A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland
Abstract Background Symptomatic chronic obstructive pulmonary disease (COPD) is a global health problem associated with a number of co-morbidities, disproportionately affecting people who are poor. Sub-optimal management of symptomatic COPD and co-morbidities negatively impacts quality of life, abil...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-07-01
|
| Series: | Pilot and Feasibility Studies |
| Online Access: | https://doi.org/10.1186/s40814-025-01681-x |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849767257889046528 |
|---|---|
| author | Richard Lowrie David Anderson Aziz Sheikh Jane Moir Andrew McPherson Bethany Stanley Gillian Cameron Lynda Attwood Donald Noble Elaine Rankine Jennifer Anderson Nicola Greenlaw Fiona Hughes Emma McIntosh Samuel Owusu Achiaw Caitlin Jones Frances S. Mair |
| author_facet | Richard Lowrie David Anderson Aziz Sheikh Jane Moir Andrew McPherson Bethany Stanley Gillian Cameron Lynda Attwood Donald Noble Elaine Rankine Jennifer Anderson Nicola Greenlaw Fiona Hughes Emma McIntosh Samuel Owusu Achiaw Caitlin Jones Frances S. Mair |
| author_sort | Richard Lowrie |
| collection | DOAJ |
| description | Abstract Background Symptomatic chronic obstructive pulmonary disease (COPD) is a global health problem associated with a number of co-morbidities, disproportionately affecting people who are poor. Sub-optimal management of symptomatic COPD and co-morbidities negatively impacts quality of life, ability to work and survival. Previous trials of healthcare professional-led complex interventions have targeted COPD management, but not also simultaneously targeted the treatment of co-morbidities. Recommendations for complex intervention testing include feasibility studies followed by pilot randomised controlled trials (RCTs), including economic and parallel process evaluations. Following a feasibility study, a Tailored, home-based Intervention for people with COPD and Co-morbidities by generalist prescribing Pharmacists collaborating with Consultant respiratory Physicians (TICC PCP) is undergoing pilot testing. The pilot study aims to recruit at least 70% of invited participants within 4 months; deliver TICC PCP to at least 70% of participants in the intervention arm; retain at least 80% of participants (excluding those who died or developed incapacity before the end of the study) until 21-month data collection; and collect at least 90% of in person data at each study time point. In addition, findings from the economic and process evaluations along with information obtained on the proposed quantitative efficacy outcomes inform on the sample size required for a subsequent definitive RCT will help inform on future research. Methods We describe methods for a multicentre pilot RCT, with parallel economic and qualitative process evaluations of TICC PCP. Set in Glasgow and Edinburgh (Scotland), we plan to recruit 100 people with symptomatic COPD and conduct home-based assessments at baseline and at subsequent three monthly follow up visits over a period of 21 months. Independent researchers will collect extensive health and social care data at recruitment (baseline) before participants are randomised (stratified by site and number of respiratory hospitalisations in the past 12 months), to TICC PCP in addition to usual care (UC), or UC alone. Collected data will include objective and subjective measures of health, healthcare utilisation (including prescribing), home circumstances, health related quality of life, healthcare resource use and intervention costs. Follow up data will be collected three monthly for 21 months. The intervention, delivered by NHS Pharmacists visiting participants at home monthly for 6 months, then every 2 months for the next 6 months, involves clinical assessment and intervention at home including prescribing for COPD and co-morbidities. Pharmacists will also assess and help participants to address wider health needs, e.g. appointment attendance and home equipment. Pharmacists will collaborate mainly with consultant respiratory physicians, and General Practitioners. Discussion A holistic, 1 year long, individualised home-based intervention for people with symptomatic COPD and co-morbidities may help address unmet health needs. We will utilise the information obtained from this pilot study, including: the recruitment and retention rates; the sample size required to detect a minimal clinically important difference in the proposed efficacy outcomes of interest; the economic analyses; and process evaluation, to determine whether we should progress to a definitive RCT with parallel process and economic evaluation. Trial registration The trial is registered with the UK Clinical Trials Registry (ISRCTN 43508703). |
| format | Article |
| id | doaj-art-f0c1b4d759874f17a32a93d124b0ac57 |
| institution | DOAJ |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-f0c1b4d759874f17a32a93d124b0ac572025-08-20T03:04:17ZengBMCPilot and Feasibility Studies2055-57842025-07-0111111210.1186/s40814-025-01681-xA protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in ScotlandRichard Lowrie0David Anderson1Aziz Sheikh2Jane Moir3Andrew McPherson4Bethany Stanley5Gillian Cameron6Lynda Attwood7Donald Noble8Elaine Rankine9Jennifer Anderson10Nicola Greenlaw11Fiona Hughes12Emma McIntosh13Samuel Owusu Achiaw14Caitlin Jones15Frances S. Mair16Centre for Homelessness and Inclusion Health, School of Health in Social Science, University of EdinburghNHS Greater Glasgow and ClydeUsher Institute, University of EdinburghNHS Greater Glasgow and ClydeNHS Greater Glasgow and ClydeThe Robertson Centre for Biostatistics, University of GlasgowRobertson Centre for Biostatistics, University of GlasgowRobertson Centre for Biostatistics, University of GlasgowRobertson Centre for Biostatistics, University of GlasgowRobertson Centre for Biostatistics, University of GlasgowNHS Greater Glasgow and ClydeThe Robertson Centre for Biostatistics, University of GlasgowNHS Greater Glasgow and ClydeHealth Economics and Health Technology Assessment, University of GlasgowHealth Economics and Health Technology Assessment, University of GlasgowGeneral Practice and Primary Care, School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of GlasgowGeneral Practice and Primary Care, School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of GlasgowAbstract Background Symptomatic chronic obstructive pulmonary disease (COPD) is a global health problem associated with a number of co-morbidities, disproportionately affecting people who are poor. Sub-optimal management of symptomatic COPD and co-morbidities negatively impacts quality of life, ability to work and survival. Previous trials of healthcare professional-led complex interventions have targeted COPD management, but not also simultaneously targeted the treatment of co-morbidities. Recommendations for complex intervention testing include