Physician BehaviorNCT04073732
Family Physician Contract Services and Impacts in China Based on Physician Agency Theory
An observational study of Physician Behavior and Hypertension, run by Peking University at 1 site in China.
Trial summary
In June 2016, the Health Reform Office in the State Council released "the Announcement about Guiding Opinions of Promoting Family Physician Contract Services". Family Physician Contract Service is an important tool to change the health service models in primary care organizations in China. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physician Behavior, Hypertension
- How many people
- 682 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2019to 28 Nov 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1）Family physician team participating in family physician contract services, including family doctors, nurses, public security personnel, etc.; 2) Residents, Residents who come to the community health service center
Who may be able to join
- Family physician
- a family doctor (general practitioner), has a formal medical license, does not retire;
- must be directly facing the patient, participate in the patient's diagnosis, prescription, treatment and return visits, with the outpatient service as the main treatment;
- family doctors average weekly Must receive at least 20 patients and receive an average of no less than 2 days per week;
- Signing informed consent.
- Residents 1) Can complete the questionnaire independently； 2）Oral participation.
Who cannot join
- Family physician Not signing informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Chiangning District health commission
Shanghai, Shanghai Municipality
About this study
In June 2016, the Health Reform Office in the State Council released "the Announcement about Guiding Opinions of Promoting Family Physician Contract Services". Family Physician Contract Service is an important tool to change the health service models in primary care organizations in China. The relationship between patients and physicians can be regarded as principles and agents.
Physician agency theory has been used to study physician behaviors in economics and management. Family physician contract services regulate the principle-agent relationship between patients and physicians using a formal contract, and there are lots of potentials to employ the physician agency theory to study family physician contract services in China. In theoretical aspects, the present project will study the analysis frameworks and methods of family physician contract services in China under the capitation and global budget payment mechanisms after systematically reviewing Chinese and English literatures about the physician agency theory. In empirical aspects, the present project will collect data from family physician contract services and examine the effects of specific contract forms, incentives, and fees on family physician behaviors and their impacts on health status and medical expenditures of hypertensive and diabetic patients.
Read the detailed description
- From a theoretical point of view, using the physician agency theory to construct a family physician contract services and a family physician (team) behavior theory analysis framework and research method system suitable for China's national conditions.
- From the empirical point of view, from the demand side, analyze the needs of the family physician contract service, the status quo, and the behavior of the visit; from the supplier, understand the behavior changes and satisfaction of the family physician (team) after the implementation of the family physician contract service Degree situation
- From an empirical perspective, from the level of primary medical institutions, use the sample area data to analyze the impact of family physicians' signing services on the number of visits and medical expenses;
- From an empirical perspective, using the constructed theoretical analysis framework to analyze the implementation of the Chinese family physician contract service, including incentive mechanism (income, incentive performance salary and contract service fee), family physician team composition, family bed service, etc. The impact, especially on the quality and quantity of services.
- From the empirical point of view, taking the key monitoring population (hypertension patients as an example) as a sample, further study the family physicians' contractual services, the changes in the practice behavior of family physicians to the key monitoring population (hypertension, diabetes patients), health outcomes, medical expenses The effect is to propose policy recommendations for family physicians' contracting services and physicians' behavior in the new medical reform in the future.
- Conditions
- Physician Behavior, Hypertension
- Keywords
- family physician contract services, physician agency theory, physician Behavior, family physician, health service supply
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| family physician team | Family physician team in four regions (Beijing, Shanghai, Hangzhou and Xia'men), including general practitioners, nurses and public health personnel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contracted residents
Health-care quantity
Measured: 2018.1-2019.6
Average treatment time
Health-care quality
Measured: 2018.1-2019.6
Absolute value of diastolic blood pressure
Health outcome
Measured: 2018.1-2019.6
Medical expenses for patients with hypertension
Health-care cost
Measured: 2018.1-2019.6
Number of service residents per day
Health-care quantity
Measured: 2018.1-2019.6
Absolute value of systolic blood pressure
Health outcome
Measured: 2018.1-2019.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start15 Sep 2019
- Primary completion15 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Physician BehaviorStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hai Fang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073732
- Sponsor's protocol ID
- 71774006
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contains a large amount of personal information, this research and various agencies signed a data confidentiality agreement
Publications
Frolich A, Talavera JA, Broadhead P, Dudley RA. A behavioral model of clinician responses to incentives to improve quality. Health Policy. 2007 Jan;80(1):179-93. doi: 10.1016/j.healthpol.2006.03.001. Epub 2006 Apr 19.
