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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT00134615
Study groupRoleWhat they receive
RQP-MHExperimentalThese 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.

  1. Patient activation

    Measured: at 4, 6 and 8 weeks

  2. Patient empowerment at 4, 6 and 8 weeks

    Measured: at 4, 6 and 8 weeks

  3. 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.

  1. First posted25 Aug 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

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)
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

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.

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