ClinicalTrials.gg
CompletedNCT00134615RQPUpdated Jun 3, 2016

Testing the Right Question Project (RQP) Health Education Strategy in a Mental Health Setting

An interventional study of RQP patient health education module in Diagnosis, Psychiatric, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
231
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diagnosis, Psychiatric

Keywords

  • decision-making
  • patient activation
  • empowerment
  • mental health
  • Depression
  • Anxiety
  • Other Psychiatric Disorder
03

In context

Mental Disorders

2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.

This study's enrollment of 231 is above the median of 96 across 1,607 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be a mental health outpatient at selected clinics

Exclusion criteria

Exclusion Criteria:

  • Unable to verbalize or take verbal direction
  • Unable to sit still in one place to participate in education modules
  • Potentially violent towards others
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
231 participants (actual)

Study arms

  • Experimental
    RQP-MH

    These participants receive the RQP-MH intervention

    Behavioral: RQP patient health education module

Interventions

  • BehavioralRQP patient health education module
06

What researchers measure

Primary outcomes

  1. Patient activation

    Time frame: at 4, 6 and 8 weeks

  2. Patient empowerment at 4, 6 and 8 weeks

    Time frame: at 4, 6 and 8 weeks

  3. Retention in care at one year

    Time frame: at one year

07

Study locations

2 sites
  • Windsor Street Health Center
    Cambridge, Massachusetts 02139, United States
  • MGH Chelsea Healthcare Center
    Chelsea, Massachusetts 02150, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2004, a primary completion of Dec 2005 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2005
First posted
Aug 25, 2005
Start
Aug 2004
Primary completionActual
Dec 2005
CompletionActual
Dec 2005
Last update
Jun 3, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00134615
Responsible party
Margarita Alegria, PhD (Chief, Disparities Research Unit, Massachusetts General Hospital) — Principal investigator
First posted
Aug 25, 2005
Start date
Aug 2004
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Jun 3, 2016

Study contacts

Margarita Alegria, PhD
principal investigator · Cambridge Health Alliance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion