Trial Outcomes & Findings for Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs (NCT NCT02287883)
NCT ID: NCT02287883
Last Updated: 2017-12-15
Results Overview
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).
COMPLETED
2176 participants
1 year
2017-12-15
Participant Flow
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).
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
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
1081
|
1095
|
|
Overall Study
One-year Follow-up Survey
|
622
|
669
|
|
Overall Study
COMPLETED
|
622
|
669
|
|
Overall Study
NOT COMPLETED
|
459
|
426
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Death
|
8
|
7
|
|
Overall Study
No longer eligible
|
222
|
182
|
|
Overall Study
Non-response to survey
|
229
|
237
|
Baseline Characteristics
Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs
Baseline characteristics by cohort
| Measure |
Patients at High PAE Practices
n=1081 Participants
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.
|
Patients at Low PAE Practices
n=1095 Participants
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.
|
Total
n=2176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Patient Activation Measure (PAM-13)
|
3.27 units on a scale
STANDARD_DEVIATION 0.45 • n=99 Participants
|
3.27 units on a scale
STANDARD_DEVIATION 0.44 • n=107 Participants
|
3.27 units on a scale
STANDARD_DEVIATION 0.45 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
491 Participants
n=99 Participants
|
513 Participants
n=107 Participants
|
1004 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
590 Participants
n=99 Participants
|
582 Participants
n=107 Participants
|
1172 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
599 Participants
n=99 Participants
|
592 Participants
n=107 Participants
|
1191 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
482 Participants
n=99 Participants
|
503 Participants
n=107 Participants
|
985 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
371 Participants
n=99 Participants
|
358 Participants
n=107 Participants
|
729 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
668 Participants
n=99 Participants
|
699 Participants
n=107 Participants
|
1367 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
230 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
265 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
412 Participants
n=99 Participants
|
601 Participants
n=107 Participants
|
1013 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
316 Participants
n=99 Participants
|
315 Participants
n=107 Participants
|
631 Participants
n=206 Participants
|
|
Patient Assessment of Chronic Illness Care (PACIC)
|
2.72 units on a scale
STANDARD_DEVIATION 0.83 • n=99 Participants
|
2.65 units on a scale
STANDARD_DEVIATION 0.84 • n=107 Participants
|
2.68 units on a scale
STANDARD_DEVIATION 0.83 • n=206 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 8a
|
2.37 units on a scale
STANDARD_DEVIATION 1.03 • n=99 Participants
|
2.34 units on a scale
STANDARD_DEVIATION 1.06 • n=107 Participants
|
2.35 units on a scale
STANDARD_DEVIATION 1.05 • n=206 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 12a
|
2.01 units on a scale
STANDARD_DEVIATION 0.89 • n=99 Participants
|
1.99 units on a scale
STANDARD_DEVIATION 0.88 • n=107 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 0.88 • n=206 Participants
|
|
Patient Health Questionnaire 4 (PHQ-4)
|
1.55 units on a scale
STANDARD_DEVIATION 0.75 • n=99 Participants
|
1.51 units on a scale
STANDARD_DEVIATION 0.72 • n=107 Participants
|
1.53 units on a scale
STANDARD_DEVIATION 0.74 • n=206 Participants
|
|
Systolic Blood Pressure
|
133.11 mmHg
STANDARD_DEVIATION 14.99 • n=99 Participants
|
130.31 mmHg
STANDARD_DEVIATION 13.19 • n=107 Participants
|
131.70 mmHg
STANDARD_DEVIATION 14.18 • n=206 Participants
|
|
Diastolic Blood Pressure
|
76.14 mmHg
STANDARD_DEVIATION 8.65 • n=99 Participants
|
75.47 mmHg
STANDARD_DEVIATION 8.10 • n=107 Participants
|
75.80 mmHg
STANDARD_DEVIATION 8.39 • n=206 Participants
|
|
Low density lipoprotein cholesterol (LDL-C)
|
91.82 mg/dL
STANDARD_DEVIATION 32.27 • n=99 Participants
|
90.58 mg/dL
STANDARD_DEVIATION 31.50 • n=107 Participants
|
91.22 mg/dL
STANDARD_DEVIATION 31.89 • n=206 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.33 percentage
STANDARD_DEVIATION 1.63 • n=99 Participants
|
7.20 percentage
STANDARD_DEVIATION 1.49 • n=107 Participants
|
7.27 percentage
STANDARD_DEVIATION 1.57 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients who completed surveys at both baseline (2015) and at one year follow-up (2016).
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).
Outcome measures
| Measure |
Patients at High PAE Practices
n=617 Participants
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.
|
Patients at Low PAE Practices
n=674 Participants
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.
|
|---|---|---|
|
PROMIS Short Form 8a
|
-0.05 units on a scale
Standard Deviation 0.83
|
-0.03 units on a scale
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients completing a survey at both baseline (2015) and one-year follow-up (2016).
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).
Outcome measures
| Measure |
Patients at High PAE Practices
n=617 Participants
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.
|
Patients at Low PAE Practices
n=674 Participants
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.
|
|---|---|---|
|
PROMIS Short Form 12a
|
-0.07 units on a scale
Standard Deviation 0.51
|
-0.05 units on a scale
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients who completed a survey at both baseline and at one-year follow-up.
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).
Outcome measures
| Measure |
Patients at High PAE Practices
n=617 Participants
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.
|
Patients at Low PAE Practices
n=674 Participants
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.
|
|---|---|---|
|
PHQ-4
|
0.03 units on a scale
Standard Deviation 0.62
|
-0.04 units on a scale
Standard Deviation 0.57
|
Adverse Events
Patients at High PAE Practices
Patients at Low PAE Practices
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Patricia Ramsay, Project Drector
University of California, Berkeley
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place