PubMed 16624440Arrow KJ. Uncertainty and the welfare economics of medical care. 1963. Bull World Health Organ. 2004 Feb;82(2):141-9. Epub 2004 Mar 16. No abstract available.
PubMed 15042238Fang H, Liu H, Rizzo JA. Has the use of physician gatekeepers declined among HMOs? Evidence from the United States. Int J Health Care Finance Econ. 2009 Jun;9(2):183-95. doi: 10.1007/s10754-009-9060-8. Epub 2009 Apr 9.
PubMed 19357948Fang H, Rizzo JA. Managed care and physicians' perceptions of drug formulary use. Am J Manag Care. 2009 Jun;15(6):395-400.
PubMed 19514805Wilson DM, Taylor DW, Gilbert JR, Best JA, Lindsay EA, Willms DG, Singer J. A randomized trial of a family physician intervention for smoking cessation. JAMA. 1988 Sep 16;260(11):1570-4.
PubMed 3411737Avery DM Jr, Hooper DE, McDonald JT Jr, Love MW, Tucker MT, Parton JM. The economic impact of rural family physicians practicing obstetrics. J Am Board Fam Med. 2014 Sep-Oct;27(5):602-10. doi: 10.3122/jabfm.2014.05.140052.
PubMed 25201930Yip WC, Hsiao W, Meng Q, Chen W, Sun X. Realignment of incentives for health-care providers in China. Lancet. 2010 Mar 27;375(9720):1120-30. doi: 10.1016/S0140-6736(10)60063-3.
PubMed 20346818Conrad DA. The Theory of Value-Based Payment Incentives and Their Application to Health Care. Health Serv Res. 2015 Dec;50 Suppl 2(Suppl 2):2057-89. doi: 10.1111/1475-6773.12408. Epub 2015 Nov 9.
PubMed 26549041
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Physician Contract Services and Impacts in China Based on Physician Agency Theory
- ClinicalTrials.gov ID
- NCT04073732
- Acronym / sponsor ID
- 71774006
- Conditions
- Physician Behavior, Hypertension
- Keywords
- family physician contract services, physician agency theory, physician Behavior, family physician, health service supply
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 29 Aug 2019 (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.
In June 2016, the Health Reform Office in the State Council released "the Announcement about Guiding Opinions of Promoting Family Physician Contract Services". Family Physician Contract Service is an important tool to change the health service models in primary care organizations in China. The relationship between patients and physicians can be regarded as principles and agents.
Physician agency theory has been used to study physician behaviors in economics and management. Family physician contract services regulate the principle-agent relationship between patients and physicians using a formal contract, and there are lots of potentials to employ the physician agency theory to study family physician contract services in China. In theoretical aspects, the present project will study the analysis frameworks and methods of family physician contract services in China under the capitation and global budget payment mechanisms after systematically reviewing Chinese and English literatures about the physician agency theory. In empirical aspects, the present project will collect data from family physician contract services and examine the effects of specific contract forms, incentives, and fees on family physician behaviors and their impacts on health status and medical expenditures of hypertensive and diabetic patients.
Detailed description
- From a theoretical point of view, using the physician agency theory to construct a family physician contract services and a family physician (team) behavior theory analysis framework and research method system suitable for China's national conditions.
- From the empirical point of view, from the demand side, analyze the needs of the family physician contract service, the status quo, and the behavior of the visit; from the supplier, understand the behavior changes and satisfaction of the family physician (team) after the implementation of the family physician contract service Degree situation
- From an empirical perspective, from the level of primary medical institutions, use the sample area data to analyze the impact of family physicians' signing services on the number of visits and medical expenses;
- From an empirical perspective, using the constructed theoretical analysis framework to analyze the implementation of the Chinese family physician contract service, including incentive mechanism (income, incentive performance salary and contract service fee), family physician team composition, family bed service, etc. The impact, especially on the quality and quantity of services.
