Patient Generated Goals in Mental Health: Better Outcomes?
March 9, 2023 updated by: Kathleen Pajer, Children's Hospital of Eastern Ontario
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as Usual
Patients will receive their standard care at the Outpatient Mental Health Service
|
Patients will receive their standard care at the Outpatient Mental Health Service
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient/Family Satisfaction
Time Frame: Administered at study completion (up to 52 weeks)
|
Measured using the Experience of Service Questionnaire
|
Administered at study completion (up to 52 weeks)
|
|
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)
|
Administered at the first appointment and at study completion (up to 52 weeks)
|
|
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
|
Administered at the first appointment and at study completion (up to 52 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kathleen Pajer, MD, Children's Hospital of Eastern Ontario
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
May 15, 2022
Study Registration Dates
First Submitted
February 18, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 17, 2018
Study Record Updates
Last Update Posted (Estimate)
March 10, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 8374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.