Multiple Chronic ConditionsNCT03885401
Enhanced Care Planning for Patients With Multiple Chronic Conditions
A study testing Enhanced care planning in people with Multiple Chronic Conditions and Health Behavior, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Patients with multiple chronic conditions (MCC) have a range of needs that extend beyond traditional medical care, including behavioral, mental health, and social needs. While primary care does its best to address these needs, few practices can undertake a systematic approach without broader health system and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Chronic Conditions, Health Behavior, Mental Health
- What is being tested?
- Enhanced care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two or more chronic conditions
- At least one uncontrolled condition
- Completes baseline survey
Who cannot join
- Participating in Richmond Accountable Health Community study
- Clinician excludes patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23219
About this study
Official title: Enhanced Care Planning and Clinical-Community Linkages to Comprehensively Address the Basic Needs of Patients With Multiple Chronic Conditions
Patients with multiple chronic conditions (MCC) have a range of needs that extend beyond traditional medical care, including behavioral, mental health, and social needs. While primary care does its best to address these needs, few practices can undertake a systematic approach without broader health system and coordinated community support. Fortunately, communities and health systems are investing in new models of care to address these needs. New tools are emerging that allow for enhanced care planning to identify and prioritize patients' needs based on their values, preferences, social, and clinical context. Additionally, support systems to promote partnerships between patients and clinical and community care teams are emerging. Building on work occurring as part of the Richmond Accountable Health Community, the investigators propose to (a) evaluate the implementation of an enhanced care planning approach, paired with community-clinical linkages support to address health behavior, mental health, and social needs; (b) determine within a randomized controlled trial the benefit of this approach compared to usual care; and (c) assess which person, family, community, and system contextual factors that influence MCC.
Read the detailed description
The number of patients in the United States with multiple chronic conditions (MCC) is growing. Many patients with poorly controlled MCC also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address these basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems. Responding to the Special Emphasis Notice NOT-HS-16-013, Optimizing Care for People Living with MCC through the Development of Enhanced Care Planning, the investigators propose a clinician-level randomized controlled trial to study how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. This study will build on the Centers for Medicare and Medicaid Services (CMS)-funded Accountable Health Community (AHC) in Richmond, Virginia. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record (EHR), clinicians will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to 50 randomly selected patients; 10 respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected, with over-sampling of minorities. The intervention includes two components. First, an enhanced care planning tool called My Own Health Report (MOHR) will screen patients for health behavior, mental health, and social needs. Clinical navigator support will help patients prioritize needs, create care plans based on preferences, and write a personal narrative to guide the care team. Patients will update care plans quarterly. Second, community-clinical linkage support will include community resource registries, personnel to span settings (clinical navigators, community health workers), and care team coordination tools (sharing MOHR content, secure messaging, and virtual visits). The investigators will compare patient-level intervention and control outcomes to assess improvements in MCC outcomes (primary outcome) and self-reported PROMIS-29 measures (physical health, mental health, social wellbeing) six months and two years post-enrollment. the investigators will also conduct a mixed-methods, multilevel assessment of person-, family-, community-, and system-level contextual influences on implementation and effectiveness. Data sources will include EHR and MOHR data, chart reviews, patient surveys, field notes, and semi-structured interviews of patients, clinicians, and community stakeholders. If effective, this study will help inform efforts by primary care clinicians to participate in the growing number of AHC-like systems as a strategy to better control MCC.
