Mental Illness PersistentNCT03881657
Reverse Colocated Integrated Care Intervention Among Persons With Severe Persistent Mental Illness at US-Mexico Border
A study testing Reverse Colocated Integrated Care in people with Mental Illness Persistent and Chronic Disease, run by Health Resources in Action, Inc..
Trial summary
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness Persistent, Chronic Disease, Hypertension
- What is being tested?
- Reverse Colocated Integrated Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2015to 22 Aug 2017
- 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
- Reside in Cameron, Hidalgo, or Willacy County
- Have a severe, persistent mental illness as diagnosed by a licensed behavioral health care provider
- Be eligible to receive behavioral health services from TTBH
- Must not be receiving any primary care outside of TTBH (as ascertained via patient self-report)
- Have a diagnosis of one or more chronic conditions:
- Hypertension (blood pressure of 140/90 mmHg or higher)
Show all 9Show fewer
- Obesity (body mass index of 30.0 or higher)
- Poorly controlled diabetes (HbA1c over 8.5%)
- Hypercholesterolemia (Total cholesterol level above 200)
Who cannot join
- Not actively suicidal at time of enrollment
About this study
Official title: Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.
Read the detailed description
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points. The primary outcome of interest was systolic blood pressure. Additional secondary outcomes of interest were diastolic blood pressure, HbA1c, BMI, total cholesterol, depressive symptoms, and life functioning. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models.The intervention and control groups were patients with an SPMI diagnosis over 18 years of age who were not receiving primary care services prior to enrollment and were eligible to receive behavioral health services from TTBH. The participants resided in Cameron or Hidalgo County and had one or more chronic conditions: hypertension (blood pressure of 140/90 mmHg or higher), poorly controlled diabetes (HbA1c over 8.5%), obesity (body mass index of 30.0 or higher), or hypercholesterolemia (total cholesterol level above 200).
- Conditions
- Mental Illness Persistent, Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression
- Being tested
- Reverse Colocated Integrated Care, Usual Care
- Keywords
- Integrated Behavioral Health, Reverse Colocation, Integrated Care
- Medical subject headings
- Chronic Disease, Hypertension, Diabetes Mellitus, Hypercholesterolemia, Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Colocated Integrated CareBehavioural
A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.
Usual CareBehavioural
Behavioral health services without primary care or integrated care services
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group received a reverse colocated integrated behavioral health intervention or usual care Receives: Behavioral: Reverse Colocated Integrated Care |
| Control Group | Active comparator | The control group received behavioral health services only (usual care) Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
Measured: One year
Secondary outcomes (5)
Blood glucose concentration
Blood glucose concentration was measured via blood test for HbA1c as a continuous variable
Measured: One year
Body mass index
Height and weight were measured at baseline, and body mass index was calculated
Measured: One year
Total cholesterol
Measured as a continuous variable in milligrams per deciliter
Measured: One year
Depressive symptoms
Measured as a score on the Patient Health Questionnaire-9 tool
Measured: One year
Life functioning
Measured as a score composite of the Adult Needs and Strengths Assessment Tool
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start24 Nov 2015
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Illness PersistentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group participants were randomized to receive primary care in addition to behavioral health services within a behavioral health setting. Control group participants received behavioral health care services as usual.
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Resources in Action, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
- Responsible party
- Principal investigator, Karen Errichetti, Health Resources in Action, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881657
- Sponsor's protocol ID
- 100001
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Errichetti KS, Flynn A, Gaitan E, Ramirez MM, Baker M, Xuan Z. Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas. J Gen Intern Med. 2020 Jul;35(7):2035-2042. doi: 10.1007/s11606-020-05778-2. Epub 2020 Apr 20.
PubMed 32314132Sautter Errichetti K, Ramirez MM, Flynn A, Xuan Z. A reverse colocated integrated care model intervention among persons with severe persistent mental illness at the U.S.-Mexico border: A randomized controlled trial protocol. Contemp Clin Trials Commun. 2019 Nov 12;16:100490. doi: 10.1016/j.conctc.2019.100490. eCollection 2019 Dec.
