Original Article
Cost-Effectiveness of a Standard Intervention Versus a Navigated Intervention on Colorectal Cancer Screening Use in Primary Care David R. Lairson, PhD1; Melissa DiCarlo, MPH, MS2; Ashish A. Deshmuk, MPH1; Heather B. Fagan, MD3; Randa Sifri, MD4; Nora Katurakes, RN, MSN, OCNOCN5; James Cocroft, MA2; Jocelyn Sendecki, MSPH6; Heidi Swan, MPH2; Sally W. Vernon, PhD7; and Ronald E. Myers, PhD2
BACKGROUND: Colorectal cancer (CRC) screening is cost-effective but underused. The objective of this study was to determine the cost-effectiveness of a mailed standard intervention (SI) and tailored navigation interventions (TNIs) to increase CRC screening use in the context of a randomized trial among primary care patients. METHODS: Participants (n 5 945) were randomized either to a usual care control group (n 5 317), to an SI group (n 5 316), or to a TNI group (n 5 312). The SI group was sent both colonoscopy instructions and stool blood tests irrespective of baseline preference. TNI group participants were sent instructions for scheduling a colonoscopy, a stool blood test, or both based on their test preference, as determined at baseline; then, they received a navigation telephone call. Activity cost estimation was used to determine the cost of each intervention and to compute incremental cost-effectiveness ratios. Statistical uncertainty within the base case was assessed with 95% confidence intervals derived from net benefit regression analysis. The effects of uncertain parameters, such as the cost of planning, training, and involvement of those receiving “investigator salaries,” were assessed with sensitivity analyses. RESULTS: Program costs of the SI were $167 per participant. The average cost of the TNI was $289 per participant. CONCLUSIONS: The TNI was more effective than the SI but substantially increased the cost per additional individual screened. Decision-makers need to consider cost structure, level of planning, and training required to implement these 2 intervention strategies and their willingness to pay for additional individuals screened to determine whether a tailored navigation would C 2014 American Cancer Society. be justified and feasible. Cancer 2014;120:1042–9. V KEYWORDS: colorectal neoplasms, early detection of cancer, costs and cost analysis, patient navigation, intervention studies.
INTRODUCTION Estimates indicate that there will be 142,820 new cases and 50,830 deaths from colorectal cancer (CRC) in 2013.1 CRC screening can detect colorectal adenoma, a precursor to CRC. The American Cancer Society (ACS) and the United States Preventive Services Task Force (USPSTF) encourage screening in adults who are aged 50 years, asymptomatic, and at average risk for CRC.2 Colonoscopy every 10 years and annual stool blood testing (SBT) are the most frequently performed CRC screening strategies.3 Although US rates of CRC screening are increasing, they lag behind those for breast and cervical cancer screening.4 Healthy People 2020 called for greater than 70% CRC screening rates.5 To achieve sustainable high CRC screening rates, primary care providers need to implement cost-effective behavioral interventions. Whereas mailed contacts and reminders have a modest impact on CRC screening rates,6 personally tailored patient programs may achieve greater gains. Few studies have evaluated the cost-effectiveness of CRC screening promotion strategies.7,8 Estimates for CRC promotion range from $11 to $978 per additional individual screened.9,10 The former estimate was for a low-cost intervention directed toward disadvantaged populations in primary care clinics, whereas the higher cost was for a sophisticated tracking system in the Veterans Administration Health System. Elsewhere, we reported on the cost-effectiveness of
Corresponding author: David R. Lairson, PhD, Division of Management, Policy, and Community Health, School of Public Health, University of Texas Health Science Center at Houston, 1200 Herman-Pressler Street, Houston, TX 77030; Fax: (713) 500-9171; [email protected] 1 School of Public Health, University of Texas Health Science Center, Houston, Texas; 2Medical Oncology, Division of Population Science, Thomas Jefferson University, Philadelphia, Pennsylvania; 3Family and Community Medicine, Christiana Care Health System, Wilmington, Delaware; 4Family and Community Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania; 5Community Health Outreach and Education, Christiana Care Health System, Wilmington, Delaware; 6 Pharmacology and Experimental Therapeutics, Division of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania; 7Center for Health Promotion and Prevention Research, Division of Health Promotion and Behavioral Sciences, University of Texas School of Public Health, Houston, Texas
DOI: 10.1002/cncr.28535, Received: July 26, 2013; Revised: November 18, 2013; Accepted: November 18, 2013, Published online January 16, 2014 in Wiley Online Library (wileyonlinelibrary.com)
