A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

Barbara Clyne, Janine A Cooper, Carmel M Hughes, Tom Fahey, Susan M Smith, OPTI-SCRIPT study team, Barbara Clyne, Janine A Cooper, Carmel M Hughes, Tom Fahey, Susan M Smith, OPTI-SCRIPT study team

Abstract

Background: The OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those participating in the study and lessons for future implementation.

Methods: The OPTI-SCRIPT trial included 21 GP practices and 196 patients. The process evaluation used mixed methods. Quantitative data were collected from all GP practices and semi-structured interviews were conducted with GPs from intervention and control groups, and a purposive sample of patients from the intervention group. All interviews were transcribed verbatim and analysed using a thematic analysis.

Results: Despite receiving a standardised academic detailing session, intervention delivery varied among GP practices. Just over 70 % of practices completed medicines review as recommended with the patient present. Only single-handed practices conducted reviews without patients present, highlighting the influence of practice characteristics and resources on variation. Medications were more likely to be completely stopped or switched to another more appropriate medication when reviews were conducted with patients present. The patient information leaflets were not used by any of the intervention practices. Both GP (32 %) and patient (40 %) recruitment rates were modest. For those who did participate, overall, the experience was positively viewed, with GPs and patients referring to the value of medication reviews to improve prescribing and reduce unnecessary medications. Lack of time in busy GP practices and remuneration were identified as organisational barriers to future implementation.

Conclusions: The OPTI-SCRIPT intervention was positively viewed by both GPs and patients, both of whom valued the study's objectives. Patient information leaflets were not a successful component of the intervention. Academic detailing and medication reviews are important components in changing PIP, and having patients present during the review process seems to be a more effective approach for decreasing PIP.

Trial registration: Current controlled trials ISRCTN41694007 . Registered on 21 March 2012.

Keywords: Cluster randomised controlled trial; Potentially inappropriate prescribing; Primary care; Process evaluation.

Figures

Fig. 1
Fig. 1
Flow of practices and patients through the study. *Eligibility fraction: Proportion of potential participants who undergo screening and are eligible to enrol. ‘Recruitment fraction: Proportion of potential participants who actually enrol in the RCT. ^Enrolment fraction: Proportion of people who are eligible for participation and who actually enrol in the RCT. ~Number of patients needed to be screened: Number of patients screened in order to randomise one participant (1/recruitment fraction). Source: adapted from Gross et al. 2002 [50]
Fig. 2
Fig. 2
Time (weeks) from academic detailing to intervention practices completing all medicines reviews
Fig. 3
Fig. 3
Comparison of changes to PIP drugs during medicines reviews conducted with and without patients present
Fig. 4
Fig. 4
Patient identification and recruitment process

