Mental Health Wellness 1WENCT02263742
Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness
A study testing Peer whole health intervention and EBPs at Wellness Center in people with Mental Health Wellness 1 and Mental Illnesses, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Mental Illnesses, Other Diagnoses, Comorbidities, and Complications | Patient
- What is being tested?
- Peer whole health intervention and EBPs at Wellness Center
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Sep 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CT Mental Health Center
New Haven, Connecticut, 06511
Yale University Program for Recovery and Community Health
New Haven, Connecticut, 06513
About this study
Official title: Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness
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.
Read the detailed description
Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier due to modifiable risk factors, medical conditions, and lack of access to quality, coordinated care. Strategies for addressing this disparity have amassed evidence. What remains to be determined is who will choose to use these evidence-based practices (EBPs) when implemented in routine practice, in what combinations, with what short term effects and health outcomes, and what else might be needed for persons for whom these strategies are not effective.
Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant that established an integrated Wellness Center (WC) within the local mental health center that provides 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. Through PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on patient-centered outcomes. The investigators specific aims are:
- to assess patient preferences and use of services, short-term effects, and longer term outcomes associated with various practices for the population and subpopulations;
- to identify barriers to and facilitators of access, service use, and improvements in traditional and patient-centered health outcomes; and
- to develop and pilot a peer-led, community-based intervention in enhancing access and choice, and improving patient-centered health outcomes, among 40 treatment-refractory clients of the WC.
The investigators long-term objectives are to: a) identify which practices work for which persons with SMI in improving health and patient-centered outcomes, and b) provide stakeholders around the nation with the knowledge and tools to replicate this model efficiently, effectively, and broadly.
Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have co-morbid medical conditions. Using participatory and mixed methodology, the investigators will assess Specific Aims 1 \& 2 by collecting health and patient-centered outcome data on patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40) will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data will be collected each year through focus groups (N=48 agency stakeholders, year 1) and individual interviews (50 WC patients, years 2 \& 3).
Projected Patient Outcomes: Outcomes include both traditional medical/clinical outcomes (e.g., blood pressure, BMI, fasting plasma glucose, HbGA1c, cholesterol, triglycerides, alcohol and drug use, psychiatric symptoms) and a range of patient-centered outcomes to be identified by key stakeholders in the initial phase of research. The investigators previous research suggests that these outcomes are likely to include self-efficacy, quality of life, employment, citizenship, and social connectedness.
- Conditions
- Mental Health Wellness 1, Mental Illnesses, Other Diagnoses, Comorbidities, and Complications | Patient
- Being tested
- Peer whole health intervention, EBPs at Wellness Center
- Keywords
- Healthcare choice and outcomes, Peer-led whole health, Mental Illness, Peer Health Navigation, Health care Coordination
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer whole health interventionBehavioural
Provide wraparound peer support, education, and navigation to individuals
EBPs at Wellness CenterBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: EBPs at Wellness Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 months
Secondary outcomes (2)
Effectiveness of health care navigation in improving health outcomes for people with mental illness
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, including some patient centered measures, and also the number of times they meet with their health care navigators
Measured: up to 30 months
Universal Health screening
Look at whether clients of the Wellness Center have improvement in their overall health by looking at their health measurements and lab works from each of their 6 month appointments
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Chyrell Bellamy, Ph.D., Principal investigator, Yale UniversityKimberly D Antunes, BSW, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263742
- Sponsor's protocol ID
- 1310012851
- Acronym
- WE
- Status last verified
- Jan 2018
- First submitted
- 31 Mar 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02263742
- Acronym / sponsor ID
- WE / 1310012851
- Conditions
- Mental Health Wellness 1, Mental Illnesses, Other Diagnoses, Comorbidities, and Complications | Patient
- Keywords
- Healthcare choice and outcomes, Peer-led whole health, Mental Illness, Peer Health Navigation, Health care Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Oct 2014 (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.
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.
Detailed description
Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier due to modifiable risk factors, medical conditions, and lack of access to quality, coordinated care. Strategies for addressing this disparity have amassed evidence. What remains to be determined is who will choose to use these evidence-based practices (EBPs) when implemented in routine practice, in what combinations, with what short term effects and health outcomes, and what else might be needed for persons for whom these strategies are not effective.
Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant that established an integrated Wellness Center (WC) within the local mental health center that provides 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. Through PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on patient-centered outcomes. The investigators specific aims are:
- to assess patient preferences and use of services, short-term effects, and longer term outcomes associated with various practices for the population and subpopulations;
- to identify barriers to and facilitators of access, service use, and improvements in traditional and patient-centered health outcomes; and
- to develop and pilot a peer-led, community-based intervention in enhancing access and choice, and improving patient-centered health outcomes, among 40 treatment-refractory clients of the WC.
The investigators long-term objectives are to: a) identify which practices work for which persons with SMI in improving health and patient-centered outcomes, and b) provide stakeholders around the nation with the knowledge and tools to replicate this model efficiently, effectively, and broadly.
Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have co-morbid medical conditions. Using participatory and mixed methodology, the investigators will assess Specific Aims 1 \& 2 by collecting health and patient-centered outcome data on patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40) will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data will be collected each year through focus groups (N=48 agency stakeholders, year 1) and individual interviews (50 WC patients, years 2 \& 3).
Projected Patient Outcomes: Outcomes include both traditional medical/clinical outcomes (e.g., blood pressure, BMI, fasting plasma glucose, HbGA1c, cholesterol, triglycerides, alcohol and drug use, psychiatric symptoms) and a range of patient-centered outcomes to be identified by key stakeholders in the initial phase of research. The investigators previous research suggests that these outcomes are likely to include self-efficacy, quality of life, employment, citizenship, and social connectedness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer whole health | Experimental | Behavioral: Peer whole health interventionPeer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes |
| EBPs at Wellness Center | Active comparator | Behavioral: EBPs at Wellness CenterEBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Peer whole health interventionProvide wraparound peer support, education, and navigation to individuals | Behavioural | Peer whole health |
| EBPs at Wellness Centerfour 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 | Behavioural | EBPs at Wellness Center |
Primary outcome
Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
Time frame: up to 30 months
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
2 secondary outcomes
Effectiveness of health care navigation in improving health outcomes for people with mental illness
Time frame: up to 30 months
Universal Health screening
Time frame: up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
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.
Chyrell Bellamy, Ph.D. principal investigator
Yale University
Kimberly D Antunes, BSW study director
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer whole health intervention and EBPs at Wellness Center in people with Mental Health Wellness 1 and Mental Illnesses, run by Yale University at 2 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of a Co-located Primary Health Care Center in a Local mental health center (time frame: up to 30 months). 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 17 Jan 2018.