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Cystic FibrosisNCT04060329

Measuring and Improving Coproduction Using coopeRATE

A study testing coopeRATE Prompt in people with Cystic Fibrosis and Chronic Disease, run by Dartmouth-Hitchcock Medical Center at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cystic Fibrosis, Chronic Disease
What is being tested?
coopeRATE Prompt
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
9 sitesUnited States
Study dates
2 Dec 2019to 16 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester

    Lebanon, New Hampshire, 03756

  • University of Nebraska Medical Center / Nebraska Medical Center

    Omaha, Nebraska, 68106

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224

  • University of California San Diego

    San Diego, California, 92103

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
coopeRATE Prompt
Medical subject headings
Cystic Fibrosis, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coopeRATE PromptBehavioural

    The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.

Study groups in NCT04060329
Study groupRoleWhat they receive
Phase 1No interventionUsual care
Phase 2ExperimentalUsual care + coopeRATE Prompt intervention
Receives: Behavioral: coopeRATE Prompt
CliniciansOtherAfter Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.
Receives: Behavioral: coopeRATE Prompt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collaborative goal setting

    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.

    Measured: Immediately after the health care visit (Day 0)

Secondary outcomes (3)

  1. Shared decision-making

    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.

    Measured: Immediately after the health care visit (Day 0)

  2. Interpersonal and communication skills

    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'.

    Measured: Immediately after the health care visit (Day 0)

  3. Self-efficacy to manage chronic disease

    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.

    Measured: Immediately after the health care visit (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start2 Dec 2019
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Why it stopped: Reasons associated with COVID-19 pandemic led to cancellation of Phase 2

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
In Phase 1, participants receive usual care only. In Phase 2, a different group of participants receive the coopeRATE Prompt intervention in addition to usual care.
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060329
Sponsor's protocol ID
SFD19152
Other IDs
ELWYN18QI0
Status last verified
Jul 2020
First submitted
15 Aug 2019
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

    PubMed 23768763

  • Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.

    PubMed 24389354

  • Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.

    PubMed 17574367

  • Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.

    PubMed 25091546

  • Dalcin AT, Jerome GJ, Fitzpatrick SL, Louis TA, Wang NY, Bennett WL, Durkin N, Clark JM, Daumit GL, Appel LJ, Coughlin JW. Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Obes Sci Pract. 2015 Oct;1(1):23-32. doi: 10.1002/osp4.6. Epub 2015 Sep 9.

    PubMed 27668085

Questions about this trial

What is this clinical trial studying?

A study testing coopeRATE Prompt in people with Cystic Fibrosis and Chronic Disease, run by Dartmouth-Hitchcock Medical Center at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Reasons associated with COVID-19 pandemic led to cancellation of Phase 2). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collaborative goal setting (time frame: Immediately after the health care visit (Day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060329, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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