NCT02263742

Brief Summary

This project aims to study health outcomes of individuals with mental illness attending a co-located primary health care center in a mental health center. This study uses mixed methods to collect a range of information about who chooses to use what Wellness Center services and in what combinations, with what short and longer-term effects and with what outcomes. Based on participant interviews, identify barriers to and facilitators of access, service, and improvements in person-centered outcomes and elicit suggestions for enhancing health care outcomes and choice. Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to develop and pilot the effectiveness of a new peer-led community based intervention in enhancing access and choice and improving person-centered health outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

March 31, 2014

Last Update Submit

January 12, 2018

Conditions

Mental Health Wellness 1Mental IllnessesOther Diagnoses, Comorbidities, and Complications | Patient

Keywords

Healthcare choice and outcomesPeer-led whole healthMental IllnessPeer Health NavigationHealth care Coordination

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of a Co-located Primary Health Care Center in a Local mental health center

    Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices

    up to 30 months

Secondary Outcomes (2)

  • Effectiveness of health care navigation in improving health outcomes for people with mental illness

    up to 30 months

  • Universal Health screening

    up to 30 months

Other Outcomes (1)

  • Collaborate with persons in recovery in using data collected to develop and pilot a new peer led, community based intervention in enhancing access and choice

    up to 30 months

Study Arms (2)

Peer whole health

EXPERIMENTAL

Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes

Behavioral: Peer whole health intervention

EBPs at Wellness Center

ACTIVE COMPARATOR

EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention

Behavioral: EBPs at Wellness Center

Interventions

Peer whole health interventionBEHAVIORAL

Provide wraparound peer support, education, and navigation to individuals

Peer whole health
EBPs at Wellness CenterBEHAVIORAL

four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation

EBPs at Wellness Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Clients receiving services from CMHC and the Wellness Center.
  • Research staff will verify with CMHC staff that the potential participant is receiving services currently at CMHC.
  • Provider research subjects will be included if they are a mental health provider at CMHC or if they are members of the staff for the Wellness Center
  • Adults with serious mental illness and physical illness

You may not qualify if:

  • Participant research subjects not receiving services at CMHC and the Wellness Center
  • Provider research subjects of other agencies will be excluded
  • Children and youth under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CT Mental Health Center

New Haven, Connecticut, 06511, United States

Location

Yale University Program for Recovery and Community Health

New Haven, Connecticut, 06513, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Chyrell Bellamy, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

  • Kimberly D Antunes, BSW

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

October 13, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

US(2)