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| ID | Type | Description | Link |
|---|---|---|---|
| ELWYN18QI0 | Other Grant/Funding Number | Cystic Fibrosis Foundation |
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Reasons associated with COVID-19 pandemic led to cancellation of Phase 2
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Boston Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | No Intervention | Usual care | |
| Phase 2 | Experimental | Usual care + coopeRATE Prompt intervention |
|
| Clinicians | Other | After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coopeRATE Prompt | Behavioral | The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the health care visit (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of goals discussed during the visit | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glyn Elwyn | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92103 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23768763 | Background | 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. | |
| 24389354 | Background | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
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| Immediately after the health care visit (Day 0) |
| 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'. | Immediately after the health care visit (Day 0) |
| 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. | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 |
| Denver |
| Colorado |
| 80206 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Nebraska Medical Center / Nebraska Medical Center | Omaha | Nebraska | 68106 | United States |
| Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester | Lebanon | New Hampshire | 03756 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| 17574367 | Background | 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. |
| 25091546 | Background | 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. |
| 27668085 | Background | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |