Implementing Health Plan-Level Care Management for Solo & Small Practices

NCT02041962 | Completed Results

• 1 other identifier: R18HS021425-01A1
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if a version of the chronic care model for individuals with mood disorders seen in small or solo practices can improve patient health.

Conditions

Bipolar Disorder; Depression

Keywords

Care Management; Chronic Care Model; Mood Disorders

Outcome Measures

Primary Outcomes (2)

• Health-related Quality of Life, as Measured by the Mental Health Component Score

  Mental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.

  12-months

• Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)

  Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.

  12-months

Study Arms (2)

Educational Control

ACTIVE COMPARATOR

Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.

Other: Educational Control

Chronic Care Model for Mood Disorders

EXPERIMENTAL

Life Goals Collaborative Care

Behavioral: Chronic Care Model for Mood Disorders

Interventions

Chronic Care Model for Mood Disorders BEHAVIORAL

The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.

Also known as: Life Goals Collaborative Care

Chronic Care Model for Mood Disorders

Educational Control OTHER

Educational Control

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently covered by Aetna's HMO or preferred provider products (for whom Aetna provides mental and medical inpatient, outpatient, and pharmacy benefits) for at least 6 months
• Recent (past 6-month) hospitalization for an acute psychiatric or partial hospital unit with a manic or depressive episode and confirmation of mood disorder diagnosis in the medical record (presence of one inpatient or two outpatient ICD-9 codes: 296.1x-296.8x in previous 6 months)
• Ability to speak and read English and provide informed consent
• Current principal outpatient prescribing provider is a solo practitioner or in a practice with \<=3 providers.

You may not qualify if:

• No active substance intoxication
• No acute medical illness or dementia

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Kilbourne AM, Prenovost KM, Liebrecht C, Eisenberg D, Kim HM, Un H, Bauer MS. Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan. Psychiatr Serv. 2019 Mar 1;70(3):219-224. doi: 10.1176/appi.ps.201800336. Epub 2019 Jan 3.

  PMID: 30602344 DERIVED

• Kilbourne AM, Nord KM, Kyle J, Van Poppelen C, Goodrich DE, Kim HM, Eisenberg D, Un H, Bauer MS. Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices. BMC Psychol. 2014 Nov 13;2(1):48. doi: 10.1186/s40359-014-0048-x. eCollection 2014.

  PMID: 25520807 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mood Disorders

Interventions

Chronic Care Model

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care, Integrated; Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Dropout was substantial; the primary reason for subject dropout was disenrollment from Aetna coverage, as enrollment in Aetna was a study inclusion criterion.

Results Point of Contact

• Title: Amy Kilbourne, PhD
• Organization: University of Michigan

amykilbo@umich.edu

734-845-3452

Study Officials

• Amy M Kilbourne, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 22, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 23, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Locations

US (1)