1042
Cancer
April 1, 2014
CEA of Interventions for CRC Screening/Larison et al
targeted and tailored behavioral outreach interventions to increase CRC screening within an urban family practice in Philadelphia. Our estimates of the mean intervention cost in that project ranged from $42 to $200.11 Here, we present findings from a randomized trial designed to test the cost-effectiveness of a standard intervention (SI) and a tailored navigation intervention (TNI) on CRC screening use among patients in the Christiana Care Health System (CCHS). CCHS provides health care to approximately 66% of the Delaware population. The system includes 2 acute care hospitals with over 42,000 inpatient admissions and more than 125,000 annual emergency department visits and a network of primary care practices in family medicine, internal medicine, pediatrics, and obstetrics/gynecology. We recently reported the research design and screening outcomes of SI and TNI compared with usual care (control).12 Interventions that help patients address barriers to screening and help providers deliver the screening message increase CRC screening adherence.13-17 The population outreach strategies used in this randomized trial and the detailed screening outcome and cost data provide information for decision-makers’ assessment of CRC prevention methods. MATERIALS AND METHODS We conducted a prospective, 3-group, randomized controlled trial in 10 primary care practices affiliated with CCHS between 2007 and 2011.12 Computerized and manual reviews of electronic medical records (EMRs) identified potentially eligible patients ages 50 to 79 years with no prior diagnosis of colorectal neoplasia or inflammatory bowel disease who had complete contact information, were noncompliant with USPSTF CRC screening guidelines, and had visited the participating practices within the previous 2 years.18 Visit criteria were selected to increase the availability of current contact information. A manual review of the EMR excluded patients who were up to date with screening. Potentially eligible patients were verified and consented by telephone after receiving an introductory letter. Thomas Jefferson University and the CCHS institutional review boards approved the study (registered clinical trial NCT00617071). Intervention
After the baseline telephone survey, participants were randomly assigned to 1 of 3 study groups. The control group received usual care. The SI group received a booklet on CRC screening, a personalized letter with a colonoscopy information number, and an SBT kit. A nurse gave callers Cancer
April 1, 2014
the telephone number of a primary care practiceapproved gastroenterology or surgical provider. Participants were mailed a reminder letter 30 days after randomization. TNI participants were mailed the CRC screening booklet and materials keyed to their baseline surveydetermined preferred CRC screening test. Those who preferred colonoscopy received a letter and a message page with the colonoscopy information number. Participants with an equal preference for colonoscopy and SBT received a letter and message page with the colonoscopy information number and an SBT kit. Participants who preferred SBT received a letter and a message page with an SBT kit. Approximately 10 days after the TNI mailing, a nurse navigator initiated a structured navigation call. The navigator confirmed receipt of the mailing and asked the participant whether they had any questions about the materials. Materials were resent if the respondent reported that they were not received. The navigator reassessed the participants’ screening test preference, encouraged completion of the test by providing instructions as appropriate for completing the SBT, identifying sites available for colonoscopy, and encouraging participants to schedule colonoscopies. If the participant changed their baseline test preference, then additional materials were mailed within 4 days. A reminder mailing with an SBT kit was sent at 30 days for the TNI group participants who preferred SBT or had an equal preference for SBT and colonoscopy screening. For those who preferred colonoscopy, a reminder mailing was sent at 90 days. In the SI group, 316 participants were mailed an initial SBT, and 261 (83%) received a second mailed SBT. In the TNI group, 177 participants received an initial mailed SBT, and 74 (42%) received a second mailed SBT. Effect Estimation
Screening results were combined with an estimate of intervention costs to assess the cost-effectiveness of the intervention strategies, including a secondary analysis of TNI subgroups compared with controls according to whether participants expressed a preference for a screening modality.12 Endpoint chart audits were conducted 6 months and 12 months after initial random assignment to allow for delays because of scheduling and colonoscopy completion. Adherence was defined as any ACS-recommended or USPSTF-recommended CRC screening test.2,3,19-22 The literature indicates that there is modest overreporting of CRC screening in survey responses23 and modest under-reporting in EMRs.24 No single source of CRC screening performance is error-free, and screening 1043
