DiabetesACTIVATENCT02287883
Impact of Patient Activation and Engagement on Patient-Centered Outcomes of Care in ACOs
An observational study of Diabetes and Cardiovascular Disease, run by University of California, Berkeley at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- What is being tested?
- Observational: Patient Activation and Engagement (PAE)
- How many people
- 2,176 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to 30 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4368 patients with diabetes or cardiovascular disease receiving care from selected clinics at two Accountable Care Organizations in Los Angeles, CA and Chicago, IL.
Who may be able to join
- adult, 18-82
- diagnosis of diabetes or cardiovascular disease
- receives primary care at one of 16 selected clinical sites from two Accountable Care Organizations
Who cannot join
- Incomplete mailing address available from Electronic Medical Record
- Patient language other than English or Spanish
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of California, Berkeley
Berkeley, California, 94720
Advocate Health Care
Chicago, Illinois, 60515
Dartmouth Colelge
Hanover, New Hampshire, 03755
HealthCare Partners Insitute for Applied Research and Education
Torrance, California, 90502
About this study
Official title: The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations
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.
Read the 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
- 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.
- Conditions
- Diabetes, Cardiovascular Disease
- Being tested
- Observational: Patient Activation and Engagement (PAE)
- Keywords
- Patient activation and engagement, Patient reported outcomes, Accountable Care Organizations, Chronic illness, Vulnerable population, Comparison of approaches
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Patient Participation, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: 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) Receives: Other: Observational: Patient Activation and Engagement (PAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Wake Forest University Health Sciences, HealthCare Partners Institute for Applied Research and Education
- Responsible party
- Sponsor
- Investigators
- Stephen M Shortell, PhD,MPH,MBA, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287883
- Sponsor's protocol ID
- IHS-1310-06821
- Acronym
- ACTIVATE
- Status last verified
- Oct 2017
- First submitted
- 6 Nov 2014
- Last updated
- 15 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Impact of Patient Activation and Engagement on Improving Patient-Centered Outcomes of Care in Accountable Care Organizations
- ClinicalTrials.gov ID
- NCT02287883
- Acronym / sponsor ID
- ACTIVATE / IHS-1310-06821
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- Patient activation and engagement, Patient reported outcomes, Accountable Care Organizations, Chronic illness, Vulnerable population, Comparison of approaches
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,176 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Dartmouth College, Wake Forest University Health Sciences, HealthCare Partners Institute for Applied Research and Education
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients at high PAE clinic | – | Other: Observational: Patient Activation and Engagement (PAE)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 | – | Other: Observational: Patient Activation and Engagement (PAE)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) |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4368 patients with diabetes or cardiovascular disease receiving care from selected clinics at two Accountable Care Organizations in Los Angeles, CA and Chicago, IL.
Key inclusion criteria (3 listed)
- adult, 18-82
- diagnosis of diabetes or cardiovascular disease
- receives primary care at one of 16 selected clinical sites from two Accountable Care Organizations
Key exclusion criteria (2 listed)
- Incomplete mailing address available from Electronic Medical Record
- Patient language other than English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational: Patient Activation and Engagement (PAE)Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities. | Other | Patients at high PAE clinic, Patients at low PAE clinic |
Primary outcome
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).
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Shortell, PhD,MPH,MBA principal investigator
University of California, Berkeley
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Disease, run by University of California, Berkeley at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Short Form 8a (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.