Domain

Clinical Informatics

Type

Case Study or Comparative Case Study

Theme

effectiveness; population; quality; operations

Start Date

7-6-2014 1:15 PM

End Date

7-6-2014 2:45 PM

Structured Abstract

BACKGROUND:

Clinical data registries (CDR) are one of the primary means to generate CER evidence using electronic clinical data. Each has been used to aggregate data and produce reports on the appropriateness and effectiveness of care delivered to patients across the U.S. Consequently, there has been immense interest from various stakeholders (e.g. providers, payers, and policy makers) to leverage the data from CDRs for research and policy analysis purposes. However, these organizations are faced with ongoing challenges such as unsustainable business models and technical challenges associated with the collection, linkage, and secure transmission of patient data from a variety of clinical data sources managed by many healthcare organizations across the country

OBJECTIVES:

The purpose of this multi-case study is to collect, synthesize, and share lessons from four U.S.-based clinical data registry programs (that utilize electronic clinical data) and discuss how each has built a sustainable business model and data infrastructure that addresses the facilitators and barriers to constructing a CDR. The primary goal is to develop a conceptual framework that can be leveraged by other registry programs and highlight unique challenges that can be addressed by policy.

RESEARCH QUESTION:

Two central research questions:

1. What are the primary facilitators and barriers for constructing a CDR? 2. How can program administrators address these sustainability and informatics barriers?

METHODS:

This dissertation utilizes qualitative multi-case study research method to answer the research questions. This multi- case study highlights four U.S.-based patient registry programs and discusses how each has built a sustainable business model and technological infrastructure while managing the challenges unique to CDRs. The literature on CDRs reveals that the core facilitators and barriers fall into four primary domains (as seen below): (1) Standards; (2) Information governance; (3) Privacy & information security; and (4) Business model.

The goal of this manuscript is to compare and contrast each CDR utilizing the framework. The findings were generated using exploratory semi-structured interviews conducted under naturalistic inquiry over the course of three months (March-May 2013). Themes, challenges, and innovations were identified using both primary and secondary data collection methodologies.

DATA COLLECTION AND ANALYSIS:

More than twenty semi-structured interviews were conducted via telephone following the interview guide with a variety of interviewees, including program representatives, physicians, policy makers, technology experts, and industry personnel. There were large amounts of data collected as a part of this qualitative study. The data collected from the interviews was triangulated with observations and electronic documents to build a case profile for each CDR. The researcher used a qualitative software tool called QSR*NVIVO to assist in the collection, aggregation, and thematic analysis of the data collected. These themes were grouped in parent and child relationships to identify the prominent applicability across participants. The themes highlighted similarities and differences in the business models, data governance practices, key challenges, and the future plans for each program.

RESULTS:

All the studied cases share a vision of improving the overall healthcare system, but each differs in its therapeutic focus, organizational design, and funding sources. Success will be simply defined as continuous enrollment of new participants, generating new medical knowledge, and creating new revenue streams for the program.

CONCLUSIONS:

Common facilitators and barriers to developing a CDR were identified in this study. The results confirmed the importance of a sound business model to sustain the registry. It highlighted innovative approaches to addressing the informatics challenges associated with utilizing electronic clinical data sources. Moreover, it identified the significance that CDRs can play in clinical and public policy decision-making.

Acknowledgements

N/A

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.

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Jun 7th, 1:15 PM Jun 7th, 2:45 PM

Addressing Sustainability and Informatics Challenges for Clinical Data Registries

BACKGROUND:

Clinical data registries (CDR) are one of the primary means to generate CER evidence using electronic clinical data. Each has been used to aggregate data and produce reports on the appropriateness and effectiveness of care delivered to patients across the U.S. Consequently, there has been immense interest from various stakeholders (e.g. providers, payers, and policy makers) to leverage the data from CDRs for research and policy analysis purposes. However, these organizations are faced with ongoing challenges such as unsustainable business models and technical challenges associated with the collection, linkage, and secure transmission of patient data from a variety of clinical data sources managed by many healthcare organizations across the country

OBJECTIVES:

The purpose of this multi-case study is to collect, synthesize, and share lessons from four U.S.-based clinical data registry programs (that utilize electronic clinical data) and discuss how each has built a sustainable business model and data infrastructure that addresses the facilitators and barriers to constructing a CDR. The primary goal is to develop a conceptual framework that can be leveraged by other registry programs and highlight unique challenges that can be addressed by policy.

RESEARCH QUESTION:

Two central research questions:

1. What are the primary facilitators and barriers for constructing a CDR? 2. How can program administrators address these sustainability and informatics barriers?

METHODS:

This dissertation utilizes qualitative multi-case study research method to answer the research questions. This multi- case study highlights four U.S.-based patient registry programs and discusses how each has built a sustainable business model and technological infrastructure while managing the challenges unique to CDRs. The literature on CDRs reveals that the core facilitators and barriers fall into four primary domains (as seen below): (1) Standards; (2) Information governance; (3) Privacy & information security; and (4) Business model.

The goal of this manuscript is to compare and contrast each CDR utilizing the framework. The findings were generated using exploratory semi-structured interviews conducted under naturalistic inquiry over the course of three months (March-May 2013). Themes, challenges, and innovations were identified using both primary and secondary data collection methodologies.

DATA COLLECTION AND ANALYSIS:

More than twenty semi-structured interviews were conducted via telephone following the interview guide with a variety of interviewees, including program representatives, physicians, policy makers, technology experts, and industry personnel. There were large amounts of data collected as a part of this qualitative study. The data collected from the interviews was triangulated with observations and electronic documents to build a case profile for each CDR. The researcher used a qualitative software tool called QSR*NVIVO to assist in the collection, aggregation, and thematic analysis of the data collected. These themes were grouped in parent and child relationships to identify the prominent applicability across participants. The themes highlighted similarities and differences in the business models, data governance practices, key challenges, and the future plans for each program.

RESULTS:

All the studied cases share a vision of improving the overall healthcare system, but each differs in its therapeutic focus, organizational design, and funding sources. Success will be simply defined as continuous enrollment of new participants, generating new medical knowledge, and creating new revenue streams for the program.

CONCLUSIONS:

Common facilitators and barriers to developing a CDR were identified in this study. The results confirmed the importance of a sound business model to sustain the registry. It highlighted innovative approaches to addressing the informatics challenges associated with utilizing electronic clinical data sources. Moreover, it identified the significance that CDRs can play in clinical and public policy decision-making.