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Ptients Question-Asking Behvior During Primry Cre Visits: A Report From the AAFP Ntionl Reserch Network Jmes M. Glliher, PhD 1,2,3 Dougls M. Post, PhD 4 Brry D. Weiss, MD 5 L. Mirim Dickinson, PhD 1,3 Brin K. Mnning, MPH 1 Elizbeth W. Stton, MSTC 1,3 Judith Belle Brown, PhD 6 John M. Hickner, MD, MS 7 Aron J. Bonhm, MS 8 Bridget L. Ryn, PhD 6 Wilson D. Pce, MD 1,3 1 Americn Acdemy of Fmily Physicins Ntionl Reserch Network, Lewood, Knss 2 Deprtment of Sociology, University of Missouri Knss City, Knss City, Missouri 3 Deprtment of Fmily Medicine, University of Colordo Helth Sciences Center t Denver, Denver, Colordo 4 Deprtment of Fmily Medicine, Ohio Stte University, Columbus, Ohio 5 University of Arizon, Deprtment of Fmily nd Community Medicine, Tucson, Arizon 6 Deprtment of Fmily Medicine, University of Western Ontrio, London, Ontrio, Cnd 7 Deprtment of Fmily Medicine, Clevelnd Clinic, Clevelnd, Ohio 8 Deprtment of Informtic Medicine nd Personlized Helth, University of Missouri Knss City, Knss City, Missouri Confl icts of interest: none reported CORRESPONDING AUTHOR Jmes M. Glliher, PhD AAFP Ntionl Reserch Network 11400 Tomhwk Creek Pkwy Lewood, KS 66208 jgllihe@fp.org ABSTRACT PURPOSE The Ask Me 3 (AM3) helth communiction progrm encourges ptients to sk specific questions during office visits with the intention of improving understnding of their helth conditions nd dherence to tretment recommendtions. This study evluted whether implementing AM3 improves ptients question-sking behvior nd increses dherence to prescription medictions nd lifestyle recommendtions. METHODS This rndomized tril involved 20 prctices from the Americn Acdemy of Fmily Physicins Ntionl Reserch Network tht were ssigned to n AM3 intervention group or control group. Forty-one physicins in the prctices were ech sked to enroll t lest 20 ptients. The ptients visits were udio recorded, nd recordings were reviewed to determine whether ptients sked questions nd which questions they sked. Ptients were interviewed 1 to 3 weeks fter the visit to ssess their recll of physicins recommendtions, rtes of prescription filling nd tking, nd ttempts t complying with lifestyle recommendtions. RESULTS The study enrolled 834 eligible ptients in 20 prctices. There were no significnt difference between the AM3 nd control ptients in the rte of sking questions, but this rte ws high (92%) in both groups. There lso were no differences in rtes of either filling or tking prescriptions, lthough rtes of these outcomes were firly high, too. Control ptients were more likely to recll tht their physicin recommended lifestyle chnge, however (68% vs 59%, P =.04). CONCLUSIONS In ptient popultion in which sking questions lredy occurs t high rte nd levels of dherence re firly high, we found no evidence tht the AM3 intervention results in ptients sking specific questions or more questions in generl, or in better dherence to prescription medictions or lifestyle recommendtions. Ann Fm Med 2010;8:151-159. doi:10.1370/fm.1055. INTRODUCTION Numerous studies document the need to improve physicin-ptient communiction. 1-4 Ptients report tht physicins re not sufficiently ttentive to their concerns, nd ptients often do not understnd wht they re told. 5 When interviewed immeditely fter offi ce visits, ptients recll only one-hlf or less of importnt informtion given to them. 2 Limited helth litercy cn further complicte communiction between physicins nd ptients. 4 Ptients with limited cpcity to obtin, process, nd understnd bsic helth informtion nd services needed to mke pproprite helth decisions 6 hve trouble understnding common medicl terms nd written helth-relted mterils. 7-12 Reserch suggests tht better physicin-ptient communiction improves ptient outcomes. 13-18 Yet, some physicins view better communiction s time-consuming nd imprcticl during offi ce visits verging only 17 minutes. 19 151

