Health Services AccessibilityPCORINCT02235597
Improving Healthcare Systems for Access to Care by Underserved Patients
An observational study of Health Services Accessibility, run by Indiana University at 7 sites in United States.
Trial summary
The investigators seek to improve health systems so underserved people, patients without insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access health care for common problems and acute care needs (same day appointments). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services Accessibility
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2014to Dec 2016
- How long will I take part?
- 2 Years
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Clinic patient Population
Who may be able to join
- patient at an approved site Community health clinic and over 18 yrs of age.
Who cannot join
- do not receive care at an approved site Community health clinic and/or under 18 yrs of age.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Valley Professionals Community Health Center
Cayuga, Indiana, 47928
North Central Nursing Clinics
Delphi, Indiana, 46923
Shalom Health Center
Indianapolis, Indiana, 46222
HealthNet Health Center
Indianapolis, Indiana, 46224
Riggs Community Health Center
Lafayette, Indiana, 47904
Open Door Community Health Clinic
Muncie, Indiana, 47302
North Shore Health Center
Portage, Indiana, 46368
About this study
The investigators seek to improve health systems so underserved people, patients without insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access health care for common problems and acute care needs (same day appointments).
Read the detailed description
There are different types of participants in this study. Measurements will be assessed with a questionnaire. The first category includes patients, caregivers, clinical and operational leaders, and researchers who will be invited for the Delphi study to identify potential barriers to access and strategies to improve access. The second category includes clinic staff (physicians, nurses, medical assistants, registrars, etc.) and patients who will be interviewed during their clinic visits to identify key processes and patients' opinion about barriers to access. The third category includes all enrolled patients to identify the patient population characteristics. The fourth category includes the patients and providers of CHCs in the participating clinics who will be surveyed to assess experience with access to care and satisfaction with the changes in workflow and efficiency.Category 1: Delphi study. The investigators will invite 50-60 individuals (patients, caregivers, clinical and operational leaders, and researchers) for a panel size of 40-50. Category 2: Key Informant Interviews (Patients and clinic staff (physicians, nurses, medical assistants, registrars, etc). The investigators will interview at least one patient every time we go to the participating clinics. The investigators plan to visit each of the participating CHCs approximately every two months. The investigators expect to interview approximately 12 patients at each clinic each year, for a total of 84 each year at the seven clinics. Thus, the total number of patients interviewed will be 252 in three years (12 patients / clinic x 7 clinics = 84 patients per year). The interview questions will be related to access barriers and efficiency of clinic processes. The investigators will receive the consent of the patient before starting the interview. The investigators will use IRB-approved consent forms for the study. The investigators will interview ten staff members during each visit to identify the key processes. The investigators anticipate interviewing approximately 8 providers and staff in each clinic during our bimonthly visits, as well as 3-4 during our bimonthly phone calls during the project period. This is expected to total 12 staff (including providers and managers) every two months at each clinic, or 6 x 12 = 72. This should total 72 x 7 = 504 at all the clinics each year. Some of these interviews will be quite brief, lasting only a few minutes, while others may last 45-60 minutes. Category 3: The investigators will collect de-identified patient data for the patient populations cared for by the participating CHCs, that will include age, gender, race, marital status, education, language, income, insurance, distance to healthcare facility, reason of the visit, diagnoses, co-morbidities, number of regular visits, visit types and durations, provider types, and time between visits. The investigators will work with IT and/or quality improvement staff at each of the CHCs to develop standard procedures to retrieve and de identify the data from electronic medical records and scheduling system. The investigators will analyze the data to determine patient population characteristics and care needs to inform the simulation models and analysis of impact of the interventions. In 2011, the total number of patients seen in seven partner clinic systems were approximately 130,000. However, the partner clinics provide care services at several sites. The investigators will choose a single site from each CHC system and analyze the data for the patients who had at least two prior visits to the selected site within two years prior to baseline. The investigators expect to analyze the visits for 60,000 patients. The data for each clinic will be analyzed separately. Category 4; The investigators anticipate surveying a sample of patients at each of the clinics to assess familiarity with how to obtain access to care, knowledge of the intervention and satisfaction with access. This will be a blinded (deidentified survey) and not linked to any individual data, other than study site. The investigators anticipate sampling 100 patients at each site, including approximately 65 patients who participate at each site., per site. In this study, the investigators will not consider special vulnerable populations (fetuses, neonates, prisoners, and institutionalized individuals).
- Conditions
- Health Services Accessibility
- Keywords
- patient access, patient centered care, scheduling, access barriers, improve efficiency, decision making tools, underserved
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 |
|---|---|---|
| Patients and Staff of Community Clinics | Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients will have improved access to providers
Patients in participating clinics will report improved access to providers for acute and regularly occurring appointments
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Services AccessibilityStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Arizona State University, Parkview Health
- Responsible party
- Principal investigator, Huanmei Wu, Indiana University
- Investigators
- Huanmei Wu, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235597
- Sponsor's protocol ID
- PCORI-WU-4198014
- Other IDs
- Improving Healthcare Systems
- Acronym
- PCORI
- Status last verified
- Nov 2017
- First submitted
- 3 Sep 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coulter A, Locock L, Ziebland S, Calabrese J. Collecting data on patient experience is not enough: they must be used to improve care. BMJ. 2014 Mar 26;348:g2225. doi: 10.1136/bmj.g2225. No abstract available.