Original Article
from 1 source may not be captured by another. Therefore, any screening reported on the endpoint survey that was identified in the laboratory records or in the medical records was counted as long as the report was accompanied by a date within the target window. Cost Estimation
Labor, supply, and overhead costs were estimated from the provider perspective in 2011 US dollars. Data sources included questioning staff to determine the approximate time required to complete tasks, study invoices, and current market prices for supplies. Total costs for each activity were divided among the intervention arms according to the number of patients in each group and the number of patients involved in each activity. Baseline survey costs were estimated at 33% of recorded time, eliminating the time required for research and including the time to introduce the study, assess eligibility, and ask questions about test preference. If baseline survey time was missing, then 33% of the average was applied. Survey costs were included only for the TNI group, which required a preference-based mailing. Participants in the SI group received a generic mailing that could be sent to members of a practice without an advance survey. Personnel cost
Personnel costs were computed by multiplying the hours spent on each activity by adjusted salary per hour, using the base salary for each position to calculate the adjusted salary per hour.25 Task times were estimated retrospectively. Training and planning meeting times were adjusted by allocating training and planning costs by the percentage of staff member time required within each study arm. Supply cost
Supplies included questionnaires, printing costs, envelopes, paper, postage, cell phone use, and other resources used to enroll participants and to produce intervention materials. Costs were calculated by quantifying the materials for each activity and pricing according to current market rates. Professionally printed materials were accounted from project invoices. Overhead
Administrative services, utilities, computer use, software, and office space were estimated by multiplying the total direct cost (base) by a hypothetical indirect rate of 30%, consistent with the health care costing literature.26 The indirect cost base is the summed personnel and supply cost. 1044
Cost-Effectiveness Analysis
Incremental cost-effectiveness ratios (ICERs) represented the cost per additional individual screened, comparing the control group first with the SI group and then with the TNI group. Investigator time and salary were examined with sensitivity analysis. The base case scenario applied a 50% estimate of investigator time (range, 25%75%), assuming different proportions of time spent on different research aspects. Investigator salaries were adjusted to 2 practice managers and 1 primary care physician levels.27 Mid-level salaries were used for the base case, with a range from 15% higher to 15% lower. We examined finer gradations over the salary range, demonstrating differences only between $1 and $2 from the base case per individual cost. Statistical uncertainty was assessed with net benefit regression analysis and cost-effectiveness acceptability curves (CEACs), which indicate the probability that an intervention is cost-effective relative to an alternative for a range of willingness-to-pay values.28,29 We computed the net benefit for the individual as follows: NBi 5 k Ei 2 Ci, where k represents the decision-maker’s willingness to pay for a unit of E, and C is the cost of providing the intervention to person i. NBi is the dependent variable in the net benefit regression model NBi 5 b0 1 b1I 1 e, where I is the indicator for the intervention received, which is set to 1 if the participant received SI and 0 if the participant was in the control group. The coefficient b1 measures the mean difference in net benefit between the SI and control groups. The SI is cost-effective relative to control if b1 is positive. The 1-sided P value for b1 determines the probability that SI is cost-effective relative to control, which forms 1 point on the x-axis in the cost-effectiveness acceptability (Fig. 1).28 The net benefit regression was estimated for several hypothetical k values, and the results were used to determine the remaining points on the CEAC. RESULTS The baseline survey was completed by 945 respondents in the control group (n 5 317), the SI group (n 5 316), and the TNI group (n 5 312). The majority of respondents were women, white, aged
