- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977206
Engaging Patients in Mutual Goal-Setting in Hospitalized Patients
May 19, 2022 updated by: Teresa Jerofke-Owen, Marquette University
Mutual goal setting and action planning in patients with long-term conditions in outpatient settings is associated with favorable effects on measures of physical health, psychological health, subjective health status, self-management self-efficacy levels, activation levels, and perceived empowerment.
The purpose of this study is to examine the impact of an educational intervention delivered to the staff nurses of two surgical units on how to engage patients in mutual goal-setting in the acute care setting.
Staff nurses from two 32-bed surgical units will be scheduled to attend an hour-long educational intervention.
A total of 630 chart audits will be conducted one month prior and one and three months following the intervention per unit, to examine the number of patients with a daily goal recorded in the prior 24 hours and the quality of the recorded goal using the SMART-GEM.
The self-efficacy of engaging in mutual goal-setting with patients will be examined by asking nurses to complete the Appraisal Inventory Tool (AIT) prior to and immediately following the intervention.
The patient experience of engaging in mutual goal-setting will be examined by having a total of 165 patients complete the Patient Experience of Mutual Goal-Setting Tool (PEMGST) one month prior to the intervention and one and three months following the intervention on each of the two units.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
500
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 Contact
- Name: Teresa A Jerofke-Owen, PhD
- Phone Number: 2624423696
- Email: teresa.jerofke@marquette.edu
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert Memorial Hospital
-
Contact:
- Kristi Opper, MSN
- Phone Number: 414-454-7357
-
Principal Investigator:
- Teresa Jerofke-Owen, PhD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- At least 18 years of age or older
- Must be alert and oriented to person, place, and time
- Inpatient on one of two included units
Exclusion Criteria
- Less than 24 hour length of stay
- Non English-speaking
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
Patients receiving usual care
|
|
|
Experimental: Intervention
Patient's receiving care following nurse education on mutual goal-setting
|
Nurses will receive both written and verbal instruction on mutual goal-setting with patients using SMART methodology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in percentage of charts reviewed with an individualized goal recorded in the electronic health record
Time Frame: Over the course of one month before delivery of education intervention and one and three months post delivery of intervention
|
percentage of charts reviewed with individualized goals recorded in their electronic health record
|
Over the course of one month before delivery of education intervention and one and three months post delivery of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of goals as measured by the SMART-GEM.
Time Frame: Over the course of one month before delivery of education intervention and one and three months post delivery of intervention
|
Quality of charted individualized goals using talhe SMART-GEM tool.
The SMART-GEM (Bowman, Mogensen, Marsland, & Lannin, 2015) is an objective tool that can be used to score the quality of a SMART goal.
The interrater agreement on total scores was very good (ICC=.0895,
95% CI = .743
to .986,
p=.001) with excellent internal consistency (alpha = .995).
|
Over the course of one month before delivery of education intervention and one and three months post delivery of intervention
|
|
Change in patient experience with mutual goal-setting using the Patient Experience of Mutual Goal-Setting Tool.
Time Frame: Over the course of one month before delivery of educational intervention and one and three months post delivery of intervention
|
Patient experience with mutual goal setting using the Patient Experience of Mutual Goal-Setting Tool, a 5-item survey created by PI to measure the patient experience of mutual goal-setting (involvement, satisfaction, knowledge, feeling heard, achievement of goals).
Questions are on a 6-point Likert scale, with higher scores indicating a more favorable experience.
|
Over the course of one month before delivery of educational intervention and one and three months post delivery of intervention
|
|
Change in nurse self-efficacy participating in mutual goal-setting with patients pre and post-intervention using the Appraisal Inventory Tool.
Time Frame: Immediately before starting the educational intervention and immediately following the conclusion of the educational intervention
|
Nurse self-efficacy participating in mutual goal-setting with patients.
The Appraisal Inventory Tool is a 5-item survey created by PI to measure nurse self-efficacy for mutual goal-setting using Bandura's (2006) guidelines.
The items use an 11-point Likert scale, and higher scores indicate a higher self-efficacy score
|
Immediately before starting the educational intervention and immediately following the conclusion of the educational intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
May 19, 2022
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
March 30, 2023
Study Registration Dates
First Submitted
June 22, 2021
First Submitted That Met QC Criteria
July 14, 2021
First Posted (Actual)
July 26, 2021
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HR-3725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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