Behavioral HealthNCT03034369
Caring for the Whole Person
An observational study of Behavioral Health, run by Providence Health & Services at 1 site in United States.
Trial summary
The goal of this study is to identify outcomes associated with Behavioral Health Integration (BHI) that matter to patients, to compare changes in outcome over time to measure the impact of different BHI models on different patients, and to create and maintain an Integration Learning Collaborative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Health
- What is being tested?
- Access to Care, Depression Screening and Patient-Provider Relationship
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Observational
- 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
Study population: Patients accessing care at safety net clinic in Oregon.
Who may be able to join
- Age >= 18
- Received care at a safety net care clinic in Oregon
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Outcomes Research and Education, Providence Health & Services
Portland, Oregon, 97213
About this study
Official title: Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations
The goal of this study is to identify outcomes associated with Behavioral Health Integration (BHI) that matter to patients, to compare changes in outcome over time to measure the impact of different BHI models on different patients, and to create and maintain an Integration Learning Collaborative.
Read the detailed description
Twelve safety net clinics have been selected to be a part of this study. The clinics vary on a BHI continuum level, which includes minimal collaboration, basic collaboration at a distance, basic collaboration on site, close collaboration (partially integrated) and close collaboration (fully integrated).
Twelve-thousand patients will be randomly selected from the 12 clinics to be invited to participate in the study. Patients who elect to participate will complete a survey at baseline to collect patient-reported outcomes and again twelve months later.
The Oregon All Providers All Claims (APAC) database will be accessed to analyze financial data regarding the patients at baseline and 12 months.
The hypothesis is that the degree of clinic BHI will predict patient outcomes.
- Conditions
- Behavioral Health
- Being tested
- Access to Care, Depression Screening, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma
- Keywords
- Integration, Primary Care, Behavioral Health, Health Care Reform, Medical Home, Accountable Care Organization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to CareOther
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.
Depression ScreeningOther
Analysis of health care claims data for depression screenings at baseline and 12 months.
Patient-Provider RelationshipOther
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.
Patient-Clinic InteractionsOther
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.
StigmaOther
Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.
Provider ContinuityOther
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.
Symptom SeverityOther
Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.
DiagnosesOther
Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.
Social supportOther
Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.
Preventive ScreeningOther
Analysis of health care claims data for preventive screenings at baseline and 12 months.
Inpatient Hospitalization UtilizationOther
Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.
Inpatient ReadmissionsOther
Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.
Post-Admission follow-upOther
Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Safety Net Clinic Patients | A Cohort of patients in 12 different primary care clinics will be studied to measure how changes in different integration factors impacts the following patient reported outcomes at baseline and 12 months: Access to Care, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma, Provider Continuity, Symptom Severity, Diagnoses, and Social Support. Health care claims data will be accessed to analyze Depression Screening, Preventive Screening, Inpatient Hospitalization Utilization, Inpatient Readmissions, and Post-Admission follow-up at baseline and 12 months. Receives: Other: Access to Care; Other: Depression Screening; Other: Patient-Provider Relationship; Other: Patient-Clinic Interactions; Other: Stigma; Other: Provider Continuity; Other: Symptom Severity; Other: Diagnoses; Other: Social support; Other: Preventive Screening; Other: Inpatient Hospitalization Utilization; Other: Inpatient Readmissions; Other: Post-Admission follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported outcomes
Change in patient reported outcomes at baseline and 12 months
Measured: 12 months
Change in health care claims
change in health care claims at baseline and 12 months
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 posted27 Jan 2017 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral HealthStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Oregon Health and Science University, Cascadia Addiction Research and Education, LLC, Umpqua Community Health Center, Mosaic Medical, North Portland Clinic, Providence Medical Group, Rockwood Clinic, The Bend Clinic, Yamhill CCO, The Annex, Cascadia Gardiner Clinic, Umpqua Expanded Care Clinic, Bridges Clinic
- Responsible party
- Sponsor
- Investigators
- Bill J. Wright, PhD, Principal investigator, Director, Center for Outcomes Evaluate and Education, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034369
- Sponsor's protocol ID
- 14-247A
- Status last verified
- Jun 2017
- First submitted
- 25 Jan 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations
- ClinicalTrials.gov ID
- NCT03034369
- Acronym / sponsor ID
- 14-247A
- Conditions
- Behavioral Health
- Keywords
- Integration, Primary Care, Behavioral Health, Health Care Reform, Medical Home, Accountable Care Organization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Oregon Health and Science University, Cascadia Addiction Research and Education, LLC, Umpqua Community Health Center, Mosaic Medical, North Portland Clinic, Providence Medical Group, Rockwood Clinic, The Bend Clinic, Yamhill CCO, The Annex, Cascadia Gardiner Clinic, Umpqua Expanded Care Clinic, Bridges Clinic
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- 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.
