TY - JOUR
T1 - The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease
AU - Masterson-Algar, Patricia
AU - Burton, Christopher R.
AU - Brady, Marian C
AU - Nicoll, Avril
AU - Clarke, Carl E
AU - Rick, Caroline
AU - Hughes, Max
AU - Au, Pui
AU - Smith, Christina H.
AU - Sackley, Catherine M
N1 - OA article
Acceptance date from PDF
Funding note: This trial is funded by the National Institute for Health Research Health Technology Assessment programme (HTA 10/135/02). MCB and the Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, are funded by the Scottish Government, Health and Social Care Directorate.
PY - 2017/8/29
Y1 - 2017/8/29
N2 - Background: The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Methods/design: Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. Discussion: To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. Trial registration: ISRCTN Registry, ISRCTN12421382. Registered on 18 April 2016.
AB - Background: The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Methods/design: Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. Discussion: To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. Trial registration: ISRCTN Registry, ISRCTN12421382. Registered on 18 April 2016.
KW - protocol
KW - Parkinson's disease
KW - Fidelity
KW - Complex interventions
KW - Speech and language therapy
KW - Process evaluation
KW - Lee Silverman Voice Treatment
U2 - 10.1186/s13063-017-2130-1
DO - 10.1186/s13063-017-2130-1
M3 - Article
C2 - 28851443
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
M1 - 397
ER -