Ask Me 3 (AM3) is simple pproch designed to fcilitte communiction between helth cre professionls nd ptients. AM3 ws developed by the Prtnership for Cler Helth Communiction (http://www. npsf.org/skme3/). The AM3 pproch encourges ptients to sk 3 questions t every visit with clinicin: (1) Wht is my min problem? (2) Wht do I need to do (bout the problem)? nd (3) Why is it importnt for me to do this? The AM3 progrm is bsed on the theoreticl rgument tht ptients incresed communiction (vi ptient question-sking) nd subsequent understnding (or incresed helth litercy) will led to better dherence to tretment recommendtions (eg, recommended mediction nd lifestyle chnges). This study compred ptient-physicin communiction between primry cre prctices tht implemented the AM3 progrm nd control primry cre prctices tht did not. We conducted prcticl clinicl tril, design tht exmines interventions s they would occur in routine clinicl prctice, nd tht provides useful informtion regrding clinicl effectiveness. 20 Our reserch questions were s follows: (1) Does the AM3 intervention ffect ptients question-sking behvior? (2) Does the AM3 intervention ffect dherence to selected physicins tretment recommendtions? nd (3) Is there reltionship between ptient question-sking, in generl, nd these sme dherence outcomes? Our prestudy hypotheses were tht (1) ptients in prctices implementing AM3 would verge more questions thn ptients in control prctices; (2) ptients in AM3 prctices would show greter dherence to physicins tretment recommendtions; nd (3) s ptients sk more questions, they would show greter dherence to physicins tretment recommendtions. METHODS Overview This prcticl clinicl tril, known s the Improving Communiction During Offi ce Visits tril, involved 20 primry cre prctices from the Americn Acdemy of Fmily Physicins Ntionl Reserch Network (AAFP NRN). Prctices were rndomly ssigned to n AM3 intervention group or to control group in which AM3 ws not introduced. The study ws pproved by the University of Missouri Knss City Socil Science Institutionl Review Bord (IRB) nd locl IRBs of prticipting prctices. Ptient enrollment nd dt collection occurred between November 2004 nd My 2005. Prctices We rndomly ssigned 10 prctices to the intervention group nd 10 to the control group. The study sites were locted in 18 sttes distributed cross the United Sttes. The prctices included 41 physicins: 23 in AM3 prctices nd 18 in control prctices. Prctices in both study groups rnged in size from 1 physicin to 3 or more. Five prctices (3 AM3) were urbn, 6 prctices (2 AM3) were suburbn, nd 9 prctices (5 AM3) were rurl. Most prctices were physicin owned; 8 (4 AM3) were residency progrms. Ptients Ech prctice recruited 20 to 25 ptients per study physicin bsed on smple size clcultions described below. Ech prctice selected, priori, smpling strtegy for ptient enrollment: every second, third, fourth, or fi fth ptient who visited the offi ce on given dy to see the study physicin for ny reson. Offi ce study coordintors obtined informed consent from ptients. Eligible ptients were ged 18 yers or older nd cpble of giving informed written consent in either English or Spnish. Ptients were excluded if pregnnt, too ill to prticipte, or not cpble of being contcted by telephone for follow-up interview. AM3 Intervention Group We used severl strtegies simultneously to introduce AM3 into the intervention prctices. First, AM3 brochures were mde vilble in witing rooms, nd AM3 posters were plced in witing rooms nd exmintion rooms. Second, front offi ce stff members were trined to give AM3 pmphlets to ptients t check-in. Third, when nurses nd medicl ssistnts escorted ptients to exmintion rooms, they reminded ptients to sk the physicin the 3 questions. Ptients lso could write their questions in the provided pmphlets to ddress with their physicin lter. Intervention prctices were instructed to implement the intervention s described here in their prctices for t lest 1 week before enrolling ptients. Physicins nd stff from these prctices ttended 1-dy fce-to-fce trining session (in Knss City, Missouri) tht covered both the AM3 progrm nd the study protocol. Control Group Physicins nd stff from the control group prctices ttended seprte trining session in which dt collection protocols were reviewed. They were not told bout AM3 or specifi c detils bout helth litercy. They were insted informed tht we were conducting study bout physicin-ptient communiction, nd they were sked not to chnge their current communiction behviors with ptients during the study. Control prctices received the AM3 informtion fter the study ended. 152

