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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Cystic Fibrosis, Chronic Disease
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | coopeRATE Prompt Receives: Behavioral: coopeRATE Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted6 Jan 2021
- Study start14 Jan 2021
- Primary completion3 Sep 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Glyn Jones-Elwyn, Dartmouth-Hitchcock Medical Center
- Investigators
- Glyn Elwyn, Principal investigator, Dartmouth College
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 28851459Dalcin 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 27668085Elwyn 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 23768763Barr 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations in Adult Cystic Fibrosis Care
- ClinicalTrials.gov ID
- NCT04696484
- Acronym / sponsor ID
- Pro00047666
- Conditions
- Cystic Fibrosis, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: coopeRATE PromptcoopeRATE Prompt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coopeRATE PromptThe 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. | Behavioural | Intervention |
Primary outcome
Use of intervention responses with physician (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
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'.
22 secondary outcomes
Intervention completion (patient-reported)
Time frame: 1-4 days before the healthcare visit
Intervention acceptability (patient-reported)
Time frame: 1-4 days before the healthcare visit
Utility of intervention (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Way(s) in which intervention was helpful (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Initiator of discussion (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Satisfaction with time spent (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Preference for sharing intervention responses with other team members (patient-reported)
Time frame: 1-4 days before the healthcare visit
Use of intervention responses with other team members (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Satisfaction with intervention timing (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Preferred intervention timing (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Future receipt of intervention (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Collaborative goal setting (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Shared decision-making (patient-reported)
Time frame: Within 24 hours after completion of the healthcare visit
Frequency of intervention receipt (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Use of intervention responses with patients (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Utility of intervention (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Way(s) in which intervention was helpful (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Impact on time spent with patients (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Reason(s) for not using intervention (never used) (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Reason(s) for not using intervention (sometimes used) (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Intervention acceptability (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Future use of intervention (clinician-reported)
Time frame: Within 1 month following completion of patient data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 28851459Weiner 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.
- Background: PubMed 27668085Dalcin 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.
- Background: PubMed 23768763Elwyn 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.
- Background: PubMed 24389354Barr 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Elwyn principal investigator
Dartmouth College
4 sites in 1 country: see every site and its status.
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.