- Conditions
- Multiple Chronic Conditions, Health Behavior, Mental Health, Social Determinants of Health
- Being tested
- Enhanced care planning
- Medical subject headings
- Multiple Chronic Conditions, Health Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced care planningBehavioural
The intervention includes (1) screening for unhealthy behaviors, mental health needs, and social needs, (2) creation of a care plan, (3) quarterly updates to the plan, (4) a clinical navigator and community health worker to support accomplishing the care plan, (5) registry of community resources and programs, and (6) messaging and video-visit system for team members.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced care planning | Experimental | The intervention consists of two components - enhanced care planning and clinical-community linkages. The enhanced care plan is created using MOHR (https://myownhealthreport.org). MOHR screens patients for unhealthy behaviors, mental health needs, and social needs. Patients identify the needs they would like to address and create a care plan, which they update quarterly. A clinical navigator and community health worker (CHW) help patients address their care plans using clinical-community linkages, which has four components. First, clinicians and clinical navigators have a resource registry identifying community programs and support - No Wrong Door (NWD) and https://navigator.aafp.org/. Second, MOHR shares information (care plans, patient narrative, and patient progress) across clinical and community team members. Third, MOHR supports messaging and video visits for team members and patients. Finally, MOHR sends care team members quarterly patient progress updates. Receives: Behavioral: Enhanced care planning |
| Usual medical care | No intervention | Clinicians randomized to the control condition will continue to provide "usual care." This includes current non-systematic assessment of health behaviors, mental health needs, and social needs. Neither clinicians nor patients will be eligible to receive CHW support or have access to NWD. Clinicians may refer some control patients to community programs as part of their current usual care. Control clinicians will be blinded as to which patients are included in the study. At the end of the study, the investigators will share with control clinicians our lessons learned, access to MOHR, and lists of useful community resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced care plan creation (implementation outcome)
This outcome reports the percent of intervention patients who complete the creation of an enhanced care plan (numerator = intervention patients who create an enhanced care plan / denominator = all enrolled intervention patients).
Measured: Within 6 months of enrollment
Health behavior, mental health, and social needs
This outcome will measure the number of health behavior, mental health, and social needs that patients have who complete an enhanced care plan. This is a frequency count of each specific need based on the health risk assessment output.
Measured: Within 6 months of enrollment
Referral to and connection to community resources (implementation outcome)
This outcome will measure which community resources intervention patients are referred to for assistance with addressing health behaviors, mental health, and social needs. This is a frequency count of the number of intervention patients referred to each potential community resource.
Measured: Over 2 years after enrollment
Effectiveness - chronic condition control
Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
Measured: 6 months after creating a care plan
Maintenance - chronic condition control
Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
Measured: 2 years after creating a care plan
Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29)
Pre-post change in eight Patient Reported Outcomes Measurement Information System (PROMIS-29) domains for intervention patients versus usual care. Norm-based scores will be calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population. Higher scores means that the patient is reporting greater symptoms. Scores will be calculated using the Healthmeasures Scoring Service (http://www.healthmeasures.net/score-and-interpret/calculate-scores).
Measured: 6 months after creating a care plan
Maintenance - quality of life: eight PROMIS-29 domains
Pre-post change in eight PROMIS-29 domains for intervention patients versus usual care
Measured: 2 years after creating a care plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start20 Sep 2020
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a clinician level randomized controlled trial. Sixty clinicians will be randomized to intervention (enhanced care planning for health behaviors, mental health, and social needs) or control condition (usual care). The investigators will randomly survey all patients with MCC from each clinicians' patient panel. Patients with at least one uncontrolled MCC will be randomly selected for inclusion until 10 patients are recruited from each clinician. The investigators will use hybrid implementation-effectiveness design to measure outcomes. Implementation outcomes include enhanced care plan completion; the prevalence of health behavior, mental health, and social needs; goals patients prioritize and how they want to address them; and the type, intensity, and follow-up of care team support provided to address patient goals. Effectiveness outcomes include the number of uncontrolled chronic conditions and patient reported physical, mental, and social health..
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Alex H Krist, MD MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885401
- Sponsor's protocol ID
- HM20015553
- Other IDs
- 1R01HS026223-01A1
- Status last verified
- Jun 2025
- First submitted
- 9 Mar 2019
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krist AH, O'Loughlin K, Woolf SH, Sabo RT, Hinesley J, Kuzel AJ, Rybarczyk BD, Kashiri PL, Brooks EM, Glasgow RE, Huebschmann AG, Liaw WR. Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial. Trials. 2020 Jun 11;21(1):517. doi: 10.1186/s13063-020-04463-3.
