Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices
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. Method...
Ausführliche Beschreibung
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| Autor*in: |
Ruud, Kari L [verfasserIn] |
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E-Artikel |
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| Sprache: |
Englisch |
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2013 |
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| Anmerkung: |
© Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 14(2013), 1 vom: 21. Aug. |
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| Übergeordnetes Werk: |
volume:14 ; year:2013 ; number:1 ; day:21 ; month:08 |
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| DOI / URN: |
10.1186/1745-6215-14-267 |
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SPR030064066 |
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| 520 | |a 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. Trial registration ClinicalTrials.gov NCT01029288 | ||
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| 700 | 1 | |a LeBlanc, Annie |4 aut | |
| 700 | 1 | |a Mullan, Rebecca J |4 aut | |
| 700 | 1 | |a Pencille, Laurie J |4 aut | |
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| 700 | 1 | |a Branda, Megan E |4 aut | |
| 700 | 1 | |a Van Houten, Holly K |4 aut | |
| 700 | 1 | |a Heim, Sara R |4 aut | |
| 700 | 1 | |a Kurland, Margary |4 aut | |
| 700 | 1 | |a Shah, Nilay D |4 aut | |
| 700 | 1 | |a Yawn, Barbara P |4 aut | |
| 700 | 1 | |a Montori, Victor M |4 aut | |
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10.1186/1745-6215-14-267 doi (DE-627)SPR030064066 (SPR)1745-6215-14-267-e DE-627 ger DE-627 rakwb eng Ruud, Kari L verfasserin aut Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Trial registration ClinicalTrials.gov NCT01029288 Practical trials (dpeaa)DE-He213 Trial methodology (dpeaa)DE-He213 Recruitment and enrollment (dpeaa)DE-He213 LeBlanc, Annie aut Mullan, Rebecca J aut Pencille, Laurie J aut Tiedje, Kristina aut Branda, Megan E aut Van Houten, Holly K aut Heim, Sara R aut Kurland, Margary aut Shah, Nilay D aut Yawn, Barbara P aut Montori, Victor M aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 21. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:21 month:08 https://dx.doi.org/10.1186/1745-6215-14-267 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 21 08 |
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10.1186/1745-6215-14-267 doi (DE-627)SPR030064066 (SPR)1745-6215-14-267-e DE-627 ger DE-627 rakwb eng Ruud, Kari L verfasserin aut Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Trial registration ClinicalTrials.gov NCT01029288 Practical trials (dpeaa)DE-He213 Trial methodology (dpeaa)DE-He213 Recruitment and enrollment (dpeaa)DE-He213 LeBlanc, Annie aut Mullan, Rebecca J aut Pencille, Laurie J aut Tiedje, Kristina aut Branda, Megan E aut Van Houten, Holly K aut Heim, Sara R aut Kurland, Margary aut Shah, Nilay D aut Yawn, Barbara P aut Montori, Victor M aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 21. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:21 month:08 https://dx.doi.org/10.1186/1745-6215-14-267 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 21 08 |
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10.1186/1745-6215-14-267 doi (DE-627)SPR030064066 (SPR)1745-6215-14-267-e DE-627 ger DE-627 rakwb eng Ruud, Kari L verfasserin aut Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Trial registration ClinicalTrials.gov NCT01029288 Practical trials (dpeaa)DE-He213 Trial methodology (dpeaa)DE-He213 Recruitment and enrollment (dpeaa)DE-He213 LeBlanc, Annie aut Mullan, Rebecca J aut Pencille, Laurie J aut Tiedje, Kristina aut Branda, Megan E aut Van Houten, Holly K aut Heim, Sara R aut Kurland, Margary aut Shah, Nilay D aut Yawn, Barbara P aut Montori, Victor M aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 21. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:21 month:08 https://dx.doi.org/10.1186/1745-6215-14-267 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 21 08 |
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10.1186/1745-6215-14-267 doi (DE-627)SPR030064066 (SPR)1745-6215-14-267-e DE-627 ger DE-627 rakwb eng Ruud, Kari L verfasserin aut Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Trial registration ClinicalTrials.gov NCT01029288 Practical trials (dpeaa)DE-He213 Trial methodology (dpeaa)DE-He213 Recruitment and enrollment (dpeaa)DE-He213 LeBlanc, Annie aut Mullan, Rebecca J aut Pencille, Laurie J aut Tiedje, Kristina aut Branda, Megan E aut Van Houten, Holly K aut Heim, Sara R aut Kurland, Margary aut Shah, Nilay D aut Yawn, Barbara P aut Montori, Victor M aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 21. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:21 month:08 https://dx.doi.org/10.1186/1745-6215-14-267 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 21 08 |
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10.1186/1745-6215-14-267 doi (DE-627)SPR030064066 (SPR)1745-6215-14-267-e DE-627 ger DE-627 rakwb eng Ruud, Kari L verfasserin aut Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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. Trial registration ClinicalTrials.gov NCT01029288 Practical trials (dpeaa)DE-He213 Trial methodology (dpeaa)DE-He213 Recruitment and enrollment (dpeaa)DE-He213 LeBlanc, Annie aut Mullan, Rebecca J aut Pencille, Laurie J aut Tiedje, Kristina aut Branda, Megan E aut Van Houten, Holly K aut Heim, Sara R aut Kurland, Margary aut Shah, Nilay D aut Yawn, Barbara P aut Montori, Victor M aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 21. Aug. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:21 month:08 https://dx.doi.org/10.1186/1745-6215-14-267 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 21 08 |
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Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices |
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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. Trial registration ClinicalTrials.gov NCT01029288 © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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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. Trial registration ClinicalTrials.gov NCT01029288 © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
| abstract_unstemmed |
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. Trial registration ClinicalTrials.gov NCT01029288 © Ruud et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices |
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LeBlanc, Annie Mullan, Rebecca J Pencille, Laurie J Tiedje, Kristina Branda, Megan E Van Houten, Holly K Heim, Sara R Kurland, Margary Shah, Nilay D Yawn, Barbara P Montori, Victor M |
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LeBlanc, Annie Mullan, Rebecca J Pencille, Laurie J Tiedje, Kristina Branda, Megan E Van Houten, Holly K Heim, Sara R Kurland, Margary Shah, Nilay D Yawn, Barbara P Montori, Victor M |
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