feasibility studies followed by pilot randomised controlled trials (RCTs), including economic and parallel process evaluations. Following a feasibility study, a Tailored, home-based Intervention for people with COPD and Co-morbidities by generalist prescribing Pharmacists collaborating with Consultant respiratory Physicians (TICC PCP) is undergoing pilot testing. The pilot study aims to recruit at least 70% of invited participants within 4 months; deliver TICC PCP to at least 70% of participants in the intervention arm; retain at least 80% of participants (excluding those who died or developed incapacity before the end of the study) until 21-month data collection; and collect at least 90% of in person data at each study time point. In addition, findings from the economic and process evaluations along with information obtained on the proposed quantitative efficacy outcomes inform on the sample size required for a subsequent definitive RCT will help inform on future research. Methods We describe methods for a multicentre pilot RCT, with parallel economic and qualitative process evaluations of TICC PCP. Set in Glasgow and Edinburgh (Scotland), we plan to recruit 100 people with symptomatic COPD and conduct home-based assessments at baseline and at subsequent three monthly follow up visits over a period of 21 months. Independent researchers will collect extensive health and social care data at recruitment (baseline) before participants are randomised (stratified by site and number of respiratory hospitalisations in the past 12 months), to TICC PCP in addition to usual care (UC), or UC alone. Collected data will include objective and subjective measures of health, healthcare utilisation (including prescribing), home circumstances, health related quality of life, healthcare resource use and intervention costs. Follow up data will be collected three monthly for 21 months. The intervention, delivered by NHS Pharmacists visiting participants at home monthly for 6 months, then every 2 months for the next 6 months, involves clinical assessment and intervention at home including prescribing for COPD and co-morbidities. Pharmacists will also assess and help participants to address wider health needs, e.g. appointment attendance and home equipment. Pharmacists will collaborate mainly with consultant respiratory physicians, and General Practitioners. Discussion A holistic, 1 year long, individualised home-based intervention for people with symptomatic COPD and co-morbidities may help address unmet health needs. We will utilise the information obtained from this pilot study, including: the recruitment and retention rates; the sample size required to detect a minimal clinically important difference in the proposed efficacy outcomes of interest; the economic analyses; and process evaluation, to determine whether we should progress to a definitive RCT with parallel process and economic evaluation. Trial registration The trial is registered with the UK Clinical Trials Registry (ISRCTN 43508703).https://doi.org/10.1186/s40814-025-01681-x |
| spellingShingle | Richard Lowrie David Anderson Aziz Sheikh Jane Moir Andrew McPherson Bethany Stanley Gillian Cameron Lynda Attwood Donald Noble Elaine Rankine Jennifer Anderson Nicola Greenlaw Fiona Hughes Emma McIntosh Samuel Owusu Achiaw Caitlin Jones Frances S. Mair A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland Pilot and Feasibility Studies |
| title | A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland |
| title_full | A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland |
| title_fullStr | A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland |
| title_full_unstemmed | A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland |
| title_short | A protocol for a pilot randomised controlled trial of a Tailored Intervention for people with moderate-to-severe Chronic Obstructive Pulmonary Disease and Co-morbidities delivered by Pharmacists and Consultant respiratory Physicians (TICC-PCP) in Scotland |
| title_sort | protocol for a pilot randomised controlled trial of a tailored intervention for people with moderate to severe chronic obstructive pulmonary disease and co morbidities delivered by pharmacists and consultant respiratory physicians ticc pcp in scotland |
| url | https://doi.org/10.1186/s40814-025-01681-x |
| work_keys_str_mv | AT richardlowrie aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT davidanderson aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT azizsheikh aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT janemoir aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT andrewmcpherson aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT bethanystanley aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT gilliancameron aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT lyndaattwood aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT donaldnoble aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT elainerankine aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT jenniferanderson aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT nicolagreenlaw aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT fionahughes aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT emmamcintosh aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT samuelowusuachiaw aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT caitlinjones aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT francessmair aprotocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT richardlowrie protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT davidanderson protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT azizsheikh protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT janemoir protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT andrewmcpherson protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT bethanystanley protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT gilliancameron protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT lyndaattwood protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT donaldnoble protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT elainerankine protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT jenniferanderson protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT nicolagreenlaw protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT fionahughes protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT emmamcintosh protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT samuelowusuachiaw protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT caitlinjones protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland AT francessmair protocolforapilotrandomisedcontrolledtrialofatailoredinterventionforpeoplewithmoderatetoseverechronicobstructivepulmonarydiseaseandcomorbiditiesdeliveredbypharmacistsandconsultantrespiratoryphysiciansticcpcpinscotland |