To determine the impact of losing health insurance coverage on perceived need for and access to m... more To determine the impact of losing health insurance coverage on perceived need for and access to mental health care in women screened for postpartum depression (PPD) in primary care settings. The study sample included 2343 women enrolled in a 12-month, multisite, randomized trial that compared clinical outcomes of a comprehensive PPD screening and management program with usual care (March 1, 2006, through August 31, 2010). Screening for PPD occurred at the first postpartum visit (5-12 weeks) using the Edinburgh Postnatal Depression Scale followed by the 9-item Patient Health Questionnaire. Insurance status during the prenatal period, at delivery, and during the first postpartum year and perceived need for and access to mental health care during the first postpartum year were assessed via questionnaires completed by individual patients and participating practices. Rates of uninsured increased from 3.8% during pregnancy and delivery (n=87 of 2317) to 10.8% at the first postpartum visit...
Increased duration of cancer survival may allow a longer window for detection of metastases, incl... more Increased duration of cancer survival may allow a longer window for detection of metastases, including brain metastases. Using the entire population of Olmsted County, Minnesota, we looked at trends in the rate of brain metastases in people diagnosed with primary lung or breast cancers between January 1, 1988, and December 31, 2001. Yearly rates of brain metastases detection following the primary tumors were calculated from a combination of medical record and SEER database information. Trends in rates and gender differences were assessed. There was no discernible increase in the rates of brain metastases secondary to lung or breast cancer during the period of observation. However, women were twice as likely as men to have brain metastases detected following a primary lung cancer. This difference was constant over the time period. This twofold difference in brain metastases detected in women versus men with lung cancer deserves further evaluation and confirmation.
To study the incidence of de novo multimorbidity across all ages in a geographically defined popu... more To study the incidence of de novo multimorbidity across all ages in a geographically defined population with an emphasis on sex and ethnic differences. Historical cohort study. All persons residing in Olmsted County, Minnesota, USA on 1 January 2000 who had granted permission for their records to be used for research (n=123 716). We used the Rochester Epidemiology Project medical records-linkage system to identify all of the county residents. We identified and removed from the cohort all persons who had developed multimorbidity before 1 January 2000 (baseline date), and we followed the cohort over 14 years (1 January 2000 through 31 December 2013). Incident multimorbidity was defined as the development of the second of 2 conditions (dyads) from among the 20 chronic conditions selected by the US Department of Health and Human Services. We also studied the incidence of the third of 3 conditions (triads) from among the 20 chronic conditions. The incidence of multimorbidity increased st...
Journal of exposure science & environmental epidemiology
Living near traffic adversely affects health outcomes. Traffic exposure metrics include distance ... more Living near traffic adversely affects health outcomes. Traffic exposure metrics include distance to high-traffic roads, traffic volume on nearby roads, traffic within buffer distances, measured pollutant concentrations, land-use regression estimates of pollution concentrations, and others. We used Geographic Information System software to explore a new approach using traffic count data and a kernel density calculation to generate a traffic density surface with a resolution of 50 m. The density value in each cell reflects all the traffic on all the roads within the distance specified in the kernel density algorithm. The effect of a given roadway on the raster cell value depends on the amount of traffic on the road segment, its distance from the raster cell, and the form of the algorithm. We used a Gaussian algorithm in which traffic influence became insignificant beyond 300 m. This metric integrates the deleterious effects of traffic rather than focusing on one pollutant. The density...
Postpartum depression (PPD) is a common, potentially disabling, and, in some cases, life-threaten... more Postpartum depression (PPD) is a common, potentially disabling, and, in some cases, life-threatening condition. Fortunately, PPD is also readily detectable in routine practice and is amenable to treatment by a wide variety of modalities that are effective for treating nonpuerperal major depression. Postpartum depression screening can improve case identification (an Edinburgh Postnatal Depression Scale score of ≥ 13 indicates a high risk of PPD) and, when associated with a diagnostic and follow-up program, leads to improved clinical outcomes. Symptom severity, patient preference, past response to treatment, availability of local mental health care resources, and patient decisions about breast-feeding will drive management decisions. In general, cognitive-behavioral therapy and interpersonal therapy are preferred psychotherapies for women with mild to moderate PPD, whereas antidepressants are appropriate in more severe cases. Many patients will require other types of assistance, such as parenting support, case management, or care coordination because many barriers to receiving adequate PPD treatment must still be overcome.
