Measuring and Improving Coproduction Using coopeRATE

July 7, 2020 updated by: Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center

Measuring and Improving Coproduction Using coopeRATE: A Before-and-after Study in Adult Cystic Fibrosis Care

The purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.

Study Overview

Status

Status

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

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.

Detailed Description

This study has 3 specific aims: Aim 1 will assess the construct validity of the coopeRATE Measure in the before phase of a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Measure is a generic, patient-reported experience measure of collaborative goal setting that was recently developed in consultation with patients and other key stakeholders. Aim 2 will assess the impact of the coopeRATE Prompt intervention on collaborative goal setting and other outcomes in a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Prompt intervention is a set of questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals. Aim 3 will evaluate the feasibility and acceptability of implementing the coopeRATE Prompt and Measure in routine adult cystic fibrosis care.

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 (Actual)

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.
280

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 Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • University of Nebraska Medical Center / Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

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:

  1. Have a diagnosis of cystic fibrosis
  2. Are 18 years of age or older
  3. Can read and write in English
  4. Are attending a participating site for a routine cystic fibrosis care visit
  5. Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry
  6. Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
  7. Have not previously participated in the study

Exclusion Criteria:

  1. Do not have a diagnosis of cystic fibrosis
  2. Are less than 18 years of age
  3. Cannot read and write in English
  4. Are not attending a participating site for a routine cystic fibrosis care visit
  5. Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry
  6. Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
  7. Have previously participated in the study

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential 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: Phase 1
Usual care
Experimental: Phase 2
Usual care + coopeRATE Prompt intervention
Behavioral: coopeRATE Prompt
The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.
Other: Clinicians
After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.
Behavioral: coopeRATE Prompt
The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.

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
Collaborative goal setting
Time Frame: Immediately after the health care visit (Day 0)
A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and their clinician during the health care visit. Each item is rated on a 4-point scale ranging from 0 ('Strongly disagree') to 3 ('Strongly agree'), with an additional 'Not sure' option. Scoring method is to be determined.
Immediately after the health care visit (Day 0)