PubMed 32527322
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Care Planning and Clinical-Community Linkages to Comprehensively Address the Basic Needs of Patients With Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT03885401
- Acronym / sponsor ID
- HM20015553
- Conditions
- Multiple Chronic Conditions, Health Behavior, Mental Health, Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with multiple chronic conditions (MCC) have a range of needs that extend beyond traditional medical care, including behavioral, mental health, and social needs. While primary care does its best to address these needs, few practices can undertake a systematic approach without broader health system and coordinated community support. Fortunately, communities and health systems are investing in new models of care to address these needs. New tools are emerging that allow for enhanced care planning to identify and prioritize patients' needs based on their values, preferences, social, and clinical context. Additionally, support systems to promote partnerships between patients and clinical and community care teams are emerging. Building on work occurring as part of the Richmond Accountable Health Community, the investigators propose to (a) evaluate the implementation of an enhanced care planning approach, paired with community-clinical linkages support to address health behavior, mental health, and social needs; (b) determine within a randomized controlled trial the benefit of this approach compared to usual care; and (c) assess which person, family, community, and system contextual factors that influence MCC.
Detailed description
The number of patients in the United States with multiple chronic conditions (MCC) is growing. Many patients with poorly controlled MCC also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address these basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems. Responding to the Special Emphasis Notice NOT-HS-16-013, Optimizing Care for People Living with MCC through the Development of Enhanced Care Planning, the investigators propose a clinician-level randomized controlled trial to study how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. This study will build on the Centers for Medicare and Medicaid Services (CMS)-funded Accountable Health Community (AHC) in Richmond, Virginia. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record (EHR), clinicians will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to 50 randomly selected patients; 10 respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected, with over-sampling of minorities. The intervention includes two components. First, an enhanced care planning tool called My Own Health Report (MOHR) will screen patients for health behavior, mental health, and social needs. Clinical navigator support will help patients prioritize needs, create care plans based on preferences, and write a personal narrative to guide the care team. Patients will update care plans quarterly. Second, community-clinical linkage support will include community resource registries, personnel to span settings (clinical navigators, community health workers), and care team coordination tools (sharing MOHR content, secure messaging, and virtual visits). The investigators will compare patient-level intervention and control outcomes to assess improvements in MCC outcomes (primary outcome) and self-reported PROMIS-29 measures (physical health, mental health, social wellbeing) six months and two years post-enrollment. the investigators will also conduct a mixed-methods, multilevel assessment of person-, family-, community-, and system-level contextual influences on implementation and effectiveness. Data sources will include EHR and MOHR data, chart reviews, patient surveys, field notes, and semi-structured interviews of patients, clinicians, and community stakeholders. If effective, this study will help inform efforts by primary care clinicians to participate in the growing number of AHC-like systems as a strategy to better control MCC.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a clinician level randomized controlled trial. Sixty clinicians will be randomized to intervention (enhanced care planning for health behaviors, mental health, and social needs) or control condition (usual care). The investigators will randomly survey all patients with MCC from each clinicians' patient panel. Patients with at least one uncontrolled MCC will be randomly selected for inclusion until 10 patients are recruited from each clinician. The investigators will use hybrid implementation-effectiveness design to measure outcomes. Implementation outcomes include enhanced care plan completion; the prevalence of health behavior, mental health, and social needs; goals patients prioritize and how they want to address them; and the type, intensity, and follow-up of care team support provided to address patient goals. Effectiveness outcomes include the number of uncontrolled chronic conditions and patient reported physical, mental, and social health..