Dt Collection Dt were collected from ptients nd physicins, nd from their interction during the visit using 2 questionnires, udio recordings, nd follow-up telephone interview (Tble 1). Ptient Postvisit Questionnire Immeditely fter their offi ce visit, ptients in both groups completed questionnire. The questionnire sked bout demogrphics nd helth litercy. The litercy items were drwn from previously vlidted instruments 21 nd modifi ed to decrese the reding demnd nd to plce questions in primry cre rther thn hospitl-bsed context. Physicin Postvisit Questionnire Physicins in both groups completed questionnire immeditely fter the ptient visit. The questionnire sked (1) bout the physicin s perceptions of her/his communiction with the ptient, (2) bout the nture of the ptient s problems, (3) whether medictions were prescribed, nd (4) whether lifestyle chnges were recommended. Recordings of Physicin-Ptient Visits In both sets of prctices, stff plced n udio recorder in the exmintion room, nd the entire office visit of consenting ptients ws recorded. The recordings were miled to the AAFP NRN for review nd coding. Informtion bstrcted for coding included (1) number of times ech AM3 question ws sked, (2) totl number of AM3 questions sked, (3) totl number of questions of ny type sked, (4) whether mediction ws prescribed, nd (5) whether lifestyle recommendtion ws mde. Coders worked together during the first few dys of coding nd subsequently once per week using the sme udio recordings to check ech others coding, interprettions, nd ssumptions. Where differences occurred, consensus ws reched on interprettion nd coding decisions. We ssessed relibility of these mesures by hving the 2 (of the project s 5) reserch ssocites who hd coded the mjority of recordings rndomly select 75 (10%) of the recordings nd independently code the sme informtion, nd then evluting the concordnce between the 2 coders. The coders greement ws 97% ( Ws Ask Me 3 question 1 sked? ), 68% ( Ws Ask Me 3 question 2 sked? ), nd 93% ( Ws Ask Me 3 question 3 sked? ), with men greement cross the 3 items of 86%. These items κ vlues were 0.653, 0.138, nd 0.269, respectively. Ptient Postvisit Telephone Interview Ptients were telephoned for follow-up interviews if their physicin indicted tht new or refi ll mediction Tble 1. Dt Collection: Sources nd Timing Source Ptient postvisit questionnires Physicin postvisit questionnires Timing of Collection Immeditely fter visit Immeditely fter visit No. (%) of Enrolled Ptients With Usble Dt (n = 834) 829 (99) 829 (99) Audio recordings During visit 763 (92) Ptient follow-up telephone interviews About 2 weeks fter visit 455 (87) Of 524 ptients eligible for follow-up. Ptients were eligible for follow-up telephone interview if their study physicin stted in the postvisit questionnire tht prescription (new, refill, both) hd been written t the office visit. Tble 2. Selected Questions Asked of Ptients During the Follow-up Telephone Interview 1. Did [nme of study physicin] write/give you ny new prescriptions t tht visit? 2. Hve you hd these new prescriptions filled t phrmcy? 3. Did [nme of study physicin] write you ny refill prescriptions for medicine you were tking before this doctor s visit? 4. Hve you hd these prescriptions filled t phrmcy? 