Back to resultsPROMs To Improve Care- Standardized vs Patient Specific
Primary Purpose
Hand Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Specific Functional Scale
PROMIS PF
Sponsored by
About this trial
This is an interventional health services research trial for Hand Injuries
Eligibility Criteria
Inclusion Criteria:
- hand surgery patients over age 18, english fluency and literacy, able to take informed consent
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
PSFS group
PROMIS PF group
Arm Description
Patients in this arm will complete the patient specific functional scale (PSFS) during their visits
Patients in this arm will complete the PROMIS Physical Function during their visits
Outcomes
Primary Outcome Measures
Decisional Conflict Scale (DCS)
DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04027569
Brief Title
PROMs To Improve Care- Standardized vs Patient Specific
Official Title
PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics (Research Staffing)
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSFS group
Arm Type
Active Comparator
Arm Description
Patients in this arm will complete the patient specific functional scale (PSFS) during their visits
Arm Title
PROMIS PF group
Arm Type
Experimental
Arm Description
Patients in this arm will complete the PROMIS Physical Function during their visits
Intervention Type
Other
Intervention Name(s)
Patient Specific Functional Scale
Intervention Description
A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.
Intervention Type
Other
Intervention Name(s)
PROMIS PF
Intervention Description
A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.
Primary Outcome Measure Information:
Title
Decisional Conflict Scale (DCS)
Description
DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.
Time Frame
Immediately after the clinical encounter, same day as clinical encounter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hand surgery patients over age 18, english fluency and literacy, able to take informed consent
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin N Kamal, MD MBA
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD
Learn more about this trial
PROMs To Improve Care- Standardized vs Patient Specific
We'll reach out to this number within 24 hrs