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
Shared decision-making
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported shared decision-making during the health care visit, assessed using the 3-item collaboRATE measure (Elwyn et al., 2013; Barr et al., 2014). Each item is rated on a 10-point scale ranging from 0 ('No effort was made') to 9 ('Every effort was made'). Respondent's are assigned a score of 1 if every item is rated 'Every effort was made' and a score of 0 for all other response combinations.
Immediately after the health care visit (Day 0)
Interpersonal and communication skills
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported interpersonal and communication skills of their clinician during the health care visit, assessed using a 14-item version of the Communication Assessment Tool (CAT) (Makoul, Krupat, & Chang, 2007). Each item is rated on a 5-point scale ranging from 1 ('Poor') to 5 ('Excellent'). A respondent's total scale score is the percentage of items rated as 'Excellent'.
Immediately after the health care visit (Day 0)
Self-efficacy to manage chronic disease
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported self-efficacy for managing their chronic disease immediately following the health care visit, assessed using an adapted version of the 6-item Self-Efficacy to Manage Chronic Disease Scale (Ritter & Lorig, 2014). Each item is rated on a 10-point scale ranging from 1 ('Not at all confident') to 10 ('Totally confident'). A respondent's total score is the mean of all item responses.
Immediately after the health care visit (Day 0)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Description of goals discussed during the visit
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported goals discussed during the health care visit (if goals were discussed), assessed using a single item with open-text response format.
Immediately after the health care visit (Day 0)
Preference for discussing goals
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported preference for discussing goals with their clinician during the health care visit, assessed using a single item with multiple choice (single answer) format.
Immediately after the health care visit (Day 0)
Use of coopeRATE Prompt
Time Frame: Immediately after the health care visit (Day 0) - Phase 2 only
Patient-reported use of the coopeRATE Prompt intervention during the health care visit, assessed using a single item with multiple choice (single answer) format.
Immediately after the health care visit (Day 0) - Phase 2 only
Reason(s) for not using coopeRATE Prompt (patient)
Time Frame: Immediately after the health care visit (Day 0) - Phase 2 only
Patient-reported reason(s) for not using the coopeRATE Prompt intervention during the health care visit (if intervention was not used), assessed using a single item with multiple choice (multiple answer) format.
Immediately after the health care visit (Day 0) - Phase 2 only
Perceived helpfulness of coopeRATE Prompt
Time Frame: Immediately after the health care visit (Day 0) - Phase 2 only
Patient-reported perceived helpfulness of the coopeRATE Prompt intervention (if intervention was used), assessed using a single adapted item (Dalcin et al., 2015). The item is rated on a 5-point scale ranging from 0 ('Not at all helpful') to 4 ('Extremely helpful').
Immediately after the health care visit (Day 0) - Phase 2 only
Way(s) in which coopeRATE Prompt helpful
Time Frame: Immediately after the health care visit (Day 0) - Phase 2 only
Patient-reported way(s) in which the coopeRATE Prompt intervention was helpful (if intervention was perceived to be at least slightly helpful), assessed using a single item with multiple choice (multiple answer) format.
Immediately after the health care visit (Day 0) - Phase 2 only
People seen during health care visit
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported people seen (e.g., doctor, nurse) during the health care visit, assessed using a single item with multiple choice (multiple answer) format.
Immediately after the health care visit (Day 0)
History with people seen during health care visit
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported history with people seen during the health care visit, assessed using a single item with multiple choice (single answer) format.
Immediately after the health care visit (Day 0)
Type of health care visit
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported type of health care visit, assessed using a single item with multiple choice (multiple answer) format.
Immediately after the health care visit (Day 0)
Participation in other research
Time Frame: Immediately after the health care visit (Day 0)
Patient-reported participation in other research studies during the health care visit, assessed using two single items with multiple choice (single answer) format.
Immediately after the health care visit (Day 0)
Receipt of coopeRATE Prompt
Time Frame: Within one month after completion of Phase 2 patient data collection
Clinician-reported receipt of the coopeRATE Prompt intervention, assessed using a single item with multiple choice (single answer) format.
Within one month after completion of Phase 2 patient data collection
Frequency of use of coopeRATE Prompt
Time Frame: Within one month after completion of Phase 2 patient data collection
Clinician-reported frequency of using the coopeRATE Prompt intervention to guide conversations with patients (if intervention was ever received), assessed using a single item with multiple choice (single answer) format.
Within one month after completion of Phase 2 patient data collection
Reason(s) for not using coopeRATE Prompt (clinician)
Time Frame: Within one month after completion of Phase 2 patient data collection
Clinician-reported reason(s) for not using the coopeRATE Prompt intervention to guide conversations with patients (if intervention was not always used), assessed using two single items with multiple choice (multiple answer) format.
Within one month after completion of Phase 2 patient data collection
Frequency of coopeRATE Prompt improving conversations
Time Frame: Within one month after completion of Phase 2 patient data collection
Clinician-reported frequency of the coopeRATE Prompt intervention improving the quality of conversations with patients (if intervention was ever used), assessed using a single item with multiple choice (single answer) format.
Within one month after completion of Phase 2 patient data collection
Frequency of coopeRATE Prompt increasing consultation time
Time Frame: Within one month after completion of Phase 2 patient data collection
Clinician-reported frequency of the coopeRATE Prompt intervention increasing consultation time with patients (if intervention was ever used), assessed using a single item with multiple choice (single answer) format.
Within one month after completion of Phase 2 patient data collection

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.
Dartmouth-Hitchcock Medical Center

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.
Boston Children's Hospital
Cystic Fibrosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 2, 2019

Primary Completion (Actual)

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.
March 16, 2020

Study Completion (Actual)

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 16, 2020

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).
August 15, 2019

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.
August 15, 2019

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.
August 19, 2019

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.
July 9, 2020

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.
July 7, 2020

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.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • SFD19152
  • ELWYN18QI0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

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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