To describe the prevalence of multimorbidity involving 20 selected chronic conditions in a geogra... more To describe the prevalence of multimorbidity involving 20 selected chronic conditions in a geographically defined US population, emphasizing age, sex, and racial/ethnic differences. Using the Rochester Epidemiology Project records linkage system, we identified all residents of Olmsted County, Minnesota, on April 1, 2010, and electronically extracted the International Classification of Diseases, Ninth Revision codes associated with all health care visits made between April 1, 2005, and March 31, 2010 (5-year capture frame). Using these codes, we defined the 20 common chronic conditions recommended by the US Department of Health and Human Services. We counted only persons who received at least 2 codes for a given condition separated by more than 30 days, and we calculated the age-, sex-, and race/ethnicity-specific prevalence of multimorbidity. Of the 138,858 study participants, 52.4% were women (n=72,732) and 38.9% had 1 or more conditions (n=54,012), 22.6% had 2 or more conditions (n=31,444), and 4.9% had 5 or more conditions (n=6853). The prevalence of multimorbidity (≥2 conditions) increased steeply with older age and reached 77.3% at 65 years and older. However, the absolute number of people affected by multimorbidity was higher in those younger than 65 years. Although the prevalence of multimorbidity was similar in men and women overall, the most common dyads and triads of conditions varied by sex. Compared with white persons, the prevalence of multimorbidity was slightly higher in black persons and slightly lower in Asian persons. Multimorbidity is common in the general population; it increases steeply with older age, has different patterns in men and women, and varies by race/ethnicity.
A housing-based socioeconomic index (HOUSES) was previously developed to overcome an absence of s... more A housing-based socioeconomic index (HOUSES) was previously developed to overcome an absence of socioeconomic status (SES) measures in common databases. HOUSES is associated with child health outcomes in Olmsted County, Minnesota, USA, but generalisability to other geographic areas is unclear. To assess whether HOUSES is associated with asthma outcomes outside Olmsted County, Minnesota, USA. Using a random sample of children with asthma from Sanford Children's Hospital, Sioux Falls, SD, USA, asthma status was determined. The primary outcome was asthma control status using Asthma Control Test and a secondary outcome was risk of persistent asthma. Home address information and property data were merged to formulate HOUSES. Other SES measures were examined: income, parental education (PE), Hollingshead and Nakao-Treas index. Of a random sample of 200 children, 80 (40%) participated in the study. Of those, 13% had poorly controlled asthma. Addresses of 94% were matched with property ...
The value and appropriateness of universal postpartum depression (PPD) screening remains controve... more The value and appropriateness of universal postpartum depression (PPD) screening remains controversial in the United States. To date, several PPD screening programs have been introduced and a few have been evaluated. Among those programs that have been evaluated, most report screening rates, diagnosis rates, or treatment initiation rates. Only four studies included patient outcomes such as the level of depressive symptoms at 6 to 12 months postpartum, and only two reported success in improving outcomes. Program characteristics that appear to result in low rates of diagnosis and followup after PPD screening include requirements for a formal psychiatric evaluation, the need to refer women to another site for therapy, and failure to integrate the PPD screening into the care provided at the woman's or her child's medical home. The two programs that reported improved outcomes were both self-contained within primary care and included specific followup, management, and therapy procedures. Both resulted in the need for outside referrals in less than 10% of women diagnosed with postpartum depression. Future studies should be based on the successful programs and their identified facilitators while avoiding identified barriers. To affect policies, the future program must report maternal outcomes going beyond the often reported process outcomes of screening, referral, and therapy initiation rates.
