Early Rehabilitation of Rheumatoid Arthritis (RA)

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1 Early Rehabilitation of Rheumatoid Arthritis (RA) Results and Hands-On Experiences with the Implementation of a Randomized Controlled Trial in Health Services Research Susanne Schlademann University of Luebeck - European Doctoral Workshop on Health Economics, Social Medicine and Health Policy - Kiel Institute for World Economics; November 24, 2005

2 Background Disease Pattern - With an incidence rate of 0.03 % and a point prevalence of 0.5 % to 1 % RA is the most prevalent inflammatory rheumatic disease (cf. Kvien 2004). - Gender differences: In women the prevalence and incidence rates are 2- to 4-fold higher and the clinical symptoms are more severe than in men. - Up to now, the cause of disease remains unclear, but there seem to be connections to genetic and autoimmunological processes. - Seven American Rheumatism Association criteria for the classification of RA: morning stiffness ( 1 h), arthritis of 3 joint areas, symmetric, arthritis of hand joints, rheumatoid nodules, positive rheumatoid factor, radigraphic changes 4 criteria present for at least six weeks : RA (Arnett et al.1988) - Diseaseprogression might result in the affection of other joints, joint distortion or (rarely) the involvement of other organs like eyes, lachrymal and salivary glands, skin, heart or lung.

3 Background Social Medical Consequences - limited participation of the individual: functional disability, pain, joint destruction redefinition of social roles, fatigue, low self-esteem, mental distress, depression - high direct costs: 1/3 of patients requires surgery within 10 yrs after disease onset - substantial indirect costs: Within the first 3 to 4 yrs of RA up to 40% of the patients gainfully employed at disease onset become work disabled (cf. Mau et al. 1996). Compared to the general population the SER (Standardised Employment Rate) is significantly lower in RA (SER=.78; cf. Mau et al. 2005). - In Germany, the suspicion of undersupply, escpecially in in-patient and regional care (cf. Raspe et al.1994 and 1996, Mau et al. 1996), is strengthened by data of the National Database of the German Collaborative Arthritis Centres (nationwide documentation of clinical and patient derived data on RA since 1993 in 24 centers; cf. Zink et al. 2004). - International clinical studies and evidence-based guidelines emphasize the importance of an early multimodal multidisciplinary team care as in Germany provided by specialised clinics through medical in-patient rehabilitation (cf. Schneider et al. 2004).

4 Object of Research - The randomized controlled trial explores the efficacy of a counselling interview on a 3-week multimodal multidisciplinary in-patient rehabilitation to significantly improve somatic, mental and social medical parameters in gainfully employed members of statutory health and pension insurances with RA. - Additionally, to avoid the problem of a selection bias caused by a recruitment via clinics or doctors, the feasibility to recruit a study population via databases of the co-operating statutory health insurances is examined. - The project is funded by the German Federal Ministry of Education and Research (BMBF). - The trial has been registered at (NCT ).

5 Flowchart Implementation agreement on data security Search run in databases of health insurances (ICD-10, medical prescriptions) screening questionnaire; without reminder Selection of eligible participants combination of ACR-criteria and expert decision Baseline measurement health status (questionnaire); two reminders R Intervention group Control group currently Counselling interview on a 3- week in-patient rehabilitation 12-months follow-up health status (questionnaire); two reminders usual care 12-months follow-up health status (questionnaire); two reminders Data transmission Health insurances: work disability, hospitalisation,occupational rehabilitation Pension insurances: applications for & decisions on pension and in-patient rehabilitation

6 Co-operating Institutions Statutory Health Insurances AOK S-H * BEK Nord BKK Draeger & Hanse DAK S-H IKK S-H TK S-H Self-help Group DRL S-H e.v Professional Association BDRh e.v. Statutory Pension Insurances BfA LVA S-H Clinic Rheumaklinik Bad Bramstedt * S-H means the federal state of Schleswig-Holstein

