Top

Published in:

Open Access 01-12-2012 | Study protocol

The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly

Authors: Franca GH Ruikes, Antoinette RM Meys, Gijs van de Wetering, Reinier P Akkermans, Betsie GI van Gaal, Sytse U Zuidema, Henk J Schers, Theo van Achterberg, Raymond TCM Koopmans

Published in: BMC Primary Care | Issue 1/2012

Abstract

Background

With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly.

Methods/design

The CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation.

Discussion

The CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care.

Trial registration

The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797

Available only for authorised users

van Duin C, Garssen J: Bevolkingsprognose 2010–2060: sterkere vergrijzing, langere levensduur. 2010, Den Haag/ Heerlen: Centraal Bureau voor de Statistiek

Reuben DB: Meeting the needs of disabled older persons: can the fragments be pieced together?. J Gerontol A Biol Sci Med Sci. 2006, 61 (4): 365-366. 10.1093/gerona/61.4.365.CrossRefPubMed

Clarfield AM, Bergman H, Kane R: Fragmentation of care for frail older people–an international problem. Experience from three countries: israel, canada, and the united states. J Am Geriatr Soc. 2001, 49 (12): 1714-1721. 10.1046/j.1532-5415.2001.49285.x.CrossRefPubMed

ZonMW The Netherlands Organisation for Health Research and Development: National programme of care for the elderly. 2008, The Hague: Ministry of Health, Welfare and Sports, the Netherlands, 54-

Boult C, Wieland GD: Comprehensive primary care for older patients with multiple chronic conditions: "Nobody rushes you through". JAMA. 2010, 304 (17): 1936-1943. 10.1001/jama.2010.1623.CrossRefPubMed

Bodenheimer T, Wagner EH, Grumbach K: Improving primary care for patients with chronic illness. JAMA. 2002, 288 (14): 1775-1779. 10.1001/jama.288.14.1775.CrossRefPubMed

Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A: Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001, 20 (6): 64-78. 10.1377/hlthaff.20.6.64.CrossRef

Clarkson P, Brand C, Hughes J, Challis D: Integrating assessments of older people: examining evidence and impact from a randomised controlled trial. Age Ageing. 2011, 40 (3): 388-391. 10.1093/ageing/afr015.CrossRefPubMed

Reuben DB: Organizational interventions to improve health outcomes of older persons. Medical care. 2002, 40 (5): 416-428. 10.1097/00005650-200205000-00007.CrossRefPubMed

10.

Wolff JL, Boult C: Moving beyond round pegs and square holes: restructuring medicare to improve chronic care. Ann Intern Med. 2005, 143 (6): 439-445.CrossRefPubMed

11.

Bernabei R, Landi F, Gambassi G, Sgadari A, Zuccala G, Mor V, Rubenstein LZ, Carbonin P: Randomised trial of impact of model of integrated care and case management for older people living in the community. BMJ. 1998, 316 (7141): 1348-1351. 10.1136/bmj.316.7141.1348.CrossRefPubMedPubMedCentral

12.

Boyd CM, Reider L, Frey K, Scharfstein D, Leff B, Wolff J, Groves C, Karm L, Wegener S, Marsteller J, et al: The effects of guided care on the perceived quality of health care for multi-morbid older persons: 18-month outcomes from a cluster-randomized controlled trial. J Gen Intern Med. 2010, 25 (3): 235-242. 10.1007/s11606-009-1192-5.CrossRefPubMed

13.

Beland F, Bergman H, Lebel P, Clarfield AM, Tousignant P, Contandriopoulos AP, Dallaire L: A system of integrated care for older persons with disabilities in canada: results from a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2006, 61 (4): 367-373. 10.1093/gerona/61.4.367.CrossRefPubMed

14.

Beswick AD, Rees K, Dieppe P, Ayis S, Gooberman-Hill R, Horwood J, Ebrahim S: Complex interventions to improve physical function and maintain independent living in elderly people: a systematic review and meta-analysis. Lancet. 2008, 371 (9614): 725-735. 10.1016/S0140-6736(08)60342-6.CrossRefPubMedPubMedCentral

15.

