Feasibility of Collateral Information Review and Its Impa... | NCT04635748

Studies
Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making

NCT04635748

Sponsor

Mclean Hospital

Status

Completed

Last Update Posted

Oct 26, 2021Actual

Enrollment

89Actual

Phase

Not provided

Conditions

Depressive Disorder
Anxiety Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2019Actual

Primary Completion Date

Mar 14, 2020Actual

Completion Date

Mar 14, 2020Actual

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 13, 2020

First Posted Date

Nov 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2021

Last Update Posted Date

Oct 26, 2021Actual

Name	Class
Once Upon a Time Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan.

Detailed Description

This study aims to explore how reviewing collateral information sources (CIS) may affect clinical decision-making for clinicians treating participants with varied mood disorders. Investigators will assess the types of collateral information used in the clinical setting and treatment decisions made after a clinical session. We will gather this information from interested clinicians who will provide this information after each patient visit over the course of one week.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
McLean Treatment Tracking Survey	Clinicians will find the McLean Treatment Tracking Survey easy to use in their clinical care and we will measure rate of use and completion.	Over the course of 1 week

Secondary Outcomes

Measure	Description	Time Frame
Clinical Outcome - Increased treatment decisions made	Investigators will explore whether reviewing more collateral information sources leads to more clinical actions taken for treatment.	Over the course of 1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Credentialed to provide psychopharmacology or psychotherapy at McLean and Licensed by the State of Massachusetts
Practice pharmacotherapy and either adjunctive or stand-alone evidence-based psychotherapy (e.g., CBT, DBT, supportive psychotherapy, etc.)
Fluent in English

Exclusion Criteria:

Clinicians who do not meet the inclusion criteria detailed above

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

- Clinicians from McLean Hospital Outpatient Programs (geriatric, child and adult) and the McLean Behavioral Health Partial Program, which predominantly treat patients with mood disorders.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ipsit V Vahia, MD	Mclean Hospital	Principal Investigator
Kerry J Ressler, MD; PhD	Mclean Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLean Hospital		Belmont	Massachusetts	02478	United States

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided