Clinical trial NCT04060329: Measuring and Improving Coproduction Using coopeRATE
Official title: Measuring and Improving Coproduction Using coopeRATE: A Before-and-after Study in Adult Cystic Fibrosis Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Chronic Disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: Boston Children's Hospital
First posted: 2019-08-19
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collaborative goal setting
timeFrame: Immediately after the health care visit (Day 0)
Secondary outcomes:
measure: Shared decision-making
timeFrame: Immediately after the health care visit (Day 0)
measure: Interpersonal and communication skills
timeFrame: Immediately after the health care visit (Day 0)
measure: Self-efficacy to manage chronic disease
timeFrame: Immediately after the health care visit (Day 0)
Other outcomes:
measure: Description of goals discussed during the visit
timeFrame: Immediately after the health care visit (Day 0)
measure: Preference for discussing goals
timeFrame: Immediately after the health care visit (Day 0)
measure: Use of coopeRATE Prompt
timeFrame: Immediately after the health care visit (Day 0) - Phase 2 only
measure: Reason(s) for not using coopeRATE Prompt (patient)
timeFrame: Immediately after the health care visit (Day 0) - Phase 2 only
measure: Perceived helpfulness of coopeRATE Prompt
timeFrame: Immediately after the health care visit (Day 0) - Phase 2 only
measure: Way(s) in which coopeRATE Prompt helpful
timeFrame: Immediately after the health care visit (Day 0) - Phase 2 only
measure: People seen during health care visit
timeFrame: Immediately after the health care visit (Day 0)
measure: History with people seen during health care visit
timeFrame: Immediately after the health care visit (Day 0)
measure: Type of health care visit
timeFrame: Immediately after the health care visit (Day 0)
measure: Participation in other research
timeFrame: Immediately after the health care visit (Day 0)
measure: Receipt of coopeRATE Prompt
timeFrame: Within one month after completion of Phase 2 patient data collection
measure: Frequency of use of coopeRATE Prompt
timeFrame: Within one month after completion of Phase 2 patient data collection
measure: Reason(s) for not using coopeRATE Prompt (clinician)
timeFrame: Within one month after completion of Phase 2 patient data collection
measure: Frequency of coopeRATE Prompt improving conversations
timeFrame: Within one month after completion of Phase 2 patient data collection
measure: Frequency of coopeRATE Prompt increasing consultation time
timeFrame: Within one month after completion of Phase 2 patient data collection
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center / Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester
state: New Hampshire
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Dartmouth College
name: Glyn Elwyn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.