HypertensionCOHERENCT05022316
COHERE - COntextualized Care in cHcs' Electronic Health REcords
A study testing CDS Tool Access in people with Hypertension and Diabetes Mellitus, Type 2, run by Kaiser Permanente at 3 sites in United States.
Trial summary
This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- CDS Tool Access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2022to 15 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinic has conducted >200 social risk screenings in the last 12 months at the time of randomization.
- Clinic provides primary care
- Joined OCHIN by 07/01/2021
Who cannot join
- Clinic participated in pilot
- Clinic is a school-based health center
- Clinic provides care to prison population
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
OCHIN, Inc
Portland, Oregon, 97228
University of California, San Francisco
San Francisco, California, 94143
About this study
This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.
Read the detailed description
The investigators will use a randomized quasi-experimental design to assess impact of the CDS tools designed to support social risk-informed care. After conducting a 12-month pilot study with 3 CHCs to test and further refine the CDS tools, 6 CHCs will be recruited to participate in the main trial. All OCHIN clinics with >200 SDH screenings (excluding the pilot clinics) will be identified and randomized to a potential intervention group or a control group. Clinics from the potential intervention group will be recruited in a random order until 6 agree to participate. This recruitment method ensures randomization between intervention and control clinics, without recruiting CHCs to a study in which they might not receive an intervention. Intervention sites will be trained in how to use the tools shortly before the tools are activated and will be followed for 12 months to assess tool adoption and impact on the CQMs of interest. Use of the CDS tools will occur as part of the regular care patients receive and will not require special clinic visits. Patients will interact with providers as they normally would, augmented by the intervention when clinicians choose to utilize the CDS tools. For all study clinics, quantitative data will be collected (via EHR data extraction) on social risk data collection and action by care team members. Limited clinical data will be collected on patients who are seen at a study CHC during the study period. Qualitative data will also be collected which includes semi-structured interviews with clinic staff from all study CHCs enrolled in the main trial.
NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the clinic level. While CHCs will be recruited that have previously screened patients for social risks, it is unlikely that these CHCs will have screened all patients in their clinics. Thus, the CDS tools will not apply to all patients in participating clinics, and it cannot be guaranteed that individual patients will receive an intervention.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Being tested
- CDS Tool Access
- Keywords
- Social Determinants of Health, Decision Support Systems, Clinical, Electronic Health Records, Community Health Centers, Health Status Disparities
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDS Tool AccessOther
Clinics receiving the intervention will have access to EHR-based CDS tools designed to support social risk-informed care. Prior to tool activation in participating community health centers (CHCs), clinic staff members will be oriented to the CDS tools by an EHR trainer (either on-site or remotely).
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Control clinics will not receive an intervention. |
| Intervention Arm | Experimental | Intervention clinics will have the CDS tools turned on in their EHR. Receives: Other: CDS Tool Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypertension control
binary outcome of patient having a blood pressure of <140/90 at the time of the clinic visit (0=no, 1=yes)
Measured: 12 months
diabetes control
binary outcome of patient with diabetes having an HbA1c of <9% at the time of the clinic visit (0=no, 1=yes)
Measured: 12 months
Secondary outcomes (3)
completion of social risk screening
binary outcome of patient whose last social risk screening is >12 months old at the time of an encounter (0=no, 1=yes)
Measured: 12 months
SDH z-codes added to problem list and/or visit list
binary outcome of patient with a positive screening for social risks and without an associated SDH z-code having the z-code added to the problem/visit list (0=no, 1=yes)
Measured: 12 months
completion of medication adherence documentation
binary outcome of patient with prescribed medications has up-to-date medication adherence data documented in the EHR (0=no, 1=yes)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start12 Sep 2022
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized quasi-experimental design will be used to assess the impact of the newly developed CDS tools designed to support social-risk informed care.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- OCHIN, Inc., University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Rachel Gold, PhD, MPH, Principal investigator, Kaiser Permanente Center for Health Research; OCHINLaura Gottlieb, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022316
- Sponsor's protocol ID
- 5R01MD014886
- Acronym
- COHERE
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All EHR data are proprietary to the OCHIN clinics and thus will not be made directly available beyond the study team.
Publications
Gunn R, Pisciotta M, Gold R, Bunce A, Dambrun K, Cottrell EK, Hessler D, Middendorf M, Alvarez M, Giles L, Gottlieb LM. Partner-developed electronic health record tools to facilitate social risk-informed care planning. J Am Med Inform Assoc. 2023 Apr 19;30(5):869-877. doi: 10.1093/jamia/ocad010.