Low LF, Yap M, Brodaty H: A systematic review of different models of home and community care services for older persons. BMC Health Serv Res. 2011, 11: 93-10.1186/1472-6963-11-93.CrossRefPubMedPubMedCentral

16.

Shannon GR, Wilber KH, Allen D: Reductions in costly healthcare service utilization: findings from the care advocate program. J Am Geriatr Soc. 2006, 54 (7): 1102-1107. 10.1111/j.1532-5415.2006.00799.x.CrossRefPubMed

17.

Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, et al: The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial. Arch Intern Med. 2011, 171 (5): 460-466. 10.1001/archinternmed.2010.540.CrossRefPubMedPubMedCentral

18.

Counsell SR, Callahan CM, Tu W, Stump TE, Arling GW: Cost analysis of the geriatric resources for assessment and care of elders care management intervention. J Am Geriatr Soc. 2009, 57 (8): 1420-1426. 10.1111/j.1532-5415.2009.02383.x.CrossRefPubMedPubMedCentral

19.

Blackwood B: Methodological issues in evaluating complex healthcare interventions. J Adv Nurs. 2006, 54 (5): 612-622. 10.1111/j.1365-2648.2006.03869.x.CrossRefPubMed

20.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M: Developing and evaluating complex interventions: the new medical research council guidance. BMJ. 2008, 337: a1655-10.1136/bmj.a1655.CrossRefPubMedPubMedCentral

21.

Hulscher ME, Laurant MG, Grol RP: Process evaluation on quality improvement interventions. Qual Saf Health Care. 2003, 12 (1): 40-46. 10.1136/qhc.12.1.40.CrossRefPubMedPubMedCentral

22.

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, group C, Pragmatic Trials in Healthcare g: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral

23.

van Kempen JAL, Schers HJ, Jacobs A, Zuidema SU, Zuidema FGH, Robben SHM, Melis RJF, Olde Rikkert MGM: Development of an instrument for the identification of frail elderly as a target population for integrated care. Br J Gen Pract. 2012, in press

24.

Robben SH, Perry M, Huisjes M, van Nieuwenhuijzen L, Schers HJ, van Weel C, Olde Rikkert MG, van Achterberg T, Heinen MM, Melis RJ: Implementation of an innovative web-based conference table for community-dwelling frail older people, their informal caregivers and professionals: a process evaluation. BMC Health Serv Res. 2012, 12 (1): 251-10.1186/1472-6963-12-251.CrossRefPubMedPubMedCentral

25.

Sergi G, De Rui M, Sarti S, Manzato E: Polypharmacy in the elderly: can comprehensive geriatric assessment reduce inappropriate medication use?. Drugs Aging. 2011, 28 (7): 509-518. 10.2165/11592010-000000000-00000.CrossRefPubMed

26.

van Eijken M, Melis R, Wensing M, Rikkert MO, van Achterberg T: Feasibility of a new community-based geriatric intervention programme: an exploration of experiences of GPs, nurses, geriatricians, patients and caregivers. Disabil Rehabil. 2008, 30 (9): 696-708. 10.1080/09638280701400508.CrossRefPubMed

27.

Grol R, Wensing M: What drives change? Barriers to and incentives for achieving evidence-based practice. Med J Australia. 2004, 180 (6 Suppl): S57-S60.PubMed

28.

Weinberger M, Samsa GP, Schmader K, Greenberg SM, Carr DB, Wildman DS: Comparing proxy and patients' perceptions of patients' functional status: results from an outpatient geriatric clinic. J Am Geriatr Soc. 1992, 40 (6): 585-588.CrossRefPubMed

29.

van der Zee K, Sanderman R: Het meten van de algemene gezondheidstoestand met de Rand-36, een handleiding. 1993, Groningen: Noordelijk Centrum voor Gezondheidsvraagstukken

30.

Krabbe PF, Stouthard ME, Essink-Bot ML, Bonsel GJ: The effect of adding a cognitive dimension to the EuroQol multiattribute health-status classification system. J Clin Epidemiol. 1999, 52 (4): 293-301. 10.1016/S0895-4356(98)00163-2.CrossRefPubMed

31.

