Chronic IllnessNCT01503853
Discussing Costs in the Doctor-Patient Encounter
An observational study of Chronic Illness and Financial Burden, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: The costs of medical care have a major effect on patients during illness and treatment. Surveys with patients and doctors show that both are interested in discussing the costs of treatment. But they rarely talk about these issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness, Financial Burden
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2011to 16 Sep 2016
- Phase
- Observational
- 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
- ELIGIBILITY CRITERIA:
- RAND Corp Survey Research Group will be in charge of recruiting participants. They will work with an experienced focus group recruitment vendor to identify, screen and schedule eligible participants from the LA/Santa Monica area and the Washington DC area. Candidates for the focus groups must be individuals who are 18 years old or older, able to provide informed consent, and who speak English or Spanish well enough to participate in one of the focus groups. In addition, participants must have health insurance coverage at the time of recruitment. The focus groups will include a mix of participants in terms of gender, age, race/ethnicity, educational level, SES, and health insurance coverage type. While we will not be excluding HHS or other federal employees from participating (as we see no compelling reason to do so), we will not be recruiting predominantly HHS or other federal employees because we seek a generalizable sample.
- Participants will be either English or Spanish speaking adults. Focus groups will include participants with the following varied characteristics:
- age (working adults with and without dependents and retirees); ethnic/racial groups (African American, Latino, Non-Hispanic whites);
- varied economic status (incomes below 300% of the Federal poverty threshold, and above).
- Specifically, participants will be recruited to ensure sufficient socio-demographic representation and adequate numbers to test our study hypotheses. Because we will recruit subjects with the intention of producing generalizable results, we will not recruit disproportionate numbers of HHS or other federal employees (although these individuals will not be excluded from participation).
- After the two pilot groups, twenty focus groups each including 8-12 participants will be conducted for a maximum total of 264 participants. Of the twenty focus groups, sixteen will be conducted in English and 4 will be conducted in Spanish.
- Half of participants will have incomes under 300% of the federal poverty threshold in order to guarantee ascertainment of perspectives of participants of varied socio-economic status.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
- The costs of medical care have a major effect on patients during illness and treatment. Surveys with patients and doctors show that both are interested in discussing the costs of treatment. But they rarely talk about these issues. Both worry about whether it is appropriate to discuss financial matters in the clinical setting. They are also concerned about whether this topic will be an awkward one. Researchers are interested in studying how people want their doctors to talk to them about the costs of illness and medical care.
Read more
Objectives:
- To explore and better understand patients views on whether and how doctors should talk about the costs of illness and medical care.
Eligibility:
- English- or Spanish-speaking adults (at least 18 years of age) who are covered by health insurance.
Design:
- Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people will come together to discuss their thoughts and opinions.
- A member of the research team will lead the group discussion. The leader will ask a list of questions about health care payment issues. Those in the focus group will discuss these issues.
- Participants will receive a small cash payment and a light snack.
Read the detailed description
BACKGROUND:
The cost of illness and medical care has profound implications for society as a whole and for individual patients as they experience being sick and seeking treatment. It is both appropriate and imperative that these costs be discussed in the doctor-patient encounter. Surveys with patients and doctors show that both parties have the desire to discuss costs, yet they rarely have these conversations because of worries about the appropriateness and potential awkwardness of discussing financial matters in the clinical encounter.
In the existing literature we find that patients express a preference for more care, newer care, and expensive care (as they believe cost indicates better care), and they react negatively to conversations they perceive as encouraging rationing. Yet rationing - the use of allocation criteria to distribute resources - is inevitable when resources are limited, and acceptable when done fairly. Recognizing the need for bedside rationing and endeavoring to promote bedside rationing are not antithetical to patient-centered care, however. Open and honest conversations about rationing, when carried out appropriately, can be consistent with patient-centered care and the view of patients as moral agents.
Patients resistance to discussions of rationing, coupled with the financial burden of illness and the reality of rising health care costs, all point to the pressing need to explore strategies for how physicians can address costs in ways that are understanding, empathic, and palatable to patients. In the literature we find scant empirical evidence about how patients would react to doctors talking about (and considering) costs. This study seeks the patient perspective on how these honest conversations about costs can be carried out in a sensitive and appropriate manner.
OBJECTIVE:
This project aims to explore and better understand patients perspectives about whether and how doctors should talk about and address the costs of illness and medical care. Ultimately we hope to promote the ability of doctors to discuss and address financial issues in their encounters with patients in a way that maintains trust, advocacy and integrity.
- Participants will be more receptive to discussing personal costs than societal (pooled) costs with their physicians.
- Willingness to discuss personal cost in the clinical encounter will vary with participant socio-demographic characteristics.
- Following group discussions about addressing cost of care in the clinical encounter, participants will be more receptive to discussion of costs in the clinical encounter.
- Following group discussion, participants will be more inclined to choose less expensive care.