Cost-Effectiveness of a Standard Intervention Versus a Navigated Intervention on Colorectal Cancer Screening Use in Primary Care David R. Lairson, PhD1; Melissa DiCarlo, MPH, MS2; Ashish A. Deshmuk, MPH1; Heather B. Fagan, MD3; Randa Sifri, MD4; Nora Katurakes, RN, MSN, OCNOCN5; James Cocroft, MA2; Jocelyn Sendecki, MSPH6; Heidi Swan, MPH2; Sally W. Vernon, PhD7; and Ronald E. Myers, PhD2
BACKGROUND: Colorectal cancer (CRC) screening is cost-effective but underused. The objective of this study was to determine the cost-effectiveness of a mailed standard intervention (SI) and tailored navigation interventions (TNIs) to increase CRC screening use in the context of a randomized trial among primary care patients. METHODS: Participants (n 5 945) were randomized either to a usual care control group (n 5 317), to an SI group (n 5 316), or to a TNI group (n 5 312). The SI group was sent both colonoscopy instructions and stool blood tests irrespective of baseline preference. TNI group participants were sent instructions for scheduling a colonoscopy, a stool blood test, or both based on their test preference, as determined at baseline; then, they received a navigation telephone call. Activity cost estimation was used to determine the cost of each intervention and to compute incremental cost-effectiveness ratios. Statistical uncertainty within the base case was assessed with 95% confidence intervals derived from net benefit regression analysis. The effects of uncertain parameters, such as the cost of planning, training, and involvement of those receiving “investigator salaries,” were assessed with sensitivity analyses. RESULTS: Program costs of the SI were $167 per participant. The average cost of the TNI was $289 per participant. CONCLUSIONS: The TNI was more effective than the SI but substantially increased the cost per additional individual screened. Decision-makers need to consider cost structure, level of planning, and training required to implement these 2 intervention strategies and their willingness to pay for additional individuals screened to determine whether a tailored navigation would C 2014 American Cancer Society. be justified and feasible. Cancer 2014;120:1042–9. V KEYWORDS: colorectal neoplasms, early detection of cancer, costs and cost analysis, patient navigation, intervention studies.
INTRODUCTION Estimates indicate that there will be 142,820 new cases and 50,830 deaths from colorectal cancer (CRC) in 2013.1 CRC screening can detect colorectal adenoma, a precursor to CRC. The American Cancer Society (ACS) and the United States Preventive Services Task Force (USPSTF) encourage screening in adults who are aged 50 years, asymptomatic, and at average risk for CRC.2 Colonoscopy every 10 years and annual stool blood testing (SBT) are the most frequently performed CRC screening strategies.3 Although US rates of CRC screening are increasing, they lag behind those for breast and cervical cancer screening.4 Healthy People 2020 called for greater than 70% CRC screening rates.5 To achieve sustainable high CRC screening rates, primary care providers need to implement cost-effective behavioral interventions. Whereas mailed contacts and reminders have a modest impact on CRC screening rates,6 personally tailored patient programs may achieve greater gains. Few studies have evaluated the cost-effectiveness of CRC screening promotion strategies.7,8 Estimates for CRC promotion range from $11 to $978 per additional individual screened.9,10 The former estimate was for a low-cost intervention directed toward disadvantaged populations in primary care clinics, whereas the higher cost was for a sophisticated tracking system in the Veterans Administration Health System. Elsewhere, we reported on the cost-effectiveness of
Corresponding author: David R. Lairson, PhD, Division of Management, Policy, and Community Health, School of Public Health, University of Texas Health Science Center at Houston, 1200 Herman-Pressler Street, Houston, TX 77030; Fax: (713) 500-9171; [email protected] 1 School of Public Health, University of Texas Health Science Center, Houston, Texas; 2Medical Oncology, Division of Population Science, Thomas Jefferson University, Philadelphia, Pennsylvania; 3Family and Community Medicine, Christiana Care Health System, Wilmington, Delaware; 4Family and Community Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania; 5Community Health Outreach and Education, Christiana Care Health System, Wilmington, Delaware; 6 Pharmacology and Experimental Therapeutics, Division of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania; 7Center for Health Promotion and Prevention Research, Division of Health Promotion and Behavioral Sciences, University of Texas School of Public Health, Houston, Texas
DOI: 10.1002/cncr.28535, Received: July 26, 2013; Revised: November 18, 2013; Accepted: November 18, 2013, Published online January 16, 2014 in Wiley Online Library (wileyonlinelibrary.com)
