Contributions
Abstract: P1286
Type: Poster
Abstract Category: Therapy - disease modifying - Others
Background: The “nurse decision coach” intervention (DECIMS) aims to redistribute health professionals" tasks in supporting immunotherapy decision making processes by people with multiple sclerosis (PwMS), following the principles of shared decision making. Currently, a multi-centre randomised controlled trial (RCT) is performed to test the intervention"s efficacy. This pilot study aimed to test the randomisation procedure and to gather data on feasibility to inform the main trial.
Methods: Programme development followed the MRC framework for developing and evaluating complex interventions and was evaluated through a pilot-RCT and an embedded process evaluation. A convenient sample of 75 PwMS (age ≥ 18 y) with suspected or relapsing-remitting MS facing an immunotherapy treatment decision was recruited in two German MS centres between March 2014 and June 2015. PwMS were randomised to the intervention (IG) or control group (CG). PwMS in the IG received decision coaching by a trained nurse, in the CG care as usual. Both groups had access to an evidence-based online information platform. Nurses were not blinded to group assignment, while PwMS and physicians were kept blinded. Primary outcome was "informed choice", using a multi-dimensional measure including the sub-dimensions risk knowledge (questionnaire assessed after 14 days), attitude concerning immunotherapy (one question assessed after physician consultation), and treatment uptake (survey after six months). Secondary outcomes included an analysis of videotaped coaching videos assessing shared decision making.
Results: In total 73 PwMS were included, 38 in the IG and 35 in the CG. Groups were comparable at baseline. Data of 49 PwMS were available for the primary endpoint calculation. A difference was shown with 15 of 29 (52%) PwMS in the IG achieving informed choice after six months compared with 6 of 20 (30%) PwMS in the CG, which was not significant. Analysis of coaching videos showed good levels of PwMS involvement in the coaching process. Process evaluation analysis showed a positive response of PwMS, nurses and physicians towards the intervention.
Conclusions: The innovative approach of delegating treatment information provision to trained nurses using evidence-based patient information has the potential to change current doctor-focussed practice in Germany.
This study was funded by the Competence Network Multiple Sclerosis (01GI1206).
Disclosure: Anne Christin Rahn: nothing to disclose
Imke Backhus: nothing to disclose
Sascha Köpke: nothing to disclose
Jürgen Kasper: nothing to disclose
Anna Krützelmann: nothing to disclose
Ingrid Mühlhauser: nothing to disclose
Ingo Kleiter has received honoraria for consultancy or lectures and travel reimbursement from Bayer Health Care, Biogen Idec, Chugai, Novartis, and Roche and grant support from Biogen Idec, Novartis, Chugai and Diamed.
Christoph Heesen has received research grants, congress travel compensations, and salaries for talks from BiogenIdec, Genzyme, Sanofi-Aventis, Bayer Healthcare, Merck Serono, Teva Pharma, and Novartis.
Abstract: P1286
Type: Poster
Abstract Category: Therapy - disease modifying - Others
Background: The “nurse decision coach” intervention (DECIMS) aims to redistribute health professionals" tasks in supporting immunotherapy decision making processes by people with multiple sclerosis (PwMS), following the principles of shared decision making. Currently, a multi-centre randomised controlled trial (RCT) is performed to test the intervention"s efficacy. This pilot study aimed to test the randomisation procedure and to gather data on feasibility to inform the main trial.
Methods: Programme development followed the MRC framework for developing and evaluating complex interventions and was evaluated through a pilot-RCT and an embedded process evaluation. A convenient sample of 75 PwMS (age ≥ 18 y) with suspected or relapsing-remitting MS facing an immunotherapy treatment decision was recruited in two German MS centres between March 2014 and June 2015. PwMS were randomised to the intervention (IG) or control group (CG). PwMS in the IG received decision coaching by a trained nurse, in the CG care as usual. Both groups had access to an evidence-based online information platform. Nurses were not blinded to group assignment, while PwMS and physicians were kept blinded. Primary outcome was "informed choice", using a multi-dimensional measure including the sub-dimensions risk knowledge (questionnaire assessed after 14 days), attitude concerning immunotherapy (one question assessed after physician consultation), and treatment uptake (survey after six months). Secondary outcomes included an analysis of videotaped coaching videos assessing shared decision making.
Results: In total 73 PwMS were included, 38 in the IG and 35 in the CG. Groups were comparable at baseline. Data of 49 PwMS were available for the primary endpoint calculation. A difference was shown with 15 of 29 (52%) PwMS in the IG achieving informed choice after six months compared with 6 of 20 (30%) PwMS in the CG, which was not significant. Analysis of coaching videos showed good levels of PwMS involvement in the coaching process. Process evaluation analysis showed a positive response of PwMS, nurses and physicians towards the intervention.
Conclusions: The innovative approach of delegating treatment information provision to trained nurses using evidence-based patient information has the potential to change current doctor-focussed practice in Germany.
This study was funded by the Competence Network Multiple Sclerosis (01GI1206).
Disclosure: Anne Christin Rahn: nothing to disclose
Imke Backhus: nothing to disclose
Sascha Köpke: nothing to disclose
Jürgen Kasper: nothing to disclose
Anna Krützelmann: nothing to disclose
Ingrid Mühlhauser: nothing to disclose
Ingo Kleiter has received honoraria for consultancy or lectures and travel reimbursement from Bayer Health Care, Biogen Idec, Chugai, Novartis, and Roche and grant support from Biogen Idec, Novartis, Chugai and Diamed.
Christoph Heesen has received research grants, congress travel compensations, and salaries for talks from BiogenIdec, Genzyme, Sanofi-Aventis, Bayer Healthcare, Merck Serono, Teva Pharma, and Novartis.