5. How mny of the medictions (new nd old) tht were prescribed to you t the visit re you tking? b Response options were Yes, No, nd Don t remember. b Response options were All of them, Some of them, nd None of them. hd been prescribed t the visit. The men number of dys between the index visit nd follow-up ws 14.2 (SD = 10.1) nd 14.1 (SD = 12.3) for the intervention nd control ptients, respectively. Across ll eligible ptients, 84% were interviewed within 3 weeks. The interviewers sked bout ptients dherence to recommendtions mde during the visit (Tble 2). Dt Anlysis Sttisticl nlyses were conducted using SPSS, version 11.5.1 (SPSS for Windows, SPSS Inc, Chicgo, Illinois) nd SAS 9.1 (SAS Institute Inc, Cry, North Crolin). We computed frequency distributions nd descriptive sttistics for survey questions nd bstrcted items from the udio recordings. We used χ 2 tests nd t tests for ctegoricl nd continuous dependent vribles, respectively, when ssessing the bivrite reltionships. Multivrite nlyses were used to ddress the primry reserch questions using generl liner mixed models (SAS Proc Mixed) for continuous (or semicontinuous) outcomes or generlized liner mixed models with logit link (SAS Proc Glimmix) for dichotomous outcomes, djusting for ptients clustered within physicins. 22,23 Although physicins were clustered within prctices, in most cses, there were too few physicins per prctice to model both physicin- nd prctice- 153

level rndom effects. Ptient sex, ge ctegory, rce/ ethnicity, mritl sttus, eduction, helth litercy, nd number of yers with study physicin were included s covrites in every model with group (intervention vs control) included s fi xed effect. We clculted tht minimum smple size of 400 ptients in ech group would provide 80% power to detect difference (α =.05) of 25% between the intervention nd control ptients in sking 1 or more AM3 questions. We ssumed n intrclss correltion coeffi - cient (ptients within physicins) of 0.10 nd estimted tht bout 50% of the intervention ptients would sk some vrint of these questions, compred with 25% of the control ptients. RESULTS Prticiption Rtes nd Usble Dt Overll, 1,088 ptients were invited nd 834 (77%) consented to prticipte in the study 445 (76%) in intervention prctices nd 389 (78%) in control prctices (Figure 1). Dt from 5 ptients were unusble (becuse the ptients were underge or their signed informed consent form ws missing), leving 829 ptients. The intervention physicins enrolled n verge of 19.3 ptients (SD = 7.4, medin = 23), compred with 21.6 ptients (SD = 3.7, medin = 21) for the control physicins. In ll, 763 (92%) of the udio recordings were usble. Resons for unusble udio recordings included the recorder ws not turned on, the Figure 1. Recruitment of prctices nd ptients into the tril ssessing the effects of the Ask Me 3 ptient intervention. Recruited prctices from AAFP NRN (20) Rndom ssignment of prctices Intervention (Ask-Me-3) 10 prctices/23 physicins Control (stndrd cre) 10 prctices/18 physicins Ptients invited 587 Ptients invited 501 Enrolled 445, 76% Refused 142, 24% Enrolled 389, 78% Refused 112, 22% Usble dt 443 Unusble dt 2 Usble dt 386 Unusble dt 3 Eligible for FU interview 287, 65% Not eligible for FU interview 152, 34% FU eligibility unknown 4, 1% Eligible for FU interview 237, 61% Not eligible for FU interview 144, 37% FU eligibility unknown 5, 2% Interviewed 247, 86% Not interviewed 40, 14% Interviewed 208, 88% Not interviewed 29, 12% AAFP NRN = Americn Acdemy of Fmily Physicins Ntionl Reserch Network; FU = follow-up. 154

Tble 3. Ptients Chrcteristics s Obtined From the Postvisit Questionnire, for Intervention Prctices (n = 445 Ptients) nd Control Prctices (n = 389 Ptients) Chrcteristic Intervention Ptients % or Men Control Ptients % or Men P Vlue Sex (n) (443) (386).06 Mle 68 62 Femle 32 38 Age ctegory (n) (435) (382).09 18-30 y 14 10 31-40 y 15 12 41-50 y 19 25 51-60 y 19 24 61-70 y 19 17 71-80 y 14 12 Rcil identifiction (n) (431) (378).60 White 85 83 Blck 10 12 Other/ 2 responses 4 5 Ethnic identifiction (n) (431) (378).002 Hispnic 10 4 Not Hispnic 90 96 Current mritl sttus (n) (434) (383).048 Mrried 64 54 Living together 4 6 Seprted 4 3 Divorced 10 14 Widowed 9 12 Never mrried 10 12 Employed full-time (n) (434) (383).21 Yes 44 40 No 56 60 Employed prt-time (n) (443) (386).63 Yes 13 14 No 87 86 Retired (n) (443) (386).05 Yes 26 20 No 74 80 Eductionl ttinment (n) (432) (384).02 <High school 11 16 High school grdute 33 28 Some college 30 27 College grdute 19 16 Postgrdute study 8 13 