Chronic Disease, Cystic Fibrosis
Conditions
Brief 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.
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.
Interventions
BEHAVIORALcoopeRATE 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.
Sponsors
Cystic Fibrosis Foundation
Boston Children's Hospital
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collaborative goal setting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared decision-making | 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. |
| Interpersonal and communication skills | 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'. |
| Self-efficacy to manage chronic disease | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived helpfulness of coopeRATE Prompt | 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'). |
| Way(s) in which coopeRATE Prompt helpful | 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. |
| People seen during health care visit | 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. |
| History with people seen during health care visit | 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. |
| Type of health care visit | 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. |
| Description of goals discussed during the visit | 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. |
| Receipt of coopeRATE Prompt | 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. |
| Frequency of use of coopeRATE Prompt | 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. |
| Reason(s) for not using coopeRATE Prompt (clinician) | 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. |
| Frequency of coopeRATE Prompt improving conversations | 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. |
| Frequency of coopeRATE Prompt increasing consultation time | 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. |
| Participation in other research | 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. |
| Preference for discussing goals | 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. |
| Use of coopeRATE Prompt | 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. |
| Reason(s) for not using coopeRATE Prompt (patient) | 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. |
Countries
United States
Outcome results
None listed