Brouwer WB, van Exel NJ, van Gorp B, Redekop WK: The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 2006, 15 (6): 1005-1021. 10.1007/s11136-005-5994-6.CrossRefPubMed

32.

Campbell MK, Fayers PM, Grimshaw JM: Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials. 2005, 2 (2): 99-107. 10.1191/1740774505cn071oa.CrossRefPubMed

33.

Cohen J: Statistical power analysis for the behavioural sciences. 1988, Lawrence Erlbaum Associates, Inc, second

34.

Cohen J: A power primer. Psychol Bull. 1992, 112 (1): 155-159.CrossRefPubMed

35.

Hakkaart-van Roijen L, Tan SS, Bouwmans CAM: Handleiding voor kostenonderzoek: Methoden en standaard kostprijzen voor economische evaluaties in de gezondheidszorg. 2010, Diemen: College van Zorgverzekeraars

36.

Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L: The friction cost method for measuring indirect costs of disease. J Health Econ. 1995, 14 (2): 171-189. 10.1016/0167-6296(94)00044-5.CrossRefPubMed

37.

Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ: [Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff]. Ned Tijdschr Geneeskd. 2005, 149 (28): 1574-1578.PubMed

38.

Saunders RP, Evans MH, Joshi P: Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Heal Promot Pract. 2005, 6 (2): 134-147. 10.1177/1524839904273387.CrossRef

39.

Steckler AL L: Process evaluation for public health interventions and research. 2002, San Francisco: Jossey-Bass

40.

Wensing M, van Lieshout J, Jung HP, Hermsen J, Rosemann T: The Patients Assessment Chronic Illness Care (PACIC) questionnaire in The Netherlands: a validation study in rural general practice. BMC Heal Serv Res. 2008, 8: 182-10.1186/1472-6963-8-182.CrossRef

41.

Vrijhoef HJ, Berbee R, Wagner EH, Steuten LM: Quality of integrated chronic care measured by patient survey: identification, selection and application of most appropriate instruments. Health Expect. 2009, 12 (4): 417-429. 10.1111/j.1369-7625.2009.00557.x.CrossRefPubMed

42.

Dutch Institute for Examination of Health Care NIVEL: Questionnaire on experiences with family practice care, other caregivers, version 13. Consumer Quality Index Family Practice Care. 2011, The Netherlands: Utrecht

43.

Strauss ALC J: Basics of qualitative research; techniques and procedures for developing grounded theory. 1998, Thousand Oaks: Sage

44.

Boulton G, Rawlins M, Vallance P, Walport M: Science as a public enterprise: the case for open data. Lancet. 2011, 377 (9778): 1633-1635. 10.1016/S0140-6736(11)60647-8.CrossRefPubMed

45.

Melis RJ, Vehof H, Baars L, Rietveld MC, Olde Rikkert MG: Sharing of research data. Lancet. 2011, 378 (9808): 1995-CrossRefPubMed

46.

Smelt AF, van der Weele GM, Blom JW, Gussekloo J, Assendelft WJ: How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials. Br J Gen Pract. 2010, 60 (576): e305-e318. 10.3399/bjgp10X514819.CrossRefPubMedPubMedCentral

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/13/115/prepub

Title: The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
Authors: Franca GH Ruikes
Antoinette RM Meys
Gijs van de Wetering
Reinier P Akkermans
Betsie GI van Gaal
Sytse U Zuidema
Henk J Schers
Theo van Achterberg
Raymond TCM Koopmans
Publication date: 01-12-2012
Publisher: BioMed Central
Published in: BMC Primary Care / Issue 1/2012
Electronic ISSN: 2731-4553
DOI: https://doi.org/10.1186/1471-2296-13-115

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2012

Choosing to biopsy or refer suspicious melanocytic lesions in general practice

How patients understand depression associated with chronic physical disease – a systematic review

Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the diagest 3-GP motivation study

Medication documentation in a primary care network serving North Carolina medicaid patients: results of a cross-sectional chart review

Ageing in general practice (AGP) trial: a cluster randomised trial to examine the effectiveness of peer education on GP diagnostic assessment and management of dementia

Chronically ill Canadians’ experiences of being unattached to a family doctor: a qualitative study of marginalized patients in British Columbia