Yers s ptient of study physicin (n) 3.07 (281) 3.37 (221).07 b Source of insurnce (n) (433) (380).07 Privte 50 47 Medicre 31 27 Medicid 6 8 Self-py 8 13 Other 5 6 χ 2 test. b Student t test for independent smples. recording ws not udible, nd the recorder stopped before the visit ended. Prticipting vs Nonprticipting Ptients In totl, 193 (76%) of the 254 ptients who declined prticiption provided their demogrphic informtion. Younger ptients were more likely to hve prticipted thn older ptients (men ge, 51.6 vs 57.6 yers; P <.001). Men nd women did not differ significntly in their prticiption, nd rcil identifi ction did not differ between the prticipnts nd nonprticipnts (dt not shown). Ptients Demogrphics nd Helth Litercy Intervention nd control ptients did not differ (P >.05) with respect to sex, ge, rcil identifi ction, employment, retirement sttus, source of insurnce, or yers s ptient of the study physicin (Tble 3). The 2 groups did differ in terms of ethnic identifi ction, mritl sttus, nd eductionl ttinment. Specifi clly, intervention ptients were more likely to be Hispnic (P =.002) nd mrried (P =.048), nd less likely to report both lck of high school grdution (11% vs 16%) nd lck of postcollege study (8% vs 13%), but lso more likely to report high school grdution, some college eduction, nd college grdution (combined 82% vs 71%, P =.02). The ptients responses to the 3 questions bout helth litercy reveled differences between the groups for the question, How esy or hrd is it to fi ll out medicl forms by yourself? (Tble 4). Intervention ptients were more likely to respond either extremely esy or very esy compred with control ptients (70% vs 62%, P =.001). Rtes of Question-Asking Hypothesis 1 stted tht intervention ptients would sk more questions on verge thn control ptients. There ws no sttisticlly signifi cnt difference between the groups in sking questions (Tble 5) s mesured by (1) the percentge of ptients sking 1 or more AM3 questions (26% vs 30%, P =.16); (2) the percentge of ptients sking t lest 1 question of ny type (92% vs 92%, P =.87); (3) the men number of AM3 questions sked (0.47 vs 0.52, P =.56); nd (4) the men number of ny questions sked, including AM3 ques- 155

Tble 4. Ptients Helth Litercy s Obtined From the Postvisit Questionnire, for Intervention Prctices (n = 445 Ptients) nd Control Prctices (n = 389 Ptients) Helth Litercy Question How often does someone help you red things your doctor gives you? (n) Intervention Ptients, % Control Ptients, % tions (6.94 vs 6.37, P =.23) nd excluding AM3 questions (6.46 vs 5.86, P =.18). When study ptients who rnked the lowest on the second helth litercy question (ese of fi lling out medicl forms) were compred with ptients with higher rnkings, their respective mens were 5.4 vs 6.7 for ll questions sked (P =.22) nd 5.1 vs 6.2 for ll non-am3 questions sked (P =.24). Multivrite nlyses yielded similr results. Intervention ptients were no more likely thn control ptients to sk ny of the 3 AM3 questions (F 1,39 = 1.18, P =.34), even fter djusting for ptient ge, sex, rce/ ethnicity, mritl sttus, eduction, helth litercy, nd number of yers with the primry cre physicin. Multivrite nlyses lso yielded similr results for number of AM3 questions sked (F 1,39 = 0.11, P =. 83), nd number of ll questions sked including AM3 (F 1,39 = 0.001, P =.82) nd excluding AM3 (F 1,39 = 0.01, P =.80). Question-Asking nd Adherence Hypothesis 2 stted tht intervention ptients would show greter dherence to physicins tretment recommendtions. The dherence outcomes in the intervention group were no better thn those in the control group (Tble 6). The only comprison showing signifi cnt difference indicted tht control ptients were more likely thn intervention ptients to ccurtely recll their physicin s recommending lifestyle chnge(s) during the visit (68% vs 59%, P =.04). These 2 ptient groups did not differ with P Vlue (436) (373).15 Alwys/often 11 15 Sometimes 28 25 Never 62 60 How esy or hrd is it to fill out medicl forms by yourself? (n) (435) (370).001 Extremely/very hrd 3 8 Somewht hrd/esy 27 29 