- Conditions
- Chronic Illness, Financial Burden
- Keywords
- Medical Costs, Health Care, Focus Groups
- Medical subject headings
- Chronic Disease, Financial Stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study start16 Apr 2011
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marion Danis, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503853
- Sponsor's protocol ID
- 999911133
- Other IDs
- 11-CH-N133
- Status last verified
- 16 Sep 2016
- First submitted
- 31 Dec 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Blendon RJ, Brodie M, Benson JM, Altman DE, Buhr T. Americans' views of health care costs, access, and quality. Milbank Q. 2006;84(4):623-57. doi: 10.1111/j.1468-0009.2006.00463.x.
PubMed 17096637Coast J. Who wants to know if their care is rationed? Views of citizens and service informants. Health Expect. 2001 Dec;4(4):243-52. doi: 10.1046/j.1369-6513.2001.00147.x.
PubMed 11703498Halpern J. What is clinical empathy? J Gen Intern Med. 2003 Aug;18(8):670-4. doi: 10.1046/j.1525-1497.2003.21017.x.
PubMed 12911651
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discussing Costs in the Doctor-Patient Encounter
- ClinicalTrials.gov ID
- NCT01503853
- Acronym / sponsor ID
- 999911133
- Conditions
- Chronic Illness, Financial Burden
- Keywords
- Medical Costs, Health Care, Focus Groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 16 Apr 2011
- Study completion
- 16 Sep 2016
- First posted
- 4 Jan 2012 (estimated)
- 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.
Background:
- The costs of medical care have a major effect on patients during illness and treatment. Surveys with patients and doctors show that both are interested in discussing the costs of treatment. But they rarely talk about these issues. Both worry about whether it is appropriate to discuss financial matters in the clinical setting. They are also concerned about whether this topic will be an awkward one. Researchers are interested in studying how people want their doctors to talk to them about the costs of illness and medical care.
Objectives:
- To explore and better understand patients views on whether and how doctors should talk about the costs of illness and medical care.
Eligibility:
- English- or Spanish-speaking adults (at least 18 years of age) who are covered by health insurance.
Design:
- Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people will come together to discuss their thoughts and opinions.
- A member of the research team will lead the group discussion. The leader will ask a list of questions about health care payment issues. Those in the focus group will discuss these issues.
- Participants will receive a small cash payment and a light snack.
Detailed description
BACKGROUND:
The cost of illness and medical care has profound implications for society as a whole and for individual patients as they experience being sick and seeking treatment. It is both appropriate and imperative that these costs be discussed in the doctor-patient encounter. Surveys with patients and doctors show that both parties have the desire to discuss costs, yet they rarely have these conversations because of worries about the appropriateness and potential awkwardness of discussing financial matters in the clinical encounter.
In the existing literature we find that patients express a preference for more care, newer care, and expensive care (as they believe cost indicates better care), and they react negatively to conversations they perceive as encouraging rationing. Yet rationing - the use of allocation criteria to distribute resources - is inevitable when resources are limited, and acceptable when done fairly. Recognizing the need for bedside rationing and endeavoring to promote bedside rationing are not antithetical to patient-centered care, however. Open and honest conversations about rationing, when carried out appropriately, can be consistent with patient-centered care and the view of patients as moral agents.
Patients resistance to discussions of rationing, coupled with the financial burden of illness and the reality of rising health care costs, all point to the pressing need to explore strategies for how physicians can address costs in ways that are understanding, empathic, and palatable to patients. In the literature we find scant empirical evidence about how patients would react to doctors talking about (and considering) costs. This study seeks the patient perspective on how these honest conversations about costs can be carried out in a sensitive and appropriate manner.
OBJECTIVE:
This project aims to explore and better understand patients perspectives about whether and how doctors should talk about and address the costs of illness and medical care. Ultimately we hope to promote the ability of doctors to discuss and address financial issues in their encounters with patients in a way that maintains trust, advocacy and integrity.
- Participants will be more receptive to discussing personal costs than societal (pooled) costs with their physicians.
- Willingness to discuss personal cost in the clinical encounter will vary with participant socio-demographic characteristics.
- Following group discussions about addressing cost of care in the clinical encounter, participants will be more receptive to discussion of costs in the clinical encounter.
- Following group discussion, participants will be more inclined to choose less expensive care.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 5 Apr 2018.
- Background: PubMed 17096637Blendon RJ, Brodie M, Benson JM, Altman DE, Buhr T. Americans' views of health care costs, access, and quality. Milbank Q. 2006;84(4):623-57. doi: 10.1111/j.1468-0009.2006.00463.x.
- Background: PubMed 11703498Coast J. Who wants to know if their care is rationed? Views of citizens and service informants. Health Expect. 2001 Dec;4(4):243-52. doi: 10.1046/j.1369-6513.2001.00147.x.
- Background: PubMed 12911651Halpern J. What is clinical empathy? J Gen Intern Med. 2003 Aug;18(8):670-4. doi: 10.1046/j.1525-1497.2003.21017.x.
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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.
Marion Danis, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Illness and Financial Burden, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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?
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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503853, which also lists 3 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 5 Apr 2018.