PubMed 36779911
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COHERE - COntextualized Care in cHcs' Electronic Health REcords
- ClinicalTrials.gov ID
- NCT05022316
- Acronym / sponsor ID
- COHERE / 5R01MD014886
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Keywords
- Social Determinants of Health, Decision Support Systems, Clinical, Electronic Health Records, Community Health Centers, Health Status Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- OCHIN, Inc., University of California, San Francisco
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 26 Aug 2021 (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.
This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.
Detailed description
The investigators will use a randomized quasi-experimental design to assess impact of the CDS tools designed to support social risk-informed care. After conducting a 12-month pilot study with 3 CHCs to test and further refine the CDS tools, 6 CHCs will be recruited to participate in the main trial. All OCHIN clinics with >200 SDH screenings (excluding the pilot clinics) will be identified and randomized to a potential intervention group or a control group. Clinics from the potential intervention group will be recruited in a random order until 6 agree to participate. This recruitment method ensures randomization between intervention and control clinics, without recruiting CHCs to a study in which they might not receive an intervention. Intervention sites will be trained in how to use the tools shortly before the tools are activated and will be followed for 12 months to assess tool adoption and impact on the CQMs of interest. Use of the CDS tools will occur as part of the regular care patients receive and will not require special clinic visits. Patients will interact with providers as they normally would, augmented by the intervention when clinicians choose to utilize the CDS tools. For all study clinics, quantitative data will be collected (via EHR data extraction) on social risk data collection and action by care team members. Limited clinical data will be collected on patients who are seen at a study CHC during the study period. Qualitative data will also be collected which includes semi-structured interviews with clinic staff from all study CHCs enrolled in the main trial.
NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the clinic level. While CHCs will be recruited that have previously screened patients for social risks, it is unlikely that these CHCs will have screened all patients in their clinics. Thus, the CDS tools will not apply to all patients in participating clinics, and it cannot be guaranteed that individual patients will receive an intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized quasi-experimental design will be used to assess the impact of the newly developed CDS tools designed to support social-risk informed care.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Control clinics will not receive an intervention. |
| Intervention Arm | Experimental | Other: CDS Tool AccessIntervention clinics will have the CDS tools turned on in their EHR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinic has conducted >200 social risk screenings in the last 12 months at the time of randomization.
- Clinic provides primary care
- Joined OCHIN by 07/01/2021
Key exclusion criteria (3 listed)
- Clinic participated in pilot
- Clinic is a school-based health center
- Clinic provides care to prison population
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 |
|---|---|---|
| CDS Tool AccessClinics receiving the intervention will have access to EHR-based CDS tools designed to support social risk-informed care. Prior to tool activation in participating community health centers (CHCs), clinic staff members will be oriented to the CDS tools by an EHR trainer (either on-site or remotely). | Other | Intervention Arm |
Primary outcome
hypertension control
Time frame: 12 months
binary outcome of patient having a blood pressure of <140/90 at the time of the clinic visit (0=no, 1=yes)
diabetes control
Time frame: 12 months
binary outcome of patient with diabetes having an HbA1c of <9% at the time of the clinic visit (0=no, 1=yes)
3 secondary outcomes
completion of social risk screening
Time frame: 12 months
SDH z-codes added to problem list and/or visit list
Time frame: 12 months
completion of medication adherence documentation
Time frame: 12 months
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 22 Jan 2025.
- Derived from this study: PubMed 36779911Gunn R, Pisciotta M, Gold R, Bunce A, Dambrun K, Cottrell EK, Hessler D, Middendorf M, Alvarez M, Giles L, Gottlieb LM. Partner-developed electronic health record tools to facilitate social risk-informed care planning. J Am Med Inform Assoc. 2023 Apr 19;30(5):869-877. doi: 10.1093/jamia/ocad010.
- Individual participant dataSharing planned: No. All EHR data are proprietary to the OCHIN clinics and thus will not be made directly available beyond the study team.
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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.
Rachel Gold, PhD, MPH principal investigator
Kaiser Permanente Center for Health Research; OCHIN
Laura Gottlieb, MD, MPH principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDS Tool Access in people with Hypertension and Diabetes Mellitus, Type 2, run by Kaiser Permanente at 3 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 3 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
hypertension control (time frame: 12 months). The study lists 2 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 NCT05022316, 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 22 Jan 2025.