Extremely/very esy 70 62 How often is it hrd to understnd written informtion bout your medicl problems? (n) (436) (372).65 Alwys/often 7 9 Sometimes 54 55 Never 39 36 χ 2 test. respect to ttempting recommended lifestyle chnges, however (92% vs 93%, P =.90). Hypothesis 3 stted tht s ptient question-sking behvior increses, ptients would show greter dherence to physicins tretment recommendtions. There were no signifi cnt differences in these outcomes bsed on whether ptients sked the AM3 questions or ny questions in generl (dt not shown). Adjusting for potentil confounders in the multivrite nlyses did not chnge these results (ll P >.05). DISCUSSION With dt gthered from ntionl prctice-bsed reserch network, we Tble 5. Question-Asking Behvior by Ptients in Intervention Prctices (n = 415 Ptients) nd Control Prctices (n = 352 Ptients) s Determined From Audio Recordings Undjusted Adjusted,b Intervention Control Intervention Control Ptients Ptients Ptients Ptients Mesure % or Men % or Men P Vlue % or Men % or Men P Vlue Did ptient sk ny AM3 questions? 26 30.16 c 26 31.34 (% Yes) Did ptient sk ny questions of ny 92 92.87 c 92 91.84 type? (% Yes) Number of AM3 questions 0.47 0.52.56 d 0.50 0.53.83 Number of questions including AM3 6.94 6.37.23 d 6.75 6.55.82 Number of questions excluding AM3 6.46 5.86.18 d 6.23 6.03.80 AM3 = Ask Me 3. F sttistic from generlized liner mixed models (for ctegoricl dt) or generl liner mixed models (for continuous dt). b Adjusted for clustering nd the following covrites: ge, sex, rce/ethnicity (non-hispnic white vs other/missing), eduction, yers with physicin. c χ 2 test. d Student t test for independent smples. 156

Tble 6. Undjusted nd Adjusted Ptient Outcomes s Obtined From the Follow-up Telephone Interviews, for Intervention Prctices (n = 415 Ptients) nd Control Prctices (n = 352 Ptients) Undjusted Adjusted,b Intervention Control Intervention Control Ptients Ptients χ 2 Test Ptients Ptients Outcome % or Men % or Men P Vlue % or Men % or Men P Vlue Accurtely reclled ny prescription (n) (247) (206).45.41 Yes 92 90 92.9 90.8 No 8 10 Accurtely reclled new prescription (n) (182) (127).40.54 Yes 74 69 74.2 70.4 No 26 31 Accurtely reclled refill prescription (n) (101) (123).67.68 Yes 81 79 81.0 78.2 No 19 21 Filled new prescription c (n) (143) (104).75.82 Yes 81 83 81.1 82.4 No 19 17 Filled refill prescription c (n) (113) (123).99.71 Yes 70 70 68.6 71.0 No 30 30 Ws tking 1 prescription d (n) (205) (170).91.96 Yes 90 91 90.3 90.5 No 10 9 Accurtely reclled lifestyle recommendtions (242) (206).04.14 (n) Yes 59 68 59.3 68.4 No 41 32 Attempted lifestyle chnge e (n) (95) (102).90.78 Yes 93 92 93.3 92.3 No 7 8 F sttistic from generlized liner mixed model. b Adjusted for clustering nd the following covrites: ge, sex, rce/ethnicity (non-hispnic white vs other/missing), eduction, yers with physicin. c Ptients self-reports of filling prescription mong those reporting hving received prescription t the visit. Some of these ptients physicins stted tht they did not write prescription t the visit. d Ptients self-reports of tking the medictions prescribed t the visit mong those who reported receiving new prescription, refill prescription, or both. e Ptients self-reports of ttempting lifestyle chnges mong those who reported tht their physicin recommended lifestyle chnge t the visit. Some of these ptients physicins stted tht they did not recommend lifestyle chnge t the visit. found no evidence tht the AM3 intervention results in ptients sking their physicins greter number of questions or more specifi c questions. The intervention did not improve dherence to tretment s we defi ned it, fi nding consistent with previous studies tht used similr, simple communiction interventions. 24-26 In contrst, studies tht use interventions tht re more personlized (eg, requesting ptients to list the questions they hve before seeing the clinicin) or intensive (eg, 15-minute previsit trining session with communictions specilist) tend to fi nd signifi cnt effects on both question frequency nd ptients dherence to tretment recommendtions. 