NCT02136732

Brief Summary

With a growing aging population, the number of persons with chronic conditions continues to escalate and challenges related to chronic care quality, effectiveness and cost remain unresolved.Federally Qualified Health Centers (FQHC) have experienced increasing numbers of patient visits for chronic conditions, and FQHC patients are more likely to have serious chronic conditions when compared to patients being cared for by non-FQHC providers. The Chronic Care Intervention (CCI) combines home visiting with health activation coaching and has resulted in improved health status and reduced expenditures (Preliminary Studies). Implementing the CCI for aging adults with multimorbidity (2 or more chronic conditions) and high baseline acute care utilization, allows us to test and expand the efficacy, external validity and cost effectiveness of the proposed intervention model. The investigators seek to improve patients' and FQHCs' abilities to effectively manage chronic conditions and reduce acute care use. This contribution is significant because it potentially extends our knowledge about effective community partnerships and best practices that can enhance the effectiveness of health homes in providing patient-centered team-based care for patients with multimorbidity and high baseline health care utilization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

November 7, 2013

Last Update Submit

May 16, 2017

Conditions

Keywords

chronic conditionsmultimorbid

Outcome Measures

Primary Outcomes (1)

  • patient activation

    Patient activation will be measured using the Patient Activation Measure. Higher scores on this tool indicate that the patient is more involved in self-managing care and partnering with health care professionals to achieve better health outcomes.

    change from baseline to 3, 6, and 12 months

Secondary Outcomes (1)

  • acute care utilization

    change in acute care utilization from baseline year to intervention year

Other Outcomes (1)

  • Participant's Health-Related Quality of Life.

    change in quality of life from baseline to 3 months, 6 months, 9 months, 12 months.

Study Arms (2)

Active self-management intervention

EXPERIMENTAL

Participants will receive home visits and phone calls from a registered nurse and social worker. The registered nurse and social worker will provide participants one on one coaching, education, support and referrals to community resources to help them manage their chronic conditions.

Other: Active self-management intervention

Attention control phone calls

ACTIVE COMPARATOR

Participants will receive an initial visit and then a phone call every other month from a social services aide who can provide information about community resources that might be helpful.

Other: Attention control phone calls

Interventions

Participants will set health goals at baseline. They will then receive, at minimum, a visit or a phone call to assess how progress and coaching toward meeting goals on a monthly basis from a nurse and/or social worker. The frequency and exact activities associated with the intervention are dependent on each participant's unique health goals.

Active self-management intervention

Participants will be called by a social service aide at 2, 4, 6, 8, 10, and 12 months.

Attention control phone calls

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older, 2 or more chronic conditions, 2 or more emergency department visits or hospital admissions in previous 12 months.

You may not qualify if:

  • terminal illness, dementia, case management elsewhere, resident of adult family home, boarding home or skilled nursing facility, homeless.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health Association of Spokane

Spokane, Washington, 99201, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Corbett, Ph.D.

    Washington State University College of Nursing

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

May 13, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations