NeoplasmsNCT02110758
Evaluating the Impact of Patient-Centered Oncology Care
An observational study of Neoplasms, run by National Committee for Quality Assurance at 1 site in United States.
Trial summary
The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Pilot of Patient-Centered Oncology Care
- How many people
- 125,250 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population consisted of patients with cancer who received their cancer care from oncology practices. We attributed patients to the study practices (pilot or comparison practices) based on the plurality of office visits for cancer diagnoses. We used sensitivity analyses to investigate other attribution rules, such as the majority of such office visits.
Who may be able to join
- Patients:
- Diagnosis of cancer
- Receives care at a pilot or comparison oncology practice located in southeastern Pennsylvania that accepts patients with Independence Blue Cross health insurance
Who cannot join
- Any person that does not meet any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
National Committee for Quality Assurance
Washington D.C., District of Columbia, 20005
About this study
The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were:
- Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
- How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?
The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.
Read the detailed description
Background. Advances in cancer treatment mean that a growing number of Americans are living with cancer and experiencing it as a chronic, long-term condition. National panels led by consumers have identified the need for improved cancer care in the areas of communication between providers and patients and their families, care planning, attention to nonmedical needs, care coordination and provision of evidence-based treatment. The patient-centered medical home (PCMH) model of care is being widely adopted as a way to provide accessible, proactive, coordinated care and self-care through primary care practices. During active treatment for cancer, the oncology practice is often the primary setting supporting the patient and coordinating cancer treatment. By implementing the patient-centered medical home model, an innovative oncology practice in Pennsylvania has been able to improve access and reduce emergency department visits and hospitalizations for its patients.
Objectives. Building on these recommendations and experience, the National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. We sought PCORI support to pilot and evaluate this model. Specific research questions were:
- Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
- How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?
Methods. The demonstration occurred in 5 oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices. Patients, clinicians, and health plan leaders helped design the project, and disseminate results. The project used Patient Centered Outcomes Research Institute (PCORI) resources efficiently by building on ongoing efforts. Our evaluation consisted of a retrospective, pre-post study design with a concurrent non-randomized control group of 18 local practices for the utilization and patient experience outcomes. We used difference-in-difference regression models that accounted for practice-level clustering and used functional forms appropriate to the dependent variables. For quality, we compared baseline and follow-up pilot practice performance to national and regional benchmark performance data.
Patient Outcomes. People with cancer are seeking high quality, coordinated and supportive care. The Patient-Centered Oncology Model has the potential to address current gaps in cancer care.
- Conditions
- Neoplasms
- Being tested
- Pilot of Patient-Centered Oncology Care
- Keywords
- Patient Care Management, Patient Care Planning, Patient-Centered Care, Patient Care Team, Advance Care Planning, Delivery of Health Care, Evidence-based Practice, Health Care Costs, Health Care Quality, Access, and Evaluation, Quality of Health Care, Neoplasms, Medical Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot of Patient-Centered Oncology CareOther
Patient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Practices Patient Survey Cohort | Patients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania Receives: Other: Pilot of Patient-Centered Oncology Care | |
| Comparison Practices Patient Survey Cohort | Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania | |
| Pilot Practices Utilization Cohort | Patients with an evaluation \& management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania Receives: Other: Pilot of Patient-Centered Oncology Care | |
| Comparison Practices Utilization Cohort | Patients with an evaluation \& management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania | |
| Pilot Practices Quality Measures Cohort | Patients with a new diagnosis of cancer in the past two years Receives: Other: Pilot of Patient-Centered Oncology Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Experience From Baseline to Follow up
Patient experience survey composite scores were evaluated in the pilot practice group and in the comparison practice group during the intervention period and the follow-up period using a modified version of the cancer CAHPS patient survey.
We calculated survey composite scores on a 0-100 scale using proportional scoring and the summated rating method based on the CAHPS macro.This method calculates the mean responses to each survey item in the composite, after transforming each response to a 0-100 scale (100 representing the most positive response on any given item response scale; 0 representing the least positive). For example, on a Yes/No response scale, if "Yes" represents the most positive response, then Yes= 100 and No = 0; on an Always/Usually/Sometimes/Never response scale, if "Always" represents the most positive response, then Always = 100, Usually = 67, Sometimes = 33 and Never = 0. A higher score means that practices were rated more positively for care on that item.
Measured: At baseline and 24 months follow up
Change in Quality of Care From Baseline to Follow up: Percentage of Patients Receiving Recommended Care
Quality measure performance rates were evaluated in the pilot practice group during the baseline period and the follow-up period. Data were abstracted from medical records for a sample of patients diagnosed with an invasive malignancy within previous 2 years and with at least 2 visits to the practice in the previous six months at baseline and at 36 months follow-up.
Measured: Two years prior to baseline and at 36 months follow-up
Change in Health Care Utilization From Baseline to Follow up
Per member per month hospitalizations, emergency department visits, primary care visits and specialist visits were evaluated in the pilot group and in the comparison group using insurance claims data during the baseline, start-up, intervention and follow-up periods.
Measured: Two years prior to baseline and at 36 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Committee for Quality Assurance
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology, Independence Blue Cross, National Coalition for Cancer Survivorship, Oncology Management Services, RAND
- Responsible party
- Sponsor
- Investigators
- Sarah H Scholle, DrPH, MPH, Principal investigator, National Committee for Quality Assurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110758
- Sponsor's protocol ID
- IH-12-11-4383
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2014
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Patient-Centered Oncology Care
- ClinicalTrials.gov ID
- NCT02110758
- Acronym / sponsor ID
- IH-12-11-4383
- Conditions
- Neoplasms
- Keywords
- Patient Care Management, Patient Care Planning, Patient-Centered Care, Patient Care Team, Advance Care Planning, Delivery of Health Care, Evidence-based Practice, Health Care Costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125,250 participants (actual)
- Lead sponsor
- National Committee for Quality AssuranceUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology, Independence Blue Cross, National Coalition for Cancer Survivorship, Oncology Management Services, RAND
- Study start
- Feb 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were:
- Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
- How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?
The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices.
Detailed description
Background. Advances in cancer treatment mean that a growing number of Americans are living with cancer and experiencing it as a chronic, long-term condition. National panels led by consumers have identified the need for improved cancer care in the areas of communication between providers and patients and their families, care planning, attention to nonmedical needs, care coordination and provision of evidence-based treatment. The patient-centered medical home (PCMH) model of care is being widely adopted as a way to provide accessible, proactive, coordinated care and self-care through primary care practices. During active treatment for cancer, the oncology practice is often the primary setting supporting the patient and coordinating cancer treatment. By implementing the patient-centered medical home model, an innovative oncology practice in Pennsylvania has been able to improve access and reduce emergency department visits and hospitalizations for its patients.
Objectives. Building on these recommendations and experience, the National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. We sought PCORI support to pilot and evaluate this model. Specific research questions were:
- Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays?
- How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption?
Methods. The demonstration occurred in 5 oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices. Patients, clinicians, and health plan leaders helped design the project, and disseminate results. The project used Patient Centered Outcomes Research Institute (PCORI) resources efficiently by building on ongoing efforts. Our evaluation consisted of a retrospective, pre-post study design with a concurrent non-randomized control group of 18 local practices for the utilization and patient experience outcomes. We used difference-in-difference regression models that accounted for practice-level clustering and used functional forms appropriate to the dependent variables. For quality, we compared baseline and follow-up pilot practice performance to national and regional benchmark performance data.
Patient Outcomes. People with cancer are seeking high quality, coordinated and supportive care. The Patient-Centered Oncology Model has the potential to address current gaps in cancer care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pilot Practices Patient Survey Cohort | – | Other: Pilot of Patient-Centered Oncology CarePatients with any active drug therapy treatment for cancer receiving care at pilot practice in southeastern Pennsylvania |
| Comparison Practices Patient Survey Cohort | – | –Patients with any active drug therapy treatment for cancer receiving care at comparison practice in southeastern Pennsylvania |
| Pilot Practices Utilization Cohort | – | Other: Pilot of Patient-Centered Oncology CarePatients with an evaluation \& management claim attributed to a medical oncology pilot practice in southeastern Pennsylvania |
| Comparison Practices Utilization Cohort | – | –Patients with an evaluation \& management claim attributed to a medical oncology comparison practice in southeastern Pennsylvania |
| Pilot Practices Quality Measures Cohort | – | Other: Pilot of Patient-Centered Oncology CarePatients with a new diagnosis of cancer in the past two years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients with cancer who received their cancer care from oncology practices. We attributed patients to the study practices (pilot or comparison practices) based on the plurality of office visits for cancer diagnoses. We used sensitivity analyses to investigate other attribution rules, such as the majority of such office visits.
Key inclusion criteria (3 listed)
- Diagnosis of cancer
- Receives care at a pilot or comparison oncology practice located in southeastern Pennsylvania that accepts patients with Independence Blue Cross health insurance
Key exclusion criteria (1 listed)
- Any person that does not meet any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot of Patient-Centered Oncology CarePatient-Centered Oncology Care addresses six domains: track \& coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track \& coordinate care, and measure and improve performance. | Other | Pilot Practices Patient Survey Cohort, Pilot Practices Quality Measures Cohort, Pilot Practices Utilization Cohort |
Primary outcome
Change in Patient Experience From Baseline to Follow up
Time frame: At baseline and 24 months follow up
Patient experience survey composite scores were evaluated in the pilot practice group and in the comparison practice group during the intervention period and the follow-up period using a modified version of the cancer CAHPS patient survey. We calculated survey composite scores on a 0-100 scale using proportional scoring and the summated rating method based on the CAHPS macro.This method calculates the mean responses to each survey item in the composite, after transforming each response to a 0-100 scale (100 representing the most positive response on any given item response scale; 0 representing the least positive). For example, on a Yes/No response scale, if "Yes" represents the most positive response, then Yes= 100 and No = 0; on an Always/Usually/Sometimes/Never response scale, if "Always" represents the most positive response, then Always = 100, Usually = 67, Sometimes = 33 and Never = 0. A higher score means that practices were rated more positively for care on that item.
Change in Quality of Care From Baseline to Follow up: Percentage of Patients Receiving Recommended Care
Time frame: Two years prior to baseline and at 36 months follow-up
Quality measure performance rates were evaluated in the pilot practice group during the baseline period and the follow-up period. Data were abstracted from medical records for a sample of patients diagnosed with an invasive malignancy within previous 2 years and with at least 2 visits to the practice in the previous six months at baseline and at 36 months follow-up.
Change in Health Care Utilization From Baseline to Follow up
Time frame: Two years prior to baseline and at 36 months follow up
Per member per month hospitalizations, emergency department visits, primary care visits and specialist visits were evaluated in the pilot group and in the comparison group using insurance claims data during the baseline, start-up, intervention and follow-up periods.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah H Scholle, DrPH, MPH principal investigator
National Committee for Quality Assurance
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 Neoplasms, run by National Committee for Quality Assurance 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?
The sponsor lists 3 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 9 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Patient Experience From Baseline to Follow up (time frame: At baseline and 24 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.