PubMed 24671966Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
PubMed 23381514
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthcare Systems for Access to Care by Underserved Patients
- ClinicalTrials.gov ID
- NCT02235597
- Acronym / sponsor ID
- PCORI / PCORI-WU-4198014
- Conditions
- Health Services Accessibility
- Keywords
- patient access, patient centered care, scheduling, access barriers, improve efficiency, decision making tools, underserved
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Arizona State University, Parkview Health
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Sep 2014 (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.
The investigators seek to improve health systems so underserved people, patients without insurance, Medicaid, Medicare, as well as self pay and their caregivers can better access health care for common problems and acute care needs (same day appointments).
Detailed description
There are different types of participants in this study. Measurements will be assessed with a questionnaire. The first category includes patients, caregivers, clinical and operational leaders, and researchers who will be invited for the Delphi study to identify potential barriers to access and strategies to improve access. The second category includes clinic staff (physicians, nurses, medical assistants, registrars, etc.) and patients who will be interviewed during their clinic visits to identify key processes and patients' opinion about barriers to access. The third category includes all enrolled patients to identify the patient population characteristics. The fourth category includes the patients and providers of CHCs in the participating clinics who will be surveyed to assess experience with access to care and satisfaction with the changes in workflow and efficiency.Category 1: Delphi study. The investigators will invite 50-60 individuals (patients, caregivers, clinical and operational leaders, and researchers) for a panel size of 40-50. Category 2: Key Informant Interviews (Patients and clinic staff (physicians, nurses, medical assistants, registrars, etc). The investigators will interview at least one patient every time we go to the participating clinics. The investigators plan to visit each of the participating CHCs approximately every two months. The investigators expect to interview approximately 12 patients at each clinic each year, for a total of 84 each year at the seven clinics. Thus, the total number of patients interviewed will be 252 in three years (12 patients / clinic x 7 clinics = 84 patients per year). The interview questions will be related to access barriers and efficiency of clinic processes. The investigators will receive the consent of the patient before starting the interview. The investigators will use IRB-approved consent forms for the study. The investigators will interview ten staff members during each visit to identify the key processes. The investigators anticipate interviewing approximately 8 providers and staff in each clinic during our bimonthly visits, as well as 3-4 during our bimonthly phone calls during the project period. This is expected to total 12 staff (including providers and managers) every two months at each clinic, or 6 x 12 = 72. This should total 72 x 7 = 504 at all the clinics each year. Some of these interviews will be quite brief, lasting only a few minutes, while others may last 45-60 minutes. Category 3: The investigators will collect de-identified patient data for the patient populations cared for by the participating CHCs, that will include age, gender, race, marital status, education, language, income, insurance, distance to healthcare facility, reason of the visit, diagnoses, co-morbidities, number of regular visits, visit types and durations, provider types, and time between visits. The investigators will work with IT and/or quality improvement staff at each of the CHCs to develop standard procedures to retrieve and de identify the data from electronic medical records and scheduling system. The investigators will analyze the data to determine patient population characteristics and care needs to inform the simulation models and analysis of impact of the interventions. In 2011, the total number of patients seen in seven partner clinic systems were approximately 130,000. However, the partner clinics provide care services at several sites. The investigators will choose a single site from each CHC system and analyze the data for the patients who had at least two prior visits to the selected site within two years prior to baseline. The investigators expect to analyze the visits for 60,000 patients. The data for each clinic will be analyzed separately. Category 4; The investigators anticipate surveying a sample of patients at each of the clinics to assess familiarity with how to obtain access to care, knowledge of the intervention and satisfaction with access. This will be a blinded (deidentified survey) and not linked to any individual data, other than study site. The investigators anticipate sampling 100 patients at each site, including approximately 65 patients who participate at each site., per site. In this study, the investigators will not consider special vulnerable populations (fetuses, neonates, prisoners, and institutionalized individuals).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and Staff of Community Clinics | – | –Patients and Staff of Community Clinics who shared strategies and solutions to overcome barriers to accessing health care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Clinic patient Population
Key inclusion criteria (1 listed)
- patient at an approved site Community health clinic and over 18 yrs of age.
Key exclusion criteria (1 listed)
- do not receive care at an approved site Community health clinic and/or under 18 yrs of age.
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
patients will have improved access to providers
Time frame: 2 years
Patients in participating clinics will report improved access to providers for acute and regularly occurring appointments
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 29 Nov 2017.
- Results publication: PubMed 24671966Coulter A, Locock L, Ziebland S, Calabrese J. Collecting data on patient experience is not enough: they must be used to improve care. BMJ. 2014 Mar 26;348:g2225. doi: 10.1136/bmj.g2225. No abstract available.
- Results publication: PubMed 23381514Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013 Feb;32(2):223-31. doi: 10.1377/hlthaff.2012.1133.
- Individual participant dataSharing planned: No
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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.
Huanmei Wu, PhD principal investigator
Indiana University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services Accessibility, run by Indiana University at 7 sites 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?
The sponsor lists 1 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does the primary outcome measure?
patients will have improved access to providers (time frame: 2 years). 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 NCT02235597, which also lists 2 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 29 Nov 2017.