Diagnosis, PsychiatricRQPNCT00134615
Testing the Right Question Project (RQP) Health Education Strategy in a Mental Health Setting
A study testing RQP patient health education module in people with Diagnosis, Psychiatric, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this pilot project is to test the effectiveness of three 20 minute health education modules on patient empowerment, patient activation and retention in care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diagnosis, Psychiatric
- What is being tested?
- RQP patient health education module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Dec 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a mental health outpatient at selected clinics
Who cannot join
- Unable to verbalize or take verbal direction
- Unable to sit still in one place to participate in education modules
- Potentially violent towards others
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Windsor Street Health Center
Cambridge, Massachusetts, 02139
MGH Chelsea Healthcare Center
Chelsea, Massachusetts, 02150
About this study
Official title: Testing the Right Question Project Health Education Strategy in a Mental Health Setting
The purpose of this pilot project is to test the effectiveness of three 20 minute health education modules on patient empowerment, patient activation and retention in care.
Read the detailed description
Recent research has demonstrated positive outcomes for patients who take an active role in their mental health care (Linhorst \& Eckert, 2003). Patients who participate in the decision-making process are more satisfied with services, have a greater sense of self-efficacy and confidence, an increased ability to cope with daily life, and are more likely to achieve their treatment goals (Linhorst \& Eckert, 2003). As defined by Chamberlin and Schene (1997), empowerment in mental health care requires having access to information and resources, having a range of options from which to make choices, learning to think critically, and having the power to make decisions. Cooper-Patrick et al. (1999) indicate that minority patients are less likely to have a collaborative relationship with providers than are otherwise similar white patients. Thus, there is a need for minority patients to learn to take a more active role in their care. One way to address the need for increased empowerment and activation among minority mental health patients is to provide them with training to enhance their communication and decision-making skills. The Right Question Project (RQP) is a consumer educational technique designed for this purpose and developed for use in multiple settings. The proposed study will examine the effectiveness of RQP with a Latino population.
The Right Question Project (RQP) is a non-profit organization that works primarily with low- and moderate-income communities with a history of disengagement from education, health care, and other social services. The RQP approach differs from traditional models of client empowerment in that instead of supplying clients with solutions to problems, the RQP gives them a means to develop their own solutions. RQP teaches clients to identify important issues, formulate questions, and devise plans to communicate and act in effective ways that address factors impacting their health. The RQP methodology involves:
- establishing a set of beliefs, principles, and values about client involvement;
- teaching a skill-building technique that helps clients to think critically and ask the "right" questions, leading to the answers they need; and
- giving clients a framework to create action plans and use their question-formulation skills.
The RQP methodology is designed to build a permanent skill that clients can apply in health care, as well as in other contexts that involve self-advocacy (e.g., getting better child care). Thus far, implementation of the Right Question Project has shown that clients of any education or literacy level can easily participate and benefit from the methodology's three-step approach. RQP has been particularly successful in educational settings (Cohen, 1995).
The focus of the RQP health education module is to help patients learn how to formulate and ask questions of their health care providers, in order to improve the quality of their care. The Right Question Project, Inc. developed this protocol and trained staff at the Cambridge Health Alliance (CHA) to conduct health education modules with psychiatry outpatients. The pilot study uses a pre-post test design with two groups of 100 patients each from two clinics that serve primarily Latino patients. The group at the CHA clinic will serve as the "treatment" group. This group will receive the training modules and will be interviewed about their experience in care. The group at the clinic at Massachusetts General Hospital will serve as the "control" group. This group will be interviewed without first receiving the training. Outcomes for the groups will be compared to look for an effect. If the RQP training appears to have a positive affect on patients at CHA, then MGH patients will be offered the RQP training. By testing the effectiveness of this educational module, we hope to establish its usefulness as a means for the Cambridge Health Alliance to become even more patient-centered and to assist in the integration and institutionalization of patient empowerment/activation.
- Conditions
- Diagnosis, Psychiatric
- Being tested
- RQP patient health education module
- Keywords
- decision-making, patient activation, empowerment, mental health, Depression, Anxiety, Other Psychiatric Disorder
- Medical subject headings
- Mental Disorders, Patient Participation, Empowerment, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RQP patient health education moduleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| RQP-MH | Experimental | These participants receive the RQP-MH intervention Receives: Behavioral: RQP patient health education module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient activation
Measured: at 4, 6 and 8 weeks
Patient empowerment at 4, 6 and 8 weeks
Measured: at 4, 6 and 8 weeks
Retention in care at one year
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis, PsychiatricStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
- Investigators
- Margarita Alegria, PhD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134615
- Sponsor's protocol ID
- CHA-IRB-0080/07/04
- Other IDs
- P20MD000537
- Acronym
- RQP
- Status last verified
- Jun 2016
- First submitted
- 24 Aug 2005
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Right Question Project Health Education Strategy in a Mental Health Setting
- ClinicalTrials.gov ID
- NCT00134615
- Acronym / sponsor ID
- RQP / CHA-IRB-0080/07/04
- Conditions
- Diagnosis, Psychiatric
- Keywords
- decision-making, patient activation, empowerment, mental health, Depression, Anxiety, Other Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Aug 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 25 Aug 2005 (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.