The goal of this study is to identify outcomes associated with Behavioral Health Integration (BHI) that matter to patients, to compare changes in outcome over time to measure the impact of different BHI models on different patients, and to create and maintain an Integration Learning Collaborative.
Detailed description
Twelve safety net clinics have been selected to be a part of this study. The clinics vary on a BHI continuum level, which includes minimal collaboration, basic collaboration at a distance, basic collaboration on site, close collaboration (partially integrated) and close collaboration (fully integrated).
Twelve-thousand patients will be randomly selected from the 12 clinics to be invited to participate in the study. Patients who elect to participate will complete a survey at baseline to collect patient-reported outcomes and again twelve months later.
The Oregon All Providers All Claims (APAC) database will be accessed to analyze financial data regarding the patients at baseline and 12 months.
The hypothesis is that the degree of clinic BHI will predict patient outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety Net Clinic Patients | – | Other: Access to Care, Other: Depression Screening, Other: Patient-Provider Relationship, Other: Patient-Clinic Interactions, Other: Stigma, Other: Provider Continuity, Other: Symptom Severity, Other: Diagnoses, Other: Social support, Other: Preventive Screening, Other: Inpatient Hospitalization Utilization, Other: Inpatient Readmissions, Other: Post-Admission follow-upA Cohort of patients in 12 different primary care clinics will be studied to measure how changes in different integration factors impacts the following patient reported outcomes at baseline and 12 months: Access to Care, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma, Provider Continuity, Symptom Severity, Diagnoses, and Social Support. Health care claims data will be accessed to analyze Depression Screening, Preventive Screening, Inpatient Hospitalization Utilization, Inpatient Readmissions, and Post-Admission follow-up at baseline and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients accessing care at safety net clinic in Oregon.
Key inclusion criteria (2 listed)
- Age >= 18
- Received care at a safety net care clinic in Oregon
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Access to CarePatient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care. | Other | Safety Net Clinic Patients |
| Depression ScreeningAnalysis of health care claims data for depression screenings at baseline and 12 months. | Other | Safety Net Clinic Patients |
| Patient-Provider RelationshipPatient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship. | Other | Safety Net Clinic Patients |
| Patient-Clinic InteractionsPatient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions. | Other | Safety Net Clinic Patients |
| StigmaPatient reported outcome survey administered at baseline and 12 months to measure perceived stigma. | Other | Safety Net Clinic Patients |
| Provider ContinuityPatient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity. | Other | Safety Net Clinic Patients |
| Symptom SeverityPatient reported outcome survey administered at baseline and 12 months to measure symptom severity. | Other | Safety Net Clinic Patients |
| DiagnosesPatient reported outcome survey administered at baseline and 12 months to measure diagnoses. | Other | Safety Net Clinic Patients |
| Social supportPatient reported outcome survey administered at baseline and 12 months to assess social support and outlets. | Other | Safety Net Clinic Patients |
| Preventive ScreeningAnalysis of health care claims data for preventive screenings at baseline and 12 months. | Other | Safety Net Clinic Patients |
| Inpatient Hospitalization UtilizationAnalysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months. | Other | Safety Net Clinic Patients |
| Inpatient ReadmissionsAnalysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months. | Other | Safety Net Clinic Patients |
| Post-Admission follow-upAnalysis of health care claims data for Post-Admission follow-up at baseline and 12 months. | Other | Safety Net Clinic Patients |
Primary outcome
Change in patient reported outcomes
Time frame: 12 months
Change in patient reported outcomes at baseline and 12 months
Change in health care claims
Time frame: 12 months
change in health care claims at baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Center for Outcomes Research and Education, Providence Health \& ServicesLink provided by the sponsor.
- 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.
Bill J. Wright, PhD principal investigator
Director, Center for Outcomes Evaluate and Education, Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Health, run by Providence Health & Services 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jun 2017. 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?
Results are not available in the source record.
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?
Change in patient reported outcomes (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?
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 Jun 2017.