Impact of Extensive Consultation on Career Development Grant Outcomes

In this study we wish is to determine whether extensive (up to 15 hours) multidisciplinary consultation in biostatistics, study design, data management, ethics, and writing provided by the UCSF Clinical and Translational Science Institute's (CTSI) Consultation Services program, improves peer review scores of career development grants compared to usual levels of consultation.

We hypothesize that extensive multidisciplinary consultation will improve peer review scores of career development grants compared to usual levels of consultation.

We hypothesize that extensive multidisciplinary consultation will lead to greater numbers of funded grants when compared to the usual levels of consultation.

Study Overview

• Status: Completed
• Conditions: Career Development Grant Outcomes
• Intervention / Treatment: Other: Extensive Consultations

Detailed Description

CTSI Consultation Services is one of the largest programs within the UCSF CTSI. It was created to improve the quality and efficiency of clinical and translational research through the provision of expert consultation. The program is divided into units that provide access to expert consultants in biostatistics, research design (with consultants representing multiple distinct methodologies and disease interests), data management (including data structure and database design), ethics, and scientific writing. With funding from the NIH, the program is able to offer a free hour of consultation in each of its units (up to 4 hours) but charges for additional services to cover costs.

There have been no studies of research consultation services. Though the benefit may seem self evident, such programs are expensive and distract senior researcher from more creative work. Justifying research consultation is important given the multitude of activities vying for attention and funding. Observational studies of the impact of research consultation services will always be limited by confounding, particularly confounding by indication since those seeking such services may be more highly motivated and organized. Thus, a randomized trial is warranted.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94144
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Applying for a Career Development grant from the NIH.
• Anticipated submission date is 3 or more months in the future
• Resident, fellow, or junior faculty member at UCSF or a CTSI-affiliated institution.

• Recognized potential benefit from additional consultation

  • Additional areas that could be improved as judged by the subject and the initial consultant
  • Adequate time to provide consultation before submission date

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Extensive Consultations; Intervention- Receives extensive consulting services	Other: Extensive Consultations; receives 15 free hours of multidisciplinary consultations towards the preparation of their career development grant.; Other Names: Consultations; Extensive Multi-disciplinary Consultations
No Intervention: 2-Regular levels of service; Control - Receives regular levels of service; one hour free services from each of the 4 units, with option to pay for more.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NIH priority score of the reviewed proposal, with unsubmitted or unscored proposals counted as priority scores that are right-censored at 300 (old system) or 50 (new system)	30 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who obtain funding for the submitted proposal	30 Months
Institute-specific percentile of the priority score	30 Months
Percentage of subjects who submit proposals for funding	30 Months
Percentage of subjects who received a good score (<40 or <200) which may be associated with future funding of a resubmission	30 Months
Percentage of subjects who obtained any career development award funding	30 Months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Alka Kanaya, MD, University of California, San Francisco; Study Director: Peter Bacchetti, PhD, University of California, San Francisco; Study Director: Clay Johnston, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: April 17, 2008
• First Submitted That Met QC Criteria: April 18, 2008
• First Posted (Estimate): April 21, 2008

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Application; Consultation; K Grant; Career Advancement; Award; K; The NIH priority score of the reviewed proposal.; Percent of subjects who obtain funding for proposal.; Percent of subjects who submit proposals for funding.
• Other Study ID Numbers: K-Trial