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Incorporating Patient Capacity Into the Clinical Landscape

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Capacity Assessment Instrument
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring Patient Capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implementation Arm

Arm Description

Outcomes

Primary Outcome Measures

Number of resource limitations measured by medical record review

Secondary Outcome Measures

Full Information

First Posted
February 19, 2015
Last Updated
January 7, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02390570
Brief Title
Incorporating Patient Capacity Into the Clinical Landscape
Official Title
Incorporating Patient Capacity Into the Clinical Landscape
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 22, 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to answer why "patient capacity" (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the Electronic Medical Record (EMR) in a way that is useful for clinicians. Through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Patient Capacity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient Capacity Assessment Instrument
Intervention Description
The Patient Capacity Assessment instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinicial conversations of primary care.
Primary Outcome Measure Information:
Title
Number of resource limitations measured by medical record review
Time Frame
Baseline up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasey Boehmer, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31481553
Citation
Boehmer KR, Dobler CC, Thota A, Branda M, Giblon R, Behnken E, Organick P, Allen SV, Shaw K, Montori VM. Changing conversations in primary care for patients living with chronic conditions: pilot and feasibility study of the ICAN Discussion Aid. BMJ Open. 2019 Sep 3;9(9):e029105. doi: 10.1136/bmjopen-2019-029105.
Results Reference
derived

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Incorporating Patient Capacity Into the Clinical Landscape

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