1042
Cancer
April 1, 2014
CEA of Interventions for CRC Screening/Larison et al
targeted and tailored behavioral outreach interventions to increase CRC screening within an urban family practice in Philadelphia. Our estimates of the mean intervention cost in that project ranged from $42 to $200.11 Here, we present findings from a randomized trial designed to test the cost-effectiveness of a standard intervention (SI) and a tailored navigation intervention (TNI) on CRC screening use among patients in the Christiana Care Health System (CCHS). CCHS provides health care to approximately 66% of the Delaware population. The system includes 2 acute care hospitals with over 42,000 inpatient admissions and more than 125,000 annual emergency department visits and a network of primary care practices in family medicine, internal medicine, pediatrics, and obstetrics/gynecology. We recently reported the research design and screening outcomes of SI and TNI compared with usual care (control).12 Interventions that help patients address barriers to screening and help providers deliver the screening message increase CRC screening adherence.13-17 The population outreach strategies used in this randomized trial and the detailed screening outcome and cost data provide information for decision-makers’ assessment of CRC prevention methods. MATERIALS AND METHODS We conducted a prospective, 3-group, randomized controlled trial in 10 primary care practices affiliated with CCHS between 2007 and 2011.12 Computerized and manual reviews of electronic medical records (EMRs) identified potentially eligible patients ages 50 to 79 years with no prior diagnosis of colorectal neoplasia or inflammatory bowel disease who had complete contact information, were noncompliant with USPSTF CRC screening guidelines, and had visited the participating practices within the previous 2 years.18 Visit criteria were selected to increase the availability of current contact information. A manual review of the EMR excluded patients who were up to date with screening. Potentially eligible patients were verified and consented by telephone after receiving an introductory letter. Thomas Jefferson University and the CCHS institutional review boards approved the study (registered clinical trial NCT00617071). Intervention
After the baseline telephone survey, participants were randomly assigned to 1 of 3 study groups. The control group received usual care. The SI group received a booklet on CRC screening, a personalized letter with a colonoscopy information number, and an SBT kit. A nurse gave callers Cancer
April 1, 2014
the telephone number of a primary care practiceapproved gastroenterology or surgical provider. Participants were mailed a reminder letter 30 days after randomization. TNI participants were mailed the CRC screening booklet and materials keyed to their baseline surveydetermined preferred CRC screening test. Those who preferred colonoscopy received a letter and a message page with the colonoscopy information number. Participants with an equal preference for colonoscopy and SBT received a letter and message page with the colonoscopy information number and an SBT kit. Participants who preferred SBT received a letter and a message page with an SBT kit. Approximately 10 days after the TNI mailing, a nurse navigator initiated a structured navigation call. The navigator confirmed receipt of the mailing and asked the participant whether they had any questions about the materials. Materials were resent if the respondent reported that they were not received. The navigator reassessed the participants’ screening test preference, encouraged completion of the test by providing instructions as appropriate for completing the SBT, identifying sites available for colonoscopy, and encouraging participants to schedule colonoscopies. If the participant changed their baseline test preference, then additional materials were mailed within 4 days. A reminder mailing with an SBT kit was sent at 30 days for the TNI group participants who preferred SBT or had an equal preference for SBT and colonoscopy screening. For those who preferred colonoscopy, a reminder mailing was sent at 90 days. In the SI group, 316 participants were mailed an initial SBT, and 261 (83%) received a second mailed SBT. In the TNI group, 177 participants received an initial mailed SBT, and 74 (42%) received a second mailed SBT. Effect Estimation
Screening results were combined with an estimate of intervention costs to assess the cost-effectiveness of the intervention strategies, including a secondary analysis of TNI subgroups compared with controls according to whether participants expressed a preference for a screening modality.12 Endpoint chart audits were conducted 6 months and 12 months after initial random assignment to allow for delays because of scheduling and colonoscopy completion. Adherence was defined as any ACS-recommended or USPSTF-recommended CRC screening test.2,3,19-22 The literature indicates that there is modest overreporting of CRC screening in survey responses23 and modest under-reporting in EMRs.24 No single source of CRC screening performance is error-free, and screening 1043