24,27-30 One explntion for our fi ndings, however, is not tht the AM3 intervention lcks effect but rther tht ceiling effect prevented detection of differences between the 2 groups. With more thn 9 of 10 ptients in the control group lredy sking questions even without prompting, nd the vst mjority fi lling recommended prescriptions for medictions (70% for refi lls nd >80% for new medictions), it would be diffi cult for ny intervention to improve question sking or dherence. In ddition, our smple my not be the pproprite trget for n intervention such s AM3, s the helth litercy levels nd eductionl ttinment of both ptient groups were reltively high. It is possible tht AM3 might be more effective mong ptients who hve lower helth litercy skills. Our study hd reltively few low-litercy individuls, nd we could not demonstrte n effect for this subgroup. Although not sttisticlly signifi cnt, the dt suggested tht ptients scoring lower on helth litercy were more likely to sk fewer questions overll during their offi ce visits. 157

Another possibility is tht physicins in the intervention group my hve nticipted the specifi c AM3 questions. Tht is, rther thn witing for questions to be sked explicitly by ptients, physicins my hve nswered these questions in dvnce. To exmine this possibility we reviewed rndom smple of 75 (17%) of the intervention visits recordings nd did not fi nd ny instnces in which physicins preemptively nswered the AM3 questions. Regrdless of the reson for our findings, they re nonetheless importnt to consider when selecting ptient communiction interventions to use in clinicl settings. A more specifi c, personlized intervention, supported by more detiled trining nd supplemented by coching, my hve been more effective, but lso more expensive, complicted, nd lbor intensive. 17,24,27-33 Unfortuntely, this type of intervention typiclly is not sustinble in prctice once reserch funding hs cesed. Alterntive methods of communiction, other thn question-prompting intervention, re vilble nd my improve ptients understnding of helth informtion. These methods include technology-bsed pproches such s interctive video pplictions, udiotpes, electronic linkges to ptient eduction, computerized reminders to both ptients nd physicins, nd others. 33,34 Additionl reserch is wrrnted to defi ne the effectiveness of such pproches in primry cre. Limittions There re severl limittions of this study, including the possible vrition in how AM3 ws implemented in prctices. Even though the physicins nd stff in the intervention prctices prticipted in both centrlized nd telephone trining, ctul implementtion of AM3 ws the responsibility of 1 physicin nd 1 study coordintor per prctice. Vribility in how the intervention is delivered is common in effectiveness trils nd mimics how AM3 would be used in clinicl prctice. Self-report bis is other possible limittion. Dt on ptient prescription fi lling nd tking were bsed on self-reports, not phrmcy records. The possibility of this bis is noteworthy becuse ptients did not lwys recll visit content ccurtely substntil proportions did not remember being prescribed new mediction (25%) or refi ll mediction (23%), even when physicins postvisit questionnires indicted tht such prescribing hd occurred. Similrly, sizble proportion (37%) did not ccurtely recll their physicin s recommendtions for lifestyle chnges. For both prescription ordering nd lifestyle recommendtions, however, we bsed recll ccurcy on ptient interview dt nd its greement with the physicin report. In t lest some cses, physicin reports of prescription ordering nd behviorl recommendtions rther thn ptient reports conceivbly were the ones in error. We conducted follow-up interviews with 75 (25%) of the noneligible ptients, tht is, ptients whose study physicins reported tht they hd not ordered either new or refi ll prescription t the visit. When these ptients were queried, 22 (29%) reported hving received either new or refi ll prescription t tht visit. This fi nding suggests there were recll errors on the prt of ptients nd physicins like. Even so, there is no indiction