAE PracticesPROMIS Short Form 12a-0.05 units on a scaleStandard Deviation 0.55
p-value: 0.48t-test, 2 sided
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).

Time frame: 1 year

Population: Patients who completed surveys at both baseline (2015) and at one year follow-up (2016).

ArmMeasureValue (MEAN)Dispersion
Patients at High PAE PracticesPROMIS Short Form 8a-0.05 units on a scaleStandard Deviation 0.83
Patients at Low PAE PracticesPROMIS Short Form 8a-0.03 units on a scaleStandard Deviation 0.86
p-value: 0.8t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026