Clinical Trials Logo

Clinical Trial Summary

The Right Question Project-Mental Health (RQP-MH) is a three-session health education intervention that teaches clients to participate effectively in mental health care. The methodology teaches clients to identify important issues of their illness or treatment, formulate questions, and devise plans to communicate and act in effective ways that address factors impacting their mental health care, with the expectation that this behavior will increase patient-provider communication and improve the therapeutic alliance between patient and provider.

The investigators hypothesize that participants receiving the intervention will be more likely to engage and remain in mental health care, and that they will report higher activation and self-management scores as compared to control patients.


Clinical Trial Description

The intervention is one of two Cambridge Health Alliance (CHA) projects from the University of Puerto Rico-Cambridge Health Alliance Research Center of Excellence (UPR-CHA RCE). The overall goal of the project is to evaluate an intervention that teaches patients a set of skills needed to facilitate a more active patient role in the mental health encounter, emphasizing the patient's decision-making process during mental health treatment. The project also aims to support collaborative provider-patient relationships in order to increase engagement and retention and, consequently, reduce service disparities. The intervention has been pilot-tested in the Right Question Project-Mental Health I (RQP-MH I) study (Alegría, 2008), conducted as part of the UPR-CHA EXPORT Center from September 2004 through February 2006.

The first aim of the current project is to conduct a multi-site randomized controlled trial to test the Patient Activation and Self-Management (PASM) intervention, also called RQP-MH II, in predominantly Latino mental health clinics. The investigators will assess the intervention's impact on engagement and retention in mental health care. The second aim is to explore the racial/ethnic differences in the effect of the RQP-MH II intervention for Latinos as compared to non-Latino whites, as little is known about the impact of patient race/ethnicity on the effectiveness of patient activation interventions. The fourth aim is to explore the role of patient-provider communication and therapeutic alliance as mediators of the relationship between patient activation and engagement and retention in care. It is expected that increased patient-provider communication and a stronger therapeutic alliance will result from increased participation in the decision-making process. These potential changes in the process of care are expected to consequently increase patient engagement (keeping scheduled appointments) and retention (reduction of premature unilateral termination) in mental health care.

Data shows that patients may not readily state their concerns in their medical visits (Roter et al., 1997; Korsch, Gozzi & Francis, 1968) and usually refrain from engaging in information-seeking (Beisdecker & Beisdecker, 1990). Minority patients are even less likely than their white counterparts to have a collaborative relationship with providers (Cooper-Patrick et al., 1999). This is a problematic situation particularly for minority patients, such as Latinos, who cherish maintaining a warm personal connection with their providers (American Medical Association, 1994) and may worry that bringing up questions or asking for explanations might jeopardize the relationship.

Minority patients may not be as informed about diagnosis, prognosis, and medication side effects (Schaafsma, Raynor & de Jong-van den Berg, 2003) and consequently feel disappointed that they do not receive needed information (Levinson et al., 1993). They may therefore be less compliant with treatment (Kalichman et al., 1999), and more likely to drop out of care (Takeuchi et al., 1992). Minority patients may have a less comprehensive understanding of mental health care compared to White patients (Miranda and Cooper, 2004). As a result, they are at a greater risk of assuming that the provider's decisions reflect their best interest (Flynn et al., 2004). This is exemplary of Latinos who hold traditional role expectations that oppose active involvement in the clinical encounter and prefer to delegate decisions about their care to their providers (Levinson et al., 2005; Xu, Borders & Arif, 2003).

To contend with difficulties in communication, most interventions focus on provider training (Post, Cegala & Miser, 2002), with less attention on teaching patients how to effectively express their concerns and questions to their providers (Andersen & Sharpe, 1991; Roter, 1977). Yet results from assessments of self-management of chronic conditions (Hall, Roter & Katz, 1988; Stewart et al., 1993) indicate that greater patient activation and self-management in treatment can augment satisfaction with care (Blanchard et al., 1990), improve the health care process (Rosenberg, Lussier & Beaudoin, 1997; Epstein et al., 1993), ensure the receipt of guideline concordant treatments (Clever et al., 2006), and potentially enhance health outcomes (Kaplan, Greenfield & Ware, 1989).

Most studies of patient activation and self-management in the field of mental health care have not been conducted with minority populations of low literacy nor in a language other than English. Most have not included mixed-methods (qualitative and quantitative) to evaluate the effectiveness of the intervention, and have not obtained cost information that can help evaluate whether changes in patient activation and self-management, or in treatment engagement and retention, could potentially produce savings in treatment or health care outcomes.

The proposed project is expected to fill this gap, assessing the effects of a patient activation and self-management intervention using a mixed-methods approach, with three data collection periods. The investigators hypothesize that patients participating in the patient activation and self-management intervention will be significantly more likely to engage and remain in mental health care, and will report significantly higher activation and self-management scores as compared to control patients. Given the relationship of patient participation and health outcomes, increasing Latino patient's participation in decision-making a as mechanism to eliminate service disparities is the goal of the proposed intervention. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT01226329
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date July 2008
Completion date October 2011

See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT06012149 - Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Active, not recruiting NCT02907658 - Efficacy of Internet Use Disorder Prevention N/A
Completed NCT02710344 - Using Telehealth to Improve Psychiatric Symptom Management N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Active, not recruiting NCT02761733 - The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers N/A
Completed NCT01947283 - Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01415323 - Agitation in the Acute Psychiatric Department
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT01701765 - Outcomes and Discharge of Long-stay Psychiatric Patients N/A
Completed NCT00375167 - Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery N/A
Terminated NCT00757497 - Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia Phase 1
Terminated NCT03527550 - Cognitive Control Training for Urgency in a Naturalistic Clinical Setting N/A
Withdrawn NCT03518996 - Non-Invasive Brain Stimulation and Delirium N/A