Journal of the American Medical Informatics Association, 2014
We validated an algorithm designed to identify new or prevalent users of antidepressant medicatio... more We validated an algorithm designed to identify new or prevalent users of antidepressant medications via population-based drug prescription records. We obtained population-based drug prescription records for the entire Olmsted County, Minnesota, population from 2011 to 2012 (N=149,629) using the existing electronic medical records linkage infrastructure of the Rochester Epidemiology Project (REP). We selected electronically a random sample of 200 new antidepressant users stratified by age and sex. The algorithm required the exclusion of antidepressant use in the 6 months preceding the date of the first qualifying antidepressant prescription (index date). Medical records were manually reviewed and adjudicated to calculate the positive predictive value (PPV). We also manually reviewed the records of a random sample of 200 antihistamine users who did not meet the case definition of new antidepressant user to estimate the negative predictive value (NPV). 161 of the 198 subjects electronically identified as new antidepressant users were confirmed by manual record review (PPV 81.3%). Restricting the definition of new users to subjects who were prescribed typical starting doses of each agent for treating major depression in non-geriatric adults resulted in an increase in the PPV (90.9%). Extending the time windows with no antidepressant use preceding the index date resulted in only modest increases in PPV. The manual abstraction of medical records of 200 antihistamine users yielded an NPV of 98.5%. Our study confirms that REP prescription records can be used to identify prevalent and incident users of antidepressants in the Olmsted County, Minnesota, population.
The Journal of the American Board of Family Medicine, 2014
Practice-based research continues to evolve and has become a major methodology for many pragmatic... more Practice-based research continues to evolve and has become a major methodology for many pragmatic studies. While early practice-based network projects were usually short term, current studies often introduce or compare practice innovations that require long-term evaluation. That change requires that practice sites remain engaged in research work for up to 5 years, a time that can allow for a significant "voltage drop," or decline in active participation. Over the past 15 years we have developed and adapted several strategies to facilitate and encourage the continued active engagement of practices in practice-based research network studies of up to 5 years' duration. The concepts, details, evaluation, and results (when available) of the strategies are described. Eight strategies that enhance practice sites' attention to enrollment, data collection and continued use of the implemented practice change are described. The loss of momentum, or "voltage drop," that happens in longer-term practice-based research network studies can be addressed using multiple strategies.
Socioeconomic status (SES) is an important determinant of health, but SES measures are frequently... more Socioeconomic status (SES) is an important determinant of health, but SES measures are frequently unavailable in commonly used datasets. Area-level SES measures are used as proxy measures of individual SES when the individual measures are lacking. Little is known about the agreement between individual-level versus area-level SES measures in mixed urban-rural settings. We identified SES agreement by comparing information from telephone self-reported SES levels and SES calculated from area-level SES measures. We assessed the impact of this agreement on reported associations between SES and rates of childhood obesity, low birth weight <2500 g and smoking within the household in a mixed urban-rural setting. 750 households were surveyed with a response rate of 62%: 51% male, 89% Caucasian; mean child age 9.5 years. Individual-level self-reported income was more strongly associated with all three childhood health outcomes compared to area-level SES. We found significant disagreement rates of 22-31%. The weighted Cohen's κ indices ranged from 0.15 to 0.22, suggesting poor agreement between individual-level and area-level measures. In a mixed urban-rural setting comprised of both rural and urbanised areas, area-level SES proxy measures significantly disagree with individual SES measures, and have different patterns of association with health outcomes from individual-level SES measures. Area-level SES may be an unsuitable proxy for SES when individual rather than community characteristics are of primary concern.