7 But Too Many Cooks Spoil The Broth A) Continuousness of Contact Persons - Multiple changes of contact persons led to loss of important information. B) Legal Basis - The discussion on questions of data security caused a 3-months delay of the project. - It took us about five months (!) to reach an agreement on the legal foundation of the recruitment search runs within databases of the six co-operating health insurances on work disability (ICD-10 diagnoses), hospital discharge (ICD-10 diagnoses) and medical prescriptions plus the data transmission by health and pension insurances to the Institute for Social Medicine at the end of the project

8 Recruitment Search Runs - The co-operating health insurances received standardised search criteria to identify potential participants within their databases: age currently gainfully employed RA-specific medical prescriptions and/or ICD-10 diagnoses M05 / M06 / M13 / M79.0 in case of work disability and/or ICD-10 diagnoses M05 / M06 / M13 / M79.0 in case of hospital discharge within the past 2 yrs - For all identified insurants data on age, sex and the source(s) of identification were transmitted to the Institute for Social Medicine ( nonresponse analysis). Results - N=2200 insurants could be identified (61.8% female; age M=45.9, SD=10.3). - The range of N=23 to N=1132 identified persons per health insurance reflects differences in the implementation of the given search criteria and the strategy of searching. - The most important source were data on work disability (66%) and on medical prescriptions (24%).

9 Screening Questionnaire - Each of the N=2200 potential participants was given an ID code by her/his health insurance. Exclusively, this code has been used to personalize all questionnaires and data transmitted to the Institute for Social Medicine. - All identified insurants received a two-page screening questionnaire to check the in-/ exclusion criteria and verify the ACR criteria for the classification of RA (Arnett et al. 1988). - The questionnaire was mailed by the health insurance and included a cover letter plus some short information on the study. - Response questionnaires were returned directly to the Institute for Social Medicine in a selfaddressed envelope. Response Number Percentage refusals N = % no reaction N = % valid responses N = % Total N = %

10 Screening - Nonresponse Analysis Screening Nonresponse Analysis Total (N=2200) Age (years) M = 45.9 SD = 10.3 Sex female male N % Responders (N=943) M = 46.9 SD = 9.8 N % Nonresponders (N=1257) Level of Significance M = 45.1 SD = 10.7 p <.001 N % p <.001 Health Insurance AOK BEK BKK DAK IKK TK N % N % N % p =.199

11 Selection of Eligible Participants - The recruitment phase was followed by a two-stage selection of eligible participants. - Initially, all responders were checked in terms of fulfillment of the following in- /exclusion criteria: Inclusion Member of a co-operating statutory pension insurance currently gainfully employed maximal duration of RA: five years 3 or more ACR-criteria fulfilled fulfillment of all criteria pursuant to insurance law to receive a medical in-patient care programme Exclusion permanent incapacity for work participation in a medical in-patient care programme within the past four years - Secondly, the questionnaires of the remaining responders were given to two experts. They reviewed these cases and selected eligible participants by the clinical symptom pattern described in the questionnaire (e.g. joint mannequin). - N=82 early RA discontinue or change inclusion criteria? N=176 RA (8% of N=2200)

12 Baseline Measurement - All of the N=176 selected insurants were contacted directly by their health insurance for the baseline measurement. - The mailed documents consisted of: a questionnaire on health status functional capacity pain somatic disorders depression quality of life employment in-patient rehabilitation (demand, participation) health care utilisation medical prescriptions non-medical prescriptions sociodemographics information on the focus, aim and process of the study a form sheet to declare informed consent - If necessary, up to two reminders were sent out (three and six weeks after initial mailing). N=20 insurants had to be excluded subsequently (N=19 incorrect mailing; N=1 status of insurance). N=156 baseline questionnaires were mailed out correctly.

