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Patient Generated Goals in Mental Health: Better Outcomes?

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ClinicalTrials.gov Identifier: NCT03527914
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kathleen Pajer, Children's Hospital of Eastern Ontario

Tracking Information
First Submitted Date  ICMJE February 18, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Patient/Family Satisfaction [ Time Frame: Administered at study completion (up to 52 weeks) ]
    Measured using the Experience of Service Questionnaire
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Patient/Family Satisfaction [ Time Frame: Administered at study completion (up to 52 weeks) ]
    Measured using the Experience of Service Survey
  • 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)
  • 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
Change History Complete list of historical versions of study NCT03527914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Generated Goals in Mental Health: Better Outcomes?
Official Title  ICMJE Patient Generated Goals in Mental Health: Better Outcomes?
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mental Health
Intervention  ICMJE
  • 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.
  • Other: Treatment as Usual
    Patients will receive their standard care at the Outpatient Mental Health Service
Study Arms  ICMJE
  • Active Comparator: Treatment as Usual
    Patients will receive their standard care at the Outpatient Mental Health Service
    Intervention: Other: Treatment as Usual
  • Experimental: 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.
    Intervention: Other: Goal Based Outcomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2018)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-Child and youth attending group therapy at CHEO Outpatient Mental Health Services

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kathleen Pajer, MD 613-737-7600 ext 2723 kpajer@cheo.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03527914
Other Study ID Numbers  ICMJE 8374
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathleen Pajer, Children's Hospital of Eastern Ontario
Study Sponsor  ICMJE Children's Hospital of Eastern Ontario
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Pajer, MD Children's Hospital of Eastern Ontario
PRS Account Children's Hospital of Eastern Ontario
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP