Outpatient cardiac rehabilitation. Part V: study protocol multi-centre prospective controlled observational study with two parallel groups on outpatient cardiac phase III rehabilitation

Research area: Rehabilitation and occupational therapy

Additional team: Heinz Tühler
Duration: September 2011 – March 2012
Publication: Decision Support Document No. 50: https://eprints.aihta.at/971

Suggested by: Association of Austrian Health Insurance Providers (HVB)
Language: German

Background:
Six- to twelve-month outpatient cardiac phase III rehabilitation following phase II is currently provided at a few sites in Austria. Based on international studies the effectiveness of cardiac rehabilitation seems to be proven in general. But there is a lack of studies on long-term effectiveness of (short) phase II programs or on optional subsequent phase III compared to no further rehabilitative measures. There is at least limited evidence that effects (positive impact on cardiovascular risk factors), that have been achieved in phase II, are not sustainable. Phase III therefore aims at preventing aggravation of risk factors or even at a further improvement.
The planned study is based upon numerous preliminary work of LBI-HTA (outpatient cardiac rehabilitation parts I to IV): After the completion of the retrospective cohort study in June 2010 and the prolongation of the contracts between the Association of Austrian Health Insurance Providers (HVB) and outpatient rehabilitation centres of the working group on outpatient cardiac prevention and rehabilitation (AGAKAR), which is linked to an “evaluation” of phase III rehabilitation, until 2014, LBI-HTA prepared options for a prospective study to assess the effectiveness of phase III cardiac rehabilitation until July 2011 (see decision support document Nr. 48).

Now the study protocol is to be developed based on the chosen study option (prospective, non-randomised, controlled observational study with two comparison groups (with/ without phase III)).

Research question of the study:
Will patients with disadvantageous risk profile (at least three out of six risk factor categories out of the rehabilitation target area) who attend a phase III program after phase II show a health benefit (operationalized by less risk factors out of the target area at mean) compared to the control group without phase III 18 months after end of phase II?

Methods:
The study protocol will be developed based on detailed preliminary work and further project group meetings with representatives of HVB, pension insurance (PVA) and AGAKAR as well as the medical directors of the involved  inpatient cardiac rehabilitation centres.