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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No Intervention
Patients receiving usual care
Experimental: Intervention
Patient's receiving care following nurse education on mutual goal-setting
Other: Mutual Goal-Setting Education
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marquette University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Froedtert Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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