Transmural collaborative care model for the review of antipsychotics: a feasibility study of a complex intervention.

General practitioners (GPs) are often unaware of antipsychotic (AP)-induced cardiovascular risk (CVR) and therefore patients using atypical APs are not systematically monitored. We evaluated the feasibility of a complex intervention designed to review the use of APs and advise on CVR-lowering strategies in a transmural collaboration. A mixed methods prospective cohort study in three general practices in the Netherlands was conducted in 2021. The intervention comprised three steps: a digital information meeting, a multidisciplinary meeting, and a shared decision-making visit to the GP. We assessed patient recruitment and retention rates, advice given and adopted, and CVR with QRISK3 score and mental state with MHI-5 at baseline and three months post-intervention. GPs invited 57 of 146 eligible patients (39%), of whom 28 (19%) participated. The intervention was completed by 23 (82%) and follow-up by 18 participants (64%). At the multidisciplinary meeting, 22 (78%) patients were advised to change AP use. Other advice concerned medication (other than APs), lifestyle, monitoring, and psychotherapy. At 3-months post-intervention, 41% (28/68) of this advice was adopted. Our findings suggest that this complex intervention is feasible for evaluating health improvement in patients using AP in a trial.

The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial.

BACKGROUND: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1. METHODS/DESIGN: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version. DISCUSSION: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. SETTING: The study was conducted at a level 1 trauma centre in the Netherlands. PARTICIPANTS: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. INTERVENTIONS: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. MEASUREMENTS: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score--Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. RESULTS: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. CONCLUSIONS: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. TRIAL REGISTRATION NUMBERS: NCT00817128 and NTR 2090.

Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy.

OBJECTIVE: To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. DESIGN: An explorative secondary analysis of a randomised controlled trial. PARTICIPANTS: Fifty-six patients with Complex Regional Pain Syndrome type 1. INTERVENTIONS: The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. OUTCOME MEASURES: Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. RESULTS: The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. CONCLUSION: The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. TRIAL REGISTRATION: International Clinical Trials Registry NCT00817128.