The purpose of this pilot project is to test the effectiveness of three 20 minute health education modules on patient empowerment, patient activation and retention in care.
Detailed description
Recent research has demonstrated positive outcomes for patients who take an active role in their mental health care (Linhorst \& Eckert, 2003). Patients who participate in the decision-making process are more satisfied with services, have a greater sense of self-efficacy and confidence, an increased ability to cope with daily life, and are more likely to achieve their treatment goals (Linhorst \& Eckert, 2003). As defined by Chamberlin and Schene (1997), empowerment in mental health care requires having access to information and resources, having a range of options from which to make choices, learning to think critically, and having the power to make decisions. Cooper-Patrick et al. (1999) indicate that minority patients are less likely to have a collaborative relationship with providers than are otherwise similar white patients. Thus, there is a need for minority patients to learn to take a more active role in their care. One way to address the need for increased empowerment and activation among minority mental health patients is to provide them with training to enhance their communication and decision-making skills. The Right Question Project (RQP) is a consumer educational technique designed for this purpose and developed for use in multiple settings. The proposed study will examine the effectiveness of RQP with a Latino population.
The Right Question Project (RQP) is a non-profit organization that works primarily with low- and moderate-income communities with a history of disengagement from education, health care, and other social services. The RQP approach differs from traditional models of client empowerment in that instead of supplying clients with solutions to problems, the RQP gives them a means to develop their own solutions. RQP teaches clients to identify important issues, formulate questions, and devise plans to communicate and act in effective ways that address factors impacting their health. The RQP methodology involves:
- establishing a set of beliefs, principles, and values about client involvement;
- teaching a skill-building technique that helps clients to think critically and ask the "right" questions, leading to the answers they need; and
- giving clients a framework to create action plans and use their question-formulation skills.
The RQP methodology is designed to build a permanent skill that clients can apply in health care, as well as in other contexts that involve self-advocacy (e.g., getting better child care). Thus far, implementation of the Right Question Project has shown that clients of any education or literacy level can easily participate and benefit from the methodology's three-step approach. RQP has been particularly successful in educational settings (Cohen, 1995).
The focus of the RQP health education module is to help patients learn how to formulate and ask questions of their health care providers, in order to improve the quality of their care. The Right Question Project, Inc. developed this protocol and trained staff at the Cambridge Health Alliance (CHA) to conduct health education modules with psychiatry outpatients. The pilot study uses a pre-post test design with two groups of 100 patients each from two clinics that serve primarily Latino patients. The group at the CHA clinic will serve as the "treatment" group. This group will receive the training modules and will be interviewed about their experience in care. The group at the clinic at Massachusetts General Hospital will serve as the "control" group. This group will be interviewed without first receiving the training. Outcomes for the groups will be compared to look for an effect. If the RQP training appears to have a positive affect on patients at CHA, then MGH patients will be offered the RQP training. By testing the effectiveness of this educational module, we hope to establish its usefulness as a means for the Cambridge Health Alliance to become even more patient-centered and to assist in the integration and institutionalization of patient empowerment/activation.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RQP-MH | Experimental | Behavioral: RQP patient health education moduleThese participants receive the RQP-MH intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a mental health outpatient at selected clinics
Key exclusion criteria (3 listed)
- Unable to verbalize or take verbal direction
- Unable to sit still in one place to participate in education modules
- Potentially violent towards others
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 |
|---|---|---|
| RQP patient health education module | Behavioural | RQP-MH |
Primary outcome
Patient activation
Time frame: at 4, 6 and 8 weeks
Patient empowerment at 4, 6 and 8 weeks
Time frame: at 4, 6 and 8 weeks
Retention in care at one year
Time frame: at 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 3 Jun 2016.
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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.
Margarita Alegria, PhD principal investigator
Cambridge Health Alliance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RQP patient health education module in people with Diagnosis, Psychiatric, run by Massachusetts General Hospital 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 1 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 3 Jun 2016. 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?
Patient activation (time frame: at 4, 6 and 8 weeks). The study lists 3 primary outcomes in all. 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 3 Jun 2016.