Original Article
from 1 source may not be captured by another. Therefore, any screening reported on the endpoint survey that was identified in the laboratory records or in the medical records was counted as long as the report was accompanied by a date within the target window. Cost Estimation
Labor, supply, and overhead costs were estimated from the provider perspective in 2011 US dollars. Data sources included questioning staff to determine the approximate time required to complete tasks, study invoices, and current market prices for supplies. Total costs for each activity were divided among the intervention arms according to the number of patients in each group and the number of patients involved in each activity. Baseline survey costs were estimated at 33% of recorded time, eliminating the time required for research and including the time to introduce the study, assess eligibility, and ask questions about test preference. If baseline survey time was missing, then 33% of the average was applied. Survey costs were included only for the TNI group, which required a preference-based mailing. Participants in the SI group received a generic mailing that could be sent to members of a practice without an advance survey. Personnel cost
Personnel costs were computed by multiplying the hours spent on each activity by adjusted salary per hour, using the base salary for each position to calculate the adjusted salary per hour.25 Task times were estimated retrospectively. Training and planning meeting times were adjusted by allocating training and planning costs by the percentage of staff member time required within each study arm. Supply cost
Supplies included questionnaires, printing costs, envelopes, paper, postage, cell phone use, and other resources used to enroll participants and to produce intervention materials. Costs were calculated by quantifying the materials for each activity and pricing according to current market rates. Professionally printed materials were accounted from project invoices. Overhead
Administrative services, utilities, computer use, software, and office space were estimated by multiplying the total direct cost (base) by a hypothetical indirect rate of 30%, consistent with the health care costing literature.26 The indirect cost base is the summed personnel and supply cost. 1044
Cost-Effectiveness Analysis
Incremental cost-effectiveness ratios (ICERs) represented the cost per additional individual screened, comparing the control group first with the SI group and then with the TNI group. Investigator time and salary were examined with sensitivity analysis. The base case scenario applied a 50% estimate of investigator time (range, 25%75%), assuming different proportions of time spent on different research aspects. Investigator salaries were adjusted to 2 practice managers and 1 primary care physician levels.27 Mid-level salaries were used for the base case, with a range from 15% higher to 15% lower. We examined finer gradations over the salary range, demonstrating differences only between $1 and $2 from the base case per individual cost. Statistical uncertainty was assessed with net benefit regression analysis and cost-effectiveness acceptability curves (CEACs), which indicate the probability that an intervention is cost-effective relative to an alternative for a range of willingness-to-pay values.28,29 We computed the net benefit for the individual as follows: NBi 5 k Ei 2 Ci, where k represents the decision-maker’s willingness to pay for a unit of E, and C is the cost of providing the intervention to person i. NBi is the dependent variable in the net benefit regression model NBi 5 b0 1 b1I 1 e, where I is the indicator for the intervention received, which is set to 1 if the participant received SI and 0 if the participant was in the control group. The coefficient b1 measures the mean difference in net benefit between the SI and control groups. The SI is cost-effective relative to control if b1 is positive. The 1-sided P value for b1 determines the probability that SI is cost-effective relative to control, which forms 1 point on the x-axis in the cost-effectiveness acceptability (Fig. 1).28 The net benefit regression was estimated for several hypothetical k values, and the results were used to determine the remaining points on the CEAC. RESULTS The baseline survey was completed by 945 respondents in the control group (n 5 317), the SI group (n 5 316), and the TNI group (n 5 312). The majority of respondents were women, white, aged