PubMed 31872157
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sí Texas: Improving Access to Integrated Care for Rio Grande Valley Residents With Severe & Persistent Mental Illness
- ClinicalTrials.gov ID
- NCT03881657
- Acronym / sponsor ID
- 100001
- Conditions
- Mental Illness Persistent, Chronic Disease, Hypertension, Diabetes, Hypercholesterolemia, Depression
- Keywords
- Integrated Behavioral Health, Reverse Colocation, Integrated Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Health Resources in Action, Inc.University, hospital or other
- Collaborators
- Methodist Healthcare Ministries of South Texas, Inc., Social Innovation Fund
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 19 Mar 2019 (actual)
- 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 study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points.
Detailed description
This study evaluated whether patients with severe and persistent mental illness (SPMI) who received coordinated co-located behavioral health and primary care services were more likely to improve health outcomes after 12 months compared to SPMI patients who receive only behavioral health services from the local mental health authority (LMHA) Tropical Texas Behavioral Health (TTBH).The study employed a randomized control trial (RCT) design where intervention participants receiving integrated behavioral health were compared to control participants receiving the usual care provided within an LMHA for SPMI patients. Patients were placed in each group using a randomized number process. Demographic and health outcome data were collected from intervention and control participants at baseline. Health outcome data was subsequently collected at 6-month and 12-month follow-up points. The primary outcome of interest was systolic blood pressure. Additional secondary outcomes of interest were diastolic blood pressure, HbA1c, BMI, total cholesterol, depressive symptoms, and life functioning. These outcomes were analyzed as continuous variables using linear regression with backward model selection. Longitudinal analyses were also conducted using a likelihood-based approach to general linear mixed models.The intervention and control groups were patients with an SPMI diagnosis over 18 years of age who were not receiving primary care services prior to enrollment and were eligible to receive behavioral health services from TTBH. The participants resided in Cameron or Hidalgo County and had one or more chronic conditions: hypertension (blood pressure of 140/90 mmHg or higher), poorly controlled diabetes (HbA1c over 8.5%), obesity (body mass index of 30.0 or higher), or hypercholesterolemia (total cholesterol level above 200).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment group participants were randomized to receive primary care in addition to behavioral health services within a behavioral health setting. Control group participants received behavioral health care services as usual.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Reverse Colocated Integrated CareThe intervention group received a reverse colocated integrated behavioral health intervention or usual care |
| Control Group | Active comparator | Behavioral: Usual CareThe control group received behavioral health services only (usual care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Reside in Cameron, Hidalgo, or Willacy County
- Have a severe, persistent mental illness as diagnosed by a licensed behavioral health care provider
- Be eligible to receive behavioral health services from TTBH
- Must not be receiving any primary care outside of TTBH (as ascertained via patient self-report)
- Have a diagnosis of one or more chronic conditions:
Key exclusion criteria (1 listed)
- Not actively suicidal at time of enrollment
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 |
|---|---|---|
| Reverse Colocated Integrated CareA reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting. | Behavioural | Intervention Group |
| Usual CareBehavioral health services without primary care or integrated care services | Behavioural | Control Group |
Primary outcome
Blood pressure
Time frame: One year
Blood pressure was measured as a continuous variable (systolic and diastolic) in millimeters of mercury (mmHg).
5 secondary outcomes
Blood glucose concentration
Time frame: One year
Body mass index
Time frame: One year
Total cholesterol
Time frame: One year
Depressive symptoms
Time frame: One year
Life functioning
Time frame: One year
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 19 Mar 2019.
- Derived from this study: PubMed 32314132Errichetti KS, Flynn A, Gaitan E, Ramirez MM, Baker M, Xuan Z. Randomized Trial of Reverse Colocated Integrated Care on Persons with Severe, Persistent Mental Illness in Southern Texas. J Gen Intern Med. 2020 Jul;35(7):2035-2042. doi: 10.1007/s11606-020-05778-2. Epub 2020 Apr 20.
- Derived from this study: PubMed 31872157Sautter Errichetti K, Ramirez MM, Flynn A, Xuan Z. A reverse colocated integrated care model intervention among persons with severe persistent mental illness at the U.S.-Mexico border: A randomized controlled trial protocol. Contemp Clin Trials Commun. 2019 Nov 12;16:100490. doi: 10.1016/j.conctc.2019.100490. eCollection 2019 Dec.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Colocated Integrated Care in people with Mental Illness Persistent and Chronic Disease, run by Health Resources in Action, Inc..
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 9 inclusion and 1 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood pressure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881657, which also lists 2 linked publications.
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 19 Mar 2019.