To determine the impact of losing health insurance coverage on perceived need for and access to m... more To determine the impact of losing health insurance coverage on perceived need for and access to mental health care in women screened for postpartum depression (PPD) in primary care settings. The study sample included 2343 women enrolled in a 12-month, multisite, randomized trial that compared clinical outcomes of a comprehensive PPD screening and management program with usual care (March 1, 2006, through August 31, 2010). Screening for PPD occurred at the first postpartum visit (5-12 weeks) using the Edinburgh Postnatal Depression Scale followed by the 9-item Patient Health Questionnaire. Insurance status during the prenatal period, at delivery, and during the first postpartum year and perceived need for and access to mental health care during the first postpartum year were assessed via questionnaires completed by individual patients and participating practices. Rates of uninsured increased from 3.8% during pregnancy and delivery (n=87 of 2317) to 10.8% at the first postpartum visit...
Increased duration of cancer survival may allow a longer window for detection of metastases, incl... more Increased duration of cancer survival may allow a longer window for detection of metastases, including brain metastases. Using the entire population of Olmsted County, Minnesota, we looked at trends in the rate of brain metastases in people diagnosed with primary lung or breast cancers between January 1, 1988, and December 31, 2001. Yearly rates of brain metastases detection following the primary tumors were calculated from a combination of medical record and SEER database information. Trends in rates and gender differences were assessed. There was no discernible increase in the rates of brain metastases secondary to lung or breast cancer during the period of observation. However, women were twice as likely as men to have brain metastases detected following a primary lung cancer. This difference was constant over the time period. This twofold difference in brain metastases detected in women versus men with lung cancer deserves further evaluation and confirmation.
To study the incidence of de novo multimorbidity across all ages in a geographically defined popu... more To study the incidence of de novo multimorbidity across all ages in a geographically defined population with an emphasis on sex and ethnic differences. Historical cohort study. All persons residing in Olmsted County, Minnesota, USA on 1 January 2000 who had granted permission for their records to be used for research (n=123 716). We used the Rochester Epidemiology Project medical records-linkage system to identify all of the county residents. We identified and removed from the cohort all persons who had developed multimorbidity before 1 January 2000 (baseline date), and we followed the cohort over 14 years (1 January 2000 through 31 December 2013). Incident multimorbidity was defined as the development of the second of 2 conditions (dyads) from among the 20 chronic conditions selected by the US Department of Health and Human Services. We also studied the incidence of the third of 3 conditions (triads) from among the 20 chronic conditions. The incidence of multimorbidity increased st...
Journal of exposure science & environmental epidemiology
Living near traffic adversely affects health outcomes. Traffic exposure metrics include distance ... more Living near traffic adversely affects health outcomes. Traffic exposure metrics include distance to high-traffic roads, traffic volume on nearby roads, traffic within buffer distances, measured pollutant concentrations, land-use regression estimates of pollution concentrations, and others. We used Geographic Information System software to explore a new approach using traffic count data and a kernel density calculation to generate a traffic density surface with a resolution of 50 m. The density value in each cell reflects all the traffic on all the roads within the distance specified in the kernel density algorithm. The effect of a given roadway on the raster cell value depends on the amount of traffic on the road segment, its distance from the raster cell, and the form of the algorithm. We used a Gaussian algorithm in which traffic influence became insignificant beyond 300 m. This metric integrates the deleterious effects of traffic rather than focusing on one pollutant. The density...
Postpartum depression (PPD) is a common, potentially disabling, and, in some cases, life-threaten... more Postpartum depression (PPD) is a common, potentially disabling, and, in some cases, life-threatening condition. Fortunately, PPD is also readily detectable in routine practice and is amenable to treatment by a wide variety of modalities that are effective for treating nonpuerperal major depression. Postpartum depression screening can improve case identification (an Edinburgh Postnatal Depression Scale score of ≥ 13 indicates a high risk of PPD) and, when associated with a diagnostic and follow-up program, leads to improved clinical outcomes. Symptom severity, patient preference, past response to treatment, availability of local mental health care resources, and patient decisions about breast-feeding will drive management decisions. In general, cognitive-behavioral therapy and interpersonal therapy are preferred psychotherapies for women with mild to moderate PPD, whereas antidepressants are appropriate in more severe cases. Many patients will require other types of assistance, such as parenting support, case management, or care coordination because many barriers to receiving adequate PPD treatment must still be overcome.
