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Patient Generated Goals in Mental Health: Better Outcomes?

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ClinicalTrials.gov Identifier: NCT03527914
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Kathleen Pajer, Children's Hospital of Eastern Ontario

Brief Summary:
Researchers believe that clinical care can be improved by engaging patients and families directly in planning the care process. Engagement efforts have included asking patients/families to provide information about whether they are getting better. But what does "getting better" mean? The merits of surveys, questionnaires, or rating scales have been widely discussed. Should they be disorder-specific or global? What should the investigators do if patients have difficulty reading or understanding these instruments? Investigators in the United Kingdom have proposed a simple solution: ask the patients and families what their primary goal treatment goal is and track progress together on that goal (Goal-Based Outcomes or GBO). Although there has been some work to suggest that this is helpful, it has never been tested in a controlled way. This study will do a special type of randomized controlled trial to test whether GBO improves clinical care in child and youth mental health. Although the study will use this in child and youth mental health care, if it is successful, it can be tested and applied in any care setting with any type of medical problem. This could change practice at the Children's Hospital of Eastern Ontario (CHEO) and throughout Canada.

Condition or disease Intervention/treatment Phase
Mental Health Other: Goal Based Outcomes Other: Treatment as Usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Generated Goals in Mental Health: Better Outcomes?
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: Treatment as Usual Other: Treatment as Usual
Patients will receive their standard care at the Outpatient Mental Health Service

Experimental: Goal Based Outcomes Other: Goal Based Outcomes
Up to three goals can be tracked during treatment, although patients often decide to just focus on one. Progress on the goal is then quantitatively rated by the patient, with the provider, at every appointment. Adjustments in the care are then made in an iterative process to ensure that the goal will be met.




Primary Outcome Measures :
  1. Patient/Family Satisfaction [ Time Frame: Administered at study completion (up to 52 weeks) ]
    Measured using the Experience of Service Survey

  2. Change in Symptoms [ Time Frame: Administered at the first appointment and at study completion (up to 52 weeks) ]
    Measured using the Strengths and Difficulties Questionnaire (SDQ)

  3. Change in Function [ Time Frame: Administered at the first appointment and at study completion (up to 52 weeks) ]
    Measured using the Child Global Assessment of Functioning Scale. The total score (on a scale of 0-100) will be used, with a higher score indicating better function



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children and youth
  • Attending outpatient mental health services at CHEO

Exclusion Criteria:

- there are no exclusionary criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527914


Contacts
Contact: Kathleen Pajer, MD 613-737-7600 ext 2723 kpajer@cheo.on.ca

Sponsors and Collaborators
Children's Hospital of Eastern Ontario

Responsible Party: Kathleen Pajer, Chief of Psychiatry, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT03527914     History of Changes
Other Study ID Numbers: 8374
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Pajer, Children's Hospital of Eastern Ontario:
Depression
Psychosis
Personality Disorder
Substance Abuse