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

• Sponsor: University of California, Berkeley (Other)
• Overall Status: Completed
• CT.gov ID: NCT02287883
• Collaborator: Dartmouth College (Other), Advocate Health Care (Other), HealthCare Partners Institute for Applied Research and Education (Other)
• Enrollment: 2,176
• Locations: 4
• Duration (Months): 30
• Patients Per Site: 544
• Patients Per Site Per Month: 18.1

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Apr 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. PROMIS Short Form 8a [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 [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 82 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Berkeley	Berkeley	California	United States	94720
2	HealthCare Partners Insitute for Applied Research and Education	Torrance	California	United States	90502
3	Advocate Health Care	Chicago	Illinois	United States	60515
4	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

• Principal Investigator: Stephen M Shortell, PhD,MPH,MBA, University of California, Berkeley

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2014
• Informed Consent Form - Apr 6, 2016

More Information

Publications

None provided.

• Responsible Party: University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT02287883
• Other Study ID Numbers: IHS-1310-06821
• First Posted: Nov 11, 2014
• Last Update Posted: Dec 15, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Cardiovascular Diseases

Study Results

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 Detail	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

Arm/Group Title	Patients at High PAE Practices (n=8 Practices)	Patients at Low PAE Practices (n=8 Practices)
Arm/Group Description	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 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).
Period Title: Overall Study
STARTED	1081	1095
One-year Follow-up Survey	622	669
COMPLETED	622	669
NOT COMPLETED	459	426

Baseline Characteristics

Arm/Group Title	Patients at High PAE Practices	Patients at Low PAE Practices	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	1081	1095	2176
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	491 45.4%	513 46.8%	1004 46.1%
>=65 years	590 54.6%	582 53.2%	1172 53.9%
Sex: Female, Male (Count of Participants)
Female	599 55.4%	592 54.1%	1191 54.7%
Male	482 44.6%	503 45.9%	985 45.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	371 34.3%	358 32.7%	729 33.5%
Not Hispanic or Latino	668 61.8%	699 63.8%	1367 62.8%
Unknown or Not Reported	42 3.9%	38 3.5%	80 3.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	8 0.7%	5 0.5%	13 0.6%
Asian	89 8.2%	107 9.8%	196 9%
Native Hawaiian or Other Pacific Islander	4 0.4%	5 0.5%	9 0.4%
Black or African American	230 21.3%	35 3.2%	265 12.2%
White	412 38.1%	601 54.9%	1013 46.6%
More than one race	22 2%	27 2.5%	49 2.3%
Unknown or Not Reported	316 29.2%	315 28.8%	631 29%
Patient Activation Measure (PAM-13) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.27 (0.45)	3.27 (0.44)	3.27 (0.45)
Patient Assessment of Chronic Illness Care (PACIC) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.72 (0.83)	2.65 (0.84)	2.68 (0.83)
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 8a (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.37 (1.03)	2.34 (1.06)	2.35 (1.05)
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form 12a (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.01 (0.89)	1.99 (0.88)	2.00 (0.88)
Patient Health Questionnaire 4 (PHQ-4) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.55 (0.75)	1.51 (0.72)	1.53 (0.74)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	133.11 (14.99)	130.31 (13.19)	131.70 (14.18)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	76.14 (8.65)	75.47 (8.10)	75.80 (8.39)
Low density lipoprotein cholesterol (LDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	91.82 (32.27)	90.58 (31.50)	91.22 (31.89)
Hemoglobin A1c (HbA1c) (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	7.33 (1.63)	7.20 (1.49)	7.27 (1.57)

Outcome Measures

1. Primary Outcome

Title	PROMIS Short Form 8a
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patients at High PAE Practices	Patients at Low PAE Practices
Arm/Group Description	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 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.
Measure Participants	617	674
Mean (Standard Deviation) [units on a scale]	-0.05 (0.83)	-0.03 (0.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients at High PAE Practices, Patients at Low PAE Practices
	Comments
	Type of Statistical Test	Other
	Comments	Clustered two-sample t-test
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	PROMIS Short Form 12a
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patients at High PAE Practices	Patients at Low PAE Practices
Arm/Group Description	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 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.
Measure Participants	617	674
Mean (Standard Deviation) [units on a scale]	-0.07 (0.51)	-0.05 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients at High PAE Practices, Patients at Low PAE Practices
	Comments
	Type of Statistical Test	Other
	Comments	Clustered two-sample t-test
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	PHQ-4
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patients at High PAE Practices	Patients at Low PAE Practices
Arm/Group Description	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 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.
Measure Participants	617	674
Mean (Standard Deviation) [units on a scale]	0.03 (0.62)	-0.04 (0.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patients at High PAE Practices, Patients at Low PAE Practices
	Comments
	Type of Statistical Test	Other
	Comments	Clustered two-sample t-test
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	3 years (January 2014-December 2016)
Adverse Event Reporting Description	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.
Arm/Group Title	Patients at High PAE Practices		Patients at Low PAE Practices
Arm/Group Description	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 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.
All Cause Mortality
	Patients at High PAE Practices		Patients at Low PAE Practices
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/1081 (1.3%)		14/1095 (1.3%)
Serious Adverse Events
	Patients at High PAE Practices		Patients at Low PAE Practices
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1081 (0%)		0/1095 (0%)
Other (Not Including Serious) Adverse Events
	Patients at High PAE Practices		Patients at Low PAE Practices
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1081 (0%)		0/1095 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.