| Arm | Type | Receives |
|---|---|---|
| Enhanced care planning | Experimental | Behavioral: Enhanced care planningThe intervention consists of two components - enhanced care planning and clinical-community linkages. The enhanced care plan is created using MOHR (https://myownhealthreport.org). MOHR screens patients for unhealthy behaviors, mental health needs, and social needs. Patients identify the needs they would like to address and create a care plan, which they update quarterly. A clinical navigator and community health worker (CHW) help patients address their care plans using clinical-community linkages, which has four components. First, clinicians and clinical navigators have a resource registry identifying community programs and support - No Wrong Door (NWD) and https://navigator.aafp.org/. Second, MOHR shares information (care plans, patient narrative, and patient progress) across clinical and community team members. Third, MOHR supports messaging and video visits for team members and patients. Finally, MOHR sends care team members quarterly patient progress updates. |
| Usual medical care | No intervention | –Clinicians randomized to the control condition will continue to provide "usual care." This includes current non-systematic assessment of health behaviors, mental health needs, and social needs. Neither clinicians nor patients will be eligible to receive CHW support or have access to NWD. Clinicians may refer some control patients to community programs as part of their current usual care. Control clinicians will be blinded as to which patients are included in the study. At the end of the study, the investigators will share with control clinicians our lessons learned, access to MOHR, and lists of useful community resources. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two or more chronic conditions
- At least one uncontrolled condition
- Completes baseline survey
Key exclusion criteria (2 listed)
- Participating in Richmond Accountable Health Community study
- Clinician excludes patients
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 |
|---|---|---|
| Enhanced care planningThe intervention includes (1) screening for unhealthy behaviors, mental health needs, and social needs, (2) creation of a care plan, (3) quarterly updates to the plan, (4) a clinical navigator and community health worker to support accomplishing the care plan, (5) registry of community resources and programs, and (6) messaging and video-visit system for team members. | Behavioural | Enhanced care planning |
Primary outcome
Enhanced care plan creation (implementation outcome)
Time frame: Within 6 months of enrollment
This outcome reports the percent of intervention patients who complete the creation of an enhanced care plan (numerator = intervention patients who create an enhanced care plan / denominator = all enrolled intervention patients).
Health behavior, mental health, and social needs
Time frame: Within 6 months of enrollment
This outcome will measure the number of health behavior, mental health, and social needs that patients have who complete an enhanced care plan. This is a frequency count of each specific need based on the health risk assessment output.
Referral to and connection to community resources (implementation outcome)
Time frame: Over 2 years after enrollment
This outcome will measure which community resources intervention patients are referred to for assistance with addressing health behaviors, mental health, and social needs. This is a frequency count of the number of intervention patients referred to each potential community resource.
Effectiveness - chronic condition control
Time frame: 6 months after creating a care plan
Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
Maintenance - chronic condition control
Time frame: 2 years after creating a care plan
Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 6 months after creating a care plan
Pre-post change in eight Patient Reported Outcomes Measurement Information System (PROMIS-29) domains for intervention patients versus usual care. Norm-based scores will be calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population. Higher scores means that the patient is reporting greater symptoms. Scores will be calculated using the Healthmeasures Scoring Service (http://www.healthmeasures.net/score-and-interpret/calculate-scores).
Maintenance - quality of life: eight PROMIS-29 domains
Time frame: 2 years after creating a care plan
Pre-post change in eight PROMIS-29 domains for intervention patients versus usual care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 32527322Krist AH, O'Loughlin K, Woolf SH, Sabo RT, Hinesley J, Kuzel AJ, Rybarczyk BD, Kashiri PL, Brooks EM, Glasgow RE, Huebschmann AG, Liaw WR. Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial. Trials. 2020 Jun 11;21(1):517. doi: 10.1186/s13063-020-04463-3.
- 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.
Alex H Krist, MD MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced care planning in people with Multiple Chronic Conditions and Health Behavior, run by Virginia Commonwealth University at 1 site 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enhanced care plan creation (implementation outcome) (time frame: Within 6 months of enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885401, which also lists 1 linked publication.
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 2 Jul 2025.