tht such errors were more likely to ffect 1 group compred with the other. Another study limittion is the lck of bseline mesurement on question-sking behvior mong both control nd intervention ptients. This study gthered question-sking behvior nd dherence informtion only fter AM3 hd been implemented in the intervention prctices. A longitudinl design llowing for both bseline mesurement nd sttisticl controls for possible differences between intervention nd control ptients t bseline would hve provided more rigorous ssessment of the AM3 intervention. In ddition, Hwthorne effect my hve infl u- enced our fi ndings. Ptients in both the intervention nd control groups were informed tht this ws study on communiction focus tht ws reinforced by the presence of tpe recorder in exmintion rooms. Ptients my hve chnged how they typiclly communicted nd sked more questions in this offi ce visit. Blinding ptients in the control group to the nture of the study, s ws done in the Direct Observtion of Primry Cre (DOPC) study, my hve helped to ddress this issue. 34 We found tht the AM3 intervention did not increse the frequency of ptient question-sking either for the AM3 questions specifi clly or for questions generlly. The AM3 intervention lso did not improve ptient dherence to tretment recommendtions. Further study is wrrnted in prctices with lower bseline rtes of question-sking, prescription fi lling, nd dherence to lifestyle recommendtions. A longer intervention in which ptients re exposed to the pproch over severl visits lso is needed. To red or post commentries in response to this rticle, see it online t http://www.nnfmmed.org/cgi/content/full/8/2/151. Key words: Helth litercy; prctice-bsed reserch; ptient-clinicin communictions; ptient eduction; multi-methods reserch; primry cre Submitted September 2, 2008; submitted, revised, June 30, 2009; ccepted July 27, 2009. Versions of this report were presented t the Annul Conference of the North Americn Primry Cre Reserch Group (NAPCRG) in Tucson, Arizon, on October 16, 2006, nd t the AAFP Scientific Assembly in Sn Frncisco, Cliforni, on September 30, 2005. 158

Funding support: Funding for this project ws mde possible by reserch grnt from Pfizer, Inc to the AAFP Foundtion. Acknowledgments: This reserch ws funded by n unrestricted grnt from Pfizer, Inc to the AAFP NRN vi the AAFP Foundtion. The funder plyed no role in the design or conduct of the study, or interprettion or nlysis of the dt. The study dt re owned nd controlled by the AAFP NRN. The uthors cknowledge the collbortion of the medicl prctices, study physicins, nd prctice study coordintors who executed the reserch protocol t their loctions. We thnk the following clinicins for their contributions: Alber Abrhim, MD; Olg Aris- Field; Chndr Btr, MD; Allison Brud; John Bucek, MD; Donn Bush; Shron Buskin, LPN; Cindy Crlson, RN; Penny Crter; Georgin Chn- Perdomo, MD; Elizbeth Coron; Clint Curtis, MD; Nncy Deleon; Dn Doyle, MD; Andrew Eisenberg, MD; Emil Fris, MD; John Frmer, DO; Troy Fiesinger, MD; Ptrici Glow, MD; Tom Golemon, MD; Stephnie Hrdy; Michel Hrtsell, MD; Tny Huf, RN; Meg Hyes, MD; Cindy Hendrickson, RN; Amnd Hillebrnd; Jckie Hodgson, RN; Debbie Johnson; Rj Kchori, MD, PC; Nin Ktovic; Lou Kzl, MD; Scott Knutson, MD; Donld Kollisch, MD; Chrles Korte, MD; Kim Krohn, MD, MPH; Crol Kuhle, DO; Stcey Lngley; Joel Lzr, MD; John McMster, DO; Frnces Mllet, RN, MSN; Evelyn Mzriegos; Eline Meier; Connie Mitchell; Smnth Moore, LPN; Mrion Mueller, RN; Eden Murd, MD; Denise Nichols, PhrmD; Bernrd O Brien, PAC; Shirley Ocloo, MD; Alex Perdomo, MD; Hether Pierce, MD; Robert Pieroni, MD; Dorothy Pieroni; Mrin Rikhel, MD; Michel Reis, MD; Eugene Reynolds, MD; Crol Rodgers, RN; Chris Seidler, RN; Yogesh Shh, MD; Amit Shh, MD; Lis Soldt, MD; Elisbeth Spector, MD, MPH; Jmes Stevermer, MD, MSPH; Lind Stewrt, MD; Rick Sone, MD, MPH; Gregg Stoner, MD; Steven Stripe, MD; Feliks Synik, PhD; Vilmry Vzquez, NCMA; Christy Wrd, LPN; Chris White, MD; Mrilyn Wissmiller, RN; Sonj Woods, MD; nd Frnces Wu, MD. 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