References

    1. O' Mahony D, Gallagher PF. Inappropriate prescribing in the older population: need for new criteria. Age Ageing. 2008;37(2):138–41. doi: 10.1093/ageing/afm189.
    1. Opondo D, Eslami S, Visscher S, Rooij S, Verheij R, Korevaar J, et al. Inappropriateness of medication prescriptions to elderly patients in the primary care setting: a systematic peview. PLoS ONE. 2012;7(8):e43617. doi: 10.1371/journal.pone.0043617.
    1. Tommelein E, Mehuys E, Petrovic M, Somers A, Colin P, Boussery K. Potentially inappropriate prescribing in community-dwelling older people across Europe: a systematic literature review. Eur J Clin Pharmacol. 2015;71(12):1415–27. doi: 10.1007/s00228-015-1954-4.
    1. Hedna K, Hakkarainen KM, Gyllensten H, Jonsson AK, Petzold M, Hagg S. Potentially inappropriate prescribing and adverse drug reactions in the elderly: a population-based study. Eur J Clin Pharmacol. 2015;71(12):1525–33. doi: 10.1007/s00228-015-1950-8.
    1. Cahir C, Bennett K, Teljeur C, Fahey T. Potentially inappropriate prescribing and adverse health outcomes in community dwelling older patients. Br J Clin Pharmacol. 2014;77(1):201–10. doi: 10.1111/bcp.12161.
    1. Hill-Taylor B, Sketris I, Hayden J, Byrne S, O'Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013;38(5):360–72. doi: 10.1111/jcpt.12059.
    1. Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr. 2009;9:5. doi: 10.1186/1471-2318-9-5.
    1. Forsetlund L, Eike M, Gjerberg E, Vist G. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr. 2011;11(1):16. doi: 10.1186/1471-2318-11-16.
    1. Alldred DP, Raynor DK, Hughes C, Barber N, Chen TF, Spoor P. Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev. 2013;(2):CD009095.
    1. Kaur S, Mitchell G, Vitetta L, Roberts MS. Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging. 2009;26(12):1013–28. doi: 10.2165/11318890-000000000-00000.
    1. Clyne B, Fitzgerald C, Quinlan A, Hardy C, Galvin R, Fahey T, et al. Interventions to address potentially inappropriate prescribing in community-dwelling older adults: a systematic review of randomized controlled trials. J Am Geriatr Soc. 2016;64(6):1210–22. doi: 10.1111/jgs.14133.
    1. Clyne B, Smith SM, Hughes CM, Boland F, Bradley MC, Cooper JA, et al. Effectiveness of a multifaceted intervention for potentially inappropriate prescribing in older patients in primary care: a cluster-randomized controlled trial (OPTI-SCRIPT Study) Ann Fam Med. 2015;13(6):545–53. doi: 10.1370/afm.1838.
    1. Clyne B, Bradley M, Hughes C, Clear D, McDonnell R, Williams D, et al. Addressing potentially inappropriate prescribing in older patients: development and pilot study of an intervention in primary care (the OPTI-SCRIPT study) BMC Health Serv Res. 2013;13(1):307. doi: 10.1186/1472-6963-13-307.
    1. Clyne B, Bradley MC, Smith SM, Hughes CM, Motterlini N, Clear D, et al. Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol) Trials. 2013;14(1):72. doi: 10.1186/1745-6215-14-72.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332(7538):413–6. doi: 10.1136/bmj.332.7538.413.
    1. Spinewine A, Schmader K, Barber N, Hughes C, Lapane K, Swine C, et al. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007;370:173–84. doi: 10.1016/S0140-6736(07)61091-5.
    1. Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001;39(8):II2–45.
    1. Moore G, Audrey S, Barker M, Bond L, Bonell C, Cooper C, et al. Process evaluation in complex public health intervention studies: the need for guidance. J Epidemiol Community Health. 2014;68(2):101–2. doi: 10.1136/jech-2013-202869.
    1. Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013;14(1):15. doi: 10.1186/1745-6215-14-15.
    1. Cahir C, Fahey T, Teeling M, Teljeur C, Feely J, Bennett K. Potentially inappropriate prescribing and cost outcomes for older people: a national population study. Br J Clin Pharmacol. 2010;69(5):543–52. doi: 10.1111/j.1365-2125.2010.03628.x.
    1. Sturges JE, Hanrahan KJ. Comparing telephone and face-to-face qualitative interviewing: a research note. Qual Res. 2004;4(1):107–18. doi: 10.1177/1468794104041110.
    1. Novick G. Is there a bias against telephone interviews in qualitative research? Res Nurs Health. 2008;21(4):391–8. doi: 10.1002/nur.20259.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Hasson H, Blomberg S, Dunér A. Fidelity and moderating factors in complex interventions: a case study of a continuum of care program for frail elderly people in health and social care. Implement Sci. 2012;7:23. doi: 10.1186/1748-5908-7-23.
    1. Wetzels R, Harmsen M, Van Weel C, Grol R, Wensing M. Interventions for improving older patients’ involvement in primary care episodes. Cochrane Database Syst Rev. 2007;(1):CD004273.
    1. Wensing M, Wetzels R, Hermsen J, Baker R. Do elderly patients feel more enabled if they had been actively involved in primary care consultations. Patient Educ Couns. 2007;68:265–9. doi: 10.1016/j.pec.2007.06.012.
    1. Willeboordse F, Hugtenburg JG, Schellevis FG, Elders PJM. Patient participation in medication reviews is desirable but not evidence-based: a systematic literature review. Br J Clin Pharmacol. 2014;78(6):1201–16. doi: 10.1111/bcp.12398.