To describe the prevalence of multimorbidity involving 20 selected chronic conditions in a geogra... more To describe the prevalence of multimorbidity involving 20 selected chronic conditions in a geographically defined US population, emphasizing age, sex, and racial/ethnic differences. Using the Rochester Epidemiology Project records linkage system, we identified all residents of Olmsted County, Minnesota, on April 1, 2010, and electronically extracted the International Classification of Diseases, Ninth Revision codes associated with all health care visits made between April 1, 2005, and March 31, 2010 (5-year capture frame). Using these codes, we defined the 20 common chronic conditions recommended by the US Department of Health and Human Services. We counted only persons who received at least 2 codes for a given condition separated by more than 30 days, and we calculated the age-, sex-, and race/ethnicity-specific prevalence of multimorbidity. Of the 138,858 study participants, 52.4% were women (n=72,732) and 38.9% had 1 or more conditions (n=54,012), 22.6% had 2 or more conditions (n=31,444), and 4.9% had 5 or more conditions (n=6853). The prevalence of multimorbidity (≥2 conditions) increased steeply with older age and reached 77.3% at 65 years and older. However, the absolute number of people affected by multimorbidity was higher in those younger than 65 years. Although the prevalence of multimorbidity was similar in men and women overall, the most common dyads and triads of conditions varied by sex. Compared with white persons, the prevalence of multimorbidity was slightly higher in black persons and slightly lower in Asian persons. Multimorbidity is common in the general population; it increases steeply with older age, has different patterns in men and women, and varies by race/ethnicity.
A housing-based socioeconomic index (HOUSES) was previously developed to overcome an absence of s... more A housing-based socioeconomic index (HOUSES) was previously developed to overcome an absence of socioeconomic status (SES) measures in common databases. HOUSES is associated with child health outcomes in Olmsted County, Minnesota, USA, but generalisability to other geographic areas is unclear. To assess whether HOUSES is associated with asthma outcomes outside Olmsted County, Minnesota, USA. Using a random sample of children with asthma from Sanford Children's Hospital, Sioux Falls, SD, USA, asthma status was determined. The primary outcome was asthma control status using Asthma Control Test and a secondary outcome was risk of persistent asthma. Home address information and property data were merged to formulate HOUSES. Other SES measures were examined: income, parental education (PE), Hollingshead and Nakao-Treas index. Of a random sample of 200 children, 80 (40%) participated in the study. Of those, 13% had poorly controlled asthma. Addresses of 94% were matched with property ...
The value and appropriateness of universal postpartum depression (PPD) screening remains controve... more The value and appropriateness of universal postpartum depression (PPD) screening remains controversial in the United States. To date, several PPD screening programs have been introduced and a few have been evaluated. Among those programs that have been evaluated, most report screening rates, diagnosis rates, or treatment initiation rates. Only four studies included patient outcomes such as the level of depressive symptoms at 6 to 12 months postpartum, and only two reported success in improving outcomes. Program characteristics that appear to result in low rates of diagnosis and followup after PPD screening include requirements for a formal psychiatric evaluation, the need to refer women to another site for therapy, and failure to integrate the PPD screening into the care provided at the woman's or her child's medical home. The two programs that reported improved outcomes were both self-contained within primary care and included specific followup, management, and therapy procedures. Both resulted in the need for outside referrals in less than 10% of women diagnosed with postpartum depression. Future studies should be based on the successful programs and their identified facilitators while avoiding identified barriers. To affect policies, the future program must report maternal outcomes going beyond the often reported process outcomes of screening, referral, and therapy initiation rates.
