Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310148
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-11
Brief Title:
Evaluation of the Chronic Disease Co-Care Pilot Scheme
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
An Evaluation of the Effectiveness and Cost-effectiveness of the Chronic Disease Co-Care CDCC Pilot Scheme a Commissioned Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Chronic Disease Co-Care CDCC Pilot Scheme is initiated for early screening and management of people with hypertension HT pre-diabetes mellitus pre-DM and diabetes mellitus DM in Hong Kong This study will evaluate the quality of care feasibility acceptability effectiveness and cost-effectiveness of the Scheme
This is a 12-month cohort study among the District Health Centre DHC or DHC Express healthcare providers CDCC participants and a comparison group of 1886 non-participants All the person-in charge 2 family doctors and 1 of each allied health provider from each DHCDHC Express will be administered with the questionnaires on quality of care and costing All CDCC participants will be included in subject characteristics among which a convenience sample of 548 will complete a telephone survey on experience enablement and satisfaction of the CDCC Pilot Scheme The health outcomes of 1886 CDCC participants and 1886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness
Participant characteristics enablement compliance to the standards of care and costing of CDCC Pilot Scheme will be summarized using descriptive statistics Differences in the proportion of patients meeting treatment targeted for HT pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization WHO threshold This study will inform future healthcare planning and policy for manpower and resource allocation
This is a 12-month cohort study among the District Health Centre DHC or DHC Express healthcare providers CDCC participants and a comparison group of 1886 non-participants All the person-in charge 2 family doctors and 1 of each allied health provider from each DHCDHC Express will be administered with the questionnaires on quality of care and costing All CDCC participants will be included in subject characteristics among which a convenience sample of 548 will complete a telephone survey on experience enablement and satisfaction of the CDCC Pilot Scheme The health outcomes of 1886 CDCC participants and 1886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness
Participant characteristics enablement compliance to the standards of care and costing of CDCC Pilot Scheme will be summarized using descriptive statistics Differences in the proportion of patients meeting treatment targeted for HT pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization WHO threshold This study will inform future healthcare planning and policy for manpower and resource allocation
Detailed Description:
This study aims to evaluate the quality of care feasibility acceptability effectiveness and cost-effectiveness of the CDCC Pilot Scheme in Hong Kong The objectives of this study are the following
1 Describe the characteristics of participants of the CDCC Pilot Scheme
2 Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme
3 Evaluate participant acceptability by self-reported outcomes on enablement experience and satisfaction level about the services of CDCC
4 Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months
5 Determine the provider costs and cost-effectiveness for delivering the CDCC Pilot Scheme relative to its effectiveness on participants health outcomes
The detailed study design of each objective are
Objective a All participants in CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included in the evaluation The characteristics including demographics comorbidities and medications of the participants will be summarized using descriptive statistics
Objective b For the evaluation of the structure of care quantitative data will be collected through structured questionnaires on the quality of care with DHCDHC Express managers at 6 months and repeated at 12 months Each DHCDHC Express will also nominate two family doctors and one of each network allied health professionals optometrists podiatrists dietitians and physiotherapists subject to the availability in each center within their service network to complete the questionnaire at 12 months For the evaluation of the standards on process and outcome of care all participants in the CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included
Objective c Participants will be conveniently sampled after completion of the Health Risk Factor Assessment HRFA at DHCDHC Express between 1 Jan 2024 and 31 Mar 2024 to complete surveys on self-reported outcomes For the first survey at 3 months a questionnaire will be used to assess participants enablement level and experience during the screening phase The second follow-up survey will be administered at 12 months to assess participants experience in clinical encounters
Objective d This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the effectiveness of the CDCC Pilot Scheme A total of 264 CDCC participants and 264 non-CDCC participants screened positive for HT pre-DM or DM will be included as intervention and comparison group respectively All participants will be followed up 12 months Records for CDCC participants who meet the inclusion criteria between 1 Jan 2024 and 30 Apr 2024 will be extracted from the Electronic Health Record Sharing System database Meanwhile a convenient sample of 1886 non-CDCC participants comparison group will be recruited from the community between 1 Jan 2024 and 30 Apr 2024
Objective e This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the costs and cost-effectiveness of the CDCC Pilot Scheme The total costs incurred on the CDCC Pilot Scheme from 1st January 2024 to 31st December 2024 including set-up costs ongoing operational costs and ongoing administrative and maintenance costs will be collected via questionnaires Direct medical costs for CDCC participants and non-CDCC participants will be collected after 12 months
1 Describe the characteristics of participants of the CDCC Pilot Scheme
2 Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme
3 Evaluate participant acceptability by self-reported outcomes on enablement experience and satisfaction level about the services of CDCC
4 Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months
5 Determine the provider costs and cost-effectiveness for delivering the CDCC Pilot Scheme relative to its effectiveness on participants health outcomes
The detailed study design of each objective are
Objective a All participants in CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included in the evaluation The characteristics including demographics comorbidities and medications of the participants will be summarized using descriptive statistics
Objective b For the evaluation of the structure of care quantitative data will be collected through structured questionnaires on the quality of care with DHCDHC Express managers at 6 months and repeated at 12 months Each DHCDHC Express will also nominate two family doctors and one of each network allied health professionals optometrists podiatrists dietitians and physiotherapists subject to the availability in each center within their service network to complete the questionnaire at 12 months For the evaluation of the standards on process and outcome of care all participants in the CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included
Objective c Participants will be conveniently sampled after completion of the Health Risk Factor Assessment HRFA at DHCDHC Express between 1 Jan 2024 and 31 Mar 2024 to complete surveys on self-reported outcomes For the first survey at 3 months a questionnaire will be used to assess participants enablement level and experience during the screening phase The second follow-up survey will be administered at 12 months to assess participants experience in clinical encounters
Objective d This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the effectiveness of the CDCC Pilot Scheme A total of 264 CDCC participants and 264 non-CDCC participants screened positive for HT pre-DM or DM will be included as intervention and comparison group respectively All participants will be followed up 12 months Records for CDCC participants who meet the inclusion criteria between 1 Jan 2024 and 30 Apr 2024 will be extracted from the Electronic Health Record Sharing System database Meanwhile a convenient sample of 1886 non-CDCC participants comparison group will be recruited from the community between 1 Jan 2024 and 30 Apr 2024
Objective e This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the costs and cost-effectiveness of the CDCC Pilot Scheme The total costs incurred on the CDCC Pilot Scheme from 1st January 2024 to 31st December 2024 including set-up costs ongoing operational costs and ongoing administrative and maintenance costs will be collected via questionnaires Direct medical costs for CDCC participants and non-CDCC participants will be collected after 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None