13 Baseline Measurement - Nonresponse Analysis Response Number Percentage direct response N = % response on first reminder N = % response on second reminder N = % 82.7 % refusal N = % no reaction N = % Total N = % Responders (N=129) and nonresponders (N=27) did not differ significantly in age, sex, and health insurance.

14 Baseline Measurement - Sample Sample Female (N, %) 94 (72.9) Age (M, SD, Range) 49.2 (9.1) [21-62] Educational level (N, %) high intermediate low Currently gainfully employed (N, %) full-time at least half-day less than half-day not gainfully employed Current occupation (N, %) blue-collar worker white-collar worker appointee self-employed other 15 (11.6) 61 (47.3) 53 (41.1) 72 (55.8) 48 (37.2) 4 (3.1) 5 (3.9) 13 (10.1) 111 (86.0) -- 2 (1.6) 3 (2.3)

15 Baseline Measurement Results I General Health Status (SF-36, Scale 1-5) 100 VERA (N=128) 80 Nationwide Telephone Survey 2004 (N=8318) 60 % 40 In general, the VERA population shows higher levels of impairment than the general population very good good fair poor very poor Functional Capacity (FFbH, Scale 0-100) In some parameters the described study population and reference samples are on comparable level. 60 Mean VERA (N=129) RA sample National Database 2002 (N=7100) general population Compared to other RA samples (e.g. National Database) VERA participants report less impairment in some parameters.

16 Baseline Measurement - Results II Subjective Prognosis of Work Capacity (SPE-Skala 0-3) Medical in-patient rehabilitation VERA (N=129) LVA insurants Mittag & Raspe 2003 (N=4279) ever participated % because of RA or SPE sum score SPE-Scale Score 2: 3-fold higher probability of application for a pension (5-yrs follow-up) and 2-fold higher probability of pension Score 3: 8-fold higher probability of application for a pension / pension (5-yrs follow-up; N=4.225, Mittag et al. 2005) % "yes" VERA (N=129) LVA insurants Zimmermann et al (N=4400) Nationwide Telephone Survey 2004 (N=8318) Mau et al (N=34) subjective demand 66.4 % have never participated in any inpatient rehabilitation 54.4 % report a subjective demand on an inpatient rehabilitation

17 Randomization and Intervention Randomization - The N=129 responders of the baseline measurement were randomly allocated to the intervention and control group, respectively, by external computer based block by block stratified randomization. Result - Adjusted for multiple testing, intervention group (IG; N=64) and control group (CG; N=65) were comparable in all variables. successfull randomization Intervention Health insurance: invitation (IG) Health insurance: counselling Interview Insurants (IG): apply for in-patient care

18 Acceptance of Intervention % (N=54) made use of the offer of a counselling interview. - Similar response rates were observed in a study of comparable design (PETRA; 84 %) - But N=46 (48 %) of the interview participants refused to apply for a medical in-patient rehabilitation ( PETRA: 1/3), especially for occupational reasons (N=11). Conclusion - A large percentage of responders is subjectively on high risk of work incapacity (SPE- Scale) and makes use of a counselling interview by health insurances on medical in-patient rehabilitation. - High rates in refusal to apply for medical in-patient rehabilitation for occupational reasons indicate the necessity of alternative care programs appropriate for gainfully employed patients!

19 Status Quo Follow-Up - All N=129 responders of the baseline measurement were sent a follow-up questionnaire in October Again, up to two reminders will be sent out (three and six weeks after initial mailing). - Data entry closure is planned for December The current response rate is 68.2 % (N=88), we expect about N=100 (78 %) to respond. - Thedata transmission by health insurances and pension insurances will be completed in Feburary 2006.

20 Resumee I. RCT in Health Services Research are possible! II. III. Several problems in the process of recruitment via databases of health insurances emphasize the urgency to define mandatory standards on legal foundations of data management and data processes (cf. Raspe 2005, in press). Alternative care programs for gainfully employed patients have to be established.

21 Thank you for your attention!

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