- From the empirical point of view, taking the key monitoring population (hypertension patients as an example) as a sample, further study the family physicians' contractual services, the changes in the practice behavior of family physicians to the key monitoring population (hypertension, diabetes patients), health outcomes, medical expenses The effect is to propose policy recommendations for family physicians' contracting services and physicians' behavior in the new medical reform in the future.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| family physician team | – | –Family physician team in four regions (Beijing, Shanghai, Hangzhou and Xia'men), including general practitioners, nurses and public health personnel. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1）Family physician team participating in family physician contract services, including family doctors, nurses, public security personnel, etc.; 2) Residents, Residents who come to the community health service center
Key inclusion criteria (6 listed)
- Family physician
- Residents 1) Can complete the questionnaire independently； 2）Oral participation.
Key exclusion criteria (1 listed)
- Family physician Not signing informed consent
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
Number of contracted residents
Time frame: 2018.1-2019.6
Health-care quantity
Average treatment time
Time frame: 2018.1-2019.6
Health-care quality
Absolute value of diastolic blood pressure
Time frame: 2018.1-2019.6
Health outcome
Medical expenses for patients with hypertension
Time frame: 2018.1-2019.6
Health-care cost
Number of service residents per day
Time frame: 2018.1-2019.6
Health-care quantity
Absolute value of systolic blood pressure
Time frame: 2018.1-2019.6
Health outcome
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 16 Sep 2020.
- Background: PubMed 16624440Frolich A, Talavera JA, Broadhead P, Dudley RA. A behavioral model of clinician responses to incentives to improve quality. Health Policy. 2007 Jan;80(1):179-93. doi: 10.1016/j.healthpol.2006.03.001. Epub 2006 Apr 19.
- Results publication: PubMed 15042238Arrow KJ. Uncertainty and the welfare economics of medical care. 1963. Bull World Health Organ. 2004 Feb;82(2):141-9. Epub 2004 Mar 16. No abstract available.
- Results publication: PubMed 19357948Fang H, Liu H, Rizzo JA. Has the use of physician gatekeepers declined among HMOs? Evidence from the United States. Int J Health Care Finance Econ. 2009 Jun;9(2):183-95. doi: 10.1007/s10754-009-9060-8. Epub 2009 Apr 9.
- Results publication: PubMed 19514805Fang H, Rizzo JA. Managed care and physicians' perceptions of drug formulary use. Am J Manag Care. 2009 Jun;15(6):395-400.
- Results publication: PubMed 3411737Wilson DM, Taylor DW, Gilbert JR, Best JA, Lindsay EA, Willms DG, Singer J. A randomized trial of a family physician intervention for smoking cessation. JAMA. 1988 Sep 16;260(11):1570-4.
- Results publication: PubMed 25201930Avery DM Jr, Hooper DE, McDonald JT Jr, Love MW, Tucker MT, Parton JM. The economic impact of rural family physicians practicing obstetrics. J Am Board Fam Med. 2014 Sep-Oct;27(5):602-10. doi: 10.3122/jabfm.2014.05.140052.
- Results publication: PubMed 20346818Yip WC, Hsiao W, Meng Q, Chen W, Sun X. Realignment of incentives for health-care providers in China. Lancet. 2010 Mar 27;375(9720):1120-30. doi: 10.1016/S0140-6736(10)60063-3.
- Results publication: PubMed 26549041Conrad DA. The Theory of Value-Based Payment Incentives and Their Application to Health Care. Health Serv Res. 2015 Dec;50 Suppl 2(Suppl 2):2057-89. doi: 10.1111/1475-6773.12408. Epub 2015 Nov 9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Contains a large amount of personal information, this research and various agencies signed a data confidentiality agreement
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Physician Behavior and Hypertension, run by Peking University at 1 site in China.
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 6 inclusion and 1 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 16 Sep 2020. 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 China. 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?
Number of contracted residents (time frame: 2018.1-2019.6). The study lists 6 primary outcomes in all. 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 NCT04073732, which also lists 8 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 16 Sep 2020.