    1. Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the empower cluster randomized trial. JAMA Intern Med. 2014;6(174):890–8. doi: 10.1001/jamainternmed.2014.949.
    1. de Bont EGPM, Alink M, Falkenberg FCJ, Dinant G-J, Cals JWL. Patient information leaflets to reduce antibiotic use and reconsultation rates in general practice: a systematic review. BMJ Open. 2015;5(6):e007612. doi: 10.1136/bmjopen-2015-007612.
    1. Kenny T, Wilson RG, Purves IN, Clark J, Newton LD, Newton DP, et al. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998;15(5):471–9. doi: 10.1093/fampra/15.5.471.
    1. Soumerai SB, McLaughlin TJ, Avorn J. Improving drug prescribing in primary care: a critical analysis of the experimental literature. Milbank Q. 1989;67(2):268–317. doi: 10.2307/3350142.
    1. Jamtvedt G, Young J, Kristofferson DT, O' Brien MA, Oxman AD. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2006;(2):CD000259.
    1. Hysong SJ. Meta-analysis: audit and feedback features impact effectiveness on care quality. Med Care. 2009;47(3):356–63. doi: 10.1097/MLR.0b013e3181893f6b.
    1. Dyas JV, Togher F, Siriwardena AN. Intervention fidelity in primary care complex intervention trials: qualitative study using telephone interviews of patients and practitioners. Qual Prim Care. 2014;22(1):25–34.
    1. McDermott L, Yardley L, Little P, van Staa T, Dregan A, McCann G, et al. Process evaluation of a point-of-care cluster randomised trial using a computer-delivered intervention to reduce antibiotic prescribing in primary care. BMC Health Serv Res. 2014;14:594. doi: 10.1186/s12913-014-0594-1.
    1. Bregnhoj L, Thirstrup S, Kristensen M, Bjerrum L, Sonne J. Combined intervention programme reduces inappropriate prescribing in elderly patients exposed to polypharmacy in primary care. Eur J Clin Pharmacol. 2009;65(2):199–207. doi: 10.1007/s00228-008-0558-7.
    1. Jones R, Jones R, McCowan C, Montgomery A, Fahey T. The external validity of published randomized controlled trials in primary care. BMC Fam Pract. 2009;10(1):5. doi: 10.1186/1471-2296-10-5.
    1. Fearn P, Avenell A, McCann S, Milne AC, Maclennan G. Factors influencing the participation of older people in clinical trials - data analysis from the MAVIS trial. J Nutr Health Aging. 2010;14(1):51–6. doi: 10.1007/s12603-010-0009-x.
    1. Hummers-Pradier E, Scheidt-Nave C, Martin H, Heinemann S, Kochen MM, Himmel W. Simply no time? Barriers to GPs’ participation in primary health care research. Fam Pract. 2008;25(2):105–12. doi: 10.1093/fampra/cmn015.
    1. Salmon P, Peters S, Rogers A, Gask L, Clifford R, Iredale W, et al. Peering through the barriers in GPs’ explanations for declining to participate in research: the role of professional autonomy and the economy of time. Fam Pract. 2007;24(3):269–75. doi: 10.1093/fampra/cmm015.
    1. Gunn J, McCallum Z, Sanci L. What do GPs get out of participating in research? - Experience of the LEAP trial. Aust Fam Physician. 2008;37(5):372–5.
    1. Stevens Z, Carpenter H, Gawler S, Belcher C, Haworth D, Kendrick D, et al. Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial. Trials. 2013;14(1):192. doi: 10.1186/1745-6215-14-192.
    1. Page M, French S, McKenzie J, O'Connor D, Green S. Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners’ recruitment of patients. BMC Med Res Methodol. 2011;11(1):35. doi: 10.1186/1471-2288-11-35.
    1. Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, et al. Challenges in the research ethics review of cluster randomized trials: international survey of investigators. Clin Trials. 2013;10(2):257–68. doi: 10.1177/1740774513475530.
    1. Rogers EM. Diffusion of innovations. 5. London: Simon & Schuster; 2003.
    1. Gallagher PF, Barry PJ, Ryan C, Hartigan I, O'Mahony D. Inappropriate prescribing in an acutely ill population of elderly patients as determined by Beers’ Criteria. Age Ageing. 2008;37(1):96–101. doi: 10.1093/ageing/afm116.
    1. Howard R, Rodgers S, Avery AJ, Sheikh A. Description and process evaluation of pharmacists’ interventions in a pharmacist-led information technology-enabled multicentre cluster randomised controlled trial for reducing medication errors in general practice (PINCER trial) Int J Pharm Pract. 2014;22(1):59–68. doi: 10.1111/ijpp.12039.
    1. Francis N, Phillips R, Wood F, Hood K, Simpson S, Butler C. Parents’ and clinicians’ views of an interactive booklet about respiratory tract infections in children: a qualitative process evaluation of the EQUIP randomised controlled trial. BMC Fam Pract. 2013;14(1):182. doi: 10.1186/1471-2296-14-182.
    1. Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496. doi: 10.1136/bmj.b3496.
    1. Gross CP, Mallory R, Heiat A, Krumholz HM. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med. 2002;137(1):10–6. doi: 10.7326/0003-4819-137-1-200207020-00007.
    1. O' Dowd T, O' Kelly M, O' Kelly F. Structure of General Practice in Ireland 1982–2005. Dublin: Trinity College Dublin; 2006.
    1. Health Service Executive . Primary Care Reimbursement Service statistical analysis of claims and payments 2011. Dublin: HSE; 2011.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