Journal of the American Medical Informatics Association, 2014
We validated an algorithm designed to identify new or prevalent users of antidepressant medicatio... more We validated an algorithm designed to identify new or prevalent users of antidepressant medications via population-based drug prescription records. We obtained population-based drug prescription records for the entire Olmsted County, Minnesota, population from 2011 to 2012 (N=149,629) using the existing electronic medical records linkage infrastructure of the Rochester Epidemiology Project (REP). We selected electronically a random sample of 200 new antidepressant users stratified by age and sex. The algorithm required the exclusion of antidepressant use in the 6 months preceding the date of the first qualifying antidepressant prescription (index date). Medical records were manually reviewed and adjudicated to calculate the positive predictive value (PPV). We also manually reviewed the records of a random sample of 200 antihistamine users who did not meet the case definition of new antidepressant user to estimate the negative predictive value (NPV). 161 of the 198 subjects electronically identified as new antidepressant users were confirmed by manual record review (PPV 81.3%). Restricting the definition of new users to subjects who were prescribed typical starting doses of each agent for treating major depression in non-geriatric adults resulted in an increase in the PPV (90.9%). Extending the time windows with no antidepressant use preceding the index date resulted in only modest increases in PPV. The manual abstraction of medical records of 200 antihistamine users yielded an NPV of 98.5%. Our study confirms that REP prescription records can be used to identify prevalent and incident users of antidepressants in the Olmsted County, Minnesota, population.
The Journal of the American Board of Family Medicine, 2014
Practice-based research continues to evolve and has become a major methodology for many pragmatic... more Practice-based research continues to evolve and has become a major methodology for many pragmatic studies. While early practice-based network projects were usually short term, current studies often introduce or compare practice innovations that require long-term evaluation. That change requires that practice sites remain engaged in research work for up to 5 years, a time that can allow for a significant "voltage drop," or decline in active participation. Over the past 15 years we have developed and adapted several strategies to facilitate and encourage the continued active engagement of practices in practice-based research network studies of up to 5 years' duration. The concepts, details, evaluation, and results (when available) of the strategies are described. Eight strategies that enhance practice sites' attention to enrollment, data collection and continued use of the implemented practice change are described. The loss of momentum, or "voltage drop," that happens in longer-term practice-based research network studies can be addressed using multiple strategies.
Socioeconomic status (SES) is an important determinant of health, but SES measures are frequently... more Socioeconomic status (SES) is an important determinant of health, but SES measures are frequently unavailable in commonly used datasets. Area-level SES measures are used as proxy measures of individual SES when the individual measures are lacking. Little is known about the agreement between individual-level versus area-level SES measures in mixed urban-rural settings. We identified SES agreement by comparing information from telephone self-reported SES levels and SES calculated from area-level SES measures. We assessed the impact of this agreement on reported associations between SES and rates of childhood obesity, low birth weight <2500 g and smoking within the household in a mixed urban-rural setting. 750 households were surveyed with a response rate of 62%: 51% male, 89% Caucasian; mean child age 9.5 years. Individual-level self-reported income was more strongly associated with all three childhood health outcomes compared to area-level SES. We found significant disagreement rates of 22-31%. The weighted Cohen's κ indices ranged from 0.15 to 0.22, suggesting poor agreement between individual-level and area-level measures. In a mixed urban-rural setting comprised of both rural and urbanised areas, area-level SES proxy measures significantly disagree with individual SES measures, and have different patterns of association with health outcomes from individual-level SES measures. Area-level SES may be an unsuitable proxy for SES when individual rather than community characteristics are of primary concern.
BMC Health Services Research. 2013, 13:301, Aug 2013
Background
Patient-centered diabetes care requires shared decision making (SDM). Decision aids p... more Background
Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear.
Methods
We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy.
Results
Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power.
Conclusion
DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices.
Background
The decision aids for diabetes (DAD) trial explored the feasibility of testing the ef... more Background
The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.
Methods
As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.
Results
We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.
Conclusion
Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.
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Papers by Barbara Yawn
Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear.
Methods
We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy.
Results
Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power.
Conclusion
DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices.
The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.
Methods
As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.
Results
We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.
Conclusion
Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.
Trial registration: ClinicalTrials.gov NCT01029288