Caring for the Whole Person

Behavioral Health Clinical Trial

Official title:

Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03034369
• Other study ID #: 14-247A
• Status: Active, not recruiting
• Phase: N/A
• First received: January 25, 2017
• Last updated: June 13, 2017
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18

• Received care at a safety net care clinic in Oregon

Exclusion Criteria:

Related Conditions & MeSH terms

• Behavioral Health

Intervention

Other:
• Access to Care
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.
• Depression Screening
Analysis of health care claims data for depression screenings at baseline and 12 months.
• Patient-Provider Relationship
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.
• Patient-Clinic Interactions
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.
• Stigma
Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.
• Provider Continuity
Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.
• Symptom Severity
Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.
• Diagnoses
Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.
• Social support
Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.
• Preventive Screening
Analysis of health care claims data for preventive screenings at baseline and 12 months.
• Inpatient Hospitalization Utilization
Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.
• Inpatient Readmissions
Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.
• Post-Admission follow-up
Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.

Locations

Country	Name	City	State
United States	Center for Outcomes Research and Education, Providence Health & Services	Portland	Oregon

Sponsors (15)

Lead Sponsor	Collaborator
Providence Health & Services	Bridges Clinic, Cascadia Addiction Research and Education, LLC, Cascadia Gardiner Clinic, Mosaic Medical, North Portland Clinic, Oregon Health and Science University, Patient-Centered Outcomes Research Institute, Providence Medical Group, Rockwood Clinic, The Annex, The Bend Clinic, Umpqua Community Health Center, Umpqua Expanded Care Clinic, Yamhill CCO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient reported outcomes	Change in patient reported outcomes at baseline and 12 months	12 months
Primary	Change in health care claims	change in health care claims at baseline and 12 months	12 months

External Links

•   Center for Outcomes Research and Education, Providence Health & Services