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Cystic FibrosisNCT04696484

Feasibility of a Goal-based Agenda Setting Intervention

A study testing coopeRATE Prompt in people with Cystic Fibrosis and Chronic Disease, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) 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
219 participants
Where
4 sitesUnited States
Study dates
14 Jan 2021to 19 Sep 2021
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 CF
  • are 18 years of age or older
  • can read and write English
  • have a scheduled in-person or tele-health routine CF care visit
  • have access to internet and email

Who cannot join

  • does not have a diagnosis of CF
  • is less than 18 years of age
  • cannot read and write English
  • does not have a scheduled in-person or tele-health routine CF care visit
  • does have access to internet and email

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • University of Virginia

    Charlottesville, Virginia, 22908

  • National Jewish Health

    Denver, Colorado, 80206

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations in Adult Cystic Fibrosis Care

This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care. The coopeRATE Prompt is two questions designed to elicit patients' concerns and goals to facilitate collaborative goal setting within the health care visit. This is a prospective single arm study that will be conducted at four CF care centers in the United States.

Read the detailed description

Participating patients will be asked to complete two online surveys. The first survey, which includes the coopeRATE Prompt intervention questions, is completed 1-4 days before their upcoming healthcare visit. After completing this survey and before their visit, patients' intervention responses are shared with their physician and, if requested, other members of their care team. The second patient survey is completed within 24 hours after their healthcare visit. Participating clinicians are asked to complete a single online survey within one month after completion of patient data collection.

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 before the clinical encounter that elicit their concerns and goals. The intervention is delivered to patients online, outside the clinic setting.

Study groups in NCT04696484
Study groupRoleWhat they receive
InterventionExperimentalcoopeRATE Prompt
Receives: Behavioral: coopeRATE Prompt

What is being measured

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

  1. Use of intervention responses with physician (patient-reported)

    Patient-reported discussion of intervention responses (concerns and goals) in the visit with physician, assessed using two items with multiple choice (single answer) format. The first item assesses how many of the patient concerns were discussed and the second item assesses how many of the patient goals were discussed. Item response options are 'None of them', 'Some of them', or 'All of them'.

    Measured: Within 24 hours after completion of the healthcare visit

Secondary outcomes (22)
  1. Intervention completion (patient-reported)

    Presence of a response to each of the coopeRATE Prompt intervention questions. The coopeRATE Prompt includes two items with open-text response format.

    Measured: 1-4 days before the healthcare visit

  2. Intervention acceptability (patient-reported)

    Patient-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses.

    Measured: 1-4 days before the healthcare visit

  3. Utility of intervention (patient-reported)

    Patient-reported utility (helpfulness) of intervention, 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').

    Measured: Within 24 hours after completion of the healthcare visit

  4. Way(s) in which intervention was helpful (patient-reported)

    Patient-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  5. Initiator of discussion (patient-reported)

    Patient-reported initiator of discussion of intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  6. Satisfaction with time spent (patient-reported)

    Patient-reported satisfaction with amount of time spent discussing intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  7. Preference for sharing intervention responses with other team members (patient-reported)

    Patient-reported preference for sharing intervention responses with other members of the care team, assessed using a single item with multiple choice (multiple response) format.

    Measured: 1-4 days before the healthcare visit

  8. Use of intervention responses with other team members (patient-reported)

    Patient-reported discussion of intervention responses in the visit with other members of the care team, assessed using two items. The first item assesses whether intervention responses were discussed, with a multiple choice (single answer) format. The second item assesses the specific team members with whom discussions were had, with a multiple choice (multiple answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  9. Satisfaction with intervention timing (patient-reported)

    Patient-reported satisfaction with timing of intervention delivery, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  10. Preferred intervention timing (patient-reported)

    Patient-reported preferred timing of intervention delivery, assessed using a single item with open-text response format.

    Measured: Within 24 hours after completion of the healthcare visit

  11. Future receipt of intervention (patient-reported)

    Patient-reported preference for receiving the intervention again in the future, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 24 hours after completion of the healthcare visit

  12. Collaborative goal setting (patient-reported)

    A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and physician 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: Within 24 hours after completion of the healthcare visit

  13. Shared decision-making (patient-reported)

    Patient-reported shared decision-making with physician 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: Within 24 hours after completion of the healthcare visit

  14. Frequency of intervention receipt (clinician-reported)

    Clinician-reported frequency of receiving patient intervention responses, assessed using a single item with open-text response format.

    Measured: Within 1 month following completion of patient data collection

  15. Use of intervention responses with patients (clinician-reported)

    Clinician-reported frequency of use of intervention responses with patients in the visit, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 1 month following completion of patient data collection

  16. Utility of intervention (clinician-reported)

    Clinician-reported utility (helpfulness) of intervention, 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').

    Measured: Within 1 month following completion of patient data collection

  17. Way(s) in which intervention was helpful (clinician-reported)

    Clinician-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.

    Measured: Within 1 month following completion of patient data collection

  18. Impact on time spent with patients (clinician-reported)

    Clinician-reported impact on amount of time spent with patients, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 1 month following completion of patient data collection

  19. Reason(s) for not using intervention (never used) (clinician-reported)

    Clinician-reported reason(s) for never discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.

    Measured: Within 1 month following completion of patient data collection

  20. Reason(s) for not using intervention (sometimes used) (clinician-reported)

    Clinician-reported reason(s) for only sometimes discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.

    Measured: Within 1 month following completion of patient data collection

  21. Intervention acceptability (clinician-reported)

    Clinician-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses.

    Measured: Within 1 month following completion of patient data collection

  22. Future use of intervention (clinician-reported)

    Clinician-reported preference for using the intervention with patients in the future, assessed using a single item with multiple choice (single answer) format.

    Measured: Within 1 month following completion of patient data collection

Timeline

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

  1. First posted6 Jan 2021
  2. Study start14 Jan 2021
  3. Primary completion3 Sep 2021
  4. Study completion19 Sep 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696484
Sponsor's protocol ID
Pro00047666
Status last verified
Nov 2021
First submitted
4 Jan 2021
Last updated
24 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.

Publications

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PubMed 28851459
  • 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
  • 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

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 4 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Use of intervention responses with physician (patient-reported) (time frame: Within 24 hours after completion of the healthcare visit). 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 NCT04696484, which also lists 4 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 24 Nov 2021.

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